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Official (voting member) Panel Discussion & Recommendations

FOOD AND DRUG ADMINISTRATION
 

MEDICAL DEVICES ADVISORY COMMITTEE
 

GENERAL AND PLASTIC SURGERY DEVICES PANEL

 MEETING

FRIDAY, MARCH 3, 2000

The meeting was held at 8:00 a.m. in the Ballroom of the Gaithersburg Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland, Dr. Thomas V. Whalen, Panel Chair, presiding.

PRESENT:

HOMAS V. WHALEN, M.D. Chairman

JOSEPH V. BOYKIN, JR., M.D. Voting Member

PHYLLIS CHANG, M.D. Voting Member

KAREN BANDEEN-ROCHE, Ph.D. Temporary Voting Member

BRENT BLUMENSTEIN, Ph.D. Temporary Voting Member

BOYD BURKHARDT, M.D. Temporary Voting Member

NANCY A. DUBLER, L.L.B. Temporary Voting Member

MICHAEL J. MORYKWAS, PH.D. Temporary Voting Member

MAXINE F. BRINKMAN, R.N. Consumer Representative

CINDY DOMECUS Industry Representative

DAVID KRAUSE, Ph.D. Executive Secretary

A-G-E-N-D-A

Page

Call to Order

Conflict of Interest and Opening Remarks

Labeling Presentations from Industry

McGhan Medical, Dr. Scott Eschbach

Mentor Corporation, Ms. Donna Crawford

Open Public Comments
 

Dr. Shawna Willey

Dr. Charles Bailey, Jr.

Ms. Mary McDonough

Ms. Liz Macleod

Ms. Lisa Hickey

Dr. Roberta Gartside

Dr. Saul Puszkin

Dr. Britta Ostermeyer Shoaib

Ms. Marlene Keeling

Dr. Diana Zuckerman

Ms. Martha Murdock

Ms. Anne Stansell

Ms. Amy Allina

Ms. Rosemary Locke

Panel Discussants

Ms. Nancy N. Dubler, LLB, Director, Division of

Bioethics, Montefiore Medical Center

Ms. Maxine F. Brinkman, RN, Women's and Children's Services, North Iowa Mercy Health Center

FDA Presentation
 

Dr. Stephen P. Rhodes, Branch Chief, Plastic and

Reconstructive Surgery Branch

Open Public Comments
 

Dr. Kathleen Melez

Ms. Jama Russano

Panel Deliberations and Address FDA Questions 221

P-R-O-C-E-E-D-I-N-G-S

8:02 a.m.

DR. KRAUSE: Can everyone please take their seats so we can begin. A couple of quick general announcements. Accidentally on the agenda I listed an open public comment period right after the call to order. That's not correct. It won't be until a little bit later. Also PIP America will not be presenting during the labeling presentations from the industry representatives.

Good morning, everyone. We're ready to begin day 3 of this the 56th meeting of the General Plastic Surgery Devices Panel. My name is David Krause and I'm the Executive Secretary of the panel. I'm also a biologist and reviewer in the plastic and reconstructive surgery devices branch.

I would like to remind everyone to please sign in on the attendance sheets on the table immediately outside the door to your left, my right. At that place you may also pick up an agenda, a roster of the panel members, and information about today's meeting, and also information regarding how you can find out about future meetings of this and other panels.

Before turning the meeting over to Dr. Whalen, today I am only required to read the conflict of interest statement into the record because there will be no voting.

The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude even the appearance of an impropriety. To determine if any conflict existed, the agency reviewed the submitted agenda and all financial interest reported by the committee participants.

The conflict of interest statutes prohibit special Government employees from participating in matters that could their or their employer's financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweighs potential conflict of interest involved, is in the best interest of the Government.

We would like to note for the record that the agency took into consideration certain matters regarding Drs. Burkhardt, Chang and Dr. Morykwas. Drs. Burkhardt, Chang, and Morykwas reported past related involvements with firms at issue. Since these are past involvements and there are no continuing financial interests, the agency has determined that these panelists may participate fully in the deliberations.

In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement and the exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon. Thank you.

I'd like to turn the meeting over to Dr. Whalen at this time.

DR. WHALEN: Thank you, Dr. Krause. Good morning. I'm Dr. Thomas Whalen, Chair of this General and Plastic Surgery Devices Panel. Today the Panel will be making recommendations to the food and drug administration on the content, format, and consistency issues involving the labeling information and informed consent provided to patients considering saline-filled breast protheses. Before we proceed, Dr. Celia Witten from the FDA would like to make some remarks.

DR. WITTEN: Yes. I'd like to welcome everyone to this third day of our panel discussions regarding saline breast implants. We are looking forward to the discussion today on labeling.

As we've heard over the last couple of days from a number of different people, the informed consent process is very important for these products and their use and we'll be listening very carefully to what we hear today from the public and from the panel regarding this topic.

The public has an important role in helping us as we grabble with this question and we would like to thank everyone in advance for their participation here today. Thank you. I'll turn it back over to you.

DR. WHALEN: Thank you, Dr. Witten. The first order of business then is for the companies to make brief presentations concerning their labeling. The first company to be presenting will be McGhan Medical and the presentation will be by Dr. Scott Eschbach.

DR. ESCHBACH: Mr. Chairman and members of the panel, good morning. My name is Scott Eschbach and I am President and CEO of McGhan Medical. We have a brief presentation on labeling this morning.

Like the FDA and physicians alike, McGhan Medical believes that an informed patient is a highly valuable situation. We work diligently and through a variety of media to carry information to the patient and we are anxious to see the kind of information that are the outcomes of our clinical studies shared in an effective manner.

Our task today, and for the next several months, and perhaps beyond that, is to identify the most effective way to do that. We've heard testimony from the public regarding the effectiveness of how information gets to them. We are eager to find an effective way to share with them the information we've been discussing in the last few days.

I thought it might be helpful if we very briefly covered with you the kind of vehicles we are using today to get information to the patient, to physicians and patients because, as we discussed over the last couple of days, the issue of being sure the information on procedures and the like is available to physicians in an effective manner and then how it takes the route to get to the patient.

Dissemination of information at McGhan Medical encompasses all of our labeling in its broadest sense activities. I'm going to share with you in the next few slides the route we use to disseminate information that is targeted primarily to patients and primarily to physicians.

Packaged with the device we include an information package. That is targeted primarily at the patient. That information packet includes a brochure entitled "FDA Information For Women Considering Saline-Filled Breast Implants." This information was mandated by the FDA to be included with our packaging and includes a discussion of a range of the effects, outcomes that we have been discussing over the last few days such as discussions on deflation, additional surgeries, infection, and the like. This booklet is with each of our products.

In addition, we include an informed consent to be delivered by the physician to the patient also with verbiage as mandated by the FDA. This informed consent is worded to cover many of the issues that we have discussed.

Included in that patient information packet is a discussion of our ConfidencePlus program which is a claims processing program concerning the patient's rights and activities to interface back with McGhan Medical in the event of a deflation of their implants and how we will handle the processing of such a situation.

Also included in that packet is a patient device identification card. This card allows the patient to record information on the back regarding the style and serial number of their implant. It is designed and intended to be kept with the patient so that they can keep track of which device they've had implanted.

Also packaged with the device, targeted now at the physician, of course, is all the information on our box label. This is typically information identifying the product in terms of style, serial number, date, and the like.

In the information packet we include, primarily targeted at the physician as well, the directions for use, a booklet briefly describing techniques and adverse reactions and the like.

In addition, we continue to include our registry tracking form. Although registry tracking as a mandated situation for breast implants is no longer required, we do include the registry tracking form should a patient wish to fill out this form and become a member of our database.

In addition to the device packaging, we disseminate information through a variety of pamphlets and educational materials. We make available at no charge to physicians three pamphlets entitled, "What is Silicone," "Choices in Breast Reconstruction," and "Choosing Augmentation." These pamphlets give information about and briefly describe the techniques and some of the decision-making situations concerning the decisions a patient will be making.

In addition to that information, included in each of these booklets is the verbiage from the "FDA Information for Women" pamphlet. It is included in each of these small booklets.

Pamphlets and educational material targeted at the physician include our BioDimensional planning kits with a kit like this for augmentation and for reconstruction. Within the kit among other things is an instructional monograph that describes a general surgical technique for these devices, as well as an accompanying instructional video.

We have available -- this is a small version of it. We have this little 8? by 11. We also have a large OR wall chart sized to aid in the dimensional assessment of our products for choice of the product by the physician.

We have a consultational planning tablet that physicians may use in consultation with their patients again in determining the appropriate implant for that patient.

Our web site includes the information that is contained in the three pamphlets that I have spoken to you earlier that's readily available on the McGhan Medical web site. In addition, that web site contains the verbiage contained in the "FDA Information for Women" pamphlet.

Advertising as well carries labeling information and McGhan Medical does advertise in newspapers and magazines in two ways. In the first way we do product promotional advertising and in this product promotional advertising we include fair balance. Fair balance in the advertising jargon is that kind of information again that was contained in "FDA Information for Women," adverse conditions and the like.

We also have one reminder ad out there. Reminder ads are those advertising that simply state perhaps the name of the company. Perhaps simply some suggest of cosmetic surgery like, "Have you thought about it?" Perhaps just the name of a product without making product performance or claims with regard to efficacy of the product. Such reminder ads do not necessarily carry the fair balance.

We disseminate information through advertising in medical journals and those advertisings are targeted at the physician and tend to be directed toward product technical features.

McGhan Medical has not directly been involved in radio and TV advertising. However, there are radio and TV advertising media placements that have been conducted by physicians and those physician ads do lead to the dissemination through telemarketing programs of the pamphlets from McGhan Medical and video tapes from McGhan Medical targeted patients both of which carry fair balance and information from the "FDA Information for Women."

In summary, our position I'd like to state here is McGhan Medical is widely disseminating the "FDA Information for Women" which contains a listing of the risks. However, McGhan Medical is proud of what it's been doing in the studies that it's been conducting and will continue to cooperate with the agency to include appropriate information from our clinical studies in our labeling. In addition to defining what information, we need to define also what kinds of vehicles will be most effective of getting that information to the patient.

I would ask as the panel deliberates that they consider the following points. First, that our approach to this be consistent across the industry and that actual data cited in labeling be specific to the manufacturers device, and that such labeling would be handled in a phase-in situation involving the replacement of current labeling in a controlled situation. I thank you for your consideration.

DR. WHALEN: Thank you. I'm sure you'll entertain some questions from the panel.

DR. ESCHBACH: Certainly.

DR. WITTEN: Excuse me. Can I just make a request? Although we are not here, of course, to look at any manufacturer's specific labeling and make comments on the actual words in their labeling, I think it would be helpful for you to pass that material around to the panel.

DR. ESCHBACH: This material I've got here?

DR. WITTEN: Um-hum.

DR. ESCHBACH: Certainly.

DR. WHALEN: If I could start with a question. The amount of information that you provide is large and laudable. I've been a commissioned officer in either the active or naval reserve for 27 years and the amount of information and policies and instructions that are in the military is legendary. Most of it gathers dust on shelves. There's even an instruction on instructions called the 5215 which lists all the instructions.

It would be easy, and perhaps even defensible, for a manufacturer to say, "Look, we provide all of this information. If those surgeons don't give to their patients, that's not our problem. What's your corporate policy and view on the role of the manufacturer in ensuring that such information gets to the patient and consumer?

DR. ESCHBACH: We certainly are very interested in seeing this information get to the consumer. We encourage that by trying to remove economic barriers so as much as possible this information is available freely to physicians. Over the last few years, actually, McGhan Medical has taken the position of starting to try and get this information to consumers directly.

We will respond to inquiries from patients directly to the company in a reactive sense. If we get a phone call, we are happy to provide any of the patient targeted information directly to the patient should they call. that doesn't happen very often. I have to be honest with you on that. We don't very often get that.

It's primarily, I believe, because the relationship between a patient and their physician is still a strong one. Patients still look very strongly to their physician for guidance and support and direction. We have no reluctance t all to provide that information directly to patients.

We have begun an advertising program to bring some of the information to the public directly. That has to be a fairly careful situation. We need to act responsibly to not get between a patient and their physician. And yet we as well feel the need to get this information directly to the patient. We have no reluctance to try and comply with that, Dr. Whalen.

DR. WHALEN: Ms. Dubler.

MS. DUBLER: If a patient or a patient's rights group or a consumer group asks for the physician targeted information, will you provide it?

DR. ESCHBACH: I see no reason why we wouldn't. I don't believe we have any prohibition against that. There is nothing secret in the information.

DR. WHALEN: Thank you, Dr. Eschbach.

DR. ESCHBACH: Thank you.

DR. WHALEN: Next we are to hear from Ms. Donna Crawford, Director of Corporate Regulatory Affairs at Mentor Corporation.

MS. CRAWFORD: Good morning, ladies and gentlemen. Thank you for the opportunity to speak to you today. My name is Donna Crawford. I am Director of Corporate Regulatory Affairs for Mentor Corporation.

I would like to discuss with you today the various physician and patient information and communications programs that Mentor has. We feel these are very important programs because we strongly believe that meaningful information leads to an informed choice.

I would like to outline my presentation for you. I will be discussing three different areas. First, I would like to describe what our current approach is and philosophy to our existing communication program. Then I would like to describe what existing methods of communication and labeling we have today. I'll describe the various communication channels that we use and the types of information that we provide.

Also, lastly, I would like to describe for you our proposals for some future communications to more effectively provide physicians and patients with information. Specifically I'm talking about providing the results of our clinical studies that you heard several days ago and describe how we intend to expand the communication methods that we have currently.

Mentor's physician and patient information program is designed to provide patients and physicians information that is accurate, complete, and up to date. We believe the patient information should be understandable to the lay person because obviously they do not have the medical background of the physician. We strongly believe that this information should equip both the patient and physician to make a well-informed decision.

I would like to explain to you what communication channels we currently have for providing information to the physician and the patient. First of all, we have a toll free number that a patient can call in to ask questions. It was started about seven years ago. It is staffed by registered nurses and we currently receive about 500 calls for information a month. These can come from both perspective patients and patients that have already received implants.

Secondly, we do have educational videos that are available. These are available upon request to Mentor. They are available for the patient to view in the doctor's office or a patient can request them directly from Mentor.

Also, we have a web site that has a great deal of information on it. It's designed to be interactive. It's updated. Currently we have approximately 50,000 user visits per month.

Lastly, and probably most importantly, we have labeling that is geared for both the patient and the physician. I would like to describe for you what that is and what information these contain. Our patient labeling consist of three parts. We have information for women considering saline-filled breast implant document. We have two brochures, one entitled "Options in Breast Augmentation," and one entitled "Option in Breast Reconstruction."

I would like to talk to you a little bit about the "Information for Women Considering Saline-Filled Breast Implants" document. It is enclosed in each breast implant package. In addition to having this document in the package, we also have a voluntary patient registry card and a patient ID label so that the patient will have a record of what implant they have received.

The "Information for Women Considering Saline-Filled Breast Implants" can be obtained several ways. As I mentioned, it can be provided in a breast implant package. It can also be provided to the physician upon request to Mentor so they will have extras to give to patients. It also is available directly to patients upon their request. It is available in multiple languages; English, French, German, Spanish, and Italian.

The original version was developed in cooperation with FDA as we will hear. We have recently added the complication raised from our saline perspective study. This is the version that is pending approval in the PMA today.

This document has a space for the patient to sign indicating that they have read and reviewed this information and understood it. It also has a place for a witness to sign. The physician is instructed to keep the original and to provide a copy to the patient. This document advises women to review the information prior to making a decision whether to have surgery. It mentioned other alternatives for augmentation, reconstruction.

It also advises women with their doctor's advice to decide whether they want to accept the possible risk of surgery in order to achieve their desired results. It lets women know that the physician labeling, which I will describe a little bit later on, is available from their doctors and they should request it if they would like to have it.

It gives information regarding the rates of occurrence for most of the common risks that have recently been added. Again, this is part of the labeling that is pending approval under the PMA. It also discusses known and unknown long-term risks.

Now I would like to talk about our options in breast augmentation brochure. It is provided to the patient via several ways. It is available in the doctor's office and is also available if the patient calls our 800 line or request it over our web site as I described earlier. It provides a great deal of information on the following areas.

It provides information on the anatomy of the breast, what factors to consider when choosing breast augmentation. It describes the various types of Mentor saline implants available including the types and shapes and surface characteristics.

It gives the patient information regarding the incision choices and placement choices that are available. It discusses the body's reaction to breast implants, specifically the possibility of capsular contracture.

Further, it provides information to the patient as to what to expect during the surgical procedure and the recovery period. It provides photos of some sample breast augmentation results. In addition, it gives them information regarding Mentor's product replacement policy and our limited warranty program.

It provides the potential risks and complications of breast implants. This is the same information, a duplicate of the information that is provided in the "Information for Women Considering Saline-Filled Breast Implants" that I mentioned earlier. It provides a place for the patient to sign indicating they have received and read the document, and also a place for the witness to sign.

The options in the breast reconstruction brochure is providing to the patients considering reconstruction. It is available in a manner similar to the augmentation brochure either through the doctor's office or upon request directly to Mentor. It provides information regarding the anatomy of the breast. It gives some information on the mastectomy procedure and the various options that are open for reconstruction. It describes the types of implants that are available from Mentor, as well as the body's reactions to implants.

It also tells the patient what to expect during the surgical procedure and the recovery period. It gives the potential risks and complications. Again, this is the same information as presented in the "Information for Women Considering Saline-Filled Breast Implants." It provides a glossary of medical terms. It also provides a space for the patient and the witness to sign.

I would like to talk about the physician labeling. This is a product insert data sheet that is enclosed in each breast implant package. Additional copies are also available upon request from Mentor either through our phone line or web site.

Since this is geared to the physician it provides more detailed and technical information about the device, what the various options are in terms of valves and texture surface and shapes and so on. It details the indications for use, the contraindications. It also provides the warnings and precautions to assist the physician in the safe use of the device.

Further, we have revised this document to include the adverse events that were reported during our saline perspective study. It gives information regarding the possible reactions to silicone. It provides more detailed information about the clinical study results in terms of the study population, the methods used, and the results that were obtained for both the primary safety and effectiveness parameters.

In addition, it instructs the physician to counsel the patient prior to surgery to make sure they are fully informed of the risks and to provide them with the patient labeling. It gives the physician detailed instructions for use in terms of choosing an implant, testing the implant prior to surgery, and filling the implant during surgery. It also provides the company contact information so that the physician will know where to report any adverse reactions.

Now I would like to describe for you the new initiatives that Mentor is looking into undertaking in order to communicate the new data that we now have from our saline perspective study. Mentor is committed to being responsive to the needs of the patient and the medical community consistent with what we have heard during the last two days from both the public and the panel subject to PMA approval and we will be working very closely with FDA on this.

The new detailed clinical results on both the risks and benefits will be communicated to the patient and the physician. In order to do that, we intend to extend our web site by providing full and updated patient and physician labeling on the web site for those who would like to have it.

We will make it fully interactive so that doctors and patients can ask questions and get answers to their issues or concerns. We will have links to medical specialty and third-party web sites such as ASPS, FDA, and the Institute of Medicine. We will use the web site to provide real time information updates and communicate our research findings.

In order to ensure that these methods of communication have been effective, we will be conducting focus groups to ensure that the information is, in fact, making its way to the patient.

In summary what does this all mean? Mentor is committed to providing complete, current, and accurate information to the patient and the physician. We will undertake new initiatives to expand our communications to incorporate the clinical data that we now have. Mentor will continue to work with the FDA to develop appropriate information for the patients to help them make an informed decision. We feel this is very important because we very strongly believe that meaningful information will lead to an informed choice.

That concludes my presentation. Thank you very much for your time and attention today.

DR. WITTEN: Excuse me. Do you have any material to pass around such as copies of these information brochures?

MS. CRAWFORD: I do have some. The printed versions are what we are using today and does not have the race incorporated because that is still pending FDA review and approval, but I do have some samples of that.

DR. WITTEN: Any of the information that you mentioned just now if you could pass it around to the panel.

MS. CRAWFORD: Sure.

MR. PURKAIT: Hi. This is Bobby Purkait from Mentor Corporation. We do have some samples. Who do I give it to?

DR. WHALEN: Are there any questions for Ms. Crawford? Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I have two questions. First, focus groups is a great idea. Just very briefly I know you'll work on FDA with this but who would you propose to include in the focus groups?

MS. CRAWFORD: I'd like to have Bobby answer that question.

MR. PURKAIT: Hi. This is Bobby Purkait. Good morning. Focus group, we have a very preliminary plan. We have heard and recognized the fact that we need to understand this basic understanding how patient gets this information and what is the best way to get them. Even if they do get it, do they really understand what is the timely fashion.

There are a lot of issues that we want to deal with. We really don't have a full picture in the focus group who those folks should be but we will investigate and we'll make some decision. Definitely physicians, the patient group, the advocacy group, some of the very important group where the patients can go to get some information. That kind of group will look into it. We don't have a full answer but we'll look into it.

DR. BANDEEN-ROCHE: Okay. My second question is just about the information that appears in the breast implant package including materials for a signature. Does Mentor receive any assurance that the patients have seen the information? For instance, does mentor receive a copy of the signed forms or is that strictly between the patient and the doctor?

MR. PURKAIT: It is primarily right now between the patient and the doctor. We do receive sometimes and we don't receive a lot of times. This is not a very well defined procedure.

DR. BANDEEN-ROCHE: Thank you.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: It's my understanding, because I'm familiar with your material, that the signed piece in the patient education information can not be used, can be used to go in patient chart, can go back to you. There is no process for that and there's no real requirement to use it. It's put in there for anybody's use to interpret anyway they want. Right?

MR. PURKAIT: No, that's not quite right. The information that is provided both for the patients and physicians, it is between physicians to explain to the patient. If the patient have an information requirement, they can call us and we'll further augment those. As far as the exchange of communication, what we want to establish is really the open communication channel, what we provided to them. If they have any question, they can call us anytime.

MS. BRINKMAN: Thank you. I understand that. I was talking about the area for a signature, though.

MR. PURKAIT: Yeah, the area for signature we strongly believe that there is a need for that. We provide them. We like to see that we get lot more cooperation. We will look into this with more detail. That's a very important area we're looking into it.

MS. BRINKMAN: Good. Thank you.

DR. WHALEN: Thank you.

We will now proceed to open public testimony before the panel. I would like to ask Dr. Krause to read us the four question instructions.

DR. KRAUSE: Okay. I would like to inform everyone that's going to speak of the instructions. We are requesting that all persons making statements during the open public hearing of the meeting disclose whether they have financial interest in any medical device company, or if their trip to the meeting has been paid for by someone else.

Before making your presentation to the panel, in addition to stating your name and affiliation, please address the following questions.

I would like to read the questions into the record now so that a rereading by all the presenters will not be necessary. These are the four questions.

Question 1: Has your travel and/or accommodations been paid for or will they be reimbursed by someone else? If so, please state who.

Question 2: Please indicate whether you have financial ties including grants or other compensation with industry or health professional societies.

Question 3: Please indicate whether you are a party to or a witness in a pending lawsuit related to breast implants.

Question 4: Do you derive a portion of your income from surgical procedures using saline-filled implants or from treating patients with complaints that the patients believe are related to saline-filled implants.

All of the individuals who have registered to speak today, you've been given a number. There's a reserved seating area up here. If you have not, see Ann Marie.

Would you like to just let everybody see who you are?

See Ann Marie and she will help you get organized. When your turn comes, please step up to the podium. When Ann Marie cues you, be ready to go. Thank you.

DR. WHALEN: Thank you, Dr. Krause. Just slight further housekeeping. For this morning's public session the only speakers we'll have time for are those who have been previously identified. The time allotments will be 10 minutes for those from professional societies and 10 minutes from those representing consumer groups, but five minutes for individual consumers in view of the number of people who have asked to address us and in view of reasonableness of time for this meeting.

If you have not identified yourself, meaning probably that you were late for this meeting, to Ms. Williams, we will attempt to accommodate you later but we will reduce your time by 50 percent and that will only be within the constraints of the time that we have allotted.

That being said, we'll go first to three individuals who will speak to us from professional societies, the first of which is Dr. Shawna Willey from the American College of Surgeons.

Dr. Willey.

DR. WILLEY: Thank you. Good morning. I'll answer the questions first. My travel has not been paid for by any professional society. I came here with my own provisions. I have no financial ties to any industry or health professional societies. I have never been a witness or a party to a pending lawsuit. I do not derive any portion of my income from surgical procedures using breast implants or from treating patients with complaints that are related to breast implants.

My name is Shawna Willey and I'm a general surgeon practicing in the northern Virginia and Washington, D.C. area. I'm an assistant professor of surgery at George Washington University Medical Center where I have a practice that focuses on the surgical treatment of breast disease.

On behalf of the American College of Surgeons, I would like to thank you for the opportunity to offer a general surgeon's perspective on the issue of labeling information for patients who are considering saline-filled breast implants.

I would like to focus my comments on the principles involved in obtaining informed consent and also on the idea of imposing a waiting period on patients who are considering breast implants. I believe you have written statements in front of you so I'll simply summarize my main points.

Surgeons counsel their patients about a planned operation and then the patients are asked by their surgeons whether they understand the nature of the procedure to be performed and the patients must then give their consent for the operation to continue.

This process is known as informed consent and it is perhaps the most important issue in the medical device patient labeling debate.

The college agrees that it is vital for any woman considering a breast implant procedure, or any operation for that matter, to be well informed about all the possible risks associated with the procedure as well as with the device being used.

