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FOOD AND DRUG ADMINISTRATION
MEDICAL DEVICES ADVISORY COMMITTEE
GENERAL AND PLASTIC SURGERY
DEVICES PANEL
MEETING
Wednesday, March 1, 2000
The meeting was held in the Ballroom, Gaithersburg Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland, at 8:00 a.m., Dr. thomas V. Whalen, Chairman, presiding.
PRESENT:
THOMAS 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
PRESENT (Continued):
BRENT BLUMENSTEIN, Ph.D., Temporary Voting Member
BOYD BURKHARDT, M.D., Temporary Voting Member
NANCY A. DUBLER, LLB., Temporary Voting Member
STEPHEN LI, Ph.D., Temporary Voting Member
MICHAEL J. MORYKWAS, Ph.D., Temporary Voting Member
JOHN S. ROBINSON, M.D., Temporary Voting Member
MAXINE F. BRINKMAN, R.N., Consumer Representative
CINDY DOMECUS, Industry Representative
DAVID KRAUSE, Ph.D., Executive Secretary
C-O-N-T-E-N-T-S
Introductions, Dr. Thomas WhalenConflict of Interest and Temporary Voting Member Deputization Statement FDA Modernization Act, Phil Phillips
Welcoming Remarks, Stephen P. Rhodes
Public Comment:
Elizabeth Mullen (via statement)
CONTINUES ON THE NEXT FDA FILE
Dr. Anne S. Kasper
Carol Sherman
Regulation of Saline Filled Breast Prostheses,
Dr. Celia Witten
Considerations on Imaging Patients with Breast
Implants, Dr. Wendie Berg
Mentor Corporation Presentation:
Introduction, Anthony Gette
Preclinical Data, Bobby Purkait
Clinical Studies, Pamela L. Powell
Clinical Safety, Bruce L. Cummingham
Clinical Effectiveness, Rebecca Anderson
Conclusion, Bobby Purkait
FDA Presentation:
Lead Review, Dr. David Berkowitz
Clinical Review, Dr. Sahar Dawisha
Statistical Review, Phyllis Silverman
Panel Discussants: FDA Questions to Panel, David Berkowitz Mechanical Testing, Dr. Stephen Li
Clinical, Dr. Boyd Burkhardt
Statistical, Dr. Brent Blumenstein
Public Comment:
Lale Goddard
Public Comment (Continued):
Rosmary A. Locke
Dr. Diana Zuckerman
Jill McClure
Sponsor Summation
P-R-O-C-E-E-D-I-N-G-S
(8:06 a.m.)
DR. KRAUSE: Good morning, everyone. I'd like to get the meeting started, please. If everyone could please take a seat.
Thank you.
We're ready to begin the 56th meeting of the General and 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'd like to remind everyone that you're requested to please sign in on the attendance sheets, which are available at the tables by the door. You may also pick up an agenda, a panel roster, and information about the meeting at that same table.
The information includes about how to find out about future meetings of the panel and other panels.
Before turning the meeting over to Dr. Whalen, I'm required to read two statements into the record: the deputization of temporary voting members statement and the conflict of interest statement.
The first statement is the appointment to temporary voting status. Pursuant to the authority granted under the Medical Devices Advisory Committee charter, dated October 27th, 1990, and as amended August 18th, 1999, I appoint the following individuals as voting members of the General and Plastic Surgery Devices Panel for this meeting on March 1st, 2000:
Karen Bandeen-Roche;
Brent Blumenstein;
Boyd Burkhardt;
Nancy Dubler;
Stephen Li;
Michael Morykwas; and
John Robinson.
For the record, these individuals are special government employees and consultants to this panel or other panels under the Medical Device Advisory Committee. They have undergone the customary conflict of interest review and have reviewed the material to be considered at this meeting, and this is signed by Dr. David W. Feigal, Jr., the Director of Center for Devices and Radiological Health.
The following is the conflict of interest statement.
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 interests reported by the committee participants. The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employees' financial interests.
However, the agency has determined that participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved, is in the best interest of the government.
A waiver has been granted for Dr. Stephen Li and his interests in a firm at issue that could potentially be affected by the committee's deliberations. The waiver allows this individual to participate fully in the panel's deliberations.
A copy of his waiver may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.
We would like to know for the record that the agency took into consideration certain matters regarding Drs. Burkhardt, Chang, Li, and Morykwas.
Dr. Li reported a current interest in a firm at issue, but in matters not related to the panel's agenda. Therefore, the agency has determined that he may participate fully in the deliberation.
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.
The agency would also like to note for the record that Dr. Wendie Berg, who is making a presentation today, has acknowledged a previous related financial interest with a firm at issue. Dr. Berg serves as a consultant to the Radiological Devices Panel, as well as all panels of the Medical Advisory Committee.
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.
Okay. This concludes the required statements, and I would like now to turn this meeting over to Dr. Whalen, the Chair.
CHAIRMAN WHALEN: Thank you, Dr. Krause.
Good morning. My name is Dr. Thomas Whalen. I'm head of the Division of Pediatric Surgery at Robert Wood Johnson Medical School in Camden, New Jersey, and also the Program Director of the general surgical residency there.
Today the panel will be making recommendations to the Food and Drug Administration on a pre-market approval application, but the next item of business is for those of us on the panel to introduce ourselves. These are the panel members who are giving of their time to help the FDA in these matters, and the FDA staff themselves, who will introduce themselves sitting here at the table.
I would ask that each person introduce him or herself, stating his or her specialty, position title, institution, and his or her status on the panel today as voting member, industry or consumer representative, or deputized voting member.
And I would start to my left with Dr. Chang.
DR. CHANG: I'm Phyllis Chang, an associate professor in the Section of Plastic Surgery, Department of Surgery and Division of Hand and Microsurgery, Department of Orthopedic Surgery at the University of Iowa. I am a voting panel member.
DR. MORYKWAS: I am Michael Morykwas. I'm an assistant professor of surgical sciences in the Department of Plastic and Reconstructive Surgery at the Wake Forest University School of Medicine.
MS. DUBLER: I'm Nancy Dubler. I'm Director of the Division of Bioethics at Montifiore Medical Center and a professor of bioethnics at the Albert Einstein College of Medicine in the Bronx. I'm a temporary voting member today.
DR. ROBINSON: I'm John Robinson, a rheumatologist, professor of medicine at Loyola University Medical Center in Chicago, Illinois. I'm a deputized voting member today.
MS. BRINKMAN: I'm Maxine Brinkman. I'm Director of Women's Services, Mercy Medical Center, North Iowa. I represent Department of Consumer Affairs, and I am a nonvoting member.
MS. DOMECUS: My name is Cindy Domecus. I'm Senior Vice President of Clinical Research and Regulatory Affairs for Conceptus, and I'm the industry representative on the panel today.
CHAIRMAN WHALEN: Dr. Witten.
DR. WITTEN: I'm Dr. Celia Witten. I'm the Division Director of DGRD in ODE in CDRH and FDA.
DR. LI: Stephen Li, senior scientist, Hospital for Special Surgery in New York in the Department of Biomechanics and Biomolecular Design, and I'm a temporary voting member.
DR. BLUMENSTEIN: I'm Brent Blumenstein. I'm a biostatistician. I have worked for the American College of Surgeons Oncology Group. I'm deputized.
DR. BOYKIN: My name is Joe Boykin. I'm a permanent voting member, a plastic and reconstructive surgeon from Columbia Retreat Hospital, where I'm also the Director of the Wound Healing Center and Burn Program.
DR. BANDEEN-ROCHE: I'm Karen Bandeen-Roche, associate professor of biostatistics at Johns Hopkins University in Baltimore. I'm a temporary voting member.
DR. BURKHARDT: I'm Boyd Burkhardt. I am a practitioner in plastic surgery in Tucson, Arizona, and I'm a temporary voting member.
DR. KRAUSE: I'm David Krause, the panel Executive Secretary.
CHAIRMAN WHALEN: Thank you.
I'd like to note for the record that the voting members do constitute a quorum as required by 21 Code of Federal Regulations, Part 14.
I'd like to next introduce Mr. Phil Phillips, the Deputy Director of the Office of Device Evaluation, who will tell us a little bit about the least burdensome provisions of the FDA Modernization Act.
Mr. Phillips.
MR. PHILLIPS: Mr. Chairman and members of the panel, I am Phil Phillips. I'm the Deputy Director for Science and Regulatory Policy in the Office of Device Evaluation.
Excuse our low tech presentation this morning. I was thinking that I should have put a Power Point presentation on and gone along with the rest, but nevertheless, I hope that you'll find this to be a very informative presentation.
The FDA Modernization Act of 1997 was signed into effect back in November of 1997 by President Clinton. Some individuals think that it is perhaps one of the most significant pieces of legislation in the history of FDA certainly since President Ford signed in the medical device amendments back in 1976.
I would encourage anyone who is interested on the panel to learn more about the FDA Modernization Act. You can go to our Web site, and you will find that there's a lot of information on the law, as well as the steps that the agency has taken to actually implement the law.
Today I'm going to be talking about two provisions that are included in the law, and it deals with the terms "least burdensome." I'm going to be going through the actual statute itself. I'm going to go through some of the actual mechanisms that we have in implementing the law.
The terms "least burdensome" apply in actually two different sections of the FD&C Act. It's Section 513(a) and Section 513(i), and let's look at each one of them very briefly.
Under Section 513(a), and this is the one that perhaps will have the most effect on panel deliberations because it applies to pre-market approval applications. What the law now tells us is that the Secretary shall consider in conjunction with the applicant the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood in resulting in approval.
Now, keep in mind this is the least burdensome, and this applies to the effectiveness requirements as it applies to pre-market approval applications.
The second place that the terms "least burdensome" apply is in Section 513(l). This is probably not going to be something that the panels will be as involved in as with pre-market approval applications because this applies to pre-market notification or 510(k) submissions.
Yes, indeed, there are some 510(k)'s that go before advisory committees, but it is somewhat unusual. It's more likely that as members of the panel you may receive a homework assignment that deals with a particular pre-market notification submission, and this would be an important part of the statute that would apply to those activities.
Specifically, this says that in making such requests, and this is requests for additional information to determine substantial equivalence of devices, that the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly. So the terms "least burdensome" apply in two different parts of the statute.
It's important for everyone to recognize that even though the Congress has told us to consider the least burdensome means of getting devices to market, that the FDA Modernization Act did not change the standard for pre-market clearance and approval. That is, when we deal with pre-market approval applications, it's still reasonable assurance of safety and effectiveness, and when we deal with pre-market notifications, your 510(k) submissions, it's still substantial equivalence. The terms have not changed.
As far as the implementation of these procedures, it actually started back in January of last year. There was an open public meeting that we had. We had a lot of people from the industry that was present. There were consumer groups present. There were professional societies present. It was a half a day's session that we devoted strictly to the terms least burdensome and have been trying to interpret those so that we know exactly how to apply them in our day-to-day activities.
Since then we have had internal communications inside the agency. We have also had scientific reviewer training similar to what is going on today, but of course in a little bit more detail because we had much, much more time.
There was also a guidance document that was drafted by the agency. It's called the evidence models for the least burdensome means to market. That did appear in the Federal Register back in September of last year.