The key portion of the information exchange must take place in the surgeon's office and it must be individualized to the patient's particular circumstances. Pamphlets, booklets, and video tapes are extremely helpful. We do use this kind of material. We supply that to patients anytime we're discussing a planned procedure with them.

The college believes very strongly that any patient guidance materials must emphasize the need for patients to discuss any concerns with their surgeon, and to perhaps even more importantly thoroughly review their expectations and to individualize the patient's care.

Indeed, after reading some of the studies and the reports that have been compiled on the breast implant issues, many of use have concluded that the greatest risks involved with breast implants probably isn't imposed by the implant itself but by incomplete information for the patient.

Many patients simply have unrealistic expectations as to what an implant will do. For example, patients must understand that breast implants do not last forever and that certain complications including those that require trips back to the operating room sometimes even years later can occur.

We certainly support this panel's effort to ensure that breast implant patients have access to comprehensive thoughtful material that can be used in obtaining and providing truly informed consent. But, again, we believe very strongly that such material must emphasize the surgeon's pivotal role in that process.

It's also essential that the material provided to patients differentiate clearly between the risks and complications associated with breast implants that have been scientifically proven and those that have not.

Certainly patients should be provided with information about the more controversial issues that have been raised about breast implants, but not to the point that their attention is diverted away from a thorough review of the potential risks that are, in fact, known to be associated with these devices.

Again, what is most important is that patients consent to these procedures with realistic expectations and a good understanding of the risks and benefits involved.

Now I would like to discuss the issue of the waiting period. The college strongly advises that imposing or suggesting any sort of waiting period as part of the restrictions the FDA may place on these devices.

For one thing, there simply is no accepted or medically appropriate period that can be recommended. Any interval chosen will be entirely arbitrary. On a practical level, the need to schedule an operating room and the surgeon's time after the initial patient consultation produces a de facto waiting period for nearly all operations including breast implant procedures.

It's really hard to imagine just what would be accomplished by an arbitrarily imposed waiting period and exactly who would benefit from it. In fact, there's a very real potential for needless inconvenience and maybe even some harm for some patients. As you know, those patients who choose to receive implants for aesthetic purposes are exercising an individual choice and they must pay for these rather expensive operations themselves. They are not likely to be acting on impulse and they have often thought through this decision very carefully.

On the other hand, my breast cancer patients who op for immediate reconstruction after a mastectomy have a sense of urgency of obtaining their care. They may not have access to a plastic surgeon before their cancer operation has been scheduled. I certainly would not want an arbitrarily imposed waiting period to impact on my patient's care for her breast cancer.

To conclude, let me say again that all surgeons are obliged to provide informed consent to their patients. The controversy surrounding these devices you are considering today serves only to amplify this point.

We welcome the efforts by the FDA, the Institute of Medicine, and others to ensure that materials are available to assist surgeons in this important responsibility.

I thank you for the opportunity to appear before you today and I'll welcome any questions that you may have.

DR. WHALEN: Thank you, Dr. Willey. I apologize for mispronouncing your name.

DR. WILLEY: Thank you.

DR. WHALEN: Are there any questions?

Thank you.

Next we'll hear from Dr. Mark Jewell from the American Society of Aesthetic Plastic Surgery.

Dr. Jewell.

DR. JEWELL: Thank you. Good morning. My name is Dr. Mark Jewell. I'm here today representing the American Society for Aesthetic Plastic Surgery which will reimburse my expenses for travel and accommodations. I have no financial ties to industry or other health professional societies.

I'm not a witness or party to any pending lawsuit relating to breast implants. As a board certified plastic surgeon with an active cosmetic and reconstructive practice, I derive a portion of my income from breast procedures including those that use implants.

I thank the panel for this opportunity to address the topic of patient informed consent. I have a particular interest in this subject having researched and written the patient consultation resource book which is published by the American Society of Plastic Surgeons and used by more than 40 percent of plastic surgeons in the United States.

This is a book that is also written in Spanish that has consents. This research book provides over 30 examples of plastic surgery and informed consent documents for breast augmentation, reconstruction, and revision.

My discussion today will not venture into the medical legal aspects of informed consent, though certainly these are of importance to physicians and patients. Our interest here today, I believe, is in the contribution of informed consent to quality patient care and specifically to the education of patients considering breast implants.

The process of informed consent is an opportunity for the physician or surgeon to build a relationship of respect and trust with the patient. At the same time it fulfills one of the physician's most important responsibilities ensuring that patients are given information that enables them to make informed choices about their health care.

First and foremost the doctor/patient relationship must be an ethical one. It follows that a physician must respect the patient's rights to self-determination and autonomy in rational decision making. Both require that necessary information upon which a decision is to be made is disclosed to the patient.

Understanding a risk is a crucial element of this decision-making process. However, effectively communicating risk is a complex task. The first question that arises is whether it's necessary to address all conceivable risks or only those that occur frequently, or those of recognized importance. Whether risk is material is a function of its frequency of occurrence and severity. It is obviously prohibitive and unrealistic to expect physicians to discuss with their patients every risk of a proposed treatment no matter how small or remote.

Because of the controversial nature surrounding breast implants, I believe the candidates for saline-filled breast implants want and expect the most comprehensive approach to informed consent. This would start with a discussion of appropriate indications for surgery, general description of the procedure, and alternatives should be reviewed.

This is particularly important for breast reconstruction patients who have a variety of surgical options. A discussion of risks should differentiate between inherent risks of the device and potential complications that are specific to all surgical procedures.

Inherent risks of saline breast implants would include such occurrences as capsular contracture, implant deflation, rupture, and degradation. Implant rippling and wrinkling should also be covered. Discussions should be held with regards to changes in nipple and skin sensation following surgery. Patients should be advised of the potential for surface contamination of implants during surgery. Be told that implant displacement and extrusion may occur. A seroma can occur following a breast implant placement. And there certainly are unknown risks.

Nonsurgical complications. These are associated with a variety of operations such as infection, bleeding, scarring, unsatisfactory result, allergic reaction to medications used during surgery and afterwards, the risk of surgical anesthesia, and unknown risks.

I believe it's also important to provide patients with other advisory information regarding breast imaging. Also talk about the effect of implants, that there is no known risk on fertility, pregnancy, or breast feeding. Disclose to patients that there is no known risk of implants with regards to breast disease. Discuss with patients from the information from the IOM that there is no known risk of autoimmune disease.

Also discuss with patients that there are potential for good long-term results, although changes in breast shape and size may naturally occur not relating to the implant procedure. Also, finally disclose to the patient that there is the potential in the future for the need for revision, replacement, or removal type surgery, each of which does carry risk.

The items that I have mentioned are not inclusive of all the recommended elements of informed consent. For example, patients are entitled to know the medical and scientific consensus about the potential health effects, if any, of saline-filled breast implants. Fortunately, the result of recently published studies, as well as a scientific data by the IOM and other bodies, there is reasonable assurance that there is general safety and efficacy of saline-filled breast implants.

Outcome data also confirms the benefits of breast implants far outweigh the risks. However, quantifying risks for patients still remains a somewhat difficult area. For example, in the case of saline implants we can now provide data from several well-designed studies showing the incidence of implant deflation over a given period of time. Yet, some patients may have difficulty relating to this technical data. As a consequence, they may underestimate or overestimate the significance of a particular risk.

As much as possible we should attempt to relate medical risks to familiar risks that patients encounter in their daily lives. We should attempt to provide alternative methods of communication of the same information. For example, written text, graphs, or illustrations may be useful.

We must not consider informed consent to be simply a listing of all the negatives that could occur with a surgical procedure. A signed form may constitute evidence that a patient consented to a procedure but does not prove that the consent was informed.

In the case of saline implants patients also have the right to know what benefits can reasonably be expected from a successful operation. They have reached the point of considering breast implants because they believe the surgery will offer them a positive experience.

They should be informed about the high rate of patient satisfaction with breast augmentation and breast reconstruction. They should be made aware that women undergoing these procedures often experience increased self esteem, greater self confidence, and more satisfying intimate relationships.

How detailed informed consent document can be made before it's considered information overload is debatable. I believe that we should be more concerned with the completeness rather than the conciseness of this. Despite the vast array of resources available today for medical information, there is no substitute for the relationship of trust between patients and their doctors.

Certainly plastic surgeons must spend adequate time in consultation with their patients. It's typical for a patient and it's urgent to set aside a full hour or more for the first consultation. Perspective patients often come back for a second consultation after reviewing the literature and the other information that the physician has provided.

Responsible plastic surgeons welcome the opportunity to help ensure a patient's fully informed consent. We know from experience that our happiest patients are those that have entered into a surgical procedure with a complete understanding of both risks and benefits.

With regards to a waiting period, our view is this is entirely unnecessary. This is not the kind of procedure for which the consultation is on Monday and the surgery is on Tuesday. The situation with breast reconstruction may be different. A patient's decision about breast reconstruction with implants if it is to be performed at the time of mastectomy often must be made quickly in order not to delay cancer care. Imposing a mandatory waiting period in this situation would be medically unwise.

We wish to welcome today's examination of informed consent issues in which to play a major role in developing more effective patient communication. I'm happy to share with the panel examples of informed consent documents included in the patient consultation resource book. I brought several of these with me and we'll leave them for your review.

These documents represent plastic surgeons' best efforts to provide patients with complete information on breast augmentation and reconstruction options. I believe that with the recent scientific studies that have been presented in the course of these hearings, these documents can be updated and made even more useful for patients.

In addition, our growing understanding of the best ways to communicate risk such as through comparisons to common occurrences in everyday lives can be incorporated in the future to help patients relate to complex medical information.

The 2,800 members and candidates of the American Society for Aesthetic Plastic Surgery look forward to continuing dialogue with the FDA concerning consumer education on the risks and benefits of saline breast implants. Thank you.

DR. WHALEN: Thank you, Dr. Jewell.

Any questions?

DR. BURKHARDT: I have a question for Dr. Jewell.

Dr. Jewell, based on your personal experience in private practice, approximately what percentage of patients who come in to see you requesting elective breast augmentation will then reject the procedure on the basis of this extensive informed consent document that you present to them saying, "No, I don't want to do that. I didn't realize that was too risky for me."

DR. JEWELL: I would say that's a very small percentage. Maybe one or two percent. Most patients when they come to the office have already made up their mind that they wish to undergo this procedure after thinking about it for some length of time.

DR. BURKHARDT: Within the last year can you think of a single patient who has turned down the operation on the basis of these documents?

DR. JEWELL: No, sir. In fact, I think they welcome the document because it has educational value. It serves as a medium to develop additional questions during the consultation period.

DR. BURKHARDT: Thank you.

DR. WHALEN: Thank you.

We next will hear from Dr. Bailey of the American Society of Plastic Surgeons.

DR. BAILEY: Good morning, Mr. Chairman, members of the panel. I appreciate very much the privilege of standing before you this morning and commenting on the topic of informed consent. I'm a board certified plastic surgeon in my 27th year of practice in Houston, Texas.

I also have been licensed to practice law in Texas for the past 20 years, although I try to avoid it as much as possible. I'm past Chair of our Professional Liability Committee for the now ASPS and member of the Board of Trustees of the Texas Medical Association.

When the State of Texas established the Texas Medical Disclosure Panel I was appointed to that body and that was a body that put together a list of procedures, both medical and surgical, with accompanying items which should be disclosed to patients for these procedures.

DR. WHALEN: Dr. Bailey, could you address the four questions that were posed?

DR. BAILEY: Yes, sir. My expenses here have been paid for by the ASPS. In Houston and Texas in general we had a rather -- sort of a hotbed of litigation. I think I'm still named in four or five suits which at this point have not been settled with the plaintiff. I hold no financial interest in any breast implant company. There is a fair sized group of plastic surgeons in Houston who have filed suit against two of the manufacturers who are not in this process just to ensure that we're at the table during settlement procedures by these individuals. I've had no judgments or paid no settlements in any of these cases.

DR. WHALEN: Is any portion of your income still derived from --

DR. BAILEY: I do a moderate number of augmentation mammoplasties in my practice. Yes, sir.

DR. WHALEN: Thank you.

DR. BAILEY: As I said, I'm representing the American Society of Plastic Surgeons. A little bit of my background. My dad is a physician, retired, general practice. His father was a physician as well in general practice. I look at informed consent from the perspective which perhaps is slightly different from some of my colleagues because the tradition of medical practices in my family is very strong and I consider myself a physician first and a plastic surgeon second.

I also grew up the older brother of three younger sisters and have a daughter and two granddaughters so I find myself someone protective of the women in my practice who come in for various procedures.

I think Dr. Jewell has presented an excellent overview of the process of informed consent and I think he alluded to the fact that there is legal informed consent which has its connotations. But informed consent, in my viewpoint, is a communication process which far exceeds the value that you might attribute to a legal informed consent.

I think that we are obligated and should convey essentially all the information that's been presented to you here today to our patients, not because they will base their decision to have the surgery or not have the surgery on the things that are disclosed to them generally because they have generally made up their mind.

I share Dr. Jewell's experience in that I can't really recall the last patient who upon hearing these bits of information have declined to have the procedure. It affords both parties the benefit of sitting face to face and sort of assessing one another not only medically but more or less personally and psychologically and this is extremely important.

To specifically address, however, the items that we convey to these patients, some of them are for information only but there are a few, I think, that are extremely important. The way I arrived at these extremely important items of information, I asked myself if my daughter was in an office of a plastic surgeon in Austin, Texas, what if he did not relate to her what items would perhaps cause me some serious concern if not anger. I emphasize these specific items much more to my patients than I do to the less important items.

With respect to interacting with the patients, it's not uncommon to be sitting in front of a very young patient where you feel like nothing that you're saying is being heard. I think that we have to address ourselves as physicians to belaboring some of these points and perhaps imposing our own waiting period and insisting that they come back for a second consultation.

I think that is the type of waiting period that is more natural. I think it should be imposed by the physician where he has a patient where he really sort of doubts the motivation. The other thing that we sometimes see, although fortunately not too often, is a mother who is pushing an augmentation on a daughter because of her early life experiences, or a boyfriend or a husband.

I'm very uncomfortable with these situations. It's not uncommon for me to refuse two or three patients a month based on some of these concerns when they are actually candidates physically for the procedure.

After we've gone through all these bits of information, I think our final role is to sit down and refine what we are going to do if we are indeed going to proceed with this process. I would like to point out one thing that I do emphasis and I would emphasis to my daughter if she were contemplating this surgery are the shortcomings.

I think one of the problems here is we have paired organs and I can tell you that whenever you do two operations, whether it's on two people or two operations on the same person, they never come out exactly the same. We could sit here and say, goodness, the complication rate, if we call this a complication, is extremely high.

I would stress to my daughter that if she cannot mentally deal with the fact that one of her breasts might be slightly more firm than the other or that she may feel ripples in her implants, just assume that she's going to have it and don't do it. These two things I don't particularly consider complications are common enough that I think these are a couple of the things that need to be stressed.

With respect to spherical contracture many times when I've had a patient who for years has had breast implants they will develop a very mild shrinkage of the scar capsule around an implant. If I took anybody into the room and wouldn't let them compare the two breasts, most physicians examining the so-called more firm breast would feel that it was normal. But on comparison with the other side would have to agree with the patient that there is some moderate shrinkage of the capsule. I think these things need to be emphasized to the patient.

The last thing that has not been mentioned that I do emphasize to my patients is if they have a minor shortcoming such as a mild firmness of one breast over the other or rippling, it takes a courageous surgeon to deny them a second surgery because in our elements that influence us in making our decisions, we cannot let the emotional side of our judgment override the scientific.

Of the severe problems that I have seen in consultation with breast augmentation surgery, essentially all of these patients have had multiple surgeries. Many of these patients upon completing my consultation when I tell them that there's really nothing I can do will state, "You know, it wasn't that bad the first time. I wish I had never had the second surgery."

I think that's all the pertinent material I would have to offer you here today and I would be happy to entertain any questions.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I'm just curious when you think about your daughters, what are the one or two safety related things that you would talk to them about? You know, complications or pain, that sort of thing.

DR. BAILEY: The things that I feel the strongest about?

DR. BANDEEN-ROCHE: Yes.

DR. BAILEY: Our anesthesia and with the advent of the pulse oximeter, I am not -- all of my children have had surgeries and, of course, there's anxiety there but I am not really worried about the safety with respect to life threatening issues.

Infections, I've had two in 27 years so I would certainly mention that to her. The main things, I think, are the imperfections because these minor imperfections are what usually lead to a second or third surgery.

Visualize a young guy who has just gone into plastic surgery and he's a year or two into practice and he has a lady come in with maybe sort of a strong personality who is maybe a little overly upset about a very mild difference in the softness of her two breasts.

This plastic surgeon has tremendous pressure as a new person in the community to have this person satisfied with her result. A lot of times they haven't developed the judgment or the courage to say, "Look, it's not bad enough." A lot of times a patient won't let the discussion end there.

So the things I would stress to my daughter are if you have the rippling, it's relatively common. The difference in feel is relatively common. Those are the two main things I would stress to her, the slight imperfections that we see from time to time. Then the third is to avoid secondary surgeries if possible, not to force that issue.

DR. BANDEEN-ROCHE: And one more thing, although, Chair, please cut me off if we need to be mindful of the time. For any of the first three speakers, just a very brief comment on we know that among all human beings some are less effective communicators than others. Some are more neglectful. Some are even unethical. Most doctors are wonderful but occasionally a woman will have a surgeon who is less effective. Do you propose safeguards in terms of gate keeping for those women?

DR. BAILEY: Well, you know, I grew up in the household of a wonderful physician and that rubbed off so I'm very conscious of that. Sometimes I'm very embarrassed by conduct. Not just other plastic surgeons but certainly other physicians as well.

I think it's unfortunate but I think we need these hearings. I think we need to come up with a set of facts that should be communicated because, you're right, some physicians do not communicate adequately with their patients. I think you're going about this perhaps in the best and probably the only way by coming up with an acceptable informed consent.

DR. WHALEN: Well, just before we proceed to the next question since that was asked of all three, do either Dr. Jewell or Dr. Willey have any response to that question?

DR. JEWELL: Well, I think there is a need for a sort of uniform national standard of informed consent with regards this type of medical device. As I testified earlier, you know, just signing a consent form is not informed consent. I mean, there has to be a dialogue between the physician, or the surgeon in this case, and the patient with regards to answering their questions.

I think some type of form that does have plain English explanations of risks and consequences in relating it to real events that a patient experiences in real life is meaningful versus just a laundry list of everything that can go wrong and that the benefits of the operation should be also discussed in the informed consent document.

I'm happy to leave this book with the panel today for you to review.

DR. WHALEN: Dr. Willey.

DR. WILLEY: I would echo the same that having a standard list of information available for patients is valuable for patients and I think patients like that. I don't think that standard list can individualize a patient's care and I think that's the dialogue that needs to occur. That's what a patient needs to hear from the surgeon.

The patients also need to trust themselves that they are getting that dialogue to occur. They are getting the information they need. They are getting it applied to themselves. That if they aren't getting that information, they have the option to see someone else.

DR. WHALEN: Dr. Willey, while you're at the podium, Dr. Morykwas had a question.

DR. WILLEY: Yes.

DR. MORYKWAS: Actually, it's a very short two-part question, if I may. In your personal experience what's the average interval between diagnosis and a mastectomy and what is the shortest time interval that you've ever observed?

DR. WILLEY: I try not to let more than two or three weeks go by between the time I've told the patient she needs a mastectomy and the time that she actually had definitive therapy. I would say the average is around 10 days to two weeks. I would say the shortest is two to three days.

DR. MORYKWAS: Thank you.

DR. WHALEN: Ms. Dubler, a question for Dr. Willey?

MS. DUBLER: Yes. The theory of informed consent and the practice developed in a context in which the doctor and the patient were in a private relationship. Physicians now advertise and especially cosmetic plastic surgery is the subject of advertisement. "Do something nice for yourself today. Get some new breasts."

Should we treat physicians who advertise their wares and, therefore, are attempting to convince women to get this procedures, should we treat them differently? How should we think about that issue? That's for all three of you.

DR. WHALEN: I would just insert for the record that Dr. Willey is a general surgeon and deals with breast disease. So perhaps that question needs to be answered in part also by the other gentlemen.

MS. DUBLER: No, I'd like to address this to all three.

DR. WHALEN: Okay.

MS. DUBLER: Thank you.

DR. WILLEY: Well, advertising of medical services is certainly an issue. I believe that if a surgeon has the credentials to do the operation that they are planning to do, the issue of advertisement is not necessarily to be factored into that. That doesn't release them from the obligation to communicate with their patients, nor does that make them someone I think should be considered differently.

It's still a process that needs to be gone through. Yes, they may make their initial contact with the patient by an advertisement but that doesn't sidestep the whole issue of informed consent with that individual patient. I don't think that we need to treat that necessarily differently as long as that process is occurring after the initial contact.

MS. DUBLER: Do you think it raises any issues of conflict of interest to a different level?

DR. WILLEY: Well, in some regards some of us advertise our services. Maybe it's by word of mouth of the patient. Maybe it's by the medical societies we join and, therefore, our name is on a web site. Or maybe it's because you pay for an ad to be put in a newspaper or magazine.

The conflict of interest arises in that as a plastic surgeon, for instance, you are making money off of that procedure. That's how you make a living and the more procedures you do, the more money you are going to make. The more patients you bring in for that procedure, the more money you are going to make. I don't think that negates the professionalism of the physician or the organization.

DR. WHALEN: Dr. Bailey, would you like to answer that question?

DR. BAILEY: I think the Supreme Court dealt with, you know, it was forced to become accepted when lawyers initially advertised. The Supreme Court said that professionals were permitted to advertise through freedom of speech. Generally speaking the standard that's been applied is that you cannot put anything into an advertisement that is false or deceptive and so these advertisements have to be very carefully crafted to avoid potential conflicts of interest. Most of the states have mechanisms to -- our State Board of Medical Examiners, if I were to see an ad that I thought misrepresented the services or were deceptive, I can contact our State Board of Medical Examiners and they will take action in that respect.

DR. WHALEN: Dr. Jewell.

DR. JEWELL: Thank you. I think we do have to differentiate here between marketing activities to attract patients and address that separately for informed consent. As Dr. Bailey said, I think there are issues of false and deceptive advertising that need to be addressed whether you materially misrepresent your qualifications, training, cure, or efficacy. I think that has to be separated from the issue of informed consent.

All patients need informed consent to undergo a surgical procedure. There are certainly significant variations in the type of advertising from some that is very distasteful and inappropriate to professional advertising or marketing of one's services. I think we are dealing with two separate issues here. Thank you.

DR. WHALEN: Thank you.

Dr. Burkhardt.

DR. BURKHARDT: No.

DR. WHALEN: Any other questions? Dr. Blumenstein.

DR. BLUMENSTEIN: I have a question for Dr. Bailey and then a question for all three. Why is it that you imagine a surgeon in Austin for your daughter?

DR. JEWELL: Because that's where she lives. Or a surgeon in Dallas for my baby sister. Same thing.

DR. BLUMENSTEIN: That just struck me as a more serious question. The material in informed consent oft times contains numbers like probabilities and risk percents and things of that nature. How do you feel that patients -- what level of understanding do patients have of these numbers? I don't want to put you on the spot by asking you what level of understanding you have.

DR. JEWELL: Well, my standard statement that I make to my patients is I'll say a very few people have this particular problem but if you are the person that has it, it doesn't matter how many don't. In deciding on this surgery, think about it. Think about what if it happens to me. Just because it's a small percentage, don't dismiss it completely.

If the worry of that particular problem is a deterrent, then you shouldn't have the surgery. I sort of make the analogy to if you want to drive a Miata in Houston, Texas, on the freeway, I guess you can do that. I think everybody knows the potential problems you might have with that when you have an altercation with an 18-wheeler. If you do, you're dead and the other people that have the Miatas and don't have the accident are okay.

I think you just have to sort of put it in perspective for the patient because that's just the way it is. If you get the complication, it's very little consolation that others don't have it.

DR. WHALEN: Did you wish for the other two to address that?

DR. BLUMENSTEIN: If they have comments on that issue.

DR. JEWELL: I think in terms of risk discussions with patients, I always tell a patient that they have done something very risky which is drive an automobile to my office. Yet, you don't get in the automobile predicated on thinking that you're going to have a crash.

Risk, of course, comes down to frequency and severity. Talking about infections, I've been in practice for 20 years. I've been using breast implants for over 22. I've never had an infection. I talk to my patients about that with regards to the issue of infection.

With regards to risk, I think it's also good to quantify it in terms of severity and whether there is a solution to the problem should it occur. In most situations there is a reasonable solution to the occurrence of risk or a complication.

I also talk to patients that the ultimate complication of any surgical procedure is death and that they do have to consider that, although it's extremely remote. Thank you.

DR. WHALEN: Dr. Willey.

DR. WILLEY: I think it's extremely important for patients to have some idea of the number that is being discussed whether that's two percent or 80 percent. I think patients do appreciate having some idea of what may be expected. However, my standard line to patients is that statistics fall apart when applied to an individual.

Although you can talk about large populations of people and say that 80 percent of these people had a good outcome, again when it's an individual, they have to look at all the possibilities and if that complication occurred in them, it's 100 percent for them.

Although I think the numbers are important because it gives them some sense of the frequency of problems, they have to understand that it doesn't necessarily extrapolate to their own personal experience.

DR. WHALEN: Thank you.

The last question, Ms. Dubler.

MS. DUBLER: I actually have two brief questions on different topics. One is the ability to comprehend and to judge the wisdom of behavior we hope rises with age. Would you prohibit someone from under 18 from getting a breast implant for augmentation? I'm not talking about for reconstruction or deformity. Would you discourage patients in their low 20s? In other words, are there any age guidelines that you use?

My second question is a little different, which is we've heard over the last two days that some of the complications may have far more to do with surgical technique than with the device. Therefore, would you have any suggestion about how we might deal with the issue that more qualified surgeons probably do a better job. As cosmetic surgery becomes a source of great income, it may attract people who are less able.

First the age question and then the ability question.

DR. JEWELL: I think the age question is a very good question. I personally impose -- I would not operate on a 17-year-old. I know that occasionally they are getting operated on. Theoretically at 18 they should be entitled to come in and talk to you about having this procedure done.

It raises another question. I have seen 20-year-old women who were physics majors that are more mature than I am. You are sitting there, you are having the discussion, they are paying attention, they are understanding everything perhaps better than 90 percent of the augmentation patients you have regardless of age. I had one recently and it's a wonderful feeling to have someone listening to you and understanding what you're saying.

Generally speaking when I deal with my very young patients I spend a little more time on the long term problems or occurrences. I tell all of these people that they are probably going to have at least one or two deflations during the next 50 years and maybe more than that. I emphasize that.

I personally have sort of a self-imposed size limitation that I put on the implants depending on the amount of breast tissue they have. I don't like to put in an especially large implant into someone and stretch the tissue out excessively. That is not a problem in the immediate term.

It becomes a problem if you have to take that implant out 10 or 15 years later and it may be sort of hard to manage to keep that breast looking decently. There are considerations with respect to age that I think are a little different if you're talking to, say, a 35-year-old woman versus somebody in their early 20s.

The problem that you also run into is -- I see many of the panel have raised kids -- you sort of notice as your children are in the early 20s and certainly in the teens that its immediate gratification now. Don't bother me with the details. I find that a lot of the younger people are not -- I don't feel like they are really listening and so sometimes I will impose a second visit on them or have them, you know, spend more time reading over the material and come back and sort of show me that they have an understanding of it.

DR. BURKHARDT: May I ask one question? I'm sorry.

DR. WHALEN: Is it brief?

DR. BURKHARDT: It's brief.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: Dr. Bailey, I'm going to put you on the spot for a second here. One of the jobs this committee has is to evaluate this process and decide whether it's effective. I have a six-page permit here in front of me for breast augmentation that people are supposed to sign. Obviously one of the ways we can evaluate it's effectiveness is looking at how it works in legal defense. I ask you that because you're an attorney. How are we to measure the effectiveness of this process? I've just asked Dr. Jewell and he's had nobody -- this is the permit he uses I assume. He hasn't had anybody in the last year turn the operation down after they've signed this thing. It looks like a mortgage document.

DR. BAILEY: I think mortgage document is even more onerous than this. I think certainly in theory most people maybe with a little explanation from the physician can certainly understand every aspect of what's in the six-page document.

DR. BURKHARDT: Is this process measurable is what I'm asking.

DR. BAILEY: I don't know what you would measure to tell you the honest truth. I think we are obligated to give this information to people. I feel very, very strongly that they should have access to this information. The fact that it usually doesn't influence them is a function of the fact that most of them have friends, acquaintances and so forth that have had this surgery done. Many of them have parents now that have had it done and notwithstanding the deliberations of this committee, this has been a very well accepted well tolerated and popular operation. In spite of the fact that we do have complications, very few people have to have these implants out. I think it's partly that. They listen to what you have to say but they haven't the experiences of the negative experiences.

DR. BURKHARDT: Thank you, Mr. Chairman.

DR. WHALEN: Thank you.

A request has been made to hear the other physicians. I'll allow Dr. Jewell but I would ask in the interest of time since we're not dealing with a plastic surgeon in Dr. Willey that we just hear from Dr. Jewell.

DR. JEWELL: Right. You've mentioned that the issue of this surgical technique, the augmentation, mammoplasty, attract the unqualified and untrained practitioners. I think, of course, any physician can call themselves a cosmetic or plastic surgeon and go to a weekend course.

The heritage of general surgery and plastic surgery, I think, best prepares one to do this type of breast surgeries. I think it is also known that the more you do of an operation, the better you do with regards to your results. I think having experience is no substitute for any other sort of training. Thank you.

DR. WHALEN: Thank you. We'll be shifting to hearing from individual consumers, so for the timekeeper these will be five minute limits.

We first will hear from Ms. Mary McDonough.

MS. MCDONOUGH: Good morning. My name is Mary McDonough and to participate in this hearing my travel expenses were paid for by the Sheridan Group. I am involved in litigation along with other women who are part of the global settlement with manufacturers of silicone and saline breast implant. No part of my income is derived from breast implants.

Just to try and make this brief, I would like to have my testimony just for the record, the whole thing. I'm going to try and orally be as brief as I can.

I'm hear today as a breast implant survivor. I am a mom and I am an actress. Like many of the other actresses in my field, I thought it was necessary to have implants to succeed in front of the camera. I underwent a surgery device of silicone breast implants. The health problems I began to experience are not unlike those that you've heard from women over the past couple of days.

I won't go into the details. However, I do want to say that I thought I was making an informed decision. I asked my doctor tough questions and I consulted with my friends who had received implants. I read the very little information that was available. When I began experiencing pain and chronic fatigue and was eventually diagnosed with Lupus, I actually blamed myself for making a professional decision which has had a devastating long-term effect on my life and health.

That was in 1985. Today after talking with a lot of implanted women who have had many similar experiences, I have a much different view. I did not receive true informed consent, nor did the thousands of women who have received saline and silicone breast implants.

My concern for women who have gotten or may be considering implants has led me to become involved. In 1998 I helped Senator Boxer and Congressman Gene Green launch a legislative effort to bolster information and informed consent and encourage independent research of silicone breast implants. Just last summer I met with Dr. Fiegal along with other silicone implant women to discuss the FDA's oversight of breast implants.

Once I became involved friends, colleagues began telling me about their horror stories with breast implants. Their health problems led me to believe that saline is hardly a safe alternative to silicone.

This panel's endorsement of these devices despite the lack of convincing long-term safety data means that we just have to find other ways to protect women. Approval of a supposedly life-enhancing medical device with so many postmarking conditions is hardly a wringing endorsement for their safety.

So now with the PMAs behind us, I think the course of action is to really safeguard the future of women with an informed consent document. Some how a piece of paper is supposed to make up for the manufacturer's insufficient mechanical testing, revision data, and retrieval analysis.

It's supposed to make up for inaccurate labeling and risk estimates. And it's supposed to make up for the plastic surgeon's obligation to fully inform their patients of the potential complications and reoperations and a doctor's chosen surgical procedures.

The public comment over the past couple of days has been discounted by the members of this panel so I hope that finally today the FDA and this panel are listening to the patients. There are a number of measures that the Federal Government could implement to better protect women and preserve their health and their quality of life. These measures include conducting independent research, establishing an independently operated patient database and retrieval program, and strengthening informed consent.

My first recommendation for the NIH and the FDA is to conduct the independent research that is so desperately needed in this area. I fear that saline breast implants are going to follow the dubious path of the silicone breast implants. I hope we can learn from all of the past mistakes and ensure independent research is conducted not only on silicone but also on saline implants.

This past summer the Institute of Medicine concluded first reoperations and local complications are frequent enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with breast implants.

Second, risks accumulate over the lifetime of the implant but quantitative data on this point are lacking from modern implants and deficient historically.

Third, information concerning the nature and relatively high frequency of local complications and reoperations is an essential element of adequate informed consent for women undergoing breast implantation.

The IOM review reinforced the need to study women for a very long period of time, as much as 20 years to accurately assess the health effects of those implants. Furthermore, almost no research is being done to track mastectomy patients who suffer from local complications at a much higher rate than other breast implant recipients.

My second recommendation is to strengthen the informed consent. Recently there has been a lot of focus on the inadequacies of informed consent in clinical trials. As you've heard, insufficient and inaccurate information has posed many problems for women in the breast implant trials.

Even the Institute of Medicine as some have recognized that women are not being adequately warned of rupture, painful local complications, and multiple surgeries. Until independent research is available and able to answer the long-term safety questions surrounding breast implants, women at the very least they need to be informed about what we do know, the high rate of deflation, reoperations, and local complications.

Issues surrounding breast feeding of children should be stated to reflect that there is a lack of scientific study to even determine potential side effects to offspring. The likelihood of an inaccurate mammogram --

DR. WHALEN: Ms. McDonough, could you draw it to a conclusion?

MS. MCDONOUGH: Yes. Finally, the informed consent really needs to address the financial implications and the risks related to insurability and employment, and the psychological effects not only of the positive outcomes but also the negative ones. Thanks.

DR. WHALEN: Thank you.

Next, Ms. Liz Macleod.

MS. MACLEOD: Good morning. I answered the four questions yesterday. Should I do so again?

DR. WHALEN: Yes, please.

MS. MACLEOD: Okay. I'm Liz Macleod. My travel arrangements and accommodations have been paid for by my husband and my support group, United Silicone Survivors of the World - New Mexico. The answer to the remaining questions is no.

I had a breast implant in '83 and I didn't feel I received enough information to give any semblance of informed consent. The surgery was very popular and held out to be wildly successful over a sustained period of time.

I assumed that there was Government oversight for the safety and quality of the device being inserted into my chest. Apart from the normal warnings stressing the risk of anesthesia, as we've heard those risks stressed today, the other risks were presented as rare, slight, mostly aesthetic, and all easily correctable.

My doctor was caring and compassionate and he reassured me. He really had my trust. I never doubted my safety even when I questioned my doctor about consequences I might face as a result of this surgery. I was young and I think I spent more time trying to evaluate whether to spend the money on a vacation or on getting my breasts to look the way I thought I wanted them to look.

I would like to thank now after having experienced very bad results that I would choose differently if I knew about things like shell permeability, saline expiration, gel bleed, biological reactivity, multiple surgery risks, frequent need for such surgeries, the various health complications that women have had. I would want to know about the possible bad results in terms that I could understand.

I wish I had been told that these devices were unregulated and I wish I had been told that there hadn't been appropriate and adequate study of women who had received implants. I would like to have known about failure rates. I would want to know that the devices degrade in vitro and that it is much simpler to put them in than to take them out. I would definitely have wanted to know why having an implant would make it impossible for me to get health insurance from many insurers.

I would want to have it expressly pointed out to me that it is in the financial interest of both manufacturers and plastic surgeons for these devices to fail. It is in some ways ironic that there is that conflict between the patient interest and the financial interest. I'm not saying the moral interest but the financial interest of these other parties.

For every failed implant a surgeon will be paid to explant the device and likely to replace it. For every failed implant there is a probability that it will be replaced by another manufactured implant. Effectively these parties have a repeat customer of the industry and there is no expanse in acquiring that customer. You don't have to advertise to a woman who has no choice after complications arise.

To my mind, labeling and consent are not a panisea in this matter. To the contrary, expecting the consumer to wade through this quagmire of issues and information and reach an intelligent decision about the safety of the particular implant in her case is patently absurd.

A woman isn't likely to consider getting an implant from a doctor she doesn't trust implicitly. I think medical trust will always tromp written warnings. You can't control what a doctor will tell his patient.

As one panel member suggested yesterday, legislation of surgeon conduct is like herding cats. We don't know what will be stressed or emphasized by any of the doctors but, as we've heard the doctors here today, I think their concerns are still largely about aesthetic risks. They still talk about the fact that you may have to replace these. They don't talk about how serious explanation surgery can be. The fact that just giving consent once results in the need to continue. You've given up all your consent for an ongoing process.

The effective outcome of elaborate informed consent is to place the entire burden of the risk of using these dangerous products more squarely on the shoulders of the woman user. By fixing responsibility in anticipation of the expected problems, we assure that when something goes wrong, the woman will bear the burden of the risks both physically and financially and likely legally.

I don't think it's appropriate to expect patients to maintain their own records of their implants or to decide whether to enter a registry or to interpret physician labeling, or to even remind a surgeon to wash his hands. When you consider these questions, please consider whether we want a doctor's obligations to his patients to be best summarized in these kinds of cases by the words of the hippocratic oath or by the words caveat emptor, let the buyer beware. Thank you.

DR. WHALEN: Thank you.

Next, Ms. Lisa Hickey.

MS. HICKEY: Good morning. Thank you. I am a flight attendant for a major airline and I've also had breast implant experience with problems. I have a lot of friends who've had problems. I paid for my own expenses to be here today.

I'm here to ask you if you would permanently implant a defective device near your vital organs, then sign a waiver releasing liability and agree to become uninsurable. Approval of these devices will result in that outcome for many women. Women you have or have had implants are being denied coverage just recently, a month ago. Not for complications but for health care coverage.

Unfortunately, Mentor and McGhan have a 15-year history of repeatedly violating laws of good manufacturing practices. I have a hard time believing that today all problems are corrected and products are safe.

According to these 483s under reporting of complications has occurred. Adverse events have been omitted from safety data. Saline patients are required to sign waivers agreeing to not claim implant related problems which means problems are kept quiet. There is no long-term data on implant exposure or breast feeding. Absent of data does not mean absence of problems.

Women want these products because they believe it is safe and effective. They are lured into the safety of benign salt water, have complication, and then may qualify for revision surgery with silicone gel implants. Do you realize that saline device failure causing deformity or need could put a woman at even higher risk with revision surgery using silicone gel-filled implants?

After the '92 moratorium sponsors were required to collect data on silicone gel implant users. The FDA was supposed to monitor the studies. I asked the FDA today what percentage of those patients were followed for the five-year period required by the study. Can you answer?

DR. WHALEN: Maybe you can make your statement but it's not appropriate to be asking questions. Thank you.

MS. HICKEY: It is my understanding that follow-up was as low as 30 percent. Can we be assured there will be better accountability with these saline devices?

There appears to have been a successful system of seeming collaboration between doctors, manufacturers, and possibly the FDA to preserve the economic success of the products rather than patient safety. Full disclosure of all potential problems will help a patient with true risk assessment. the IOM states that risks accumulate over time.

Women should be prepared for repeat surgeries leading to ultimate and final removal. Each repeat surgery results in loss of breast tissue. Women should understand that they may be left with scarred mutilated breasts smaller than when they began the implant process.

Had sponsors conducted long-term 15 to 20-year studies, patient satisfaction would have decreased resulting in different recommendations by this panel regarding effectiveness. The bottom line? Breast size initially increases, eventually decreases. Patient satisfaction in the short-term is high and in the long-term is low.

My 14-year-old daughter is on this trip with me today. She has see too often the devastating effects of these failed non-lifesaving devices on many of my friends and coworkers. Money for her college education paid for my device failures. Device failure can effect an entire family. Device failure can effect a woman's life permanently. Device failure is eminent so patients should be warned. Thank you.

DR. WHALEN: Ms. Hickey, thank you. I realize that was emotional but I need to ask you please before you sit down, you answered one of the four questions but not the other three. I'm sorry. You said you paid for your own travel expenses. Could you address the other three questions, please.

MS. HICKEY: I'm sorry. I don't know what the other three questions are.

DR. WHALEN: Are you involved in any litigation?

MS. HICKEY: I am not involved in litigation at all.

DR. WHALEN: I'm sure you don't derive any income from insertion of breast implants.

MS. HICKEY: I do not get any income from breast implants.

DR. WHALEN: And you have no relationship to the manufacturers of any of these devices?

MS. HICKEY: I have no relation to manufacturers.

DR. WHALEN: Thank you.

DR. BANDEEN-ROCHE: Could I ask a very brief question?

MS. HICKEY: Yes.

DR. BANDEEN-ROCHE: Could I just ask you were your medical problems ever reported to what would be considered a systematic database where it ever would have been analyzed? If not, then why do you feel that the data never got into such a database?

MS. HICKEY: My doctor -- my plastic surgeon assured me over and over that my implants were not causing my problems so I went to another doctor and had them removed and my problems resolved themselves. In the adjunct study, which I participated in, that doctor -- I left that doctor so he doesn't know what happened to me.

DR. BANDEEN-ROCHE: Thank you very much.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: You said that you were -- are you denied health insurance currently because of your past history with implants?

MS. HICKEY: I'm a flight attendant for a major airline and we have a plan where we can take leave of absence as requested. Our group coverage -- I do have coverage with my group plan which is about $600 a month. When we apply for interim policies with a major carrier of insurance that you've all heard of, their medical risk department told us that we are uninsurable because we've had implants even though we no longer have implants. We had them and we are not covered at all.

DR. BURKHARDT: Could I just comment that the usual thing that we see in practice is that insurance companies will not cover procedures that are related to or complications of cosmetic surgery.

MS. BRINKMAN: But is that the same as denying all health insurance?

MS. HICKEY: This is health care coverage period for sore throats, office visits. We've been denied coverage.

DR. BURKHARDT: I don't disbelieve you. That's just not the usual pattern that we see.

DR. WHALEN: Thank you.

MS. HICKEY: Thank you.

DR. WHALEN: Before the next speaker I'll just interject, lest I be misunderstood during that last speaker, there are certainly multiple avenues that anyone from the public can address questions to the FDA and have them satisfactorily entered and I'm sure people at the desk or during breaks would be happy to inform them of what that is.

During this session, however, only questions that are asked by the panel to be entertained are those that are appropriate and has to do with time flow and the entire conduct of our operation.

Next, Dr. Roberta Gartside.

DR. GARTSIDE: Thank you very much. My name is Dr. Roberta Gartside and I'm a practicing plastic surgeon in the northern Virginia area. I am a member of the American Society of Plastic Surgeons and a fellow of the American College of surgeons.

My travel here today was paid for by myself. I have no ties to implant manufacturers. I am not involved in any lawsuits involving breast implants. As a practicing plastic surgeon a portion of my income is derived from the use of breast implants for both cosmetic and reconstructive purposes.

As a plastic surgeon practicing in Fairfax County I would like to share my experiences using breast implants over the past 11 years. I treat women for both post-mastectomy reconstruction and cosmetic enhancement of the breasts.

For women facing mastectomy the goal is to provide them with as symmetrical and natural new breast as possible. Reconstruction after mastectomy generally involves one major operation and frequently additional procedures to continually work to the goal of symmetry.

This is the same for both implant reconstruction and autogenous tissue reconstruction. Those steps include creation of the breast mound, modification of the opposite breast if necessary, and nipple and areolar reconstruction.

For women seeking cosmetic enhancement, the goal is to determine their motives and realistic expectations. All women are informed of the potential risks and complications in my practice. Outside of the inherent risks of surgery those complications include, but are not exclusive to, capsular contracture, rupture, infection, interference with the detection of breast cancer, change in nipple sensation, and breast feeding issues.

In my personal practice out of 325 implants inserted for both cosmetic and reconstructive reasons, there have been four deflations for no apparent reason since 1995. Two additional inflations did occur, one following a motor vehicle accident and another was punctured during a needle aspiration in a post-mastectomy patient. Women are informed prior to their surgery that implants are mechanical devices and like any other mechanical device can fail.

Following surgery all my patients are given a card with their implant information and after completing their initial post-surgical follow-ups, I recall all my patients at one year after surgery.

In general, many patients do not come back for this one year follow-up. Those patients in general are not experiencing any problems. For those who do have questions or concerns, this one-year reminder prompts them to come in and address any issues.

The time spent with patients prior to surgery is well worth it, more than any amount of written material or waiting periods. The transmission of incomplete or misinterpreted information can have far reaching implications.

In my own practice this face-to-face consultation with patients resulted in the fact that the day after Connie Chung broadcast her program on silicone breast implants, my office received only one phone call. However, over the following year I saw women seeking breast reconstruction who either did not want to hear about breast implants at all, or chose a longer and more complicated form of reconstruction with a longer recovery or no reconstruction.

I fear the possibility of the same situation starting again. Just yesterday I saw a woman in my office who is seeking breast reconstruction for an upcoming mastectomy. She and her husband both heard the news reports of this hearing the night before and became very alarmed and concerned over the fact that the news media was reporting an extremely high complication rate for implants. I needed to spend twice the normal amount of time reviewing for her and her husband the data and its interpretation.

I would like to state that the relationship between physicians and their patients is extremely important. It can be the patient's best source of medical information because we were able to put things in perspective. Thank you very much.

DR. WHALEN: Thank you.

Next is Ms. Dorothy Stull.

MS. STULL: Thank you very much. To answer the four questions, I've had no one help me with my travel. I'm a local resident here in Maryland. Do I have any financial ties? No. I'm not a witness to any party pending related to breast implants. I do not derive -- I'm a housewife and I have no financial income from this.

I would like to -- my name is Dorothy Stull and I would like to thank the panel for letting me speak today. I'm a wife, mother, and a grandmother. I was diagnosed four years ago with breast cancer followed by a modified mastectomy with immediate reconstruction using a saline-filled breast implant. Needless to say I was devastated to be physically fit one day and told you have cancer the next. After much research, reading, and talking with family, friends and doctors, I chose the saline-filled breast implant. It meant that I would wake up from surgery with two breasts, a complete woman.

As I was making this decision in my life, I could only remember seeing my sister who also had breast cancer with scars and a heavy prothesis she had to wear daily. Twenty-five years ago she had no choice. Thanks to a good doctor and saline-filled breast implants, I did.

Being an active person in sports, I was able to get back into my active life of playing golf, tennis, and feeling good about my appearance, wearing a bathing suit to swim and water ski with my active sons. I can truthfully say I have not had any problems with my saline-filled implant and feel very strongly that women should have a choice.

Breast reconstruction has helped me overcome the shock of losing a breast and maintaining my self-esteem. Besides, my husband is happy with my appearance.

It is my hope that the saline-filled breast implant remain an option for all women with breast reconstruction and augmentation. Thank you for listening.

DR. WHALEN: Thank you.

Next we'll hear from Dr. Saul Puszkin.

DR. PUSZKIN: Hello. Good morning, everybody. Members of the panel, thank you. Please wake up a few minutes. I'll try to be brief.

If I were to write the guidelines or the permission or the authorization or the consenting form, I don't think any women will have a silicone or saline breast implant in their body.

DR. WHALEN: Dr. Puszkin, forgive me, but could you answer the four questions?

DR. PUSZKIN: I'm answering in the slide. Okay. I'm Dr. Saul Puszkin and I'm affiliated with Columbia University. I have my private laboratory of the Health Sciences Consultant Group. I am involved in the litigation on the side of the patients who had breast implants or their relatives. Some of the lawyers hired me to testify about what I find in the pathology of these patients. I do not -- the expenses were paid by the laboratory. I do have income from some of the pathology I do.

Okay. I don't know what you heard in the last three days but very briefly this is the mammary gland. It's a very sensitive area. During my years as Professor of Pathology and Molecular and Cellular Pathology at Mt. Sinai I worked with latex particles injecting them in the mammary gland of animals.

I found it exquisitely sensitive and very highly immunogenic in the sense of responding immunogenically to latex particles. Silicone became another agent and I understand there are publications saying that silicone gel is immunogenic.

We are dealing now with saline implant which is coated by an elastomer made of silicone polydimethylsiloxane. When you put that implant in the body of a lady, after a short while a very thick scar is formed and when the implant is removed either by leakage or other complications, contractures, calcifications, inflammation, and infection, this is the result of that surgery.

This is what I get in the laboratory and have worked with over 2,700 patients, analyzed over a similar number of implants, and about 20 percent of them were saline. My experience is over 500 pair of implants of saline that came to the lab to be analyzed by me and find out the complications they had.

Now, very briefly. I don't know if you can see. These are my statements. Polydimethylsiloxane makes the elastomer which is a chemical which crosslink and have holes or pores just like a blood vessel. It has gaps in its structure so things can penetrate either in or out.

There are ethyl bridges which I don't have to tell you too much. I'm sure if you're on the panel you are highly qualified. I see several Ph.Ds with your names there. The rigidity is due to the number of crosslinks. If you will have a very little crosslinked polydimethylsiloxane network, we will have a gel. If we have it highly crosslinked, we are going to have a rubber type material. That's the one that is being used in the elastomer.

My concern is that at the bottom field studies analyze silicone stability to cellular reactive molecules. In the three minutes that I have left, or 3?, I'm going to try to convey to you this impression from a scientific and from my professional and background experience.

This is a structure. Assuming this model -- I copy it from a cartoon used to teach extracellular matrix which is very similar to the one that we have in the elastomer shell. These are the linear molecules that are crosslinked by ethyl bridges but there are large gaps so if this is elastomer, things can move from the saline compartment out, or things can move from the tissue compartment into the implant and there is migration.

Cellular migration hides the flexibility, especially macrophages which are able to migrate into bone structure. Imagine that they can fine themself into the implant, especially when they see such a large body implanted in a very sensitive area to which they come in response to all kinds of chemical stimuli.

Inside a saline implant we have all kinds of materials form in there. These are the walls. This is high magnification, about 5,000 times magnified, of the content of saline after a year in the body. These are the walls of the macrophages and other kind of fat cells that have been able to infiltrate the implant. They become trapped in the saline and they become a good source of decay and a good source of -- just to proliferate in there and decay and to transform theirself.

Several materials are formed. This is a kind of web-like organic material crystals that are formed from the reaction of the saline with the elastomer shell.

There are micro organisms that sometimes find themself inside. This is an amoeba found in one of the implants.

This is a large magnification.

These are all kinds of precipitates from the macrophage chemicals that have formed with the reaction of the saline and the salt that has been released from the elastomer shell.

These are the particles of elastomer shell, the silicone, that have been released from the implant surface and found their way into the tissue.

And then you form granulomas in there. This is a granuloma. This is highly reactive surrounded by lymphocyte and they are trying to fight, to fend off this kind of an offense forming a reaction that the body, the tissue react against these implant.