I have included it. It's in your handouts. It's also shown here, the actual Web address so that you'll be able to access that if there's a need for you to access that particular document.
It was a subject of a comment period, and that comment period closed November 30th of 1999. Currently we're in the process of evaluating the different comments that came into the agency on that particular draft guidance document.
In addition to the FDA guidance document, there was also a least burdensome industry task force that was convened, and they gave a proposal to the agency back in March of 1999. That agency proposal was incorporated as Appendix D in the FDA guidance document that I just mentioned. So it was subject to the same comment period, which closed November 30th of 1999. We were also looking at the comments on this particular aspect of our proposal.
We have formulated what I will call an interim FDA definition. The importance to the term "interim" is that this is not final. We do not have final guidance out, but this is an operating definition that we've told our reviewers inside our organization and you as panel members that would be, I think, a reasonable attempt of trying to interpret exactly what the terms "least burdensome" means.
What we said is that least burdensome is a successful means of addressing a pre-market issue that involves the smallest investment of time, effort and money on the part of the submitter and FDA.
Now, keep in mind successful means that the applicant has met the statutory criteria: reasonable assurance for a PMA or substantial equivalence for a 510(k).
Some have suggested that in order for us to take the least burdensome approach, that we have to actually have a cultural change within our organization. Well, I don't know whether we need to change the entire culture, but clearly we all need to recognize that there can be multiple approaches to satisfying regulatory requirements. There is no one way to address any particular scientific issue.
Likewise, we need to communicate and collaborate and also compromise in the interest of public health and some of the decisions that we make. We need to understand not just the letter of the law, but also the spirit of the law, and we need to also factor issues such as time, effort and money as considerations as part of our decision making as a result of the least burdensome provisions.
Least burdensome does not mean that we need to in any way compromise scientific integrity. Clearly, I think we all recognize that scientific endeavors are affected by the availability of resources. Inside the agency and even outside the agency, all research organizations are affected certainly by available resources.
Also, good science does, in fact, include issues such as cost effectiveness. Compromise is a necessity for successful research, and lessening regulatory burden may, in fact, serve to enhance scientific progress and advance medicine. That, I believe, is the reason that the Congress put this particular provision into law.
What are some of the mechanisms that we're suggesting today that may actually lessen regulatory burden? Well, I think that we all need to insure that all regulatory decisions are made in accordance with relevant statutory criteria. Again, as panel members you've been trained on issues such as reasonable assurance of safety and effectiveness. That is the statutory criteria that you would apply to pre-market approval applications, and that has not changed as a result of anything that the FDA Modernization Act has done.
We need to use the tools provided by the FDA Modernization Act -- that's referred to as FDAMA. You may hear that on occasion -- as well as some of the process reengineering that has actually taken place within the center.
Now, for example, we have exemptions for many of the simple Class I devices so that we're not even using resources in clearing these particular types of products. That means that we can divert our resources and your time and efforts into looking at the more significant types of products that pose more risk for the American public.
There's also collaborative meetings that we are now required to have with industry as we approach evaluation of different marketing applications. There are also opportunities for third party review, that is, for certain types of devices. They can take 510(k) submissions and have them actually evaluated by recognized third parties outside of the agency that will make recommendations regarding the clearance of these products to the agency.
These are important mechanisms that I think can serve to streamline and lessen regulatory burden.
We also need to factor in relevant, publicly available information in our decision making. This is particularly important, I think, for panel members. Since you all are experts, you have a tremendous amount of knowledge. You have a lot of information that's at your fingertips.
That publicly available information is something that we should use in our decision making so that we can learn and we can lessen regulatory burden as, in fact, the level of knowledge increases.
We need to rely on nonclinical testing for decision making when possible. I mean I think it's one thing that's important to recognize that when you deal with nonclinical testing, in many cases you can get much more precision in some of our findings than you can actually get from clinical trials.
That's not to suggest that clinical trials are not very, very important. They are very important, but I think there's a tremendous amount of information that we can learn from doing some simple, preclinical testing.
In the world today, you'll find particularly when we talk about issues such as global harmonization that there's a tremendous amount of effort put into developing standards for different devices and different types of products and different types of scientific methods.
We need to rely on conformance with recognized standards as part of our decision making. It is a way that can lessen the burden, and it can certainly streamline our evaluation of different types of medical devices.
When clinical data is needed, we need to consider alternatives to randomized control trials, and here specifically I can say we can rely on literature or nonactive controls.
Now, again, there are certainly different situations where you need to have a randomized controlled clinical trial, but likewise, there are other situations where there are other viable alternatives that will address the issues that we're trying to address with the same level of assurance as doing a randomized controlled trial.
We also need to use surrogate endpoints where possible to demonstrate device effectiveness. Oftentimes, as you realize, if you look at issues of effectiveness you can talk about long term types of information. If we can find appropriate surrogates, sometimes it can shorten the duration of some of the trials at least for the purposes of clearing different devices to market.
What's the bottom line to my remarks this morning? Well, keep in mind that this is still a very early process at trying to interpret the least burdensome provisions and trying to give guidance to our internal reviewers as well as to our advisory committees.
But what I would suggest is that we all factor the least burdensome concepts into all of our pre-market activities. This would include, for example, guidance development and use, regulation development, as well as panel review and recommendation types of activities, such as is occurring today.
Above and beyond, I think we all need to remain open minded to alternative proposals for satisfying regulatory requirements. I think I can sum it up. I think that what Congress was trying very much to do by instructing us to take these least burdensome tactics is really trying to inject a degree of common sense into the regulatory process without in any way diminishing the level of safety and effectiveness that we assure the American public.
That concludes my remarks, Mr. Chairman, unless you have any questions.
CHAIRMAN WHALEN: Do any panel members have questions of Mr. Phillips?
(No response.)
CHAIRMAN WHALEN: Thank you, sir.
MR. PHILLIPS: Thank you for your time.
CHAIRMAN WHALEN: I would like to next introduce Mr. Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch, who will make some introductory remarks to the panel.
Mr. Rhodes.
MR. RHODES: Thank you, Dr. Whalen.
And good morning. I am Stephen Rhodes, the Branch Chief of the Plastic and Reconstructive Surgery Devices Branch here at the Food and Drug Administration.
Welcome, members of the panel, members of the public, and manufacturers to this important three-day meeting of the General and Plastic Surgery Panel, important because it's the first FDA panel meeting to make recommendations on the approvability of any saline filled breast implant, and you will vote on three pre-market approval applications over the next two days.
Just a word about the order of the PMAs coming before the panel. It's the order in which the PMAs were received by the agency.
Because of the high public interest in saline filled breast implants, in addition to the regular public comment periods for any PMA discussion, we will have three hours of public comment this morning on general issues related to saline filled breast implants, and two and a half hours on Friday morning for public comment on issues specific to insuring the patients are making informed decisions when considered saline filled breast implants.
As a reminder, we will not be discussing silicon gel filled breast implants at this meeting, and I request that the panel members and members of the public limit their comments and discussion to the products being evaluated, saline filled breast implants.
Panel members, we appreciate your commitment. Members of the public who have requested time to address the panel, we appreciate your comments, and, manufacturers, we appreciate your participation in presenting the safety and effectiveness data you have collected to the panel and in answering questions that the panel may have.
Thank you for your attention, and I'll turn it back to you.
CHAIRMAN WHALEN: Thank you, Mr. Rhodes.
Do any panel members have questions of Mr. Rhodes?
(No response.)
CHAIRMAN WHALEN: We will then now proceed with the open public hearing session of this meeting. All persons addressing the panel are asked to speak clearly into the microphone as the transcriptionist is dependent on this means of providing an accurate record of the meeting.
At this time I would like to ask Dr. Krause to give us some instructions for those who will be testifying before the panel.
Dr. Krause.
DR. KRAUSE: Okay. First and foremost, I would like to thank all of those of you who contacted me and asked for time to speak. I know that it's a big sacrifice to come here. Some of you have come a long way, and we appreciate that.
I'd like to give a few instructions before we starting having the speakers come up, requesting that all persons making statements during the open public hearing of the meeting disclose whether they have financial interests in any medical device company or if their trip to this 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 will read the questions into the record at this time so that a rereading by all of the presenters and later in the day will not be necessary. These are the questions for all speakers.
Question number one: has your travel and/or accommodations been paid for or will they be reimbursed by someone else? If so, please state who.
Question two: please indicate whether you have financial ties, including grants or other compensation with industry or health professional societies.
Number three: please indicate whether you are a party to or witness in a pending lawsuit related to breast implants.
And question four: 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?
What we have done this morning is if you're a speaker, you should have registered at the table outside. You will have been assigned a position in which you will testify. What we're going to try to do is get as many of you in in the morning as we can. Probably we will have to break for lunch around 12 to 12:15, and some of you may wind up testifying in the early afternoon immediately following lunch.
A couple of things that have come up is all of the time for today is full. So we can't have anybody who has not preregistered testifying today. We just have so many people testifying, and we're going to be running late as it is.
But there is some time available tomorrow morning, and I think there is some time also available Friday. If you would like to address the panel, you can go to the registration desk outside and let the people at the desk know that you wish to testify tomorrow. Unfortunately, we can't give anyone who asks to testify tomorrow very much time if a lot of people go up.
So if we get, you know, say, three or four people who wish to testify, then we can give everybody about five minutes. If we have 15 people, then we need to restrict that to about two minutes. So it will have to be flexible.
Okay. I'd like to now turn the meeting back to the chair.
CHAIRMAN WHALEN: Thank you, Dr. Krause.
As just alluded to, we will only have time for those individuals who have notified FDA of their request to present in the open session.
We are going to begin with individual consumers. Each of them will have five minutes to address the panel, which I'm sure after you answer the four questions thoroughly will leave at least six or seven seconds to make your comments.
(Laughter.)
CHAIRMAN WHALEN: I would ask that each of those presenting would pay attention to the timer light which is by the podium so that each and everyone who has been assigned a portion of time will have their just amount of time to speak to the panel.
The first individual consumer then to address the panel is listed in the program as Ms. Kitchen.
DR. KRAUSE: A quick comment about the timer. You'll get a blinking light at about a minute, and then a red light at five minutes.
MS. KITCHEN: Good morning. I'm here in support of saline implants. I think there are a lot of good reasons why saline implants should be available.
CHAIRMAN WHALEN: Forgive my intrusion, but --
MS. KITCHEN: Oh, oh.
CHAIRMAN WHALEN: -- just because you're the first one, even if there's negative answers to those questions, would you just say that at the outset?
MS. KITCHEN: Okay. My answers to all of your questions are no. I had no -- nothing to gain.
Okay. I think there are a lot of good reasons why saline implants should be available to people. In my case, I was born with a deformity of right chest, and 20 years ago, I had saline implants. I had breast augmentation surgery using saline implants to correct my deformity, and this surgery changed my life. It camouflaged my deformity and gave me a greater confidence in myself.
And I've had no problems with the implants over the course of 20 years and have lived a very healthy, happy life as a result.
I encourage you to keep them on the market, and as long as people are notified of the risks and the benefits, I believe they should stay on the market.
Thank you.
CHAIRMAN WHALEN: thank you.
Next is Ms. Faussett.
MS. FAUSSETT: Good morning. In answer to the questions, I received an honorarium of $200 to participate in the workshop yesterday, and I will use to help pay for my expenses of travel. The honorarium has been paid by a nonprofit research center, CPR for Women and Families.