I think I'm coming close to the next slide, or the last few slides. I apologize for the excess of time.

DR. WHALEN: We need to have you conclude.

DR. PUSZKIN: Okay. I can answer more questions. So my opinion is that the saline implants do have to have, if they are going to be ever used, an expiration date. The patient should know that this expires. Like saline when we have a bag and we have an infusion they have an expiration date. If they are in the body and they are warm and they are subjected to all kinds of movement, this material will decay and it will fail and it will require multiple surgeries. I don't think that this is a very good product. Thank you.

DR. WHALEN: Thank you.

DR. BURKHARDT: I have a question.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: Dr. Puszkin, have you published your material and is it available to us from a peer review journal?

DR. PUSZKIN: Yes. It has been published in the Journal of Clinical Pathology. It's not easy to publish kind of adverse material to silicone breast implant in the United States so this is an international journal published in Argentina which is my mother country. I have been invited teach there because Argentina is a haven for implantation.

DR. BURKHARDT: You've answered my question, sir. Thank you very much.

DR. PUSZKIN: Yes, I do. I'll send it to you without even a request.

DR. WHALEN: Thank you.

Next we'll hear from Dr. Britta Ostermeyer.

DR. OSTERMEYER SHOAIB: Good morning and thank you very much for the opportunity. I am a physician trained in neurology and I helped treating patients who had local and systemic problems from silicone breast implants for eight years in Houston, Texas. I have since moved on and started to train in a second specialty. I'm currently a resident in psychiatry at Columbia University in New York City.

I paid my own way to come here and I testified as a treating physician on my patients' behalf in the past. I have no relationships to manufacturers and I do not derive any income out of breast implants.

I would like to show you a small slide presentation and then give you my thoughts and conclusions. Among the women with breast implants that I have treated there was a subpopulation of women who only received saline implants and these patients had presented to us with local and systemic problems after they had received saline implants.

This is an overview of the problems they reported to us. These women were healthy previously. They had no other medical problems and since they had a combination out of these problems that was similar in the women that we saw and there was no other cause, we strongly felt after several years of research and seeing these patients that there might be a cause or link between receiving the medical device and getting these symptoms.

I'm showing you some pictures of patients that I have seen. You are supposed to see a reddish rash in the lower extremities. This is a lady who had saline implants and developed vasculitis which is inflammation in her blood vessels. She had strokes in the brain and she developed a gangrene and as a result her little pinky had to be amputated.

This lady had saline breast implants only and also had systemic autoimmune disease which is Lupus like and those are her skin rashes.

This lady had saline implants, also systemic inflammatory responses, and those are her skin rashes.

This is a spec scan which shows how the blood flow in the brain is distributed and we found findings similar of those seem in Alzheimer's and women with systemic illness.

We measured autoantibodies which is an objective indicator of systemic inflammatory responses and there were lots of findings.

We also did sural nerve and muscle biopsies and had a high number of abnormalities. This is a sural nerve. You are supposed to see fibers all over the picture and you see gaps because this nerve had lost fibers due to inflammatory reactions.

The implant capsule was examined from women who had saline implants showed silicone in the surroundings. The surrounding chest wall muscle was biopsied and showed abnormalities and also showed silicone and chronic inflammatory reactions in the surrounding of the implant.

My conclusions are that saline implants can evoke systemic and local inflammatory responses. There are objective abnormalities and I believe that more data needs to be collected about saline implants.

My conclusions are that patients need to be aware of the risk of local injury as well as local inflammatory responses that can be very painful and can cause chest pain. There is a risk of systemic injury and especially in those women who already have an underlying autoimmune tendency, these women are at higher likelihood of developing systemic problems.

I think it's important that surgeons make sure to their patients that they do understand that breast implants including saline implants don't fix a long list of psychological and psychiatric problems including body image problems, depression, anxiety, and marital problems.

Surgeons should explore the patient's expectations about the surgery and emphasize that surgery may not solve their problems and that, as a matter of fact, adverse effects may take place.

My last thing is about a comment on the insurance situation. There was a patient earlier you said that she couldn't receive medical insurance anymore. My experience over eight years is that either patients are excluded from coverage if the disease that they encountered is a result of breast implants.

Once the women are labeled or diagnosed with a problem related to implants, they can no longer receive medical coverage. If they lose their old coverage and they want to obtain new medical insurance, it's a problem because once you are ill with them, you continue medical care and the insurance companies know that. Thank you so much.

DR. WHALEN: Thank you. Seeing no questions, we'll take a 10-minute break and then reconvene. Thank you.

(Whereupon, at 10:10 a.m. off the record until 10:25 a.m.)

DR. WHALEN: Thank you. We'll resume. We are now going to proceed to testimony from those representing consumer groups and consumer information providers so each of these speakers are allotted if they need it 10 minutes. The first to address us is Ms. Marlene Keeling of the Chemically Associated Neurological Disorders.

MS. KEELING: My name is Marlene Keeling. My airfare was paid for by Chemically Associated Neurological Disorders but I am paying for my other expenses. I settled my private lawsuit in 1996 against the manufacturer who made my defective implants. Because I feel so strongly I have dedicated my small settlement to addressing patient information, informed consent, and product liability labeling issues.

I did not receive informed consent in 1978 and women still are not receiving true informed consent today. The present informed consent appears to be primarily written to allow the manufacturers to escape legal liability. I will attempt to give as many examples as possible within the 15 minutes I have been allotted.

Failure, rupture, and reoperation rates, what the product insert says. Patients should be advised that their implants may deflate, result in asymmetry and require replacement surgery.

Improvements in design, manufacture, and surgical techniques have contributed to lower rates of deflation reported in the most recent studies. In these studies that they referred to was in 1988 and 1990.

Our breast implants may not last a lifetime. Our product history indicates an overall reported average rupture rate of approximately 1 percent. The FDA estimates that rupture rates are generally between 1 to 4 percent. What the informed consent says, "Breasts implants may not last a lifetime."

What the Institute of Medicine report of July '99 says, "Several studies have addressed the frequency of reoperations after implantation with both saline and gel-filled implants." The Mayo study reported a 23.8 percent rate after 7.8 years of follow-up. It appears that a significant number of women can expect additional procedures in the first five years after implantation.

Local complications. What the product insert says. "Improvement in device design and surgical techniques have contributed to declining rates of capsular contracture. The current risk of clinically significant capsular contracture is low. Acute infection around breast implants occur frequently after augmentation with slightly higher rates associated with reconstruction.

Extrusion has been reported as an infrequent complication. Breast implants may complicate the interpretation of mammography images by obscuring some underlying breast tissue. Calcification is rare. Chest wall deformity has been reported in rare cases." What the informed consent says. "Several surveys have shown that over 90 percent of women are pleased with the results. Complications are uncommon. Calcium deposits are benign and cause no problems. If the envelope containing the saline portion breaks, the saline is absorbed harmlessly by the body within hours.

Since the breast is compressed during mammography it is possible but rare for an implant to rupture. Very rarely the implant may change positions or break through the skin. Many women with breast implants have nursed their babies successfully."

What the IOM report says. "The committee concluded local complications occur frequently and are the primary safety issue. Among the others these include overall reoperations, rupture or deflations, contractures, infections, hematomas and pain. Based on the review of the current research, women can expect early postoperative complications after reconstruction with implants by 30 to 40 percent.

The IOM concluded published reports of patient satisfaction might be misleading because most surveys are carried out by plastic surgeons and before the likely appearance of some complications. Saline implants are more prone to wrinkling, fold flaws, surface abrasion, and consequent deflation.

In reconstructed patients skin wrinkling has been reported to occur in as many as 26 percent of cases. The committee concluded that modern first-year deflations of saline implants might be in the order of 1 to 3 percent and this percentage would rise closely with time.

Microscopic calcification has been reported in 10 to 33 percent of capsules. It can occasionally be severe causing pressure atrophy of breast and underlying muscle tissue. Gram positive bacteria are often located in a bioslime film on the surface of the implant where they are largely protected by antibiotic action and they presumably contribute to infections."

The McGhan LST found 1.1 and 6.9 percent of breasts with infections after saline augmentation. Implants themselves, implant pockets or capsules and nipple secretions have yielded 23.5 to 89 percent positive bacteria cultures.

Dow in '94 suggest that the presence of subclinical infection or contaminations may contribute to systemic signs of symptoms such as fatigue, myalgia, arthralgia, and diarrhea among others. Hematoma was the indication for reoperation in 3.5 percent in the Mayo series. The experience of one plastic research clinic, 5 to 10.3 percent of patients were reoperated for hematoma.

The aggregate figures for contracture in published research on saline implanted women is 40.5 percent. Capsule formation, especially under the muscles, may result in nerve compression and pain. Usually pain with late onset 8 percent and 30 percent of reconstruction and augmentation patients respectively represent contracture pain.

As Wallace in '96 discussed, pain like sensory change, which is of similar frequency, is not surprising given the damage to the nerves, to the breast and nipple during implantation and reconstruction surgery. See values of 41.6 percent permanent nipple sensory changes, 41 percent Hetter '79, 18 percent decrease in sensation Hetter '91, nerve damage and paresis 1990, and partial to complete sensory loss in the nipple of 70 percent and in the whole breast of 12 percent after augmentation. Whether silicone from the degrading shell crosses the placenta has not been evaluated in women.

Surgery with an incision around the nipple was almost five times more likely to be associated with insufficient milk production. About 30 percent of breast implant augmentations are carried out through an incision around the nipple. The frequency of lactation insufficiency was slightly increased in women with implants, 64 percent compared to women without implants 7 percent.

Another small study of women with saline implants found 39 percent reported breast feeding problems. Data on whether cancer detection is impaired by implants do not allow definite conclusion, although it is clear that implants do interfere with screening mammography by obscuring a variable part of breast tissue, distorting breast architecture, and especially in the presence of firm contractures, which remember happens in a high percent of cases, makes a proper examination with proper compression of the breast more difficult and occasionally impossible.

All of the above information from the IOM report with percent of risk is the type of information necessary for a woman to make informed choice or give her informed consent.

Listed under risks in the informed consent is toxic shock syndrome. According to recent research 1999 there has been a rise in the number of nonmenstrual cases of toxic shock syndrome based on data compiled 1979-1996 perhaps related to a substantial increase in prosthetic devices and postoperative infections since 1980.

What is the percent of risk of this potentially fatal condition? In the last few days I have heard percentage of risk of local complications that are startling high. Breast cancer survivors need to know they can expect a 95.2 percent complication rate in five years. Young women of childbearing age in their 20s choosing implants for augmentation need to know they can expect a 60 percent or higher rate of complications within five years.

Women who are facing revision after learning their gel-filled implants have ruptured need to have accurate complication rates should they choose to be reimplanted with saline or with an additional gel-filled implant.

I heard you vote to eliminate the revision category. If this is so, it is unacceptable. I heard McGhan state that only women with prior implants with leaf valves that fail are reimplanted with implants with leaf valves. If leaf valves have an unacceptable failure rate, they should be recalled by the FDA.

DR. WHALEN: Ms. Keeling, could you conclude, please?

MS. KEELING: Yes. I have listed my recommendations and I'll be glad if I don't have additional time -- I've traveled here at great expense and I hate that you don't have time to hear my recommendations but I will give them to you in writing.

DR. WHALEN: If another of the speakers is willing to yield to you, we'll be happy to do so.

MS. KEELING: That's okay. I will -- I just want to point out the Nuremberg Code states that women and all individuals should have an informed consent and that we have an extremely high failure rate. It's now at 65,720 adverse reports to the FDLA alone on saline filled implants. I thank you for listening to my concerns and suggestions for improving consumer protection. Thank you.

DR. WHALEN: Thank you.

MS. BRINKMAN: I have a question.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: Ms. Keeling, I would like to hear your indications or your comments, your recommendations.

MS. KEELING: All right. Is that acceptable to the panel?

DR. WHALEN: You mean you want to hear the completion of her talk even though she's beyond her time limit?

MS. BRINKMAN: I want to hear her list of recommendations.

DR. WHALEN: Well, unfortunately she's already exceeded her time limit. If someone else is willing to exceed time to her, we can entertain it.

MS. BRINKMAN: Can I ask her that question then, what is your list of recommendations?

DR. WHALEN: Please complete your talk.

MS. KEELING: Thank you. With regards to product labeling, the IOM report states, "It seems reasonable to conclude that both the physical and chemical characteristics of implants should be spelled out clearly in product changes, introductions, and investigations because they may influence patient reactions and patient health.

My recommendations would be this: (1) A complete list of all of the chemicals used in the manufacture of breast prothesis must be provided along with material safety data sheets to the patient. Chemical analysis of the elastomer shell including the pageant valve must be provided. The identification of releasible chemicals must be provided to identify potentially toxic chemicals and estimate the upper limits of the chemicals that could be released to the patient.

(2) At the initial consultation a patient must be given a copy of the current product insert, current FDA breast implant information booklet, current informed consent with any specific patient contraindication, and view a video showing local complications.

(3) At the time of surgery the physician must complete and give to the patient an identification card with patient specific device information and list of chemicals. The FDA must mandate that every breast implant informed consent include the statement, "The Food and Drug Administration has not formally approved these devices as safe and effective because the manufacture has not provided the FDA adequate scientific evidence to prove their safety and effectiveness if the device is not approved."

Those are basically my recommendations. Thank you.

MS. BRINKMAN: Thank you.

DR. WHALEN: Are there questions? Thank you.

Next we'll hear from Ms. Diana Zuckerman from the National Center for Policy Research for Women and Families.

DR. ZUCKERMAN: The answer to the four questions is no. I'm Dr. Diana Zuckerman. I'm the Executive Director of the National Center for Policy Research for Women and Families which is a nonprofit organization dedicated to improving policies that affect the health and well being of women and families.

Our mission is to translate complicated research and medical information into usable information that can be easily understood by the public, the media, and policy makers. For this reason and for other reasons of the work I've done in the past, I'm particularly interested in informed consent issues.

My interest goes back from when I was in academia doing research at Harvard and Yale, to when I was working in the House of Representatives in the Senate, work on informed consent issues on federally funded research, and in the nonprofit world where I've been in the last few years.

I should also mention I'm writing some articles, one in particular for a medical journal on the issue of informed consent for breast cancer patients.

I'm very concerned about the gap between oral and written informed consent and that's something that has been raised before and something that I think we need to talk about a lot. Obviously from listening to the doctors who have testified here, the plastic surgeons in particular, they are going to say how well their patients are doing when they talk to new patients. That's very understandable because I truly believe that they would not be plastic surgeons if they didn't think their patients were doing very well.

I don't think doctors are going to intentionally harm their patients. I think they do the procedures that they think are most effective and they believe in the work that they do. Because they believe in the work that they do, they are going to tell their patients that.

They are going to tell their patients, "I've never had a patient with an infection or one in the last umpteen years." They are going to say, "My patients are very satisfied." They are going to say, "This is the procedure I would recommend to my wife or my daughter." They believe it and it's true. It is what they would recommend.

They might even say things like the statement we heard earlier this morning, "You are going to have more satisfying intimate relationships," even though I don't think we have heard any data to that effect and I don't think that was the standard used when you were voting on effectiveness yesterday and the day before.

I don't know how you can control what doctor's say but you certainly can try to help control how much of that is based on data and how some kind of recommendations about what they can say and what has to be based on data rather than their own anecdotal information.

I also ask you in your formulation in deciding what you think needs to be done to really listen to the patients. I am very concerned that patients have spoken for five minutes each. Very few questions have been asked. I have been talking to patients about this issue for many years and I learn something every single time.

Insurance is a very important issue for these women. It may not be a medical issue pe se but if a woman has a procedure that puts her in a position that she cannot be insured for the rest of her life on anything, I'm not just talking about on issues related to her breasts, that is a very, very serious piece of information that she must have. It's not true, I don't believe, of all insurance companies but it's true of a surprising number of them.

Another thing I want to just mention because of the work that I've done particularly with breast cancer patients and also with implant patients is a number of women that I have spoken to through the years who have told me things like their doctors said to them when they had fibrocystic breast disease, which many of you know is not even a disease, or when they had stage 1 breast cancer, or when they had a noninvasive breast cancer and they were told, "Let's be really careful. I recommend that you get a mastectomy and then we'll get you breast implants and you'll be better than new."

It's that kind of advice that I think we really have to be concerned about, the gap between what these women are being told and what the research actually shows. That is particularly true for breast cancer patients and that's actually something I'm focusing on. There is a whole research literature published in major journals such as the New England Journal of Medicine and JAMA talking about informed consent issues for breast cancer patients and what they are told about what their options are.

There is also, as we've heard the last two days, quite a gap between how the manufacturers understand their own data and how the FDA presented it. I found that fascinating. It was like listening to two different studies.

When you change the denominator, you change everything. These are small changes but they make tremendous difference as to what the results are. Who determines what the results are and how that is explained? I'm afraid that it should not be the manufacturers. Obviously they have their own way of looking at things but some of these are not issues of opinion. They are issues of how you analyze data statistically correctly. It has to be done correctly but it also has to be explained in ways that patients really can understand.

I also think it's terribly important that because there are some negative consequences of these kinds of surgeries that are incontrovertible. I'm talking about some cosmetic problems of clearly that there are some women, we don't know the numbers, who end up looking at lot worse when their surgery is over. I don't mean immediately after but down the road look a lot worse than when they started.

I think there should be photographs in any kind of informed consent document. A video tape would be nice, too, but I think a booklet that is clear, easy to understand, with photographs not just of what can look good but of what some of the negative consequences can be. I think that is very important.

I think it's also very important that you all understand and that the patients understand that to some extent implant surgery, any kind of implant surgery makes changes that are permanent. If a women gets breast implants tomorrow and she wants them taken out later, her breasts will have already changed. You can't just put them in and take them out and expect to look the same afterwards. Eve if you have no problems you're not going to look the same.

Women have to understand that and it's particularly hard, I think, when you're 18 and thinking about it. They have to understand the irrevocable nature of surgery, that certain changes are going to be made and you can't change back again. Even if you think there are -- even if you think the risks are not great, there still are risks and they have to understand what those risks are and they have to understand that you can never go back to exactly where you were to begin with.

I've talked to many women who had augmentation who started out with small breasts and by the time their implants were taken out for the second or third set, they ended up with almost no breast tissue at all.

The last thing I want to focus on, which I mentioned in earlier testimony, has to do with what do we know or what don't we know about systemic disease. I agree that there is no conclusive evidence that breast implants cause systemic disease, but I don't agree with the statements that there is evidence that they don't cause systemic disease. I was disappointed and surprised that it seemed that one of the assumptions of this panel to start with was that we are not going to talk about systemic disease because we don't think that breast implants cause systemic disease.

As I mentioned in the handout that I gave you what seems like a year ago but might have been a day or two ago, if you look at all the major studies of connective tissue disease, all the epi studies, the ones that are talked about by the Institute of Medicine and they are talked about by Marcia Angel and they are talked about by all the experts on this, there are 17 studies that are most widely quoted and only one of them separately analyzes women with saline implants. Only one.

By the way, that's also the only study that looks at mastectomy patients with saline implants separately. We have almost no information about reconstruction patients and we have no separate analysis of saline implants. Let me say what that means. That means that many of the studies have no women with saline implants.

The other studies have mostly women with silicone gel implants and a very small number with saline implants. Guess what? When they analyze them, this is what they do. First they analyze them all together and so you have saline implants, maybe 5 or 10 percent of the population, clearly not much information, and then they analyze them separately looking only at silicone gel. Those are what the analyses are. There are no analyses of the saline except in one study.

I also mentioned before, and I want to reiterate, the NIH is doing studies. NCI is actually doing studies on systemic disease. They are doing a study of 13,000 implant patients. That does include saline, although again it's a minority. They are looking at breast cancer, other cancers, and connective tissue disease. FDA needs to look at those studies. They are not published yet.

There is a scientific advisory committee. I happen to be on it so I can tell you that some of those data are written up but they are not published yet but I'm assuming that they would be available to FDA since they are coauthored by an FDA employee.

In closing, since I'm seeing the red light, I just want to say that I think it's terribly important that in informed consent women be told what is known and what is not known. That's what I spend all my time doing. It's not enough just to say we don't have evidence of something.

If there is no research on it, or course there is no evidence on it. We can't say it's there but we can't say it's not there. Specifically with systemic diseases but also even with the prevalence and incidence of some of these local complications.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: I have a question. Thank you very much. I enjoyed that. What kind of study would you use to convince yourself personally that breast implants, either gel or saline, do not cause systemic illness? What kind of study would be acceptable to you?

DR. ZUCKERMAN: Of course, we would all prefer perspective study but there are problems with perspective studies. I mean, it would be really nice to start out with the women who just got implants recently and follow them for as many years as possible. The disadvantage, of course, is it takes longer and --

DR. BURKHARDT: And if they get ill, how would you know that was or was not related to their implants?

DR. ZUCKERMAN: Well, that's the nature of research. You have a control group.

DR. BURKHARDT: I guess that's what I'm asking you because it's been done with control groups, as you know.

DR. ZUCKERMAN: You would have to have -- I mean, obviously this is not a double-blind study. We know that. There are a couple of things you could do. First of all, you could have comparison samples of women of the same age and health status, and probably socioeconomic status and whatever else you think influences health, and follow those women over time as well.

One of the terribly important things that seems to be missing from all the manufactures studies is that you would have the person determining their health status not be their practicing physician, not be their plastic surgeon.

DR. BURKHARDT: Who would you recommend?

DR. ZUCKERMAN: Any other doctor who has no conflict of interest financially. I mean, somebody who would be paid to do that as part of the study. If you were doing retrospective studies, which I think is obviously a quicker way to do things, and that is what was done with the NCI study, then you do to some extent what NCI did which is you identify patients. They identified the patients through the doctors, not through the lawyers as some people have charged. You identify the patients through the doctors. You get the records for all the patients they have seen. You have to do very aggressive follow-up to find out where they are now because who knows whether the doctor has seen them in the last few years.

You have follow-up done through medical exams -- through medical exams by doctors who are not -- they can't be blind, I don't think, but they can be at least not paid by anybody, not have any kind of financial conflict of interest of finding or not finding whether a women has a particular illness.

The other thing that I would really like to see is that those medical exams cover a wide variety of diagnoses and symptoms and not just rare disease like scleroderma.

DR. BURKHARDT: Thank you.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: Dr. Zuckerman, you have given us a lot of information on what you feel needs to be in a product. We're talking about informed consent. I think that developing the product will be relatively easy compared to developing the process. What are some of your thoughts and recommendations on the process?

DR. ZUCKERMAN: I'm glad you asked that because I had meant to talk about it and I forgot. I ran out of time anyway. I actually just very recently was talking to Joan Pitkin who is a state legislature in Maryland. She was instrumental. I had never met her before. We had talked on the phone years ago. She was instrumental in passing an informed consent law on breast implants in Maryland. I asked her what she thought.

I saw her just a few months ago and she said it was a total waste of time. She said that the law passed but the doctors didn't use the brochure. They developed a very good brochure. She said, "I've actually never seen it." She said the problem was the doctors wouldn't distribute it and even if they did distribute it, she wasn't at all sure what they were saying that would negate what was in it.

Let me also say in informed consent issues with breast cancer patients there was a study recently that was published, I think in the New England Journal but I'm not sure, that talked about informed consent laws that women newly diagnosed with breast cancer be given a pamphlet about lumpectomy and mastectomy and what other options they have.

What they found in the study was that there was an initial increase in women getting lumpectomies which decreased quite rapidly and a year or so later the numbers were exactly the same as before so there was a sense that they had in that research that the doctors were basically initially being a little bit more careful and cautious about providing all the information but that ultimately women are making decisions based on what their doctors tell them.

I'm not sure I'm answering your question. I'm agreeing with you how difficult it is. That's one of the reasons why I think a picture is worth -- not to be trite here -- a picture is worth a thousand words.

If you have a booklet that has some woman who has serious breast deformities as a result of her implants, even though it should be explained that this may not be a common occurrence, I think that goes a long way in protecting women to at least get them engaged in this process and to get them to understand that there are real risks involved that I think no amount of words written on a page is going to convey.

I also, of course, would like to see some kind of monitoring by some outside group in terms of what the doctors actually are saying. If you ask the patients they will tell you -- oh, let me just say, I met with some breast cancer activists a couple of weeks ago. These were women who were not particularly interested in the implant issue.

I was just talking to them about their experiences and every single one of them thought that saline breast implants were FDA approved and perfectly safe. Not only that, but -- I mean, these are activists. These were people who had come to Washington for a federally funded couple-of-day conference. These are not your typical people so they knew a lot. Several of them had saline implants. They were just shocked to learn they had never been FDA approved.

They had been told from the get go that these were approved and perfectly safety. Again, that gets into this issue. It's not just the women who are now unhappy saying, "Oh, nobody ever told me." That's my point here. It's all the women that I've talked to whether they were happy or unhappy and they are telling me the same thing.

DR. WHALEN: Thank you.

Next we'll hear from Ann Stansell from the United Silicone Survivors -- I'm sorry. I'm sorry. Martha Murdock is next, National Silicone/Saline Implant Foundation.

MS. MURDOCK: My name is Martha Murdock and I am the founder of the National Silicone/Saline Implant Foundation. We support survivors of medical implant devices. I am not compensated or retained by industry or anyone else. I did pay my own way to this meeting. I am in litigation with one of the manufacturers.

That's all I have to tell you about me, that I'm from Texas. I guess you can tell that.

Society force feeds both females and males a definition of a beautiful body. Beautiful young women grace the covers of magazines that line the supermarket checkout standards and these images serve as the source of shame for those staring down at a bag of cookies sitting right there front and center in the grocery cart.