Only a little more than two years ago I had a normal life, and I was a happy, healthy, highly organized and energetic young woman. I had graduated from college with honors, had a career in management, married the man of my dreams, and I had four wonderful children. My youngest is now five.
I had enjoyed a robust health all my life and I hadn't missed a day of work due to illness for over ten years. It was after breast feeding my children that I decided to get implants, hoping that they would help to restore my pre-pregnancy shape.
My highly respected plastic surgeon had told me that my McGhan saline breast implants would last my entire life and go with me to my grave. The risks he mainly discussed were of a local nature, such as infection, hematoma, a rupture, and I was led to believe that these were easy to remedy.
What I didn't know was that the risks were far greater than I was ever told. In January 1998, eight months after getting my implants, my world crash. My vision became disturbed. I couldn't concentrate and was unable to retain anything I read. I was extremely tired and found that sleep did not refresh me. Mentally it seemed as if a fog had descended upon my brain and clear thoughts and coordination became very difficult for me.
I was constantly dizzy and started bumping into walls and had tingling sensations in my hands. My hands were always cold, and I experienced joint pain among other unsettling symptoms.
I was frightened by this sudden drastic change in my health. Nothing in my habits or life style had changed with the exception of having received the implants.
While my original plastic surgeon downplayed my symptoms, a second plastic surgeon recommended that they be removed and I see a rheumatologist.
Blood tests showed an autoimmune response starting as evidence by an elevated rheumatoid factor, as well as a lowered C3 complement and macrocytosis. I also had a brain MRI which showed a mild degree of atrophy, quite unusual considering I was only 38 years old at the time and have no family history of these problems.
I spent the last two years of my life struggling to regain the precious health that I had. The most important step I've taken was to have my saline implants removed. There's no doubt that the implants were harming me in a terrible way, as almost all symptoms have subsided.
I thank God that I'm still recovering, but I'm gravely concerned for other women out there who are ill or who will become ill from their implants and who are not properly informed of these dangers.
The devastating health problems that ensued after I was implanted with saline implants should never ever be considered acceptable risks, especially since these are not life saving devices.
Ask my parents if the risks were acceptable. They had to drive over 2,000 miles to come and help care for me while I was ill. Ask my husband. He had to pay thousands of dollars in unexpected medical bills and lost me as a supporting partner in taking care of our family. Ask my children. They lost their smiling, nurturing mother and instead were left with a sick woman who could no longer play with them, cook their favorite dinners, or help them with their homework.
Ask me if I think the risks are worth it, and I will ask you if you would be willing to let your wife or daughter, mother or sister suffer from destroyed health, loss of career, loss of income, emotional distress, financial distress, and medical system abuse all for the sake of breast implants. Only fools will call these risks acceptable.
The information my plastic surgeon gave me was not enough to indicate fully informed consent. He never told me that I was risking the integrity of central nervous system or the functioning of my brain. He never discussed the seriousness of autoimmune disease or the fact that they are incurable.
If he had told me that neurologically I was at risk, I would have said, "No, thanks," and walked away. Nowhere in my research about implants was there any indication of the illnesses that I experienced. It was only after I became ill that my plastic surgeon told me about the FDA booklet on breast implants. Prior to that I did not know it existed.
You are mistaken if you think that women will be able to correctly evaluate the risks and make informed decisions about getting breast implants. Women go into the surgery with great anticipation of the benefits. They will not get the information they need until long term studies are done which show how many women become ill and which women are most at risk. That research has not been done, and the manufacturers' research has not answered those questions.
Two weeks ago my stepdaughter, who did not know what I went through, wrote to my husband and I asking for $6,000 for breast implants and informed us she knew all the risks, but upon questioning, she did not know the meaning of capsular contracture or she had never heard of autoimmune diseases.
She did not know that the saline in her implants could grow mold and bacteria over time and cause serious infection in her body. She was not fully informed.
She is now only because we informed her of those things, not her plastic surgeon, and she has since chosen not to get implants.
The number one mission at the FDA is to protect consumers regarding unsafe medical products. As far as myself and thousands of other women are concerned, they have failed at this mission.
Studies are needed to objectively measure how many women have experiences like mine. After long term research is completed, if the FDA improves saline implants, they should all require mandatory disclosures of the kind of ill effects women have experienced from implants like me and warn them of the very serious nature of these problems that result in the loss of jobs, career, incomes, home, family, and well-being, including life itself.
Please recommend that saline implants not be approved until more research has been done as to their long term safety.
Thank you.
I also have my implants if anyone would like to look at them.
CHAIRMAN WHALEN: Thank you.
The next speaker is Dr. Melez.
DR. MELEZ: My name is Kathleen Melez. I am a breast cancer survivor and an implant survivor. I am a physician practicing in Los Angeles, an immunologist to be training in infectious diseases.
I paid all of my expenses to come here today. I have no association with pharmaceutical industry, with medical societies. I have no conflict of interest with the manufacturers here today, although I have a lawsuit against Bristol Myers Squibb.
I see breast implant patients only as part of my regular duties to take care of patients in general medical clinics and urgent care facilities.
Working on the West Side in Los Angeles, I have seen a number of breast implant patients, both saline and silicon implant patients over the years. Both patients have a variety of manifestations of foreign body reactions. I would like to mention two problems I am trained to recognize.
Breast implantations complain of general malaise, arthralgias, myalgias, peripheral neuropathy.
This reminds me. The experiments we did in the laboratory as an immunologist, then we injected rats and mice subcutaneously, under the skin at the base of the tail with small particles, bacteria and oil, and this resulted in systemic illness.
I expect the best implants have the same result with small particles, infections, and oil from the envelope causing systemic disease, probably the same way similar to sterile arthritis in artificial joints.
The other issue I would like to touch upon is infections. The breast in not sterile tissue. In addition to infections at the time of surgery, infections do occur through the milk ducts. Such infections would stay longer and fester with the foreign body, the implant, in place.
Not only the outside of the breast implant getting infected, but the saline itself can harbor bacteria and fungi well described in the literature. In fact, normal saline bags for infusion have a limited shelf life.
I would like to offer into evidence this normal saline bag. This is produced by Baxter. The expiration date is September of this year. My understanding is that saline bags have a shelf life of 18 months. Do we expect to change saline breast implants in every patient, in every 18 months? I think these devices are unsafe, and I think they should not be allowed to remain on the market or should not be licensed.
Thank you.
CHAIRMAN WHALEN: Thank you.
The next speaker is Dr. Atagi. Forgive me. Ms. Jennifer Gardner.
MS. GARDNER: Good morning. I am traveling to this meeting at my own expense. I have no financial ties to any health professional societies or health industry companies. I am not involved as a witness or party to any pending lawsuits related to breast implants, and I derive none of my income from medical procedures or treatment of patients in relation to breast implants.
My name is Jennifer Gardner, and I would like to thank you for giving me the opportunity to speak to all of you about my experience with breast reconstruction using saline filled breast implants.
All my life up until my illness I have been health, fit, and very proud of my appearance. In November 1997, I was diagnoses with advanced breast cancer. Because of the severity of my diagnosis, there was no doubt I would lose my entire breast.
I also knew I had the option of reconstructive surgery. After one and a half years of aggressive treatment, I started researching this next step with approval from my oncologist. I selected Dr. Scott Spear at Georgetown University Medical Center. At my first meeting we discussed what my options were and what his recommendations were for my condition. Dr. Spear was extremely compassionate and explained to me the entire procedure and what risks were involved.
In September of 1999, I had my surgery. I had a tran flap procedure with an expander with a saline filled implant where my left breast had been removed. I also chose to have a subcutaneous mastectomy on my right breast, replaced with an expander and a saline implant.
I remained in the hospital for four days and recovered at home for the next three weeks. I had no complications during or after my operation.
This surgery has changed my life dramatically. It has given me back my self-esteem and sexuality. I cannot look in the mirror and no longer see what this cancer has taken away.
I feel that it is vitally important that saline breast implants remain on the market for other women and give them the same chance to look normal and feel like themselves again. Just knowing that that option was out there for me gave me hope that I could get back what I thought was lost forever.
I am now 22 months in remission, and I feel happy, healthy, and desirable again.
Thank you.
CHAIRMAN WHALEN: Thank you.
Now, Dr. Atagi.
DR. ATAGI: Good morning. I'm Dr. Tanya Atagi, a plastic surgery -- plastic and reconstructive surgery resident Fellow at the Washington University in St. Louis, Missouri. My research funding stipend and travel expenses are supported by the Washington University School of Medicine and the Division of Plastic and Reconstructive Surgery.
I'm not a member of the American Society of Plastic Surgery or a member of the American Society of Aesthetic Plastic Surgery, nor do I represent any of these implant manufacturers. I'm not a witness in or involved in any lawsuits regarding breast implants.
As a plastic surgery resident functioning essentially as a surgical assistant, I was involved in the use of breast prostheses and the care of patients with breast implants and was paid a stipend. None of my personal income is derived from breast implant surgery or from treating patients with breast implants.
My involvement in breast implant research stems from three primary interests, perhaps most obviously because I am a plastic surgeon. I am, however, particularly interested in the device and product development aspects of breast prostheses because I began my medical career as a biomedical engineer.
I'm also especially interested in the psychological effects of breast implants on women undergoing both aesthetic and reconstructive plastic surgery procedures, I think, in part, because I am woman.
I'm currently involved in several aspects of breast implant research, including the development of a physical breast model for use in testing breast prostheses and the use of digital three dimensional imagining technology, including noninvasive volumetric analysis and ultrasound evaluation of postoperative changes, and finally, the use of objective measurement techniques to evaluate capsular contracture of the breast.
This past year I've also been designing a psychological outcome study of breast augmentation patients, incorporating a battery of reliable and validated psychological test instruments. Psychological data using normed psychological test surveys to examine breast implant surgery patients has been somewhat scarce, especially in the area of aesthetic surgery.
Existing standardized health status and psychological test instruments have been shown to be sensitive in the evaluation of women undergoing breast implant surgery. In addition, more rigorously established tests are becoming available and incorporated into useful prospective studies, including those designed for use in the breast implant population.
I have found in my experience that with preoperative and postoperative psychological evaluations conducted for women undergoing both breast augmentation and reconstruction using other implant types is in agreement with other more recent studies. Surveys of women receiving saline implants, including those using both validated test instruments and self-designed questionnaires show that preoperatively the vast majority of women who undergo breast implant surgery, whether for augmentation or reconstruction, are generally physically healthy and psychologically stable with reasonable surgical expectations. They have a positive view of their bodies and expect to derive psychosocial benefits from their implants.
They are not, however, seeking to address serious psychosocial problems related to their breasts, and patients are typically not depressed and psychologically unstable as earlier studies using non-standardized, uncontrolled tests have suggested.
Women undergoing implant surgery generally demonstrate mature personalities. They harbor low levels of anxiety and are self-directed. After undergoing implant surgery, patients are less concerned about potential implant problems as they incorporate the implants into their new body image and they exhibit significantly improved levels of self-esteem and improved body image.
Women derive statistically significant benefits from their implants. They record measurable benefits and social comfort and express consistently high levels of satisfaction.
Informal and formal satisfaction surveys show that 93 to 99 percent of patients expressing levels of positive satisfaction even in the light of complications.
The plastic surgery and psychiatric communities understand the body image and self-esteem are all critical in the overall health status of the individual, and I'm confident that these groups are making concerted, often multi-disciplinary efforts to study and meet the needs of the individual as a whole.
In fact, I believe you will hear from a psychologist who studies these issues in plastic surgery patients later in the proceedings.
In summary, as an engineer, I think there is convincing evidence that saline breast implants are durable, which you will undoubtedly hear more about later, and as a plastic surgeon, I see tremendous psychosocial benefits to women in improving and in restoring self-image. I see earnest, ongoing efforts to decrease risks and complications and improve techniques and, therefore, outcomes.
And as a woman, I feel we are fortunate to have surgical enhancement and restoration incorporating saline implants as an option to us in the company of informed consent.
Overall the very real psychosocial benefits to women are exceptionally important in your consideration of saline implants.
Thank you.
CHAIRMAN WHALEN: Thank you, Dr. Atagi.
Next, Ms. Maura McGinn.
Cynthia Scott.
Who do we have next? Dr. Anderson, please.
DR. ANDERSON: Good morning, panel, and good morning, Mr. Chairman.
I answer all of the questions put forward in the negative, except for one. I do care for about 62 saline breast implant patients at this time.
My name is Norman Anderson. I have no proprietary interest in saline breast implants. I currently serve as a full-time member of the -- associate professor of the Johns Hopkins University School of Medicine.
As a internist, I do not directly implant devices into patients. However, I have some familiarity with the regulation of breast implants gleaned from 13 years of between the late 1970s and 1992, when I served variously as a consultant, panel member, and chair of the committee which I'm now addressing.
From that experience, I well recognize the importance and the pressures that each of you are facing today.
Because of that experience, I also began receiving referrals of patients with breast implant problems into my clinic in the mid-1980s. These referrals have steadily expanded over the years, and I've now been privileged to participate in the care of approximately 1,000 breast implant recipients, but only 62 clear-cut saline devices.
Because of the vast of these women presented with problems, this sampling bias prevents me in giving you an accurate insight into the general outcome of saline implant usage. However, it has given me an exposure to related complications on the dark side, and I would like to share these with you today.
Now, these comments are also well known to the manufacturers, as I have the opportunity to raise each of these points in an open FDA meeting with the manufacturers in 1993, when they were advised that PMA was about to continue.
It is my fervent hope that they now provide sound and reasonable evidence proving the safety of these devices. To my mind, the first issue to be resolved is the long term survival of saline implants. They share the same type of shell that silicone gel implants do.
With silicone gel implant review, very few implant ruptures were seen in the first two or three years. However, eight to ten, rapid increase in device failure. Depending upon what series and who you believe, 20 to 80 percent of all of those devices ruptured after ten years.
There's also evidence that the shell, silicone shell degrades in the body. Again, this was extensively reviewed in the FDA hearings in 1991 and two, and I only have to give you the anecdotal experiences of plastic surgeons who had the implant tear as they try to lift it from the body, what's happening to these shell membranes over time.
Now, with that, it's also known that the saline implants will deflate with a pinhole, whereas the silicone implant may require a larger rent or tear to have gel extrusion and collapse recognized.
With all of that, there is a big concern that the saline implants will show a very high failure rate with time. From our point of view, you also should recognize that folds on that shelf have been associated with shell failure over time.
I regret to report to you that every saline implant that we have studied with sonograph shows folds. Because of that, the characteristic of the shell change with aging, we believe that saline breast implants carry the potential to achieve the highest failure rates of any device ever presented before the FDA over time.
The surgeons have generally replied to this concern saying they're easy to replace: saline in, saline out. The worries here are gel bleed into the device from the membrane, which has been discussed; fragmentation or leaching from the membrane; and release of material of unknown hazards.
Equally important is contracture. All of us had hopes that the saline implant would minimize or avoid device contracture. We're seeing this in at least half of the patients who we're following. It is of interest, and I want to share the patient's description. Early on they complained a bit --
CHAIRMAN WHALEN: Excuse me, Doctor. I'm sorry, but I'll need to ask you to summarize, please.
DR. ANDERSON: Yes. One of the patient's words were describing a slosh when they move. This goes on to a kind of contracture where they describe the breast as feeling like plastic bubble wrap.
We see hernia when these things go through, and then finally, they develop the painful breast.
About 15 percent of the saline implants that we're following have breast implant pain, and this is the most pernicious and neglected symptom of the entire breast implant scenario. It can progress to fibrocytis and frozen shoulder.
In my view, PMA approval is being requested for devices that carry a high probability for rupture over time. They may have unknown outcome from the lechate or bleed into the saline. They have very characteristic and worrisome patterns of contracture. They do interfere with the detection of breast cancer. We just don't know the number, and the only way to solve these problems for many women is explantation and mastopexy, and that incurs many problems.
Thank you. I have stood on the other side. It's easier to be on this side. I wish you well on your endeavor today.
CHAIRMAN WHALEN: Dr. Anderson, would you entertain a question from the panel?
DR. ANDERSON: Yes, I would.
CHAIRMAN WHALEN: Dr. Burkhardt.
DR. BURKHARDT: Thank you, Dr. Anderson.
You brought up a couple of issues with which I was not familiar and just need some more information, which I'm sure you have. You indicated that the saline implants has the same type of shell as the gel filled implants. What do you mean by that? I don't understand.
DR. ANDERSON: A generic characterization as the silicone. The manufacturers will talk to you about slight differences in the catalyst and thickness, but in terms of what we believe the biologically important degradation over time and the influence of folds on rupture we think are very similar.
DR. BURKHARDT: And in regard to the back bleed of gel in the saline implant --
DR. ANDERSON: Yes, sir.
DR. BURKHARDT: -- would you explain that to me, please?
DR. ANDERSON: In the 1991-92 breast implant hearings on silicon gel, there were long, theoretical discussions on whether or not all bleeding came from the gel inside, and the theory was quite elegantly put forward by presenters from the FDA that even the membrane of the silicone device could bleed a few molecules.
DR. BURKHARDT: But you're speaking of a patient who has previously had a silicone gel implant. Where does the gel come from is what I'm trying to figure out.
DR. ANDERSON: And the answer is, to turn it around, if you look at the capsular contracture around these devices --
DR. BURKHARDT: We're talking about saline filled devices now we're talking about?
DR. ANDERSON: Yeah. We have removed six different sets. They all show scar tissue and the granulation reaction, microgranulomas that we see in association with silicone gel.
DR. BURKHARDT: Do they show silicone gel in the capsule?
DR. ANDERSON: I have never done the X-ray defraction microscopy to prove it. I think that job belongs with the manufacturers behind it.
DR. BURKHARDT: So we don't know then?
DR. ANDERSON: No. This is a -- I've raised this as a concern, sir.
DR. BURKHARDT: Thank you.
DR. ANDERSON: Yeah.
CHAIRMAN WHALEN: Thank you.
Next listed is Dr. Fritz Barton.
DR. BARTON: Good morning. Thank you for the opportunity to be here. I'm Dr. Fritz Barton, clinical professor and past Chairman of the Division of Plastic Surgery at the University of Texas Southwestern Medical School.
I've been in clinical practice for 24 years and have managed thousands of patients with breast implants. Therefore, a portion of my income is derived from breast implant surgery.
My travel expenses are paid for by the American Society for Aesthetic Plastic Surgery, of which I am president.
I have no financial ties to any implant manufacturer. I'm neither a witness nor a party to a pending lawsuit relating to breast implants. I am here today on behalf of the many thousands of our patients who tell us that breast implants have made a positive difference in their lives.
An increasing number of women today are choosing breast augmentation to enhance their appearance, nearly a million women in the past decade alone. But why is this procedure so popular?
In my experience, most patients become interested after talking to someone else who has had the surgery. Satisfied patients have created the popularity of breast augmentation.
The experience of my practice parallels very closely the documented description of the typical breast augmentation patient. The average patient is in her early 30s. Most often she is married and has children. These women do not fit the stereotype so often portrayed. They are responsible, adult women with families, careers, and very normal lives.
I've found that women seeking breast augmentation have similar motivations to other cosmetic surgery patients. The idea that women seek breast augmentation for any reason other than their own personal desire is not supported by the literature, nor by my clinical experience.
Research has shown that the vast majority of patients who have breast augmentation would make the same choice again. The high satisfaction rate and the determination that so many women undergo a surgery with the knowledge that it's not perfect suggests just how deeply the benefits are felt.
Women have to overcome tremendous obstacles to get this procedure, from societal prejudice to a wealth of misinformation. The fact that so many seek it out speaks to their strong desire.
I believe that the vast majority of plastic surgeons try to do a thorough job of informing their patients about both the benefits and the risks of implant surgery. As a physician it is my responsibility to help round out the decision making process.
A woman's right to choose breast implants is parallel by her right to be fully informed both of the risks and of the benefits. As with all cosmetic surgery consultations, part of the evaluation is judging the appropriateness of the patient's motivations and expectations. Patients who are felt to have inappropriate motivation or inappropriate or unreachable expectations are counseled against the surgery.
Saline filled breast implants provide important psychological benefits to many women. Given the proven level of safety and efficacy of these devices, women should have the right to choose them either for breast reconstruction or for augmentation.
Our responsibility as health professionals is to provide the information by which a patient can exercise her informed consent. The American Society for Aesthetic Plastic Surgery and its 2,800 Board certified plastic surgeon members and candidates are committed to this process.
Thank you very much.
CHAIRMAN WHALEN: Thank you, Dr. Barton.
Next listed is Dr. Gwendolyn Lewis.
DR. LEWIS: I am Gwendolyn Lewis, and I'm here as a volunteer to read testimony for three women who had implants who are too sick or poor to come.
My answer to all four question is no.
In all three testimonies the women were healthy, got implants, got sick, got their implants removed, and then got better.
The first woman I'd read for is Karen Decker, who's from Pennsylvania. She writes:
I am a 36 year old mother and wife. Five years ago I decided to have saline implants put in. My surgeon had very positive things to say about them and said they would last a lifetime unless I happened to get in a very bad car accident, and even if that did happen and they ended up rupturing, I would be perfectly safe because they were filled with saline, not silicone.
At the time I didn't even know they weren't FDA approved.
As soon as I had the implants put in, my breasts became very sensitive, but my doctors kept telling me not to worry, that it was just my hormones.
About two years after this, I started having memory problems to the point I couldn't remember things that had happened the night before. I was tired all the time.
I went to a specialist, but all the results came back normal. I had sharp, jabbing pains constantly running through my breasts. I also had aches and pains that left me virtually unable to move my joints, and there was overwhelming heat on my own skin.
Finally I went to the doctor again, and my ANA test revealed that I had lupus. It's been a little over a month since I've been explanted. My right breast has swelled up twice since then, and each time they had to put a large tube in it for a week to drain.
I've been on antibiotics all month, and I still have two infections. The hole is still there, and I have to put an antibacterial ointment on gauze and push it in with a Q-tip.
My left breast is healing fine. The hot skin I was having for months went completely away after explantation. I no longer get sharp, jabbing pains through my breast, and my ANA is back normal. I am still tired, but I guess that's normal with the infections.