On the other hand, consider what you see is not what you always get when you're looking at the fronts of those magazines. Advertisers paint a prettier picture than reality often times guarantees.

Ladies and gentlemen, your body is unique. It will carry you through every season of life so why not take care of it? Taking care of your body is similar to taking care of your car. For your car to run properly you must put gas in the tank and oil in the engine. The same is true for your body.

I for one am tired of having my body used as a guinea pig because that's exactly what they have done. They have used the women to do their experiments on. I don't know why they don't use the women to do the research on.

I would like to discuss some informed consent issues to be considered. The manufacturers of saline breast implants claim that women who get saline breast implants get informed consent prior to their surgical procedure. How can a woman truly give informed consent if she is not provided with all the information that the manufacturers knew about their products? The manufacturers cannot do this because they continue to deny all they know.

Rarely ever does a surgeon tell a patient these medical devices have never been approved by the FDA. There are numerous reports of silicone shells filled with medicogrates, isotonic saline causing autoimmune and other diseases. All implants leak because the silicone shells are porous.

The silicone shell will slough off silicone particles which may migrate throughout the body and lodge in your major organs. The implant manufacturer who previously advertised implants would last a lifetime actually knew at that time they would fall apart in five years. The manufacturers of saline-filled breast implants still have never tested their products to determine if there would be long-term health risks prior to putting their new implants on the market.

Any patients nightmare is just beginning when they decide to take the chance of having saline implants in their body. Within a short time of receiving implants, a formerly healthy individual may begin to have strange and unexplained medical problems. One day that patient's doctor writes in this patient's report that the patient has many illnesses. He also makes a note that this patient has saline implants.

The result of that, bingo. No more life insurance. No more health insurance. No more insurance ever. No one told that patient that within two years they would never be able to get any kind of life or medical insurance. I worked in the industry and as an assistant to the group actuary and I know they have the statistics. Why do not the other manufacturers and industry representatives?

Manufacturers of saline-filled breast implants claim that patients who get saline implants are provided package inserts prior to their surgical procedures. I personally never saw one. I can't find a friend that ever saw one of any kind. Furthermore, how can a patient truly give informed consent if they are not provided with all the information the manufacturer knows about these products.

Do those patients have the right to receive this information? My answer is absolutely yes. Do they have the right to destroy their body in making their decision? I guess they do. I wouldn't.

If any patient is told the truth that saline implants were never tested and determined to be safe for long-term human implantation, the implants would leak saline into your body from the implant shell and could travel to all your major organs and on and on the same thing, but they don't tell their patients these things.

What is wrong with hundreds of thousands of women whose only common denominator is a silicone envelope filled with a saline solution as an implant? On one hand the manufacturers claim saline breast implants are safe and do not cause health problems. They claim these women have illnesses that don't exist diagnosed by greedy doctors taking advantage of a valid concern that this untested product might be the cause, or at least a contributor to the medical problems the women are experiencing.

Could thousands of doctors treating hundreds of thousands of women for the same illness or the same symptoms or similar problems be that wrong? Could laboratories all over the country testing and evaluating the blood and specimens from these women be manipulating and orchestrating the test results so it appears these women have illnesses that don't exist? Or is it more likely than not the breast implant manufacturers have another reason to promote the fallacy of the illness that doesn't exist?

Reasonable minds would wonder. If a silicone shell filled with isotonic saline breast implants are truly safe and do not cause health problems, why is the same insurance company insuring the saline implant manufacturers and then refusing to pay health claims of women with breast implants? If saline implants are safe, why did the manufacturers only begin testing once the silicone implants were pulled off the market and restrained to only a few?

Do the insurance companies know something that we don't know? You bet they do. They have all the information in one form or another. If the members of this committee are sincerely looking for the truth, ask yourself how can so many women have an illness that doesn't exist which can be diagnosed, quantified, qualified, by scientists, epidemiologists, and researchers, not to mention the treating physicians for these scores of women.

The truth will never be found through research funded by the very manufacturers whose product has caused this illness that doesn't exist. Stated failure rates for these products that I have heard this week I find to be totally unacceptable for myself, my daughter, my granddaughter, or anyone else I know.

In closing I would like to mention the saline inflatable penile prosthesis. Given the panels views of buyer beware policy associated with your views so far as what I basically heard, would you be prepared to use the same approval with conditions for saline inflatable penile prosthesis? I seriously doubt it. The failure rate tables must be available for all breast implant and penile implant recipients in their informed consent information.

I thank you so much for your time and I'm sorry I'm hoarse. Do you have any questions of me?

DR. WHALEN: Thank you, ma'am.

Now next indeed we do have Ms. Anne Stansell from the United Silicone Survivors of the World.

MS. STANSELL: My name is Anne Stansell. I'm from New Mexico. It's unbelievable that I am here today to talk to you about something that should have been taken care of 30 years ago.

DR. WHALEN: Ma'am --

MS. STANSELL: I have no financial ties to any other matter in this other than we have a contract. We the people of the United States pay our taxes in part so the Government will provide certain protections. We trust in these protections.

When I got the news I had breast cancer, I was devastated. I had to put my trust in a borage of doctors. After the mastectomies the surgeon said, "You need breast implants." The oncologist, the psychologist, the radiologist, the plastic surgeon all said get implants and they are perfectly safe.

I felt as if they had just saved my life by removing the cancer so I trusted them. I knew they had to answer to my Government and we have a contract. So I trusted that the use of breast implants for American women was being supervised. At first a breast implant seemed okay just like you were told yesterday and the day before. I was satisfied for the first two or three years. It helped me be in denial about having my life threatened. Several women testified to that here the last few days and even one today.

One doctor hit the nail right on the head. Soon I realized these lumps on my chest were not breasts. They did not even resemble breasts anymore. One was hard as a baseball. The other shifted up to my shoulder. I looked ridiculous. I realized I was in constant pain. I had been ignoring the pain. As it became more severe I had to face it.

Then when I got sick after having implants, I started to check into whom I had so blindly trusted. I checked with the cancer organizations. They knew of no research on mastectomy patients and breast implants. I checked into the medical organizations. They could provide no evidence of research that had been done on mastectomy patients and breast implants.

Then I checked with my Government, the department that oversees our medical needs, the FDA. I was appalled to learn there was and still is no research on mastectomy patients and breast implants. We have survived breast cancer. Will be survive implants? We don't know. You don't know. Cancer survivors with implants now face a lifetime of surgery and pain. What good is it to survive cancer then?

Yesterday I heard McGhan quote a 95 percent complication rate for reconstruction patients. 95 percent and you recommended approval. 95 percent complication rate was not shown on the slick slides that we've seen today. 95 percent complication rate means a lifetime of surgery every five years per breast. that is not statistically acceptable.

Even toasters come with a better guarantee. I would not buy a toaster that came with an expected failure rate of 90 percent. Would you? Toasters come with a registration card. If something should be found defective with the appliance, there is a recall. If toasters can be tracked, why can't women's breast implants?

When you see those clean colorful bargraphs on the screen they sure look pretty, but those represent real lives, real women with real families. Most insurance companies accept women five years after breast cancer treatment if there is no recurrence. Insurance companies will not accept us if we have now or ever have had breast implants. This was not mentioned on the pretty bargraphs either.

The manufacturers talked of deflation and deflation rates. Sounds rather harmless. Not once did I hear rupture. When a breast implant deflates, it ruptures. The word rupture brings to mind the violation occurring in our tender chest.

Tell me what would happen to a physician who puts a saline IV into a patient's body with an expiration date of seven years ago? Isn't that, in fact, what happens when a seven-year-old implant ruptures?

Dr. Goldberg's research proves the rupture rate and we are providing the evidence that breast implants are not safe and effective. We are Dr. Goldberg's lab rats. We trusted the FDA to have these facts before you so negligently committed all of us to a lifetime of illness and suffering.

We have a contract. You, the Government, and we, the people -- we the women. We have come here to let you know that this generation has been betrayed. Stop. Don't betray the next generations as well. But we already have that contract. What kind of sick process is this anyway where women from all over the country have to travel here all this way to bear our souls and chests to you?

Is it not enough that we have already lost our breasts, one of the most nurturing aspects of womanhood, the very parts necessary to raise the continuation of we the people. We have a contract. You must fulfill it. You must do your part.

I would like to give the remaining three and a half minutes to Marlene Keeley.

MS. KEELING: One informed consent by the manufacturer states, "Neither Mentor nor FDA know of any reason why existing coverage policy should not continue." I have a copy of an insurance underwriters guide which states if a women applies for health insurance and she has breast implants, the standard response is to deny her coverage. American women deserve the truth. Truthful information from the FDA, the chemical companies, the manufacturers of implants, and the medical community.

May I remind this committee the Nuremberg Code states the following. "(1) The voluntary consent of the human subject is absolutely essential. The person involved should have free power of choice without any element of fraud, deceit, overreaching, or other ulterior form of constraint or coercion and should have sufficient knowledge and comprehension of the elements involved to be enabled to make an enlightened decision.

(2) No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur except perhaps in those experiments where the experimental physician also serves the subjects.

(3) During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage if he has probable cause to believe in the exercise of good faith, superior skill, and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death of the experimental subject. Once implanted, it is impossible for a woman to terminate the experiment because the degrading chemicals from the shell and the gel that spreads to all parts of her body may never be removed. Thank you.

DR. WHALEN: Would you entertain a question, ma'am?

DR. BURKHARDT: May I ask a question?

MS. KEELING: Yes.

DR. BURKHARDT: I'm intrigued by the underwriter's guide to which you referred. Do you have a copy of that?

MS. KEELING: I'm sorry. I meant to bring it with me. I'll be glad if you have a card to --

DR. BURKHARDT: From what company did you get it?

MS. KEELING: I'll have to check on that for you.

DR. BURKHARDT: Thank you.

DR. WHALEN: Thank you.

Next scheduled speaker is Amy Allina of the National Women's Health Network.

MS. ALLINA: Hello. My name is Amy Allina. I'm the Program and Policy Director of the National Women's Health Network. You heard comments Wednesday and Thursday from my colleague, Cynthia Pearson, and I'm here today to talk about the issue of patient information.

The network is an independent member supported organization dedicated to safeguarding women's health rights and interests. We accept no money from pharmaceutical companies, medical device manufacturers, or trial lawyers. I'm not a party to any implant lawsuits and I do not derive any income from implant surgery.

Throughout the three days of this meeting the question of whether or not saline-filled breast implants should be found to be safe and effective has been repeatedly presented by implant advocates as a matter of choice. Women, they say, should be able to choose whether or not to take whatever risks are associated with implantation of these devices.

The National Women's Health Network was founded on the principal that with accurate and complete information women can make good health decisions for themselves.

Our concern about saline-filled breast implants is the data that women need to make fully informed decisions about this healthcare choice are not available.

That said, we believe that all the data that are available about complication rates over time should be included in the patient information given to women receiving implants. This means that the patient information should include the total complication rate and a full explanation of the kinds of complications that might occur including infection, breakage, and contracture.

In addition to the total complication rate, it should also include a breakdown showing the different complication rates for augmentation patients and reconstruction patients. The data should be presented in a way that is easy to read and understand for consumers. We agree that they should be illustrated by photographs of the outcomes described.

We also feel that any benefit information included must also be supported by data. Patients should be told that the FDA encourages them to consult a different physician if their doctor's oral communication negates the written information that they receive.

Finally, we urge the panel to recommend that the patient information should include a statement explaining that the expert panel which approved these products did so in spite of the fact that it believed further research was needed to determine the long-term safety of these devices.

Women receiving saline-filled breast implants need to know that experts believe there is not enough data to definitively say what happens to implants and implant users beyond five years after implantation. There should also be a statement informing women that the safety of breastfeeding following implant surgery has not been adequately studied.

To make a fully informed choice women must be provided with data about what is known as well as information about what is not known. Since the panel has recommended approval of these devices, even while acknowledging the lack of long-term safety data, we ask you to be ensure that women choosing implants have the opportunity to make that choice with the full information that was available to you when you made yours and with the awareness that you, the experts, found the long-term safety data to be lacking. Thank you.

DR. WHALEN: Thank you.

Next we'll hear from the organization NABCO. I understand the speaker will be Rosemary Locke.

MS. LOCKE: Good morning. My name is Rosemary Locke and to answer your question I have no financial motives. I'm not involved in a lawsuit. I receive no compensation. However, as both Jill and I stated on Monday, our organizations do receive some funding from pharmaceuticals and in the past from some manufacturers of devices that are no longer available on the market.

DR. WHALEN: I think it was Wednesday but I don't blame you for thinking it was Monday.

MS. LOCKE: First of all, I want to thank the panel for its very thoughtful understanding of some complex issues. I had the pleasure of serving with Nancy Dubler on the last panel. This issue of informed consent and labeling is tough. I have found myself over the years in agreement often with those who are in opposition for breast implants, though my organization and a number of breast cancer organizations are in favor of choice.

Before I make the comments about labeling, and that's really why I'm here, on labeling and informed consent, I do want to point out that the breast cancer organizations, the main large ones, got together and sought funding from the IOM to review the studies on gel breast implants because it was so contentious and we felt we had to go to an unbiased source.

Now, with that these are my comments on informed consent labeling. There should be general information about all reconstruction options and devices. Along with that I would like to see the information that is given in the clinical trials, for example, with gel trial for patients. Much of that information should be included for women considering breast implants.

Women considering breast implants may have varying communication styles so that while one person might be inclined to request additional information including the package insert, another would leave the doctor's office with only the information given to her. These differences must be accounted for in a more standardized approach to disseminating information and tools to help gain a deeper understanding.

Now, I know in the instructions there was talk about focus testing. I think that is crucial. I would like to see experienced advocates included with novices who would be coming like a newly diagnosed patient so that you could see how people really receive and retain information. Those of us who have worked in counseling patients know that you can tell someone something numerous times but are they hearing and truly incorporating that information in how they are processing and coming to a decision.

Now, I think that all of the information put out by the manufacturers and FDA have to reflect the IOM review. The IOM deals with what we now know, what we don't know, and the remaining concerns. I think it has to be updated.

I would also like to see something put in there about the technique and experience of the surgeon. As many of you addressed, it's not simply a matter of the device. You need to elaborate on the risk and cost implication of revision and replacement surgery. Who pays for this?

We need to know more about the life expectancy of the implants. Since we don't know all that much, you have to acknowledge that they have to be replaced periodically and that there will be a need for an ongoing relationship with the plastic surgeon.

It is especially important for young women to know this issue of failure rate or the unknowns about failure rates. Again, I'm speaking of breast reconstruction primarily. A woman's age and the uncertainty of these devices over a long period of time might significantly influence her choice of reconstruction. And considerations for current insurability and the financial implications of selecting a device.

While both Y-ME and NABCO choose only to focus on reconstruction, for those women who do consider these devices for augmentation, a great deal of information should be given to them about the nuances of placement of that implant in relationship to what is optimal for screening mammography.

Certainly there should be duplicate copies of the package insert with the specific model and type so that the patient has one and the doctor has one. I didn't quite understand when the manufacturers presented today why it was the patient's obligation to jot down the model and the type. It seems like that should be somewhat routine coming with that particular model.

While I didn't stay for all of the PIP discussions yesterday, the idea of having kind of a bar code or something on an implant so that if it's taken out, you know exactly what model and batch it came from might not be something to be dismissed. It might be a good idea.

Clearly the description of the operation -- Sybil and I have been in agreement on the need for a registry so I would like to follow up on the manufacturer's suggestion and a card in there for having patients in a registry because that would help solve a lot of these unknowns we have about long-term studies.

I do want to compliment the FDA in its instructions, however, for pointing out to the manufacturers that if you over warn about devices, it dilutes the strength of the most frequent and serious risks. I think you have to be very careful in devising this information and the labeling so that people really understand the magnitude of the problems as the frequency and the seriousness of those.

One comment on the retrospective studies that Diana spoke to you about and many of her remarks were very thoughtful as they always are. One of the problems with the retrospective study that she has brought up several times, we fear there's the self-selection bias because those augmentation patients who they try to bring in to that study could choose to participate or could choose not to participate. It is our sense that a lot of people who are happy with their implants for augmentation probably don't want to come forward and make a point about it.

There is another problem with a retrospective study like that as far as giving usable advice now. There were so many manufacturers and so many models involved in those earlier years that it's somewhat meaningless information to give to women who are trying to select an implant now. From that point of view I don't find it terribly helpful.

Now, in closing I would say that Y-ME, and I'm sure other consumer groups, would welcome the opportunity to work with the FDA to try to develop a more uniform informed consent document that would help women truly understand the risks and the benefits of these devices and take away some of this terrible sense of betrayal that some women feel and rightly felt in the earlier years when they did not have adequate informed consent.

Thank you. Do you have any questions?

DR. BURKHARDT: I have a question. We've had so many studies to deal with. Can you tell us to which study you were referring in your comments about patient selection?

MS. LOCKE: Well, it's the one currently going on at NCI with one FDA official who is here now. Do you want me to name names?

DR. BURKHARDT: I don't know. I mean, is it a published study?

MS. LOCKE: No, it's not published.

DR. BURKHARDT: So we really don't have access to it then?

MS. LOCKE: No, we don't. But my point --

DR. BURKHARDT: No, that answers my question.

MS. LOCKE: Okay. But my point really was more of a generic nature with the retrospective studies where you have a patient. Patients can choose or not choose to participate in the study. Because of that you've already got a self-selection bias.

DR. BURKHARDT: I understand.

MS. LOCKE: Thank you.

DR. WHALEN: Thank you.

Next we'll hear from Christine Williams on behalf of the American Cancer Society. Maybe we won't. We'll hear from Jama K. Russano from Children Afflicted by Toxic Substances. Strike two. That was the list of the scheduled speakers that we had.

Before we proceed on to Mr. Rhodes presentation to us, the open panel discussion was scheduled to begin after lunch. We were going to be addressed with comments like two of the panel members for this process and Ms. Dubler may not be able to be here due to time constraints. I would ask that she address the panel with her remarks at this time.

Ms. Dubler.

MS. DUBLER: First I'd like to thank all of the people who spoke this morning for presenting to us a different quality of data than we generally receive. That is qualitative data. There are two sorts of data that medicine now looks at. It looks pretty exclusively to quantitative data but testimony over time I think has its own importance.

I would like to take a few minutes to really reflect upon this process of informed consent that we are all trying so hard to get to work and suggest to you that there are structural reasons why it's not working. I'm not exactly sure how to solve them.

Informed consent is a concept that's been around for a while, although it's interesting that it wasn't called that until a California case in 1957 so it's relatively recent doctrine. It was developed in the context of the doctor/patient relationship as a way of redressing an imbalance of power within that relationship.

It became important at the time of the rights movements; the women's rights, the patient's rights, etcetera. It was developed really and elaborated as a way of redressing a situation in which by in large doctors made decisions. They had the skill and the wisdom and the experience. It was the time of hegemony of paternalism as a mode of operation. Doctors told patients what would happen.

Informed consent was there as a way of redressing that and saying, well, it's really what's important to the patient in the context of this illness that should determine what should happen and that a patient's values and personal idiosyncratic choices are as important as the things that the doctor thinks is important. So the skill and wisdom and options and explanations that the doctor could provide were to be used by the patient to make a choice.

Now, this notion of patient choosing is an old one. The best quote I know, there is a wonderful New York State case from 1914, Schloendorff v. Society of New York Hospital where the court says every human being of adult years and sound mind shall have the right to determine what shall be done with his own body.

So informed consent is a doctrine that developed in the following way. First of all, it requires a "decisionally capable patient." That is, in common parlance an adult patient, not a child, who isn't retarded and who's come to have the general capacity to weigh and value what's important.

Now, I don't say wisdom. Some of us get wisdom when we get older and some of us never gain wisdom. Informed consent doesn't require wisdom and that's really important in the context of what we're talking about.

I hear the people talking this morning who want to get out there fists and say, "You silly woman. Can't you read these data the way we do?" Well, informed consent doesn't require that a woman be able to evaluate data the way some of us would like her to. It requires a decisionally capable person who is able to articulate and identify personal values, who is provided with sufficient information to understand to the greatest degree possible for that person what the issues are, and to make a personally valid choice, and to communicate and act on that choice.

That's the classic notion of informed consent. I'm here to tell you since I work in the trenches in the Bronx that it hardly ever operates the way we would like to see it operate. If it ever works at all, I would like to say it works well between two white upperclass males in Scarsdale where they all share the same values and the same economics and the same life view, and it helps if they went to the same college together.

But once you introduce race and class and power and economics and differentials and education, it's a very hard doctrine to make work. That's the context in which we are trying to make it work now. One other comment about how it exist now. It is largely not a doctrine for empowerment and deciding. Over the last 15 to 20 years it's become a risk management technique. Hospitals, institutions, and physicians have said if we can get all these risks on the table and we can document that the patient saw them, then we are not liable if they happen. So that violates everything that we really want out of an ethical doctrine of informed consent, but it's now the dominant mode of how the concept is used.

I like to say that it's what I call the smorgasbord theory of consent. Physicians some of whom are very angry about this doctrine and about issues of liability put out their options. "Here is a little cheese. Here's a little salami. Here's some pickles. Okay, patient, you make your sandwich." That's not really what the doctor/patient relationship is. The doctor/patient relationship is one of advice and trust, but informed consent has worked unfortunately to undercut that.

So where does that leave us? I think it leave us with having to develop something of a new paradigm and the FDA having to really articulate what that is and make it work. Because this dual relationship that was the basis for informed consent, the doctor and the patient, has changed. What we now have are, as I analyze them in any ethical analysis, I ask who are the parties, what are their interests, are their interests in conflict, and how do we resolve that conflict.

We have a lot of parties who are players here. We have the sponsors and the manufacturers. Their interest is in selling and advertising and increasing the market for their devices. We have the surgeons. Some of them are very well trained and very adept and are probably very good at what they do and some of them are not. There is a great reluctance within the surgical community to become involved in identifying who fits into which one of those pots.

We have surgical organizations. We have consumer organizations. We have patients. Something we haven't' heard a lot about at this meeting, but I hear a lot about in my work, and those are the partners of women who go for especially augmentation, men who are their partners who have very heavy commitments to this surgery. We haven't heard that and there aren't data to support it, only my own useless anecdotes.

So what do we do? Well, I would suggest that there are three principles that should guide what the FDA does. One is the notion of transparency. That is, any data that exist should be given to the woman, and it should be given to the woman in the best form that the FDA can help the sponsor to put it in. And those data should be very stark and very informing. There is a 60 percent rate of complication and resurgery over x number of years so any data that are there should have to be in the sponsor's informing material in a way that the FDA approves of.

Second is awareness, the second principle. That is, within this very complex world of different players that the FDA should work to make an awareness of the risks of continued surgery, capsular contracture, whatever the major risks are, highlighted to a woman, not set in the context of advertising and promotional literature in the way that the company thinks supports its interest, but that a way the FDA supports the interest of informing the individual patient.

Finally, I'm going to suggest, because I think this really is a field of great conflict, that we think about having some independent source of information in the process. Let me give you an example from the research world. Many of us who work in research ethics have for a while written about the problem of the researcher and the clinician being the same person, the duel hat problem.

For example, my IRB in very complex psychopharmacological protocols now require simply that there be two people. The clinician and the researcher be two different people. If you're going to take someone off medication for schizophrenia, you're going to leave that clinician to work with the patient.

I'm not sure that we can provide an independent advocate for every woman and I'm not sure that all women would want that. But I do think the FDA in its materials can make very clear where the web sites are, where you can get independent information, and perhaps what the phone numbers would be, the 800 numbers of advocacy groups which we will very clearly identify as groups that will argue against.

So transparency, awareness of risks, and the availability of an independent source of information would be the three principles that I think we would add to the standard principles of informed consent that deal with this very complex arena of players and conflicting interest. Thank you.

DR. WHALEN: Thank you, Ms. Dubler.

Do any of the panel have questions or comments on those remarks? Dr. Burkhardt.

DR. BURKHARDT: I do again. I would just like to comment, Ms. Dubler, that many surgeons have no reluctance whatsoever to comment on the lack of qualifications of individuals who are doing this procedure. The problem is that we have no authority under the anti-trust statutes to control that activity and I'm sure that you realize that. In many cases we are indeed faced with an instance of caveat emptor which we do not like but over which we have no control as a professional.

The second issue that concerns me is the web site suggestion. In general I have no problem at all with access to information but my experience is that the information that my patients are now getting on the web site they regard as written on stone tablets because it's on their monitor. In fact, if they can't properly judge the information I give them as a responsible surgeon, they sure can't judge the accuracy of the information that they receive from advocacy groups.

DR. WHALEN: Any other questions?

MS. DUBLER: Can I answer?

DR. WHALEN: Oh, certainly. Feel free.

MS. DUBLER: Yes, but. The but is if our goal is to raise an awareness that there are problems that they better investigate further, I grant you there's no quality control over web information, but at least we will feel we have done our best to give a clear notion that there are two sides of the issue.

DR. BURKHARDT: I would like to ask you a question. I am very interested in your presentation. Do you feel that the -- I don't know what the legalities are here but do you feel that the authority of the FDA as the supervising agency here should extend to the promotional material that is published really by the companies?

What the companies do, of course, they want to sell their stuff. I don't blame them. If I was in the business, I would want to sell my stuff, too. So they'll go through an advertising agency and they will give them a certain basis on which to work with. One of the things that I noticed, as I'm sure you did, there weren't any ugly women in those photographs that come through. Should we attempt to control that area of commerce in the name of fair balance?

MS. DUBLER: Without question. Without question. Can the FDA do that?