My memory problem is still there, but I hope in time that also changes around.
This is from a 29 year old woman, Cheryl. I'm a 29 year old woman who got McGhan textured saline implants in 1996 for cosmetic reasons. About a year later the problems started. Although I had not had health problems in the past, in 1997, I developed a number of allergies.
In January of 1999, I was rushed to the emergency room with severe abdominal pain. At the time they diagnosed me with urinary and vaginal infections and sent me home, but the pain never got better, and the infections never went away.
I had polyps and infections. Last April my skin all over my body started to burn. It felt like burning inside my veins, and my joints were tremendously painful.
I went to several doctors and my blood work all came back normal. In May I went for a mammogram which came back fine, but within three weeks of the mammogram I felt horrible. I had extreme burning and a sense of strong pressure in my chest, particularly around and behind my implants. My eyes and mouth were extremely dry, and soon after I noticed my hair falling out in clumps.
I was so fatigued that I couldn't even get myself something to eat and soon found myself out of work. Emotionally this was difficult for me to deal with because I've always been a health and active person. I rarely ever had a cold, even in the middle of flu season. Now at 28 my body was falling apart.
It got worse. By July I was so weak that I could barely get up to use the bathroom and get a drink. I was diagnosed with extremely dry eyes. Since 1998, my eyeglass prescription has changed three times. Before that my prescription changed only once in four years.
It seems like I couldn't remember anything anymore. I would get up from the couch to go get a tissue, and by the time I had gotten to the restroom, I had no idea what I was doing or getting.
I would often become cold, and nothing seemed to be able to warm me up. For instance, I remember feeling like my feet were freezing and decided to put on a pair of socks and wrap a blanket around them.
Two hours later, they still felt cold. Even a heating blanket wouldn't warm me up. My aches and pains were so awful.
Last August I decided to remove my implants. I just wanted to feel better. When I was explanted in September, I noticed some of my symptoms going away. My hands weren't swelling anymore. All of my chest pains were gone, and although I am still really tired all the time, I began to be able to do more things for myself.
I still have health problems, and I still can't work, and at the age of 29 I find myself with no income and no way to take care of myself.
I thank God for my family, friends and my boyfriend who have been supporting me through this, both financially and emotionally. Without their help I would be homeless.
I'm glad I'm getting better, but it's not quite quickly enough. I would have loved to have come to this meeting, but my health prevents me from doing so.
I see this as flashing to stop.
CHAIRMAN WHALEN: I'm afraid I'll have to ask you to do so.
DR. LEWIS: Okay.
CHAIRMAN WHALEN: That is your five minutes.
DR. LEWIS: Thank you.
CHAIRMAN WHALEN: Thank you.
I'm sorry. Doctor, Dr. Lewis. Dr. Burkhardt would like to ask you a question if you don't mind.
DR. BURKHARDT: Are you a physician?
DR. LEWIS: No, I'm a sociologist.
DR. BURKHARDT: I see. Is it your position then that because of these tragic stories that other women should not be allowed to have this surgery?
DR. LEWIS: I think they should be investigated thoroughly. Yes, I think these tragic stories do point --
DR. BURKHARDT: But it's your position that they should not be allowed to have this surgery at the present time. Is that what you're recommending to the -- because that's what a negative vote on this committee would probably do.
DR. LEWIS: Well, I think you're the experts and will have to decide that.
DR. BURKHARDT: Thank you.
DR. LEWIS: I'm not in a position to do that.
CHAIRMAN WHALEN: Thank you, Dr. Lewis.
Next listed is Jean Pentolino. Not here.
Dr. Cheston Berlin.
DR. BERLIN: Good morning. My name is Cheston M. Berlin, Jr. I am Chief of the Section on General Pediatrics in the Department of Pediatrics of the Pennsylvania State University College of Medicine at the Milton S. Hershey Medical Center. I am also university professor of pharmacology at the same institution.
In addition to my academic and clinical appointments, I am a member of the Academy for Breast Feeding Medicine, the International Lactation Consultants Association, the American Society for Nutritional Sciences, the American Society for Clinical Nutrition, and I'm a Board member of the International Board of Lactation Consultant Examiners.
I wish to emphasize that I am not representing these organizations, but with to indicate my professional interest in pediatric nutrition, especially in lactation.
I'm also a member of the American Academy of Pediatrics and have served as Chair of the Committee on Drugs. At the present time I am Chair of the Network Steering Committee of the National Institutes of Health and Pediatric Pharmacology Research Units.
One of my research interests is in the transfer of drugs and chemicals in the human milk. I may be the only person to make a presentation to you this morning on the only purpose that those of us in pediatrics see for the human breast, which is breast feeding.
I am paying for my own transportation today from my university professorship fund. I have no financial interest, nor have I consulted with any manufacturer of saline implants.
I have served as a consultant to the pharmaceutical industry, including Pfizer and Merck, Ascent, and Mediva, and I participated in the clinical trial for Mediva.
I am neither a witness nor a party to any litigation involving breast implants. I do no surgery involving breast implants, and I do not care for women with complaints they believe are related to breast implants.
Because of my interest in the silicone filled implants, I have served as a consultant with both industry and with women with silicone implants.
A major thrust in pediatrics over the past 25 years has been to increase the incidence of breast feeding 75 percent by the year 2000. We shall not achieve that goal. The best estimation is that now approximately 60 percent of infants are discharged from the hospital, if indeed they stay long enough to be breast fed, and there is a 50 percent attrition rate over the following six months. We are very anxious to change these numbers in a positive trend.
One of the frequent reasons for not starting or for cessation of breast feeding has been the need for a mother to take a medication. She frequently will receive instructions that she must terminate breast feeding.
A similar situation exists with regard to exposure to environmental chemicals, including the issue of breast feeding in women with breast implants. The initial implants contained a silicone gel within the silicone based capsule.
It has been estimated, as you've heard this morning, that nearly one million women have had breast implants. Many of these have been in the child bearing age. Concern has been raised over the exposure of children to milk from mothers who have had silicone implants. There's only one report in the literature of a group of offspring of mothers with breast implants who had esophageal dismodality (phonetic). This study has been criticized on methodology background.
There does not appear to be any secretion of silicone related compounds from human milk from mothers with these implants. Since saline filled implants would not have the silicone gel interior, this would not even be a hypothetical concern.
It is important that we continue our emphasis toward increasing the incidence of breast feeding in the United States. My presentation here is not meant as an endorsement for the cosmetic use of implants, nor for the licensing of these implants for this purpose, but to assert that there should be no concern on the panel's part over any possible medical effect on the offspring of women with implants who choose to breast feed, the so-called second generation effect.
At the present time there is no scientific data that would prohibit breast feeding in women with these implants. I'm convinced that, along with my pediatric colleagues, that breast feeding for nutritional, immunological, and psychological reasons is the most important thing that we can offer our children.
We need to make a substantial increase in the incidence of breast feeding at all infant ages in this country, and in order to do so we should not arbitrarily exclude a group of women from nursing because of a hypothetical risk without confirmatory scientific data.
There are many reasons for stopping breast feeding, including return to work, onset of maternal disease, need for pumping and storage facilities, and the institution of maternal drug therapy. All of these would interfere with the duration of milk, of lactation.
We should not add to this list any other reason without scientific support. There is no scientific data to indicate that breast feeding with saline implants would be hazardous to nursing infants.
Thank you.
CHAIRMAN WHALEN: Would you entertain a question, Doctor?
DR. BERLIN: Yes, sir.
DR. BURKHARDT: I'm sorry. I seem to be the only one asking these questions here, but, Doctor, hypothetically if a woman were to develop systemic antibodies toward either the silicone shell or something in the silicone shell, as an expert in breast feeding, would this be likely to be reflected in any way in the content or quality of the other's milk?
DR. BERLIN: I do not think so, Dr. Burkhardt, because of some of the other situations like women with lupus, who have a significant number of antibodies to many, many different tissues. They do not have difficulty, should they wish to choose to nurse.
DR. BURKHARDT: So the answer is negative then. It would not be reflected in --
DR. BERLIN: I do not think so.
DR. BURKHARDT: Thank you.
CHAIRMAN WHALEN: Thank you, Dr. Berlin.
DR. BERLIN: Is there a question there?
CHAIRMAN WHALEN: Yes, Ms. Brinkman.
MS. BRINKMAN: My question is you talk about the fact that we're not getting contamination of milk, but implants interfering with the ability to breast feed, what has been your experience?
DR. BERLIN: The experience with that is that certainly the type of surgery that is done for the insertion of the implant might interfere with the ability to nurse. The two things that seem to be very important in breast feeding in women with implants, regardless of their composition, is the site of the incision, particularly if any of the ducts under the nipple have been harmed or if one of the -- the fourth accessory nerve that innervates in the nipple, which comes across from the lateral side, if that's been transected.
If that's the case, there may be difficulty particularly with establishment of lactation because of the reflex of nipple to the brain in the mother. So that is a legitimate concern, but that would not affect the infant other than the fact that the mother could not make the milk.
MS. BRINKMAN: And is it your understanding this appears to be a common place for the incision for some of the augmentation patients?
DR. BERLIN: That is a common place is right under the nipple?
MS. BRINKMAN: Yes.
DR. BERLIN: Yes.
MS. BRINKMAN: Thank you.
CHAIRMAN WHALEN: Thank you, Dr. Berlin.
Next is Ms. Karen Duhala. No.
Well, we'll complete the sequence, and then we'll return to anyone who has shown up late.
Ms. Melinda Cloud.
MS. CLOUD: Good morning. My name is Melinda Cloud, and I am from Grand Rapids, Michigan.
And to answer your first question, since I am on disability, I could not afford to come here. So after asking for some assistance so that I could give a presentation, I was told that my plane fare and room would be paid for by a nonprofit support group for women with implants, Command Trust Network.
In answer to your other three questions, the answer is no.
I am here today with an unpleasant and yet very necessary story to tell regarding my experiences with saline breast implants. Were it not considered highly inappropriate, I would bear my chest to you right now, for seeing with your own eyes, it would have a greater impact than the words that I can tell you.
To me they are not breasts, but two containers of saline in silicone baggies held in place by skin. Were you to see them, you would see puckers and indentations where the containers have shifted, where the solution has dissipated.
Were you to touch them, it would feel like touching a plastic bag that moved beneath a sheath of skin. You could feel the solution slosh. You'd want to take your hand away, and I wouldn't blame you.
In 1974, I was a young model and was adamantly advised to have breast augmentation by a physician. I nursed my baby for about a year, and he said I was much to young to have such ptotic breasts.
I also had many cysts in my breast, and the doctor told me that the solution to my problems was to have my breast replaced with silicone implants, which would last a lifetime and permanently end my pain and discomfort. I had no idea that this was the beginning of a long period of pain, suffering and decline.
I ended up not have one surgery, but 12, most of them attempting to remedy severe capsular contracture and deformity. I started with silicone implants and later replaced these with several sets of saline.
I had an emergency surgery to deal with a hematoma where blood was literally spurting out of my breast. I had two more surgeries to deal with a near deadly staph infection.
In 1987, 13 years after my first surgery, I finally consulted specialists at the University of Michigan Medical center who assured me they would solve my problem once and for all, but they didn't. They couldn't.
I had several other surgeries, including getting my first set of saline implants in 1992. They told me my saline implants were the safest kind, but my worst problems started after this surgery.
On July 18, 1995, I had my first set of saline implants put in, which were described as a new, greatly improved type of saline implant. I still had a great deal of deformity from all the previous surgeries and the infection of '86.
That was my most recent breast invasion and reconstruction. There needs to be another. My doctor tells me I have to have these implants taken out of me because my health has severely declined since 1992.
I stand before you now, a recipient of Social Security disability trying to live my life on $512 per month. I was granted disability status in 1997, when I could no longer hold down a full-time job or work to support myself. I had been a relatively successful free lance writer, a highly promising student in sculpting, working also as a crisis intervention counselor for a substance abuse facility.
I lost my job because I kept getting sick. I had to quit college in order to survive. I had to sit in a courtroom with a Social Security judge and listen to people talk about me as though I were one of the most inept human beings, an incapable member of society. This was the most significantly tragic day for me.
There is not a single insurance company who will insure me. I'm considered high risk because of my saline implants.
This entire mess has cost well over a quarter of a million dollars. Why? Because I, like everyone else, believed saline solutions encased in silicone shells did not cause problems.
I have to get up every day and face chronic fatigue, wash up from night sweats, Reynault's syndrome, and moments of excruciating chest pain that has doctors sending me to the emergency room.
My immune system has been compromised. I've developed what is known as chemically induced asthma. I have blood in my urine and no one knows why. My muscles have weakened. I get sores on my skin that don't really heal. I have episodes of severe depression, and I can't even pick up my grandchildren.
I was once a very strong and health woman. I raised three children alone without the benefit of child support. Illness was not even a consideration.
Now I pray every day for God's help to keep my spirits up for I know full well that, plus the blessed love of my family and friends, this is all that keeps me going.
There is little that you can do for me anymore. The damage has been done, but you can help other women. I cannot get my breast implants out. My insurance will not pay for it because it's elective, and they have to pop first or have a great leak, and then no one knows what will happen. I also cannot get reconstructive surgery because I cannot afford it.
You are not doing any women any favor by giving them a choice that could leave them financially destitute with no ability to have a failed implant removed, which is my situation today.
I would like you to look into the answer of saline implants in place of silicone because there's no proof anywhere for anyone that that's the remedy, and for me it absolutely was not.
Thank you for this honor and opportunity to testify before you. I'm going to try once again to trust you to do your part. Please do not recommend the approval of saline implants unless you are convinced that what happened to me won't happen to anyone else.
Thank you.
CHAIRMAN WHALEN: Thank you, Ms. Cloud.
The next listed speaker is Dr. Ory.
DR. ORY: Good morning. I'm Howard Ory. Currently I'm a private consultant in epidemiology. I'm an adjunct professor of epidemiology at the Emory University School of Public Health, and in a past life, I was Deputy Director of the Epidemiology Program at the Centers for Disease Control.
My presentation today is very abbreviated from the written report that I submitted to you in collaboration with Dr. Jim Schlesselman. Both Jim and I have consulted with 3M and defended in a breast implant litigation. 3M has paid for my transportation and lodging today.
I continue to be involved with lawsuits related to breast implants. Today I will do two things. I'll present a summary of our meta analyses of the more than 20 published epidemiologic studies that examine the association of breast implants and connective tissue diseases.
Then I will present the conclusions of three blue ribbon panels that have examined this issue.
This table shows estimates of the relative risk of connective tissue disease among women with breast implants. The values range from 0.3 to 1.2. A summary estimate of the relative risk of connective tissue disease is 0.7.
The next four tables examine the most common connective tissue diseases comprising the aggregate diseases in Table 3 there.
Estimates of the relative risk of lupus range from zero to 2.3. A summary estimate of the relative risk os 0.7.
Estimates of the relative risk of rheumatoid arthritis range from .3 to 1.6. A summary estimate is 1.1.
Estimates of the relative risk of scleroderma range from zero to 1.8. A summary estimate is 1.0.
Estimates of the relative risk of Sjogren's syndrome range from .2 to 1.5. A summary estimate is 0.8.
An atypical connective -- that's definite connective tissue disease. In atypical connective tissue disease specific to breast implants has never been defined. Lacking a case definition, six studies examine conditions that represent various aspects of atypical connective tissue diseases, such as chronic fatigue syndrome, fibromyalgia, undifferentiated connective tissue diseases. A summary estimate of the relative risk is 0.8.
Based on the data I just presented, we conclude that the 25 or so epidemiologic studies now at hand provide sufficient evidence to reassure women that breast implants do not cause autoimmune disease, connective tissue disease, or atypical connective tissue disease.
Slide off, please.
Three blue ribbon -- I'm now going to switch to the three blue ribbon independent reviews, which were released in 1998 and 1999, presenting scientific evidence concerning the possible association of breast implants and systemic disease. The scientists on these panels were chosen because of their distinguished credentials and their lack of previous involvement in the issue. The conclusions that they reach about the epidemiologic data are strikingly similar to each other and to our own.
The independent review group and panel by the Ministry of Health in the U.K. concludes there's no epidemiologic evidence for any link between silicone gel implants and any established connective tissue disease. If there is a risk of connective tissue disease, it's too small to be quantified.
The IRG cannot justify further epidemiologic studies to investigate this hypothesis. Good evidence for the existence of atypical connective tissue disease or undefined conditions, such as silicone poisoning, is lacking.
The National Science Panel, empaneled by Judge Sam Pointer, Federal District Judge Pointer, who's in charge of the multi-district litigation. This panel concludes: no association was evident between breast implants and any of the individual connective tissue diseases, all definite connective tissue diseases combined or the other autoimmune rheumatic conditions.
The material presented represents an analysis of the most rigorous and relevant scientific information currently available. It's our informed opinion that a large majority of scientists in our respective disciplines would find merit in our reviews.
Finally, the Institute of Medicine essentially concludes the same thing, that there's insufficient evidence to support an association of silicone breast implants with the fine connective tissue diseases. There's no justification for the use of resources and further epidemiologic exploration. The committee finds no convincing evidence for atypical connective tissue disease, rheumatic disease or novel constellation of symptoms in women with silicone breast implants. In fact, epidemiologic evidence suggests there is no novel syndrome.
Ladies and gentlemen of the panel, based in part on the 25 studies that I presented to you, the three independent blue ribbon panels conclude that this issue is resolved. Breast implants do not cause connective tissue disease.
Thank you.
DR. BANDEEN-ROCHE: Could I ask a question?
CHAIRMAN WHALEN: Please.
DR. BANDEEN-ROCHE: Couldn't help noticing both in the printed literature and up there that the Hennekens study was notably sort of out of line with the others and that it had higher estimates of risk. I understand that this could happen by random chance alone, et cetera.
So my question to you is: are you aware of anything about the Hennekens study that systematically makes it different than the others? Was it a more or less representative population? Was it better or worse done?
I'd appreciate your comments on that.
DR. ORY: The Hennekens study relies of self-reports of both implants and diagnoses. It was conducted during the time of maximum media attention to this, and the authors themselves notes that there's a substantial likelihood of selection bias of the people who entered the study, driving the relative risks up.
In fact, of the target population, only 25 percent of the target population entered the study. So there is a substantial likelihood for selection bias.
The other thing I didn't have time to present is that I've done the meta analyses both with and without Hennekens, as has Dr. Hulka of the National Science Panel, and essentially you come to the same conclusions. The relative risks of all the connective tissue disease that you study hover around 1.0, with or without Hennekens.
CHAIRMAN WHALEN: Ms. Brinkman.
MS. BRINKMAN: Is it my understanding that these studies are done on silicone gel implants?
DR. ORY: They're done on both, and the --
MS. BRINKMAN: What percent of saline implants are included in these studies?
DR. ORY: It's hard to tell. Most of the studies didn't -- were unable to make that assessment. The best way I could give you of looking at them is that Dr. Hulka of the National Science Panel broke out silicone gel studies in her meta analysis and also showed a relative risk of about one. So I think you can infer that the relative risk for saline implants would have to be one since the overall risk is near one.
DR. BURKHARDT: May I ask a question?
DR. ORY: Yes, sir. Dr. Burkhardt.
DR. BURKHARDT: What does a relative risk of one mean?
DR. ORY: A relative risk of one means that the risk of the particular disease you're studying in women with implants is the same as in the controls, women without implants.
CHAIRMAN WHALEN: Is Ms. Brent available?
MS. PATRICIA BRENT: Good morning, and thank you very much for having me here. My name is Patricia Brent. This is my daughter, Catherine Brent. I breast fed her while implanted with a saline/silicone implant.
In answer to the questions, my travel has been paid for by my husband. He is not happy about this.
Do I have financial ties? No. Are you a witness or party to a pending lawsuit? Yes. It was filed in 1991. I have not resolved it. Catherine is also a party to a lawsuit. It was filed in 1995. It has not been resolved.
And do I derive a portion of my income? No.
I am here to voice my concerns and the concerns of many other mothers about the saline portion of our mammary gland implants. I will be referring to these as mammary gland implants because the function of the breast is to breast feed.
My implants were put in in December of 1982. I was a healthy woman of child bearing years. I had them put in because I had nursed my four older children. I had the surgery to make my breasts look the way they did before I nursed. It was a path down vanity lane. It was a sin.
I had -- I had my four other older children. In 1982 I was implanted. In 1984 I got pregnant with Catherine. Catherine was born in January of 1985, and under advice of my physician, my pediatrician, and from what I knew, it was perfectly safe for me to breast feed. That is what is still being told to young women. I disagree.
When I was explanted, my breast implants had grown black aspergillus niger fungus and bacteria. This was in the implant upon explantation. Black aspergillus niger fungus and unknown microorganisms is not a good thing to have in a mammary gland, especially when you are breast feeding.
I will now let Catherine read a letter. It was an E-mail actually that she sent to the "Oprah Winfrey Show." I did not watch this program. Catherine watched this program. This is Catherine's response to the "Oprah Winfrey Show."
MS. CATHERINE BRENT: According to your show today, it was stated that breast implants were safe for pregnancy and breast feeding. I would like to tell you that the doctor on your show lied because if he referred to the FDA, it is not known whether a mother's breast implants can have an effect on the fetus.
I am a 14 year old girl who's suffering from chronic inflammatory demyelinating polyneuropathy, esophageal motility disorder and gastroesophageal reflux disease. My young sister is also sick. We are the children my mother had after she got breast implants. She nursed us after she was told it was safe. Are four older siblings are in perfect health.
I would just like to tell you to research what you say before you air a lie.
Thank you very much. I would like to be on your show so I can tell my story, my sister's, my mother's, and all of the thousands of children sick from these unsafe implants.
Thank you. Catherine.
And please go to the FDA Web site.
MS. PATRICIA BRENT: I heard back from the "Oprah Winfrey Show" approximately two months later. It was from their legal department. It broke my heart because I know that if the legal department gets involved, I will not get the truth. People will not be told the truth.
I am now going to show you my breast implants with the fungus, and I'm going to show you a baby bottle that has black fungus on it. I do not know. I did not have this cultured. I do not know if this is aspergillus niger as mine was, but I ask you to look at the two of these and tell me, tell me as a mother it is safe for me to breast feed with this in my body.