DR. WITTEN: Well, maybe I should clarify that. We do, in fact. Labeling broadly encompasses for these PMAs. It broadly encompasses the material that goes with the product and the material that is meant to explain the product even if it's not physically accompanying the product.

DR. WHALEN: Does it also encompass the local physician's advertisement when it mentions the product name?

DR. WITTEN: It doesn't encompass the physician's advertisement.

DR. WHALEN: Is that the thing that you know of in the FTC?

DR. WITTEN: I can't answer that.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: Could I ask a question about that? Will the ability to, how should I say, be involved in the advertisement part, does that change with the status from an approved PMA to the previous status whatever that was called?

DR. WITTEN: In terms of what we can -- what we regulate it doesn't. What does change is the fact that we need to see in advance for material that accompanies the PMA, that goes out with the PMA. We approve all the labeling in advance. In other words, we have authority over the material but we don't preapprove it the way we do with the PMA.

With these products when and if we move to approving the PMAs, we would work with the sponsors to make sure that they label all the material that they send out. All the promotional material be something that is consistent with what we think it should be based on the data that the sponsor provided. Also we'll be looking at the kind of discussion that we had today to see how we will incorporate those ideas into what we tell them about their promotional material. The answer is yes, we'll be looking at all the material.

DR. BURKHARDT: Could I bring up to just follow this issue a little bit, I served on the ethics committee of our national organization for quite some time and one of our provisions at the time I served was that if a member of our society would advertise, which is okay, and showed pictures of someone purporting to represent the product or the service advertised, that individual had to be a true patient of the doctor who is advertising and not only had to be a true patient but had to have had the procedure that is being advertised.

We enforced that for quite a while. Then one of the implant companies came out with an interesting marketing program in which they now refund us "monopoly" dollars in their advertising dollars depending on our commercial relationship with them. Those dollars are used to run advertisements that are provided by the implant company but we run them in our local newspapers and magazines and so forth with our name on them.

The patients who are pictured in those advertisements are very good looking as you might imagine. They are not my patients so we've had to completely readjust our own ethical standards based on some of the commercial activity that is going on. I just wonder if you think that the implant companies should be permitted to continue to promote their product directly to the patient?

MS. DUBLER: I have a prior comment which is you were forced to adjust your ethics to commercial practice. Why? You could just as easily said it is unethical for doctors to accept money to use these advertisements.

DR. BURKHARDT: It's interesting because our attorneys -- whenever there is a problem, there's usually an attorney right in the middle of things.

DR. WHALEN: Who never solves anything.

DR. BURKHARDT: Our advice from our attorney who oversaw the process is that that would be restraint of trade.

MS. DUBLER: My LLB, a number of people have asked me what it is. It's the law degree that you got if you graduated from law school before 1968 which I did.

DR. WHALEN: At the age of 6.

MS. DUBLER: It attests to my venerable age. I don't have the skill to evaluate the wisdom of that attorney's advice. I do think that organizations have the right and the obligation to set their ethical standards according to their patterns of professional practice and their values rather than according to the vagaries of commercial behavior.

DR. BURKHARDT: I have no disagreement with that.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: I feel like I'm stepping out onto thin ice. I'm a numbers guy. We talked a lot about numbers and I'm very interested in whatever materials are produced having numbers that are, first of all, accurate and, second, understandable and so forth. I feel like I'm on solid ice there but now I'm going to step on it.

I am a father of teenagers and I have not had to face this yet but it is something that I expect might happen, and that is body piercing and tattooing. What I'm concerned about here more than anything else with this informed consent process is the younger people who are faced with this augmentation decision. I'm wondering because there seems to be a substantial difference just taking a real contrast between the informed consent that such a person is faced with. Maybe not conformed consent so much as it is the process of making the decision, versus an older woman doing it or a patient seeking reconstruction or whatever.

I'm wondering what -- I really have two questions. Are there really substantive differences between that extreme form of informed consent or that process and all the other parts of it? I would like for you to comment on that.

Then I'm wondering if there should be something like a personal responsibility web site that people should be referred to who are in that kind of a position that talks about personal responsibility and decisions regardless of whether it's tattooing, body piercing, or whatever, along those lines.

MS. DUBLER: I'm not sure. I mean, I share your concern. I'm not sure I have anything useful to respond to it. We just published a book out of my shop called The Adolescent Alone. For that we reviewed over the last two years all of the literature on developing capacity. The capacity literature says from about 13 years on most children have the ability to make decisions based on data.

However, as I'm sure you know, I pause at that point having raised kids. It takes my breath away. There is also this notion that I'm sure you know that probablistic thinking is the most abstract kind of thinking and the last one to develop in this range of skills of capacity that we have. We are dealing largely with probablistic information.

I don't think there is any way to limit these implants. Once someone reaches 18 and they are legally able to make choices, I don't see how we can effect it. Although I was very pleased to hear the surgeon say this morning that he has a different protocol for younger patients which, I hope, include the early 20s.

I mean, they are going to piece their navals and tongues and they are going to get breast implants. It's all quite consequential and the breast implants perhaps the most consequential. I don't know any way that we can limit that decision-making ability.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I'm going to step on even thinner ice but it's addressing Dr. Blumenstein's comment about the process of giving information. We had a comment this morning to the effect that we won't know how to evaluate whether people really get it or not, but there are formal methods imperfect as they may be for evaluating.

I recognize them explicitly in FDAs recommendations about how you draw up informed consent making sure that people first recognize a risk and then perceive the risk as real to themselves and health seeking. There is a very standardized literature on this imperfect as it may be.

I strongly hope that whatever materials are developed will be rigorously investigated along these lines with data on their effectiveness and people not only having read it but actually comprehending. I mean, the GRE test, you know, evaluates how well people comprehend what they read and in some sense internalize the meaning of risk, both probability of risk but also loss. That is the other component of risk even if something is very rare. If it carries a high loss, then one should internalize that, too.

DR. WHALEN: Thank you. I'm going to exercise the prerogative of the Chair since I think there's some good healthy discussion going on and ask Ms. Brinkman to go ahead and make her remarks at this time.

MS. BRINKMAN: Thanks. I would like to comment, though, in my 30 years since I was a very small child developing and evaluating patient education materials. There are very effective methods for assessing effectiveness of the materials and we do use them constantly in our settings.

As consumer representative I asked some time ago when I knew that this panel was going to convene to make myself available to consumer groups, to professional groups that had interest in the subject matter. It was a mixed blessing but I've learned a lot.

I have had the opportunity to listen to literally dozens of consumer groups and patients and communicate with professional groups as well, physician groups. I want to assure those consumer groups that are here today that I have taken extensive notes on all of your comments and will share them with the FDA so that your suggestions for things that you would like to see included are relayed to the FDA.

Some consensus amongst consumer groups. Certainly, as we all know, talk about improving our informed consent both in content and process. We have discussed adequate decision-making time, although I don't know what that is and don't pretend to.

We've talked about improved access of mediated materials which include the use of multimedia, written materials, toll free numbers, web sites, audio visuals, full disclosure of data including information from the IOM report. Certainly improve details of description of risks and benefits. We talked about using photographs of desired results and often times photographs of results that are less than desirable. We talked about easy access to additional resources such as creating a web site with hyperlinks so that the most commonly looked resources for someone who is considering some sort of breast health issue, they may go to ACS or NCI or Y-ME or whatever and have a hyperlink from their web sites to an FDA web site that talks more extensively about breast implants.

We discussed a national registry of all implant patients including a good suggestion, I thought, was not only identifying office of the manufacturer and the product number, but having on the flip side of that for the patient instructions that they could take to the mammography site with them about how their implant and being able to assess the mammography site's ability to use appropriate techniques.

We discussed about patient costs, what are they over a period of time, what is the availability of insurance, and what does this do to one's ability to get insurance.

We talked about duplication of package inserts. We talked about standardized systems to help collect more information about frequent causes of complications and their medical management.

We talked about including in education materials changes in physical properties including implanted breasts such as match, shifts, healing process, lactation, etcetera.

We talked about or had some discussion on professional responsibility and advertising and looking at what age group do we advertise to and the FDA's responsibility at least in the content of advertising.

I took notes this morning. There are many more suggestions. I will give them to the panel and I'm not going to continue. Some of them are repeats. One suggestion in particular came from a physician group which I thought was interesting.

The physician was a board certified plastic surgeon who said, "I would like to see a brief concise physician training designed by physician experts that was required before their ability to purchase any products. This would include continuous update on clinical trials and availability of patient education resources, etcetera." His comments were that this has been done for other devices and is mandatory for all physicians who wish to purchase the devices.

I believe the challenge that lies ahead of us is not only in developing an adequate product but in providing an entrepreneurial nontraditional approach to get information into the hands of consumers. I also believe in my years in healthcare that the physician/patient relationship is of utmost importance. No one would certainly want to put their life in the hands of someone that they did not trust.

I think we need to be realistic about the nature of human relationships. We have highly skilled physicians that do not have good communication skills. We have some physicians that may not be good teachers. We have some physicians that may be biased, as well as some patients that are not good listeners. They are selective listeners that have high anxiety especially after breast cancer surgery that oft times clouds their ability to be a good listener and absorb information.

We have some patients who do not care to learn at all. I think the one thing that we can all agree upon is that the majority of physicians and patients do want a positive relationship and good communication.

I think we all agree upon the fact that consumers today are more savvy and have increasing access to multimedia. Interestingly enough successful industry knows how to reach their customers and measure outcomes of their effectiveness in both content and process. Otherwise, they wouldn't be in business. I think we in healthcare need to be able to do likewise. Thank you.

DR. WHALEN: Thank you, Ms. Brinkman.

Are there any questions or comments? Obviously as an educator you presented it so perfectly that we don't need to ask any questions.

MS. BRINKMAN: Oh, yes. Well, it's not anything you probably didn't know.

DR. WHALEN: I would then like to ask that Mr. Stephen Rhodes do the FDA presentation at this time.

DR. RHODES: Good afternoon. I am Stephen Rhodes and I am the Chief of Plastic and Reconstructive Surgery Devices here at the FDA. The panel has heard from patients about the importance of making an informed decision and breast implant surgery. You have heard from the manufacturers about their process and patient information labeling for women.

I'm going to summarize the agency's history in assisting women to make informed decisions and will ask you questions that will help us to assure that patients get the right information in the most appropriate format to make informed decisions.

The FDA has published two Federal Register Notices on patient information for women considering breast implant surgery. Due to the high number of inquiries that the agency gets each year from patients either with implants or considering implant surgery, the agency has also published a breast implant Consumer Handbook which is updated regularly.

I'll summarize briefly the kinds of information that the agency has found of value to include in the handbook. FDA has also developed draft guidance for patient labeling for any type of medical device and I will mention a few highlights that are particularly relevant to women and saline-filled breast implants.

Lastly, the FDA has drafted an outline of patient informed decision information and we have questions regarding the content of this draft.

In 1991 FDA published a Notice in the Federal Register to promote the dissemination of information on risks associated with saline-filled breast implants. The Notice said that the FDA will consider breast implants misbranded if their labeling does not provide adequate written information to patients on the risks associated with these devices.

The Notice said that such information should be written so as to be easily comprehensible to most patients prior to scheduling the implantation so that patients have sufficient time to review the information and discuss it with their physicians.

To satisfy these requirements the Notice required that patient risk information must set out the known, suspected, and potential risks associated with the implantation of breast implants.

In addition to the general risk associated with any surgical procedure such as infection, the Notice stated that patients should receive information on local complications such as capsular contracture, rupture, and changes in nipple and breast sensation.

The Notice said that in addition to these numerous, patients should receive information about the unanswered questions regarding the risk of longer term systemic complications, autoimmune disease being an example.

Then in 1994 FDA solicited comments from health professional groups, consumer organizations, and manufacturers of saline-filled implants on updating the patient risk information. In 1995 FDA published another Notice in the Federal Register announcing the availability of a patient risk information sheet entitled, "Information for Women Considering Saline-Filled Breast Implant."

The manufacturers of these implants at the time, McGhan Medical and Mentor Corporation, agreed to send a Dear Doctor letter to their physician customers to remind them of the importance of providing this information to all perspective patients.

The Notice also ensured that all saline-filled breast implants include the revised patient risk sheet in their packaging. The updated sheet had information of the most common risks such as deflation, capsular contracture, and interference with breast cancer detection.

The information sheet included discussion of the known risks of saline breast implants such as additional surgery and shifting of the implant and unknown risks such as autoimmune disease, breast feeding, and candor.

Additionally, in response to a large number of patient inquiries that the FDA was receiving directly, the agency developed a Consumer Handbook for all types of breast implants, saline filled, gel filled, and alternative fillers.

The handbook is available in hardcopy and on the Internet. The handbook explains the availability and regulatory status for breast implants. It is information on both augmentation and reconstruction surgery procedures and a summary of the risk benefit factors to weigh when considering whether to have the surgery. The handbook has a section on patient risks similar to the risks in the patient information sheet.

The handbook also has information on special medical and physical considerations that patients should discuss with their physicians such as changes in the physical properties of the breast, movement or discomfort of the implant on lying down, and changes in the appearance of the breast such as unevenness or shifting.

It includes other considerations to discuss with a physician such as if a woman smokes, drinks alcohol, takes medications, past medical history, and effects of chemotherapy on the implants.

The handbook has a section on how serious problems are reported to the FDA and summarizes the number of adverse reaction reports the agency has received on breast implants. Although reporting by physicians or other health professionals is preferred, a woman may report any serious problem directly to the FDA through the Medwatch Program.

The handbook also has a section on Frequently Asked Questions such as what information should a patient obtain for her records. As an example, it suggests patient information sheet, the manufacturer sticker, package insert, informed consent form, and insurance coverage if a breast cancer patient.

Patients want to know how long an implant will last and how to properly examine her breasts. In addition, women frequently ask whether regular mammograms are needed and if there is a test to detect silicone in the body or determine whether an individual is sensitive to silicone. The handbook also advises women what to do if they are asking whether their implants should be removed.

The FDA has also developed guidance on patient labeling in general for medical devices. It is available on the Internet and has been provided to the panel. The draft guidance discusses many of the issues covered in the two Federal Register Notices on patient labeling and in the template that I will present next to you.

However, it also stresses other issues that we consider important for patient labeling including information on expectations of the surgery, expectations of the device, and information about alternatives to the device. The draft guidance suggest a stematic and formal pretesting of the target audience's reaction to the patient labeling content and format by conducting individual indepth interviews, focus group interviews, and self-administered questionnaires.

You all were provided with copies of this outline so I'll read it to you briefly. There is an introduction section. Based on the information currently available, FDA has distilled the information to assist patients in making an informed decision into this template. In addition to the public comments you have heard today, I would like you to consider how to best inform women.

After I go over this template, we'll ask you five panel questions. the first section is just a discussion of the purpose of the patient information, brief background on breast surgery, and a brief description of the implants.

The next section in the template is a section on which patients are eligible for the implant and describes the purpose of the device, a description of each indication, all applicable contraindications, and all applicable warnings and precautions.

The next section is a description of the actual surgery including description of the surgery and alternative procedures, differences in procedures for each indication, and the importance of a hearing to postoperative care regimen.

It goes on to have a description of the recovery period and signs of potential problems and options if dissatisfied with the cosmetic outcome. It has a section on the summary of clinical results which would be a description of the studies conducted, patients enrolled, summary of the complication safety data as ratified by indication.

Then followed with a section on potential risks including general risks associated with surgery, specific risks associated with breast implants, and epidemiology literature on the long-term risks such as cancer and CTD.

Lastly, a section on additional information which would be a discussion of a warranty, if applicable; index/glossary for medical jargon; patient assistance information including identification of the Consumer Handbook and company contact information; and the date of printing.

The next section is the actual questions for the panel. Shall I go on to the questions or would you like to have a discussion?

DR. WHALEN: If acceptable to you, we'll just have a brief discussion now and then this afternoon we'll have the questions formally.

Are there any questions or discussion points? Dr. Blumenstein.

DR. BLUMENSTEIN: In your list of things that are there, I didn't notice anything about insurance information. Is that planned? Any comment on that?

DR. RHODES: I have noted that as something to consider adding based on the discussions I've heard. We hadn't planned on including that information but I think that is important information that a patient should be aware of. I don't know how much -- we probably would need to get some real data on what the insurance options are.

DR. BURKHARDT: Is there a current time or has there been over recent history an FDA review of the promotional materials that the companies have used?

DR. RHODES: Well, we do review the promotional materials.

DR. BURKHARDT: Obviously the premarket approval hasn't gone through yet but have you been reviewing these materials and censoring them if necessary?

DR. RHODES: Well, I think Dr. Witten alluded to the fact that there is a shift when a company goes from a 510(K) marketing approval to a PMA approval. I think that we have a little more impact on the labeling for PMA. I think that we will be looking at and talking with the companies about all their labeling and advertising.

DR. BURKHARDT: How does the FDA make judgments about the material that is used in commercial advertising? What is the process?

DR. RHODES: We have actually a group at the FDA, Policy and Advertising staff in our Office of Compliance that looks at the way marketed products are being labeled and advertised. They get input from us on the kind of claims and the scientific nature. That is a separate harm of the agency that actually is responsible for regulating advertising.

DR. BURKHARDT: Thank you.

DR. WITTEN: Can I just add to that? I'll just add to that in terms of your recommendations for us, any recommendations you have on any type of information that goes to patients whether it's the informed consent, in particular, or any other kind of information that they would provide describing the risks and benefits of the product would be important for us to hear.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: Who actually write this information and how are these individuals selected?

DR. RHODES: The patient labeling?

MS. BRINKMAN: Informed decision making. Any of this.

DR. RHODES: Well, the handbook is written by the FDA. The patient labeling is written with the manufacturers so it's the FDA and the manufacturers who are writing the labeling. The FDA has ultimate authority over the labeling but we work together with the manufacturers.

DR. WHALEN: Ms. Dubler.

MS. DUBLER: Is there any way to get comparative information on the different manufactured products in any of these publications, handouts, whatever? In other words, if there were a real difference in what the data showed about complication rate for one of these manufacturers versus the other, is there any way to bring that information to the attention of women?

DR. RHODES: Well, in the labeling I don't know that that would be our preference to have comparative data but there are venues for information like our handbook where we could have information about all the products.

MS. DUBLER: I would agree. I don't think it belongs in the individual sponsors labeling but if that comparative information could be included some place, I think it would be helpful.

DR. WITTEN: Well, I would just mention that since each sponsor -- this is true in general for PMA products or any other product that we regulate -- the sponsor studies are all different. They were performed differently.

The protocols may be different. The populations may be different. In general in terms of doing direct comparison of one product versus another, if the study was performed in a way to be able to evaluate that comparison, it's really hard to draw those types of conclusions.

MS. DUBLER: Well, maybe you could just print both studies on opposite pages. I just think that there are some differences in the data and I know there are differences in protocol so it's not a one-to-one comparison. If they could be placed in ways that women could at least read them contiguously I think it would be helpful.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: This is a thought that I've had before and I don't know why I didn't think of it before now but the web is just an absolutely marvelous revolutionary tool for us. I've always wondered are package inserts on the web? Should they be on the web? I mean, just the raw package insert. Often times you go to a drug store and you get a drug, you ask the pharmacist for it and they say, "We don't have it. Come back later."

DR. BURKHARDT: I hear murmuring here that says they are on the web.

DR. BLUMENSTEIN: They are? All package inserts for all products?

DR. WHALEN: I doubt they all are.

DR. WITTEN: I think that would be up to a sponsor in terms of putting it on the web. We put summary of safety and effectiveness of each product on the web and we also have this handbook available on the web also. The FDA information is available on the web.

DR. BLUMENSTEIN: I wonder if maybe that shouldn't be some kind of a law for Congress to consider or something.

DR. WHALEN: That will probably depend upon whether the next President is the one who invented the web or not.

Ms. Brinkman.

MS. BRINKMAN: I'm back to the question I originally asked you about individuals that are involved in putting this together. If someone such as myself said I would like to be involved in helping the FDA put this together, that would be permissible?

DR. WHALEN: Dr. Witten.

DR. WITTEN: If the "this" that you're talking about is the label, it's really the sponsor's label that we approve and we work with them to make sure that it's in a form and has the content that we would approve. That is really the sponsor's label and we're working with them on it.

We do sometimes call on panel members to for assistance with that but it's really more the sponsor's label and our responsibility to work with them to get it into an acceptable form. We are trying to get some general advise right now that we can take back and work with the sponsors and the individual product.

Now, that's a different situation. If you're talking about the breast implant handbook, I think we would welcome some comments from that. We can talk to you about that after the meeting.

DR. RHODES: In fact, we've solicited comments for the handbook. We've sent out mailings to organizations and professional societies asking them to comment.

MS. BRINKMAN: And at this time you are planning to update this?

DR. RHODES: It's being updated. It's updated periodically.

DR. BURKHARDT: I'd like to ask the consumer representative one question. Do you think it is appropriate in general for companies, in this instance implant companies, to market their product in the usual commercial manner to perspective target populations? In other words, I guess that's called pull marketing instead of push marketing which is what people used to do. Do you think that's appropriate?

MS. BRINKMAN: Well, whether it's appropriate or not I think that -- well, I wish we didn't but I think it's a fact of the market place that they know their market and they go after their market. Whether it's even appropriate for physicians to advertise, I think it all comes back to those kinds of ethical decisions and we have no control over that. If I had my druthers, of course not. Of course I would not see ads for breast protheses or implants put in magazines that were aimed at a young population. I think unfortunately what we have the potential to do which is very frightening is to turn out to be akin to the tobacco manufacturers who have seen a market in a younger population and that's where the money lies so they have aimed products towards that population even though they claim that they don't. I think that's a very sad comment on our society. I don't know if I answered your question. Personally, no. It's a fact of life unfortunately.

DR. BURKHARDT: Thank you.

DR. WHALEN: Thank you, Mr. Rhodes.

We are going to break for lunch. I would ask that we be back to start at 1:05 at which time we will have our second period of public comment to begin the afternoon session. Thank you.

(Whereupon, at 12:26 p.m. off the record for lunch to reconvene at 1:05 p.m.)

A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

1:10 p.m.

DR. WHALEN: Good afternoon and welcome back to the panel discussion. We are going to begin with the open discussion period for which we maximally will have 30 minutes. I understand that one of this morning's speakers will be speaking to us. There will be a slight delay in that because there's a videotape involved. I would ask if anyone else wishes to address the panel and, if so, to raise your hand. Just one individual?

Very well, ma'am. If you would care to come to the podium, we can allow you five minutes.

DR. MELEZ: My name is Kathleen Melez. I did speak Wednesday morning. The answers are the same. I paid all my expenses. I do not receive any funding from pharmaceutical industries nor from any professional societies. I have a lawsuit against Bristol Myers Squibb.

I am a physician from Los Angeles. I do take care of breast implant patients. These patients walk into emergency clinics and urgent care facilities because these patients have no physician and nobody is following them so I do take care of them together with anybody else who wanders into that clinic.

I am being paid on an hourly basis to provide medical services for whoever comes into the clinic. I don't believe that's a conflict of interest. I have no conflict of interest with Mentor or McGhan.

I would like to touch upon a couple of things which came up during this last three days. I would like to talk a little bit about advertising. Drug advertising is a pain for us. It is getting to be very, very difficult to take care of patients. Patients come in and they know what they need.

Children come in because Citramax told them on the Internet to tell Mommy to ask for Citramax if they have an infection. Teenagers come in for birth control which makes their skin pretty. "Do you need birth control pills." "No, no." "Do you have problem with your skin?" "Well, one zit in the nose."

In fact, you have warning if it's a magazine you do have on the other side where they advertise the birth control pill to make your skin pretty, there is a full printout of the FDA instruction. If you have a magnifying glass, you can read all of the side effects.

Now, do I read the PDR, the Physicians Desk Reference? Yes, I consult it from time to time. I don't read it all the time. I don't have time. I don't think it should be necessary for me to do independent research in drugs I use or when I have to refill a medication which has been given to the patient.

I believe the FDA did and should take care of me anything which is in my hands to take care of patients. Whether it's a drug or a device it should be tested. I should not be getting into trouble and causing harm to the patients because I did not do independent research. Everything on the market for a physician should be properly tested and should be reliably manufactured.

Now I would like to talk and answer the questions which a little bit which was raised to one of the other speakers. What kind of a study would you want? Well, you want a life-long study. If you have a patient with a foreign implant you need to know about it. In fact, any other implant patients they knew, they carry around their medical records.

That patient, whether this is now a joint implant or a heart valve, gets special attention even if they come in for a cold or a fever or the flu because you know if you have an infection, for instance a gram negative infection of a device, then that patient looks okay one day and a couple of hours later can die from a gram negative sepsis.

I ask patients, "Do you have any device in your body?" If they do, then I do a much bigger follow-up even though they most of the time don't need it. That is, blood cultures and blood tests and an x-ray around whatever this foreign body is.

Now, the body is forever fighting a foreign body. It doesn't want to give up and won't give up. You see, when you remove breast implants, 15, 20, and 30 years still have those cells, the foreign body cells around. If those cells are not from 15 years before, they continuously try to get rid of it if possible. You see this in the clinic.

There are a lot of reported incidents. You know there are even a lot of things that don't get reported. For instance, cat gut which is absorbable, suture material, they sometimes come out years later and you pick them out from an abominable wound little by little by little.

Screws, bone screws. Who knows why 10 years later the body will reject that bone screw. Yes, as long as we have an implant in place, we have to be very vigilant from a medical point of view.

Now, from the experimental point of view as I believe that this autoimmune problem is related to a foreign body reaction similar to what the experimental animals had. You know, you varied the critical picture by varying the small particle, by varying the bacteria. That explains why sometimes you have a very late reaction.