I know I have had six children. I am a professional at this. I had natural childbirth for my last five births. I know what to do with my body when I am pregnant. I know what to eat. I know what not to eat. I know what medication to take and what not to take, and I listen to my doctors.
Doctors do not know. The average pediatrician does not know that this fungus can be in the implant. Whether it comes through into the breast milk, I feel that it does. I feel that unequivocally this is what has harmed my child.
There is no family history of this, and I will just pass this along.
I have one thing to say, and this is from Cindy Morrissy, who has three girls. Her daughter Hillary has scleroderma. Please listen to what she has to say because she could not be here today because of her children. They are too ill.
We have to have confidence, confidence in the physicians. How can we have confidence if you do not know the full picture? You do not know. You do not know what this does to a nursing child or via the placenta. You do not have these answers.
Upholding medicine in its greatest, grandest form is do no harm. Please, please, as you consider putting these on the market, do no harm.
Cindy also says: acceptable risks. One would need to greatly define the term "acceptable risk" because when I had those implants I was never told it could grow fungus and have this bacteria in it, and my child was given no acceptable risk.
On Monday, the Supreme Court allowed a case to go forward in -- it was from South Carolina. Please forgive me if I don't get this exactly right, but I know that it's about the fetus having rights, and my child had no informed consent. I had no informed consent. That is absolutely wrong.
Catherine and my daughter Christine were part of Dr. Jeremiah Levine's original study in 1992. Catherine and Christine both have the esophageal motility disorder and the reflux. None of my other children have it, and Catherine since that study has been diagnosed with the chronic inflammatory demyelinating polyneuropathy.
I will give this to you.
CHAIRMAN WHALEN: Thank you, Ms. Brent.
MS. PATRICIA BRENT: Thank you.
CHAIRMAN WHALEN: Returning to some of the other speakers who I believe have arrived, I'm told Ms. Angus is available.
MS. ANGUS: Excuse me if I sniffle. That last testimony really, really touched me.
Anyway, okay. Here we go. Are we rolling? I've got what, five minutes? That's it? Okay.
My name is Annie. I'm from Vancouver, Canada. I think I might be the only Canadian up here, down here. My travel and accommodation have not been paid for, nor will I be reimbursed by someone else. I do not have financial ties, including grants or other compensation, with industry or health professionals or societies. I am not a witness or a party to a pending lawsuit related to breast implants, and I do not derive a portion of my income from surgical procedures using breast implants or from treating patients with complaints about breast implants.
In other words, I represent myself and all of the other Jane Does out there or all of the Annies, Carols, Lauras, Miriams, and whoever else you want to call them who are too ill or too broke to be here.
I am giving this testimony with the hope that women will be spared the ill health that I have experienced as a result of being implanted with saline breast implants manufactured by Mentor. I am not seeking any monetary compensation for my suffering. No amount of money can compensate me for what I have lost.
In the spring of 1995, my husband and I were looking into the possibility of having my breast augmentation. I was 33 years old and was then in very good health. My third child had been born a year earlier, and my breasts were small and saggy.
I consulted our family physician and sought a second opinion from a well reputed plastic surgeon. I was concerned about the bad reputation of silicone implants and did not want to do anything that would jeopardize my health.
Both physicians assured us that saline implants were completely safe. I was told that with saline implants there were only two risks. One was of the implant rupturing, which is not a threat to one's health. The other possible negative side effect that I became aware of were the ingredients that could be a partial loss of sensation in the breast area.
I was given statistics, and the incidence of rupturing and lost feeling and became convinced that only a minority experience these effects, between .0 percent and four percent.
Having thought that I was well informed, I consented to the surgery and signed a waiver declaring that I would not pursue litigation if there were any complications. This act of weighting one's rights is in hindsight intentionally disempowering and needs to be readdressed.
In June of 1995, I underwent a breast augmentation with saline implants performed by a Canadian Board certified plastic surgeon. After a few months, I realized that the numb sensation in my general breast area was not going away, and that I was hypersensitive in the areola and nipple area, which is a painful and irritating sensation.
I was told by my plastic surgeon that it could take up to two years for the nerve endings to heal. I kept waiting, hoping that all of the sharp pains in my breast were signs that the sensations were returning to what I had known prior to my surgery.
Two years later I still could not stand for my breasts to be touched, and now that I have had the implants removed, my breasts still have about 30 percent of the feeling that they had originally had. It has been tragic for me to have to deal with this loss of feeling and lack of pleasure for the rest of my life.
If I had any idea that improving my appearance would jeopardize my ability to feel pleasure, I would never have played this game of Russian roulette.
One year after the implantation, it became obvious that I had developed capsular contracture. My right breast was softer than the left one, which was as hard as a softball. I had followed my plastic surgeon's instruction to massage my breasts daily to keep them soft, but it hadn't helped.
Also, there were dense lumps all around the top of the left implant that were visible if I was to wear certain clothing, like this top that I'm wearing now. I couldn't even wear a top like this before because you would see lumps sticking out on the top of my breast.
Within a year of having an operation that was supposed to improve my appearance, I became very self-conscious about appearing to be deformed. The head of plastic surgery at the University of British Columbia, by the way, has stated that up to 40 percent of implants may rupture or develop capsular contraction, not .4 percent, not four percent, but 40 percent, and I've got it on a video that CBC did when they interviewed me on their show called "Marketplace."
This means multiple surgeries for implant patients. How did this statistics grow from .4 percent to 40 percent in three years? Do we even know what accurate statistics are in this area? I think not.
Now I'm going to tell you about my real troubles. I could live with the sacrifice of the loss of sensation in my breast. I can live with my and my husband's dissatisfaction over the appearance of my implanted breasts. But I could not live without my health.
Four months after the initial surgery, I became sick with flu-like illnesses that lasted for months on end. During that time I had pneumonia, bronchitis and extreme fatigue. I would start to recover, but then would get sick again only days later.
Over the next year I felt exhausted all the time. I used to stay up until at least midnight previously, but now I'd fall into bed with exhaustion by nine o'clock at night.
Some days were worse than others, but not a day went by without a general feeling of fatigue and illness.
Another symptom was sleep disturbance since I would wake up two to three times a night soaking wet with perspiration. They call these night sweats.
In January of 1997, I became ill again with bronchitis-pneumonia for three months. On many occasions, I had such sharp chest pain that I lost my breath and was unable to move. I also began to have difficulty concentrating and often felt spaced out.
Then in April of 1997, I woke up one morning. I went to the wash room, and the toilet was filled with blood. Now, this wasn't a slight pink color, but it deep red. It was pure blood. I remember being so horrified that this happened I jumped in my car. I was on my cell phone. I was sobbing all the way to the doctor's office, and they said, "Oh, you've probably got a bladder infection."
I had had a couple of bladder infections in the past. I had never peed pure blood before, and it continued to happen after that.
A week later, I went for an ultrasound for the lumps in my breast and chest pain. The ultrasound apparently showed nothing. I had never previously had any lumps in my breasts. The doctor had no explanation, and I felt I had hit a brick wall with the medical establishment.
In the summer of 1997, I began to experience debilitating joint pain. My left hand was so stiff and was aching that I could not clinch my fingers. I felt like I had arthritis in my left hand and arm. I have no history of this disease on either side of my family.
I mean, I know I could go on forever. I'll try to sum it up. I had the saline implants removed in January of 1998. I have not been sick since then. I still have night sweats. Otherwise I don't have anymore chest pain. I have a very strong constitution, which is what I had before, and the only thing I have to deal with now is the way I look, and it's taken me two years to have the confidence to date again because my husband left me. He could not go through this with me.
I have three children, ages five, seven, and nine, and I am producing a video on body image to take to all of the high schools across North America.
I also am the founder of the Women's Investment Network. So if you want any good stock tips, just see me after.
You know, I'm a very capable and I consider myself a very smart woman. I went to university at the age of 16 and all the rest of it, and this was the most stupidest thing I ever did, was to do this because I believed the professionals, and whatever.
I have pages here that I wrote. I think the media is afraid to say anything because of where their funding comes from, and I think the Internet is the best thing that ever happened to women in this situation because they can finally be heard without any filters, and that's why most of the people in this room have given their testimony, because they've gotten on the Internet. They've become educated, and they're here today.
And I thank you very much for this opportunity.
CHAIRMAN WHALEN: Thank you, Ms. Angus.
Ms. McGinn.
MS. McGINN: Good morning. My name is Maura McGinn, and I'd like to thank you, Mr. Chairman, and the other members of the panel this morning for the opportunity to appear before you today.
Let me start by answering the questions like everybody else you asked of the witnesses at today's hearing. First, I am a professional actor and model who is appearing before you today representing only myself.
Second, I have no financial or other professional ties to any saline filled breast implant manufacturer or industry association.
Third, I am paying personally for all travel and other expenses related to my participating in this hearing.
Fourth, I am not a party to any pending lawsuit relating to breast implants.
And finally, I do not now, nor have I ever derived income of any kind from surgical procedures using breast implants or from treating patients with complaints they believe that are related to breast implants.
Why then am I here today? Because it is important that you hear from more than industry representatives who only have financial interests in the income and from researchers whose interest in the subject is merely academic.
You also need to hear from people like me, breast cancer survivors whose lives have been and will continue to be affected directly and immediately by the recommendation you make.
I want to assure you that while I am a professional actor, I am not acting this morning. My words and the emotions that prompt them are quite real and sincere.
I support fully any and every decision that will add to the information available to patients about the benefits and risks of saline filled breast implants, in much the same way that I wanted to know everything possible about the efficacy of the different treatment options I had when my cancer was diagnosed. I also want to know everything there was to know about the different options available for reconstruction.
I want to state this as clearly as it can be stated. Manufacturers of saline filled breast implants must be required to do all the research needed to assure people like me about their safety. The fact that these devices have already been implanted in my body does not diminish in any way my need to know that they are safe.
Anyone who is either already using saline filled breast implants or who will be faced with the decision in the future about using them is not just entitled to this information, but should be guaranteed that it will be provided.
My case may be instructive. Unlike other breast cancer patients, I chose not to be reconstructed immediately. In fact, I waited six years before making the decision to have additional surgery.
Why did I wait so long? Well, part of the reason was that I wanted to focus all of my emotional and intellectual energy on my treatment. Also, part of the reason was, frankly, I was not sure I was going to be around. But at least -- I am thankfully.
But at least an equal part of the reason was that I was not convinced about the safety of breast implants. At the time I was diagnosed with cancer, silicone gel implants had become very controversial, and I did not want to wade into those troubled waters, given what I was hearing, what my doctor was telling me, and my own research.
Six years later my research, combined with my doctor's advice and counsel, led me to my decision to use saline filled implants. Although the information about saline filled implants was limited to and often more conjecture than fact, nothing I had read or heard and no experience that I have had so far has come close to convincing me that my decision was incorrect.
To the contrary, my decision to be reconstructed has had a huge positive impact on my life. Because I am happier with the way I look, I am also happier with who I am.
I know that there are those who say that my appearance should not matter, and in some sense they are right, but they're also wrong. I know from personal experience that for me at least, and I suspect millions of other women as well, how I look strongly affects how I feel and how I relate to others.