Now, I also have a very small sample observation of one, myself as a physician, and I did not have any problems for 10 years. Apparently I got loss after five years. Georgetown University sent me all these questionnaires and I always answered I had no problems.

Since then I am probably one of those people forever who have no problems on all of those lists. I tried to do something about it and I wrote a letter to the Institute of Medicine when I had problems 10 years later and I never received an acknowledgement of that letter.

Very, very quickly I would like to touch upon the insurance issues. Now, I was diagnosed with breast cancer when I was a NIH fellow in 1985. The NIH radiology diagnosed me. The NIH plastic surgeon did the biopsy. The NIH pathologists, two of them, reviewed the slide talk to me. Of course, the insurance provided by NIH covered for my surgery at Georgetown University.

About a year later after numerous other problems with little lymph nodes and this and that and mammograms, they said that I have fibrocystic disease which probably was just foreign body reaction. I had a second mastectomy on the other side and all of this was paid not like 10 years later when I had problems and finally I realized that this may be related to the implants in 1996. In California the law provides for reconstructive surgery after cancer surgery so --

DR. WHALEN: Doctor, please come to a conclusion.

DR. MELEZ: I'll finish this. The insurance company paid partially for one breast and refused to pay for the other breast. Now, do you want to remove one breast implant and leave the other one in place?

DR. WHALEN: Are there any questions? Thank you.

Next we will hear from Ms. Jama K. Russano from Children Afflicted by Toxic Substances and this will be for 10 minutes, please.

MS. RUSSANO: Thank you. I'm sorry for the delay. New York planes can always be troublesome. I took a wonderful taxi cab ride around the Washington, D.C. area trying to find it so at least I arrived but a little frazzled so bear with me.

I basically had a breast implant at the age of 14, the silicone gel implant, one on the right side, due to a birth defect called a hemageoma tumor that was removed and the breast bud was removed along with it. When I was 14 I hadn't developed fully on both sides. I went to a plastic surgeon and they said that it would be perfectly fine to have a breast implant. This was in 1971, SILASTIC I implant, gel.

DR. WHALEN: Forgive my interruption but since you weren't hear this morning, I don't expect you to be acquainted with this. There are four questions.

MS. RUSSANO: Yes, I'm going to get to the saline one.

DR. WHALEN: If you could answer the questions first, that would be great.

MS. RUSSANO: Oh, sure. I'm sorry. I am the Director of a children's nonprofit foundation, CATS, Children Afflicted by Toxic Substances. It is not affiliated with any attorneys. I paid my own way. I am going to talk about the affect of saline implants on children. The other question was litigation. I have filed suit in the Dow Corning bankruptcy for silicone breast implants. I do have two children that I breast feed and gave birth to while I had my silicone implant.

The reason I'm here today based on saline implants is over the last eight years I started gathering information concerned about children born to mothers with breast implants on nursing and pregnancy. I was at an FDA hearing in 1992 or 1991 and I was basically surprised that there was no data showing research that had been compiled over the number of years identifying the safety of breast feeding and pregnancy. Also of young women implanted with breast implants like I had.

In that data of collecting over the last eight years, and more so in the last past few years, more women have had saline implants and more and more women have contacted us. Many women have contacted us asking if it is okay to have implants and can they breast feed and get pregnant. Or they have had saline implants and their doctor has told them that it's perfectly safe to get pregnant and to breast feed.

I think that it is very upsetting to find or hear when doctors just haphazardly state with no basis behind it that it is perfectly okay. I know earlier this week that there was a mother here with her two daughters that she had breast fed and this young girl had seen the Oprah show and I would like to show you this little segment of the Oprah show concerning plastic surgery and young girls.

(Whereupon, video shown.)

MS. RUSSANO: The plastic surgeon stated that if a young girl understands the reason she wants implants and has underdeveloped breasts she can have surgery. This is not like having braces. This is not like getting your ears pierced.

To date there is no scientific data that has followed young girls having breast implants or any cosmetic surgery and long-term health effects. They do not know if implants can do more emotional harm from being teased for bigger breasts or will she become promiscuous having sex at an earlier age. What kind of emotional scars will she have when her implants rupture? Or when she wants to feed a baby and finds out that she can't because her nerve endings have been cut and she was never told that? Or the doctor says it's perfectly safe with absolutely no data to back that statement up?

Does a young girl understand the importance also of losing sensation in her breasts at such an early age? Does she play sports or is she active placing her at greater risk or rupture? The mother of the girl with implants stated she met with four doctors and asked many questions. Clearly she was told it was safe to get pregnant and breast feed. The young 19-year-old girl asked the doctor directly is it safe to breast feed with breast implants and the doctor replied yes, it is perfectly safe to breast feed.

Where does he get this information? There are no studies that state the safety of breast feeding with saline-filled silicone breast implants. When we contacted the FDA about this doctor's behavior, we were told that the FDA has no jurisdiction. It is clear that the doctors and manufacturers of saline implants work off of one another.

The package insert of Mentor states, "It is not known if it is safe to breast feed." I don't understand how a doctor can turn around and say that it is perfectly safe. Manufacturers are playing and the doctors seem to be playing off of each other.

If they can put the slides up.

DR. WHALEN: You're going to need to come to a conclusion, Ms. Russano. It has been the full 10 minutes.

MS. RUSSANO: Oh, it has? All right. The point is that breast feeding today and young girl's health has not been established in the safety of pregnancy and breast feeding. It has not been established over long periods of time with hormones changing. There is not one single study out there that identifies these issues.

There is an Executive Order by President Clinton that was written in April of 1997 stating that all federal agencies must put the health and safety of children first. The health and safety of these children that are going to be over probably close to 500,000 children in the next five years -- I'll be happy to provide the panel with my speech and the documentation that I have showing the number of children -- are going to be out there basically floundering through the system.

Doctors don't know how to treat them. They don't know how to identify them. If a child goes in for a fungus or a headache or toxic shock syndrome, they don't even know -- they don't even think to identify that this problem could be related to their breast implants.

I ask the panel that if they do allow saline silicone-filled breast implants on the market that they make a clear statement that breast feeding and pregnancy, there is no research and the risks are unknown. And that they also put a very clear statement that women of young age in their teens, that there is no data showing safety. Also there is no data showing safety of women of childbearing age. Thank you.

DR. WHALEN: Are there any questions?

DR. BURKHARDT: I have a question. Is it your position that women in their teens or of childbearing age should not be allowed to have these procedures?

MS. RUSSANO: Yes, it is. Actually, they are being targeted by the plastic surgeons in various ads. I have copies of those ads. I think that not only this show but Britney Spears is 17 and she had saline implants put in. There has been a number of news articles or news shows saying how perfectly safe and they are cute and bouncy.

DR. BURKHARDT: Just to make is clear to me, it's your recommendation that they should not be allowed to do this?

MS. RUSSANO: They should not be allowed to do it and there is no scientific data that proves that it is safe for them to do it.

DR. WHALEN: Just to clarify the "they," once again, I want to make sure you heard what Dr. Burkhardt asked. He said teens and women of childbearing age.

MS. RUSSANO: Yes. Teens --

DR. WHALEN: Just to be inclusive then, that would mean the only population we haven't talked about are zero to 10 and postmenopausal women.

MS. RUSSANO: I guess so.

DR. WHALEN: Is it your recommendation that no women should ever have a breast implant?

MS. RUSSANO: Until they are absolutely proven safe and long-term studies identify that I think --

DR. WHALEN: I just wanted to clarify.

MS. RUSSANO: That's what it should be.

DR. WHALEN: Thank you.

MS. RUSSANO: Thank you.

DR. WHALEN: Are there other questions? Very well.

I would like to ask Mr. Rhodes if he can plug his computer in to start projecting the questions and we will indeed begin doing that.

DR. BURKHARDT: Mr. Chairman, at this point I am not really clear about what our charge is. I understood what our charge as a committee was up through the PMA process yesterday. Could you or the FDA clearly define what charge this committee carries?

DR. WHALEN: Dr. Witten is excited and anxious to do just that at this very moment.

DR. WITTEN: Yes. I appreciate your asking the question because we want to make sure that it is clear. As I mentioned this morning, at the time that a PMA is approved all the labeling that the sponsor has, and that is generally interpreted as not just the actual package insert but the package insert for physicians, any kind of patient information that accompanies it, any kind of promotional material, all that material would need to be approved by us.

What we want to know is in particular for the patient information that is going to be accompanying these products, what kind of information should go into the patient information in particular, but more generally also what kind of information would be helpful to have go along with these products so that information would most clearly explain the risks and the benefits of the product.

For example, the first question which says, "Provide specific suggestions on important information to include in each element to the Patient Informed Decision-Making Outline, in particular, important information regarding adverse experiences."

The decision-making outline, which was on the web site and has been passed around to you, has what we have considered at the FDA in thinking about it and thinking about what we've heard from patients and physicians and sponsors over the last several years that we have been considering this question. It contains what we think are elements that ought to go into patient information that accompanies a breast implant.

It's really just sort of a list of the kinds of information that we want in there. The way in which the information is presented, some of the questions, for example, that have related to the fact that there have been a lot of numbers presented in the PMAs but how would you present that in a clearer way so that someone could understand what those numbers meant. That kind of recommendation would be helpful from you. Is that clear? Is that clearer I should say?

While we are on the first question, can I add something? As I've been listening there is actually two other things. As you answered this first question there are two other things that would be helpful to address that I think fits in this question.

Based on the things that we've heard both from the patients today and from the physicians, the numbers -- although originally when we wrote this question I think we were thinking about how to frame the numbers maybe so that they would explain things. One point that has been brought out several times is that the numbers alone perhaps don't exactly tell the full story. There was both a patient and a physician who said when one of these adverse events happens to you, it's 100 percent. Unless the patient has an idea of what that adverse event might mean, it's a little bit hard to interpret the numbers alone. So it's specific for this question not just in terms of describing the data but if you have any suggestions about how to present the adverse events, both the ones that have cosmetic consequences that are thought to be fairly minor as well as cosmetic consequences, for example, of removal I think would be helpful to us.

I'll just say after you answer this question about adverse events, I'm going to ask a follow-on question about how to describe the cosmetic benefits of these products also, how they should be most accurately presented in labels.

DR. WHALEN: Thank you, Dr. Witten.

So we are presented with the first question as projects which is, in my opinion, the most far reaching of the five questions. I think it's probably appropriate that we begin the discussion of this with Ms. Brinkman if you would.

MS. BRINKMAN: If it's okay with you, I would like to go home and spend several days working on this.

Obviously I think some adverse effects that need to be looked at are those that we need to again talk about, what is product specific, what's procedure specific such as capsular contracture maybe or procedure deflation, infection, the kinds of things that we brought up in the past for adverse effects and then appropriate data to go with those to talk about incidence.

DR. WHALEN: Let me just interject if this is acceptable to you, Dr. Witten. Rather than our usual PMA type questions where I try to do a synopsis and ask for your blessing, I think this is more cataloging of the panel's opinions and impressions so we'll just flow with all of our answers as long as it takes. I will ask if you have been satisfied with what we've said but I will not attempt to encapsulate it.

DR. WITTEN: I think that will be fine.

DR. WHALEN: Thank you.

MS. BRINKMAN: Actually, I have a long laundry list of comments from consumers and other groups that I would like the opportunity to rewrite and give to the panel but not right this second.

DR. WHALEN: Ms. Domecus.

MS. DOMECUS: I think the adverse experience information needs to be written in a way that tells the story for the patient and isn't just tables with numbers, although I think that is important, too. I was just trying to understand even the Kaplan-Meier numbers represented as part of the presentations yesterday and the percentages look alarmingly high. When you see 33 percent of patients had breast pain by four years, does that mean one in three patients had excruciating pain for four years or was 99 percent of that one week postoperatively? I think things need to be explained in more paragraph form.

For instance, x percent of patients experienced breast pain. This majority of them has gone by one week or one month and x percentage of them the pain is so bad they need to go on and have surgery. If they have that surgery, you know, that a second surgery can be more risky than the first, etcetera, etcetera.

My other thought is I think that the labeling should clarify that the studies had a high loss to follow-up rate and that may not appropriately reflect the risks.

I was concerned by all of the public testimony about patients being told by their doctors that their symptoms aren't related to the implants and so it was very frightening to hear in light of the lost to follow-up rates.

DR. WHALEN: Dr. Morykwas.

DR. MORYKWAS: One thing that I think a little care needs to be taken with is actually in the 1995 announcement in the Federal Register is as far as other reconstruction options to me I think is misleading the way that it's written that it implies that -- it doesn't state that there is flap surgery available. It just states really that there is fat transplantation that is available for reconstruction. I just think that any references back to that shouldn't use that particular wording and really should make other surgical alternatives explicit in that there are other surgical procedures such as flap surgery available.

DR. WHALEN: Thank you.

Dr. Chang.

DR. CHANG: I believe that on a practical level very few patients receive package inserts before surgery. For myself it's not sure if someone will receive a 280 or 290 or 300 cc implant so the specific package will not be opened before the patient is in the OR. I believe on a practical level any information that is provided to the physician that is provided for information as a package insert be available for the patient before they are arriving in the OR.

I believe that it would be helpful to someone considering surgery to have some numbers based on the product specific to the sponsor of what the experience has been for deflation rates. To me that would be the most important device related outcome that could be provided to the patient.

Then finally, again it will be dependant on the communication and listening skills, both physician and patient, in terms of what is actually communicated and what is received. There are going to be those complications not entirely related to the device but rather to the surgical technique. Again, the more information the public has in terms of asking about the qualifications of their physician who is going to be implanting this device is important.

DR. WHALEN: I would like to comment myself for a change and just mention a few things in terms of informed patient decision making. The issue of insurance has been brought up several times. I don't know that FDA has either the authority nor the resources to investigate those sorts of issues across the multitude of insurers that there are across the country. I would further add that I don't think that even should be done because, quite honestly, I wouldn't believe anything that the insurance companies were to tell you. Even if they told you, they would probably change it a week later.

I do think that since we have heard testimony today that insurance companies are indeed denying coverage to patients and potentially even denying life insurance based upon having these implants, that is an extremely important element for a woman to know at any age if she were to try to make a decision in this regard.

I think that is the type of element that should be in bold print. The phraseology obviously has to be carefully worded and I'm sure that the Health Insurance Association will have some comments upon your trying to do that.

The issue of children, which is teenagers, is closer to my heart as a pediatric surgeon. Since there is within FDA's purview oversight of the advertisements that are done, I think the most stringent views should be taken on any advertisements even considering the venue of those advertisements if even the appearance or illusion is created that there is trying to be an attraction on the sponsor's or manufacturer's part towards inducing teenagers with all the hype that was just well articulated in terms of their body image taking place in those critical years.

We heard many tragic stories about women with connective tissue disorders. Everyone on the panel, I think, is well aware of the evidence. Everyone on the panel is well trained in scientific methods. Nevertheless, one of the things I often tell my surgical residents who just can't understand why they are regarded as arrogant, believe it or not, is that perceptions are 99 percent of reality.

While we can't chase every perception, these are very heart-felt issues. Indeed, if we're talking about a complication that occurs rarely being 100 percent to the person who it occurs to, then I think there should at least be allusion to the fact that there are multitudes of women who are convinced that their CTDs are attributable to these devices and that should be considered in the decision-making process.

Finally, it is difficult, if not impossible, if not even illegal, that the FDA tries to clamp down on the physician element of this critical exercise which is making a breast implant. The manufacturer is probably the smaller part of the equation.

While there are inherent difficulties in that, I would strongly urge that FDA and other appropriate Government agencies work with leading national surgical organizations and other medical organizations on trying to refine the consent process, not the consent documents and the consent information nearly as much, and to encourage perhaps through other federal agencies that there be outcome analyses of exactly what that consent process is.

Dr. Burkhardt.

DR. BURKHARDT: I have a number of comments. The question of insurance is devastating, as you say, if the information we have received today is true. I'm not sure that it is. Until I came to this -- and I'm not suggesting that anybody is being untruthful, but perceptions differ.

Until I came here today I had never heard of a patient who was denied health insurance or life insurance on the basis of their breast augmentation procedure. If that is indeed the case, I think it certainly needs to be looked at.

If that is becoming something in the industry that we need to worry about, I agree that should go in the consent forms. I question whether that is indeed the case. Most insurance people I've talked to would be happy to sell you insurance regardless of what kind of shape you're in.

The patient information issue with all the comments today there's been an overriding concern from people that they were not warned about things by their doctor or by the company. The things that they were not warned about fell into two classes. The first class was problems that were probably related to the implant. Secondary surgery, deflation of the implant, firmness of the breast, and so forth.

There is a large group of problems that they were not warned about which they weren't warned about because we don't think they are related to implants. I think that the FDA has to take into consideration the fact that it is inappropriate to warn people about illnesses that they may think are caused by implants but there is really no scientific evidence of any sort for that.

The presentation of numbers is a particular problem. Mainly because for a lot of the complications and numbers we're talking about there is no easily defined end point. Now, when a saline implant deflates, there's not much question about the end point. It is clearly diagnosable and discernable at that time.

The other major complication that we're dealing with is called capsular contracture which appears to be hardening of the implant. We have to realize that even with the so-called Baker formula which classifies this into four different degrees of severity, the classification is entirely subjective on the part of the examining physician.

Our literature shows that patients who are examined by the operating surgeon are much less likely to have this problem than the same patients who are examined by an independent authority. This is a normal bias that is built into our studies and I just don't know how you could avoid it.

In addition, in my own studies which have not been introduced in evidence here but in controlled studies that I did the incidence of significant capsular contracture, significance hardness of the breast at three and four years in a controlled study varied from zero to 40 percent depending on the particular type of implant and the particular type of surgical technique that was used. I'm not talking about good technique versus bad technique. I'm talking about options in surgery.

How on earth the agency can try to get a handle on this kind of problem in terms of rather simplistic number presentation, I don't know. I would be happy to help with it but I just don't know how you could do it.

It seems to me that one of the biggest problems that I keep hearing from the public in these things is the spin that is being put on breast implants. It's the encouragement of the population to undergo unnecessary surgery for cosmetic purposes and the surgery does have a significant incidence of complications. I think we all believe that.

Doctors do that. Some are qualified and some are not qualified. By the grace of the Justice Department we now advertise. We have very little control over advertising except for ordinary commercial standards which are applied to us like they are applied to other people.

I don't think the FDA can do very much about advertising that physicians do. I am greatly concerned about the tendency at the present time in direct marketing to patients. I don't think there is any way that an implant company can go to an advertising agency and say, "We want to sell implants. You work out our advertising for us," without putting a very positive spin on that advertising.

I think it's very difficult to ensure what the agency has previously referred to in these hearings as a fair balance. How do you ensure that marketing, which is designed to sell a product, is done with a fair balance in this kind of situation. I don't know.

I do know that the brochures that were passed around today from both implant companies showed some beautiful pictures. They showed pictures of the way people would want to look. They did not show pictures of disasters, of implant cripples. I'm not sure that if you put -- I've got some pictures that I could show you that are awful from my own practice. If those pictures are put in there, does that inappropriately discourage people from having an operation that is generally quite satisfactory for the great majority of individuals who undergo it. I don't know what the answer is to that. I think it's a reasonable regulatory decision and I just can't deal with it.

In regard to whether marketing should be directed at all to teenagers, I would just suggest to the Chairman with great difference on my part that we might use the word minors because 19-year-olds in many places feel that they are able to make this decision. They are in the majority. They have reached majority.

DR. WHALEN: Thanks, Dr. Burkhardt. If we could interject for a moment, I understand there is some information that may be able to be provided to us on the issue of insurance with a little bit more than the suppositions either one way or the other that we have just experienced. We would reinvite Dr. Leroy Young from the Plastic Surgery Educational Foundation who has investigated this issue back to the podium.

Dr. Young.

DR. YOUNG: I don't think any of my conflict of interest have changed since the other day. I had my secretary contact Blue Cross/Blue Shield and United Health Care in Missouri, who are the two largest providers in that area, and asked the question of how breast implants affect your ability to both get insurance either for reconstruction or having had it for aesthetic reasons in general and both related to your breasts.

The answers that we received is that United Health Care, first of all, does not ask applicants if they have had either cosmetic or reconstructive surgery with implants and they do not exclude applicants that have had implants for either of those reasons.

Now, they are able to put a rider onto that to say that they will not cover complications of cosmetic surgery but they tend to cover things such as rupture of implants to have the implant removed but not pay to replace it.

In the case of Blue Cross/Blue Shield, again they won't exclude you from having insurance. They may put a rider on your policy about your breasts. Usually there is a time limit on that that says if you don't have a problem within some time of a year to five years, then they will drop that requirement.

They are prevented by law from excluding people from having insurance.

I have the names of the attorneys

from the two companies that I'll be glad to give you if you want further information with regard to that. I'm sure they can provide additional detail. That is sort of a capsule summary of the situation. People are not excluded from having insurance. Thank you.

DR. WHALEN: Thank you.

MS. BRINKMAN: That's limited to Missouri and to those two companies that he talked to.

DR. WITTEN: Excuse me. I'll just say that it might be helpful to focus on some of the other issues because I think we've talked about the insurance enough that we recognize there's an issue and I'm not sure that there is anything more that could be said right now that would really help us.

DR. WHALEN: Very well.

Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: Thank you. A couple of general comments first. I strongly support each of Dr. Dubler's recommendations that were so eloquently stated. That would certainly include being sure to include information sources -- I'm sorry, independent sources of information, preferably right along with the packet of information the patients receive. Perhaps FDA's information would be one good example.

I would also very, very strongly recommend that formal evaluation is needed to determine whether there is a reasonable assurance that patients are both receiving and reasonably comprehending the information that they receive.

Let me see. Now, in terms of a couple of general comments on the overall types of data that should be included, I strongly agree with the comments to the effect that wherever there is a lack of solid scientific knowledge, that this should be made explicit.

I think that the IOM report serves at least a reasonable template for doing that so that women do not get the impression that, for instance, the rate and severity of long-term complications have solid coverage in the epidemiologic literature and, therefore, they must rely on their physicians and whatever other data sources as that sort of information accrues.

In terms of a couple of specific comments on the applications that we saw, my impression was that the Mentor application had a pretty good narrative summary in terms of the comprehensibility of describing it's data, but very little actual data, at least in the version that I saw, whereas McGhan was sort of the opposite. They had extensive data tables that looked like they were straight out of the PMA. Yet, the test was so dense that I worry that many would not be able to follow it.

I think that the extensive data should appear but should be accompanied by clear bulleted text describing major rates in way that patients can understand. This is a simple suggestion but, you know, you look in one of the applications and it says that there is something like 8.9 percent rate of reoperation within the first three years. I don't know if that would mean more if one were to say that the estimate is that approximately one out of every 10 women will have a reoperation within however many years. Something like that might be helpful.

I strongly feel that there should be some overall summary of adverse experience. Now, I'm not the one to define what counts as an adverse experience. Certainly if Dr. Burkhardt doesn't know how to do it, I don't know how to do it. I do think that it can be wrestled with and that an appropriate summary measure can be defined and given.

Specific to both of the applications, there is a list of most common risks including deflation and capsular contracture and that sort of thing. Then there is a section that's called other risks and sort of in the middle of that reoperation appears. I would strongly recommend that other surgery is not sort of an other risk. It occurs at the same rate as the most common risks and needs to be identified as such.

Then the final thing would be the issue of

-- I thinking about the younger women. How do you make them pay attention and take the material seriously. You probably need some sort of a hook. Here is why you should pay attention. Be it that while there are many women who experience very good outcomes, remember that this is a permanent thing that you are going to do. I don't know exactly how to do it but it does seem to me that some sort of consideration about that is needed.

DR. WHALEN: Thank you.

Dr. Boykin.

DR. BOYKIN: Since I do a lot of reconstructive breast surgery, I can't say enough about how important I think this whole process is. I envisioned this as a three-sided relationship between the experience and maturity of the surgeon which we have little control over, the limitations of the device which I think we've tried to understand with some great degree in the last couple of days in which we intend to expose to its fullest degree as clearly as we can.

The third side, of course, is given the situation of values, choices, and education of the patient. I think that what we can do is provide patient education, at least in the limited forms, and try to control those other avenues of education that may falsely imply security when it isn't there.

One of the things that I have to say if you want to talk about graphic details or trying to really get to the meat of the subject, patients that get involved with breast implants need to understand that this is a life-long road. Once you put these implants in, whatever you decide to do with them is going to irreversibly change the shape of your native breast tissue.

I've had to take many of these out over the years and I can tell you that the ladies that have had them removed have not been happy and they look deformed. They are not happy about this and it doesn't get any better at all. Somewhere in this message we need to let these young ladies understand that this is not a short-term relationship.

I believe the studies show that the integration of this with the body image takes about six weeks. I actually had a patient who lives out of the country who came back after having implant surgery extremely happy with herself. After a couple of years she said, "I want my implants taken out." I looked at her and I said, "Do you really understand what you're saying?" She said, "Sure. I'm doing fine and the kids are healthy and everything. I just want you to take them out. I just don't want to have to worry about them anymore."

I tried to really spend about an hour explaining to her what a different situation this would be and how dramatic it would be. Of course, she's a very intelligent lady, very strong willed. We proceeded and I took them out.

Within 24 hours I got a frantic phone call, a very depressed woman and her husband showed up at my office the next day and we had to reimplant her. She's done quite well but the reality of having the change in her breast parenchyma because of the implants was more than she could handle.

This is the road that we get on with patients. This is why there is so much of an outcry of betrayal because they don't understand that this is not a real two-way street. The objectivity of all of this data is lost. When I see patients for this operation, I say, "You can read the statistics but as far as we're concerned, it's either zero or 100. You either don't have a problem or you've got a problem and it's the worse thing in your life because these breasts are important to you." And they are.

So given that, perhaps consideration should be given to some illustration of these complications. I don't know how we can do this in a tasteful way and not offend the patients and certainly do something that will be meaningful even to the manufacturers.

I also have to say that in terms of insurance, in Virginia we have problems. We have patients who may get insurance but they move out of the category of healthy American down to a lower level because they've got the implants and their premiums go up. I have had one patient that I've had to assist in trying to regain health insurance because she was denied.

The complications should be outlined as we have mentioned and, as Karen has brought up, it's not just mentioning the complication but I think it's important to tell them what happens after you have this complication. If you have a capsular contracture, this is how a capsular contracture is handled. You may require another operation.

You will have an incision made on the breast. The implant will be removed and at that time a series of events will take place to put you in a different category. I think the complications need to be spelled out but the way that they are handled surgically need to be explained so that the patient will have the education up front about how these things will move along.

A recommendation was made for reoperative mammography and I don't think that's a bad idea. I the adult female patient who is below the range for routine surveillance for cancer, it might not be a bad idea to have a good mammogram before you commit to this operation.

There is a very low likelihood of showing anything, at least from our statistics, but at least the next person to do the study will have something to feel more comfortable about when they look at the scar patterns within the breast parenchyma. That's just an idea.

Having said all of that, I really think that the idea of the registry is an important one. I think that we need to carefully consider how we can create a secure registry for the data on all patients receiving these implants.

After they have gone through this extensive informed consent process and finally decided they are willing to take all of these risks that they can rest assured that if they have a problem, they can communicate with an agency whether it's the FDA, some educational foundation, or maybe both that will not only respond to them but ensure that this information will be shared in a meaningful way.

DR. WHALEN: Thank you.

Dr. Blumenstein.

DR. BLUMENSTEIN: I just want to say one more thing about insurance. I feel like we're kind of in a data freezone here. We have fragments of information but I don't think we have a definitive answer yet. The main thing I wanted to say about insurance is that it really is kind of a risk and perhaps should be characterized as a risk in the package insert. It is a risk that has the same magnitude and possibility of affecting life as some the other things we've talked about.

As I've thought about this, there is a couple of other things, general things. It seems to me that as we've talked here that risk versus benefit has a lot less distinction here than it does in some other kinds of mileus.

As an example, asymmetry has been characterized as a risk but really is a thing of efficacy. I think that perhaps as the thing is written that there could be a little bit more of an effort to try to identify things, less as risk versus benefit and more as events.

I think in terms of the events that do happen, I think there could be better identification of the course or the attribution of the event whether it's due to the device or due to the surgeon and so forth. I think that would help potential recipients of implants because it would show them the things for which they might want to take more care with respect to surgeon selection versus device selection.

I think there needs to be a better distinction between what I call bad things and events. In other words, the things that are truly bad should be identified as such -- clearly identified as such. The things that are just events like maybe a revision for sizing and things of that nature should be identified in that fashion.

Going on to some more technical details, I think that always we should be using actual estimates and that these actual estimates should be accompanied with the various caveats that we've heard throughout all of this. That is things like informative censoring, lack of independence between censoring and events and stuff like that.

I believe that the most useful statistic to feature is the overall risk of a bad thing. There may be several ways of doing that. For example, you may want to talk about the bad thing being a permanent explanation without replacement is one bad things, whereas another bad thing might be any kind of surgery and so forth. I think that needs some careful thought and especially with respect to the classification of various items.

A third technical item that I would like to mention is that I believe it is much better to represent the individual risks as cumulative incidents even though those they still suffer from the same caveats that we've talked about before.

Finally, two more points. I have been aware of some research in nursing where they've studied the process by which patients record the dialogue, either video or audio or both, with the healthcare provider as they are making a decision as to whether to proceed with the particular procedure. I think we could encourage patients to do that. That would be something that the patient could take home with them and review later, even review 10 years later.

Then finally the National Cancer Institute, the Office for the Protection of Research Risks and the FDA have put out some very wonderful guidelines that we and Cancer Research used to create informed consent documents specifying all the way from the font size that should be used, the level of language, and headings that should appear, and so forth. I think that document should be consulted and used whenever possible because I think a lot of people put an awful lot of work into that and it's a very wonderful piece of work.

DR. WHALEN: Thank you.

Dr. Witten, as regards to the first question as to the discussion, has it come to a satisfactory conclusion?

DR. WITTEN: Yes. Thank you. Before you go on to the second question, I would like to ask my follow-on question to the first question which is I would like to ask the panel, there has been some discussion about how to characterize the benefits and about how they have been characterized in the promotional material of the product, as well as over the past couple of days how they have been characterized in terms of how the sponsors spread their quality of life data. I'm wondering whether anyone on the panel can help us out with how to describe the benefits in a informed consent type of document or promotional material.

DR. WHALEN: Thank you. We'll go around the table and begin with Ms. Domecus.

MS. DOMECUS: I guess the first thing is that the benefits we need to stick to. There is also the studies done to date, again making any notations regarding loss to follow-up. I agree with the earlier suggestion that risks like asymmetry probably should be reflected in effectiveness discussions as well.

And that risk of removal and potential permanent disfigurement later also becomes an efficacy issue. I think those things need to be tied into the benefits discussion and probably a reference in the benefits discussion to the section on risks so that patients don't just go to that section.

DR. WHALEN: Dr. Morykwas.

DR. MORYKWAS: I think it also has to be divided up between augmentation patients and reconstruction patients because the data we were presented on increased in bra cup size is obvious for a reconstruction patient. If they go from no breasts to a breast mound, there is obviously going to be an increase which then is different from augmentation patients.

I think that care should also be taken with the quality of life presentations that were given because they already were higher than the general population before implantation and the augmentation patients. I think that should be deemphasized. As I said, they were already higher than the general population anyway so that's kind of a separate population of patients that we're dealing with.

DR. WHALEN: Dr. Chang.

DR. CHANG: I think as a general guideline some of the psychosocial terminology used specifically in the studies performed by the sponsors would be appropriate to include as a description of potential benefits in talking about change in contour as all of this is so very subjective. There are specific terminologies, patient satisfaction, that were listed in quality of life studies. I think those would be appropriate since they were included in their surveys.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: I'm not sure that the question of asymmetry, which was brought up, should be related to the products. Asymmetry is not always but almost always a result of surgical placement which is not identical on both sides. There is kind of a sense going here that asymmetry is because the implants weren't adjustable or couldn't be made the right size. That's not the problem. The problem almost always is the placement of the devices and that is really nothing the manufacturer has any control over.

I would like to make one more comment about spin and this is perhaps a personal statement. I always bothers me when I read a statement or hear a statement that the sponsors can't prove or the Government can't prove or the doctors can't prove that the implants don't cause some disease because to the lay people that sounds like a terrible deficiency. When we say there is no scientifically acceptable evidence to show that it causes the disease, we're saying exactly the same thing and sending an entirely different message. I think that any information that comes from the Government has to be particularly sensitive to those nuances in description.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: The first comment I would make is to be sure that any statements that are made are backed up by data. As an example reading out of the Mentor packet talking about augmentation, "For many women it has afforded a state of great personal satisfaction and well being." Has afforded sort of rings of causality to me and definitely not shown by data in this study. Just be careful. Be vigilant about the wording of statements such as that in terms of, you know, causal sort of statements.

In terms of the data presentation itself, in my opinion it's appropriate to present data on bra size change, bust size change, the body esteem satisfaction sort of with your body. I felt that those data were fairly solid provided that they are conditioned on a clear statement. However, at three years this doesn't reflect 25 percent of women. That's got to put the informative censoring problem into clear language.

However, the quality of life statements that I see currently I feel are not well supported. One of the studies did not even evaluate quality of life as it is usually defined. This is particularly true for the reconstruction patients. I struggle over whether the quality of life data for the reconstruction patients should even be in there because it's so totally impossible to disentangle whether improvement was due to having implantation or whether improvement was just due to recovering from cancer and I worry it could be very misleading.

DR. WHALEN: Dr. Boykin.

DR. BOYKIN: In terms of benefits just continuing what Dr. Bandeen-Roche has just mentioned, we have to be careful about these quality of life measures. If I recall, the patients, the young adults who came forward for augmentation had a very high level of self-esteem, self-assurance. As a matter of fact, highest before the operation.

That changed somewhat. I don't know if there was any statistical significance. Satisfaction may be already achieved for the most part. These may be very highly successful, highly motivated people. I think the thing I would just limit it to is the fact that from all indications there would be a moderate to significant increase in the breast size assuming the operation is successful without complication.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: I find it hard to comment on statements of efficacy because it isn't nearly as important to me. That's all I have to say.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: I have nothing else to add.

DR. WHALEN: Is that a satisfactory discussion, Dr. Witten?

DR. WITTEN: Yes. Thank you.

DR. WHALEN: Thank you. We now go on to question No. 2 which is to provide comments regarding a suggested waiting period prior to surgery in order to give a patient adequate time to make an informed decision.

Dr. Morykwas.

DR. MORYKWAS: Well, again, I'd like to divide this, I think by necessity, into the two populations of reconstruction versus the augmentation patients. I think for the reconstruction patients, and we heard Dr. Willey this morning state that it can be in her experience as sort as two days from diagnosis to a mastectomy with the option of immediate reconstruction.

I know at our hospital there have been instances where it's been the next day which is a very short time. In that state of mind dealing with the cancer, I don't know if the woman could probably give informed consent as to getting an implant at that time.

At a later time going back in I don't think it would be a problem or just due to vagaries in the surgery schedule if there was a several week interval between diagnosis and the time when they would do the mastectomy and reconstruction. I think that would be long enough to adjust and actually have fair time to evaluate the option. That's very difficult. I don't know what to say about that or recommendation to make about that.

For the augmentation patients since that is an elective procedure, I think just built into the way it happens there is a waiting period. You don't go in for the initial consultation to see a plastic surgeon or other surgeon who puts in implants and then immediately go into the operating room and have them put in.

There is a waiting period and I don't know if it's an over simplification to say that the busier surgeons are probably the more experienced surgeons so there would be a longer interval between the initial office consult and when you could do the surgery. In that way I guess a delay would be better because you potentially would get a more experienced surgeon.

I think at that time for the initial consult the patient could be given all the documents as far as informed consent, all of the options, the FDA brochure. They could take that home with them and that would give them a fair time. Actually a specific number of days there's no way I could give a number to that.

DR. WHALEN: Dr. Chang.

DR. CHANG: I have been asked on rare occasions to treat a patient who is having immediate

-- who requires immediate reconstruction. I think that it would be much too onerous to impose a time limitation or waiting period.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: If I were a woman, I think I would be deeply offended by a federal paternalism that told me that I would be unable to make a proper decision regarding elective surgery in less than, say, five days.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I support some kind of a waiting period just because of the issue of carefully evaluating material and thinking about it hard with some strong effort to make people think about things realistically. I would further hope that the waiting period would be before surgery is scheduled.

I have some -- not breast implant related -- I have direct experience with this and I can tell you once the surgery is scheduled, there is a momentum that is very hard to stop. I can't say that, you know, I would have changed my ultimate decision but I probably would have tried a few other options and would have enjoyed the extra time.

DR. WHALEN: Dr. Boykin.

DR. BOYKIN: I'm not really sure if I could decide how much time would be necessary for something this significant. I understand what Dr. Bandeen-Roche is alluding to but I really don't think I would make it a mandatory issue.

DR. WHALEN: Dr. Blumenstein, could you at least tell us what is the standard deviation of the interval should be?

DR. BLUMENSTEIN: Actually, I was thinking that there should be a waiting period. It would depend inversely on age.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: All I think you can do is encourage that there be a waiting time for the very reasons cited. There is really no way to enforce any kind of waiting time except to give evidence on why it's appropriate to have some waiting time before one actually is scheduled for surgery.

In the case of reconstruction, frequently those patients have had a consult maybe prior to surgery and it's all done in the same procedure.

DR. WHALEN: Ms. Domecus.

MS. DOMECUS: I don't think there should be any waiting period for reconstruction patients. I think arbitrarily that a week is probably a good amount of time for the augmentation patients. Having said that, though, I don't know how the FDA is going to get its hands on this one because the waiting period really happens between the physician and the patient unless FDA is just asking if we think it's a good idea to make a suggestion in the labeling.

I think at most it would be a suggestion because I don't think it could be a requirement because I don't know how manufacturers would go about policing the physician/patient waiting period requirement if they were to put that in the labeling. I think a week is a good amount of time.

DR. WHALEN: Dr. Witten, does that satisfy?

DR. WITTEN: Yes. Thank you.

DR. WHALEN: Thank you. We move then to question No. 3 which is to comment upon the postoperative symptoms that should cause patients to seek advice from their doctor.

Dr. Chang.

DR. CHANG: Read it again.

DR. WHALEN: Comment upon the postoperative symptoms that should cause patients to seek advice from their doctor.

DR. CHANG: I definitely think this is in the purview of information that a physician should give to the patient in terms of warning signs of inordinate swelling, redness, drainage, signs of infection. Those would be items that I would tell my patient so in terms of warning or advice, caution, those would be the items to convey to a patient.

DR. WHALEN: Dr. Burkhardt, if you were a woman, what symptoms would you -- no, I'm sorry. Harkening back to the last question. What symptoms should cause patients to seek advice from their doctor?

DR. BURKHARDT: I think patients are smart enough to know that. I don't think there is any hidden diseases here. I realize that people in the audience disagree with me but I don't think there is any hidden diseases we're worried about. If a woman has an infection in her breast or around her implant, she's going to know it. She's going to come in. If she has pain, she's going to come in. I don't think that needs to be listed by a Governmental agency.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I'm not qualified to comment on exactly which symptoms but I do hope that women undergoing -- choosing breast implants will see themselves as data providers. Absolutely they should report whatever is of concern to them. More so I think it would be very worthwhile to try to set up a reporting repository to track implants, to set up a registry, anything that facilitates women providing data to our knowledge.

DR. WHALEN: Dr. Boykin.

DR. BOYKIN: I'm going to disagree with Dr. Burkhardt a little bit on this. I think that part of this process is to give the patient a database from which to derive some level of comfort. Having said that, I have patients that I will intentionally not give them a list of complications because I guarantee they'll have all of them before the next morning or they will call me about something that is totally unrelated.

I think that for this process we should list -- make a list of complications that are of relative importance to the early postop patient; bleeding, swelling, fever, chills, paresthesia. I think that would be very beneficial.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: No comment.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: We do this anyhow. I mean, we always give patients a list of the kinds of things that they need to know postoperatively that would not be expected, the reasons to call the physician. That is standard practice, I believe, in most organizations. Whatever the surgeons feel are untoward effects with this particular surgery is acceptable; pain, bleeding, infection, those kinds of things.

DR. WHALEN: Ms. Domecus.

MS. DOMECUS: I have nothing to add.

DR. WHALEN: Dr. Morykwas.

DR. MORYKWAS: I'll just add some minor things. It seems that this is -- everybody is talking about immediate postoperative complications instead of long-term complications so I'll just say, again, the standard list of symptoms that can occur postsurgically. I also think this is a good time to put in a national registry. It would be good to track infection rates and some of the other rates. I think this would be a good place that that data should also be.

DR. WHALEN: Thank you. Dr. Witten, is that discussion satisfactory?

DR. WITTEN: Yes. Thank you.

DR. WHALEN: Thank you. Proceed to the question No. 4 where we are asked to discuss the types of information that patients should be given regarding differences in surgical procedures and postoperative care. Starting with Dr. Burkhardt.

DR. BURKHARDT: That's particularly difficult because I think it's very hard to get agreement among surgeons as to which are the best procedures and what procedures have what effect. I mean, we all have some agreement now that certain procedures are probably better than other procedures in particular types of patients. But there is also disagreement even about that.

Furthermore, it changes almost month to month. I don't know how this agency could get in the business of giving direct medical advice to patients who have decided that they want to have implants or reconstruction. This would become a very cumbersome process coming from this level. I really think that has to be left up to the patient and the patient's physician.

DR. WHALEN: Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: No comment.

DR. WHALEN: Dr. Boykin.

DR. BOYKIN: We have through several professional agencies -- organizations, excuse me, which have been represented here, educational materials that are normally provided to patients that discuss the different surgical procedures and postoperative care and I think very nicely. Sometimes these have become outdated over the years.

But if you're looking for some guidelines on developing such information, I will certainly confer with the American Society of Plastic Surgeons or the Aesthetic Society considering that. We might be duplicating some things but assuming this might be the initial source of contact for information, it might not be a bad idea.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: No comment.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: Although it may be difficult to do, I agree that we have to make some attempt to at least do something and not just ignore the issue. As you were saying, conferring with the American Society of Plastic Surgeons. There has to be something that we can include in this information.

DR. WHALEN: Ms. Domecus.

MS. DOMECUS: I agree with the concept that this information should be provided to patients but I don't think it should be the burden of the manufacturer. I think that's the only thing we're talking about here again. I think it would be difficult unless it was something that specifically came out of the manufacturer's study such as the Betadine issue.

I think it would be unduly burdensome to ask the manufacturer to stay on top of and provide some kind of consensus where there is difference of opinion in the medical community echoing Dr. Burkhardt's comments. I think it would put the manufacturer in the position of practicing medicine. I think that information should come from the physician.

DR. WHALEN: Dr. Morykwas.

DR. MORYKWAS: I don't really have anything more to add to this conversation.

DR. WHALEN: Dr. Chang.

DR. CHANG: I saw two examples by both of the sponsors, "Options in Breast Reconstruction" and "Options in Breast Augmentation." I thought they were very appropriate. Any additional information, as Dr. Boykin mentioned, could be put together with materials already provided by ASPS and the Aesthetic Society.

DR. WHALEN: Thank you. Dr. Witten, does that discussion satisfy?

DR. WITTEN: Yes. Thank you.

DR. WHALEN: The fifth question asked what other elements should be added to the patient informed decision information. Dr. Bandeen-Roche.

DR. BANDEEN-ROCHE: I wonder whether any of the chemical, mechanical, biological testing would be described and summarized. I don't know whether it can be made understandable. Just it is an element that we consider in evaluating safety.

DR. WHALEN: Perhaps, with an asterisk, Dr. Li's 1-800 number would be of major assistance.

Dr. Boykin.

DR. BOYKIN: I believe a description of the chemical composition of the implant should be provided like putting the ingredients of something on a box so people can understand what is there. I believe that's my only comment right now.

DR. WHALEN: Dr. Blumenstein.

DR. BLUMENSTEIN: Nothing to add.

DR. WHALEN: Ms. Brinkman.

MS. BRINKMAN: If we haven't done it any place else, I think we certainly have to talk about getting mammograms and what kind of requirements a mammographer should have. Issues of lactation, again what those issues might be.

DR. WHALEN: Ms. Domecus.

MS. DOMECUS: I guess one thing I'll go back to on this question is my earlier comment about my extreme discomfort of the combination of the loss to follow-up rates in the study and all the testimony we've heard over the last few days of patients describing situations in which they had complications postimplant, went to their physician and they were told by their physician that it wasn't related and, therefore, they sought medical care elsewhere. I'm really worry about how to capture that.

I think it would be helpful at least to put in the patient brochure some information about how to report adverse events to the FDA if there are any ongoing studies. You heard today about a couple of retrospective studies that are going on right now. I'm not sure what those are but ways to contact them. If there is a registry, remind them about that.

I'm just really worried about this loss of data and if we added that 20 percent lost to follow-up to the complication rates, what would be really have and would we have voted differently.

DR. WHALEN: Dr. Morykwas.

DR. MORYKWAS: This is a fairly specific point but it seems like most of the discussion of changes in nipple and breast sensitivity has been hyposensitivity and hypersensitivity occurs. It seems to me -- not being a woman but it seems to me like just wearing clothes and walking in that instance would be very uncomfortable so I think somewhere the delineation needs to be made between both excessive and suppressive changes in sensitivity.

DR. WHALEN: Dr. Chang.

DR. CHANG: No other additional information to add, although I would second what Ms. Domecus. We encourage reporting of adverse events so that long-term follow-up and accurate information can be gained.

DR. WHALEN: Dr. Burkhardt.

DR. BURKHARDT: I think this needs to be included in the informed consent environment. Once again, the incidence of these problems is highly debated and is very much procedure dependent on whether the implant is put behind the muscle or behind the breast or what approach is used. I just don't know how this can be made available in a relatively simply straight-forward manner.

This is not the kind of thing I think you can get a Consumer's Report comparative testing done on. What women want to know is what is the very best implant and what is the very best surgeon and what is the very best procedure that I can have done. I don't know any way that that information can be made available.

DR. WHALEN: Dr. Witten, is that discussion satisfactory?

DR. WITTEN: Yes. Thanks.

DR. WHALEN: Does any other member of the panel have further comments or recommendations in regard to labeling or patient informed consent?

Ms. Brinkman.

MS. BRINKMAN: At one time I brought up the comment or suggestion about physician education. I don't know how appropriate that is or if it's within our ability to do that but is it possible to ask physicians to receive some sort of education on breast implants prior to their ability to purchase the product?

DR. WHALEN: I would start an answer to that and welcome anyone else to join in. While certainly many individual plastic surgeons have their own ambulatory ORs and they would then be the purchaser of the product in many instances, it is not the surgeon who is purchasing the products so we get into the whole realm of institutional credential rather than purchasing of the product. It obscures that issue somewhat, not to diminish its importance in any way, shape, or form.

Dr. Witten.

DR. WITTEN: If you're asking about the FDA role in that, in general we can ask manufacturers to have training programs available but in terms of restricting availability of the product to somebody who has been trained isn't something that we would generally do.

MS. BRINKMAN: And I'm not necessarily addressing a large training program. I guess my concern is that it's not board certified plastic or aesthetic surgeons that I'm concerned about. It's the number of physicians doing these procedures without any particular formal training. Even a brief type of review or a two-hour type of information course, none of that. We can't do that or require that.

DR. BURKHARDT: May I comment on that? Even if you could do it, it's a double-edged sword. If you set up a program like that that assumes people are qualified to do the surgery, how are you going to feel if your neighborhood family internist takes a short course on inserting breast implants and then goes ahead and says, "Well, I'm qualified and I can buy implants and do the procedure." That's the problem that you get into here.

MS. BRINKMAN: I don't think it's a qualifier. I mean, I don't think it's a certification process by any means.

DR. WHALEN: The problem becomes, to follow on what Dr. Burkhardt has just suggested, anything that's even in the most benign and well-intentioned of educational fora that are provided will end up on some osteopath or allopath's wall as a certificate and then can be used. It's a very valid issue that is an entire can of worms that goes into collective bargaining issues.

It goes into professional association issues. It goes into credential and it goes into specialty against specialty emphasizing that I'm saying all this as the one nonplastic surgeon on the panel. I think that perhaps it needs to be addressed. As it is beyond FDA's purview, I don't know that we can even begin to grapple with it today.

MS. BRINKMAN: The example given by this surgeon was the fact that evidently there's some sort of very powerful high-speed drill that is available to plastic surgeons and they could not purchase it unless they had taken a particular training course in order to use this particular drill. He said that was an FDA requirement in order to purchase the drill.

DR. WHALEN: Any comment, Dr. Witten?

DR. WITTEN: Only what I said before, just that we can require that they have a training course.

DR. BURKHARDT: I'm familiar with that situation, that piece of equipment, and I think there are two differences. It's my understanding that the company requires training before they will sell you the thing. I don't think it has much to do with the FDA. The other major difference is you don't find an awful lot of unqualified people clamoring to use that drill.

DR. WHALEN: Dr. Witten, are you satisfied with the panel's recommendations and is there any further specific question that you feel we should comment upon?

DR. WITTEN: No, I'm satisfied with the recommendations and I would like to thank you for your hard work over the last three days.

DR. WHALEN: I would like to make a few brief closing remarks. Usually for people who have been to any meeting I've been at, you know I sort of blaze out the door without remarks. This is an exception.

I would like to first and foremost thank my fellow panel members. It's been a delight working with you. I applaud and admire your expertise, your professionalism. I singularly enjoy the enlightenment of these meetings in so many different ways. Thank you to all of you.

I would like to thank everyone who took the time to comment both as individual consumers and as representing organizations. There were many singularly tragic stories told to us in the past few days. One comment was made, and I'm sure it wasn't meant necessarily the way I'm phrasing it, but that the panel had disregarded such information. Believe me, we did not disregard that information. It was heard, it was conveyed, it was understood.

Finally, I would like to thank everyone from the FDA for the extraordinary job that they always do from AnnMarie guarding that door so zealously. Thank you very much and all the rest of the staff. Everybody in the FDA professional staff but just to make a few named thank yous.

I would like to, of course, thank our Executive Secretary Dr. David Krause for sending us enough information in advance to get hernias. To Mr. Stephen Rhodes and the always professional job that he has done with us and the curtesy he has extended to us. To Ms. Nancy Pluhowski who as the mom of all these panels makes sure we try to dot our Is and cross our Ts and we appreciate that very much. To our true boss, Dr. Celia Witten, for enduring this on the panel with us and keeping the ship on a straight course. Finally, a strong note of thanks not just for this meeting but for several meetings to someone we are unfortunately going to lose from this panel, and that is Mr. Jim Dillard. He's exceptionally professional, a joy to work with, and we congratulate him on his promotion.

Thank you very much and the meeting is adjourned.

DR. BLUMENSTEIN: I'd like to say thank you to our Chair for a very good meeting.

(Whereupon, the meeting was adjourned at 2:44 p.m.)

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