A moment ago I said I support all efforts, like those being considered by this panel, that will add to the information available to patients about the benefits and risks of saline filled breast implants. Anything the FDA can do to add to the base of knowledge about these implants, including continuing to vigorously implement the PMA process, should, indeed, must go forward.
The more comprehensive the research manufacturers are required to do and the more widespread they are forced to disseminate the findings, the better. There's no justifiable excuse for this not being the case.
I also want to make it clear, however, that the ultimate decision about assuming the risk of using saline filled implants must continue to be left to people like me, the cancer survivors whose lives will be affect by whether or not they are reconstructed.
Unless there is incontrovertible evidence that saline filled implants are unsafe, breast cancer patients must continue to be allowed to obtain them. Make sure that all the research is done. Make sure that the research is conducted properly, and please let us know about the suspected risks and concerns.
But do not ever allow the decision about whether I can use them to be made by someone other than me. And that includes all of the members of this panel, the FDA as a whole, the implant manufacturers, or anyone on Capitol Hill who knows -- who think they know more about my body than I do.
Thank you.
CHAIRMAN WHALEN: Thank you.
And Ms. Duhala.
MS. DUHALA: Good morning, ladies and gentlemen. My name is Karen. I'm 38 years old. I have been happily married for 14 years and the mother of two children, a daughter who is eight and a son who is six years old, and I hold a full-time working position.
I am here today to share my experience regarding my own decision to have breast implant surgery. I have personally paid for my travel expenses incurred to attend this hearing. I do not have any financial ties with breast implant manufacturers, and I have never been, nor am I currently involved as a witness in any lawsuits involving breast implants.
I am, however, an office manager for a plastic surgeon, a solo practitioner in the Baltimore, Maryland area. I have been employed with the plastic surgeon for the past six years, and being that he does perform breast augmentation, along with many other cosmetic procedures, a portion of my salary is derived from breast augmentation surgery.
I'm using my own personal vacation time today to cover the missed day at work.
When originally reading about the hearing today regarding saline filled breast implants, I did, in fact, speak with many former patients to see if they would come and share their own experiences with you. Most declined because, quite frankly, I could not guarantee their confidentiality.
I, too, like my privacy, but with respect to the past silicone breast implant controversy, the fact that most people do not like to talk about their private lives and their private decisions in the public eye and the fact that I have had a very positive experience, and my decision has affected me in a positive way, I thought it was important for me to come and to speak.
When thinking about what I was going to say today, first I went through all the statistics and I read all of the articles on the studies back from the silicone breast implants and how far we've come, and then I redirected my focus onto patients that I came across through the practice with my six years of employment, and I began jotting down their stories.
And what I found is that I am one of the patients. I, too, fit the category of the patients that we often see.
Almost all of our patients have been embarrassed by the way they look. They feel guilty about coming to a plastic surgeon and expressing how they feel. They worry about what other people will think. They're not vain. These are women who are in their late 20s to the early 40-ish age bracket. A large percentage are married with children. They're involved with schools and PTA and church organizations, civic organizations, and hold jobs. They're educated women who are making choices.
When meeting with patients in consultations, some of the women who make their decisions after meeting with the doctor that I work for, they decide not to undergo breast augmentation, breast implant surgery.
Other patients we elect to not do the surgery on, and, yes, there are those many that do elect to have the surgery and do have.
I had personally contemplated having a breast enlargement for many, many years. Years of humiliation go back as far as high school. I can still vividly remember the teasing by my friends and, oh, yes, by my family members, too; the feeling of humiliation when wearing certain clothes, let alone a bathing suit.
Please don't misunderstand me. I have never lacked self-confidence, and I feel that for the most part I'm a well rounded individual, but I, too, was self-conscious about the way I felt and in the way I looked. I avoided certain places in certain situations.
Having the surgery has not changed my life,b ut it has given me a personal boost. That is, when I walk, I walk with my back a little bit straighter, and I hold my head up a little higher. I feel better about myself.
I wish I could explain passionately what the impact has done for me, but I can't find the words. It's funny because my husband was dead set against my having this surgery. He thought I was crazy. When making my decision, I was like many others. I was reluctant. I was worried about what my family would say, what my friends would say, what my church affiliations would think, let alone the guilt of spending so much money on myself.
Would I be giving the wrong message to my two young children about really what's important in life? Shouldn't I be saving my money for the braces and the college education?
But with all of that said, the most important thing to me was it was my decision. It was my choice.
As in primarily all aspects of my life thus far, I have made personal choices, and with almost all of my choices, there are associated risks and responsibility.
I made the choice to drive, and even though I'm well educated, I went through driver's education training; I read my AAA magazine on the driver tips. I have even taken auto mechanics class to learn how to check air pressure and my oil. I still know the risk that any day I could be involved in an automobile accident.
I made the choice to have children. There were risks involved with childbirth and risks that my children would not be born so-called normal. Some of the risks were known and presented to me. Others were not, and although I received excellent prenatal care and followed my doctor's orders, no one could prevent nor no one could predict that my son would be born a bilateral cleft lip and palate baby.
I smoke. I know the risks. I'm fully aware that my smoking will some day cause my death more than likely.
My point is that breast augmentation is a choice. Like almost everything else, surgical or nonsurgical, there are choices, risks and responsibilities.
My personal experience was that I was well informed of the risks both of undergoing a surgical procedure using general anesthesia and the risk of breast implants themselves. It was my choice. I accepted the risks, and I still accept the risks that there may be complications down the road.
My choice to have breast augmentation was one of the best choices I have made personally in my life for my own self. I strongly feel that as long as women are educated about the benefits and the risks, it should be a woman's choice.
It is also my opinion that today, between the implant manufacturers, the ASPS, and the doctor's responsibility of his or her addressing the pros and cons to every surgical procedure they perform, breast implants or otherwise, that patients are well informed today.
I sometimes feel like we --
CHAIRMAN WHALEN: Excuse me. Could you come to a conclusion, Ms. Duhala?
MS. DUHALA: I can.
-- that we as a practice scare patients, and I'll just sum it up.
It was one of the best decisions. I would like to share and I'm going to leave this with you. When our patients come to our practice, because some people were talking about breast feeding and the four percent of risks, the information that we give out, and I work for a Board certified plastic surgeon, it is noted that it is 20 to 40 percent of patients do run the risks of the capsular contracture, and it's all in this booklet.
Also, there's an informed consent that we have. It's a four page informed consent about the risks, and it does stress that for certain things as far as breast feeding children, there is no studies that shows that it is or is not dangerous, and that is written out.
And that's the biggest thing. I feel that the most important thing in making a decision to have any cosmetic surgery is to have a good doctor who will educate you and give you all of the information, and with the Internet today, I agree. The information is too available if the doctor is not willing to do that, but check your doctor out, and somewhat evaluate your doctor as your doctor is evaluating you.
Thank you.
CHAIRMAN WHALEN: Thank you.
I believe all of the individuals who had been scheduled have now had time at the podium, and before we proceed to the consumer groups, we'll take a ten minutes break.
DR. KRAUSE: If everybody could please start getting back to your seats, we could go on with the meeting. Thank you. (Whereupon, the foregoing matter went off the record at 10:06 a.m. and went back on the record at 10:21 a.m.) CHAIRMAN WHALEN: If everyone will please take a seat, we'll try to resume, and we're going to be proceeding to the presentations of consumer groups and consumer information providers with the critical distinction now being that ten minutes are allotted to each of the presenters, and I would remind each of the presenters to again please try to be as fastidious as the individuals were in terms of noting the time. When the yellow light begins to flash, it is key that you begin to sum up, and if the red light flashes, then please come to a conclusion.
If there were any of the individuals who had been previously identified who showed up late who would still like to address the panel, if you could please identify yourself to the FDA, then we will try to get you in if we can.
The first listed consumer group, consumer information provider is Ms. Nicole Cummings from Implantinfo.com
MS. CUMMINGS: Good morning, ladies and gentlemen. My name is Nicole, and like many of the women that will speak before you this week, I, too, have breast implants.
However, in addition to being a breast augmentation patient, I think I bring much broader perspective to the issue before you. I host a Web site at www.implantinfo.com, also known as Breast Augmentation and Implants Information Web Site by Nicole, which I founded in early of 1998.
I paid for all of my own travel and accommodations to be here today, and I will not be reimbursed by anyone for any of my expenses.
I am here on behalf of myself as a happy breast augmentation patient and on behalf of the tens of thousands of women that visit my Web site each month.
I have no financial ties to the implant industry or to any health professional societies. I am not a witness in any lawsuits relating to breast implants.
Thanks to the sponsorship with plastic surgeons who sponsor my Web site, I've been able to allow my Web site to grow to the point where we serve up to over 16 million hits per month and to 160,000 unique visitors each month, all free to the countless women seeking information about breast augmentation.
I launched the Web site about two years ago because I wanted to provide a community for women like myself to share their experiences. The only information I could find on the Internet at the time were surgeon Web sites and society Web sites. They were very helpful, but as a patient I wanted more. I wanted to interact with other women.
Once the site was launched, women from all around the country immediately began to pose questions and answers on my form about breast implants. They wanted to know the issues and the risks.
The amount of ignorance that women came to the table with -- excuse me? Closer? Sure -- the amount of ignorance that women came to the table with was not surprising. However, the number of women that came was very surprising. I had no idea how many women felt the same way that I did.
I believe that breast augmentation patients now, however, are very different from years ago. Women are much more informed. They are actively seeking this information and taking an active role in their own preoperative education.
I think anyone who has done any research about breast augmentation knows that this surgery, like any other, poses risks. The reasons I am here today is to discuss those risks, as well as the benefits of breast implants.
I am also here to tell you that I believe women today know enough about those risks to decide to choose breast implants and to do so with proper informed consent.
My Web site is currently the number one site on the Internet relating to breast augmentation. I believe that the amount of traffic on my Web site qualifies me to briefly speak about what women know and feel about saline breast implants.
I've passed out a booklet to each of you that contains some of the stories that women have E-mailed me and posted on my forum. I've received thousands of them and just brought a few today to give you an idea of the type of knowledge that women have and what women have to say about implants and their experiences.
Some of the stories listed on my Web site are in my experiences section, and some I have simply saved in my scrapbooks to remind me on a daily basis how important it is for women to be informed about this procedure. Some of the stories are just happy stories from happy patients, and some are from women who have had complications and still feel the surgery was well worth it.
What these stories also reinforce for me in my own personal sentiment is that despite some of the imperfections that implants may have, like any manmade device, breast implants represent a very positive thing and are able to change for the better the lives of millions of women.
I would like to read some of those stories to you, and I will try and keep them brief.
This story that I'm about to read is kind of funny, and this person E-mailed me telling me why she felt she wanted to have breast augmentation.
Most women worry about diving into a pool and having their boobs fall out of a bathing suit. For me on a hot, crowded day, I dove into a pool at Caesar's Palace in Las Vegas and had both my curves fall out of my bathing suit. Did you know those things could float?
Well, as I was frantically grasping for the curves, hoping that none of the 500 people sitting by the pool would notice, one thought went through my head. "That is it. I'm getting boobs."
That was just another day in the 32 years of my life where I resembled a 12 year old boy. Has it changed my life? No, but it has changed my self of self. I am no longer self-conscious about my appearance. Okay. Maybe once in a while, like any normal person would be, but it's no longer a daily, terrible ordeal.
Another woman wrote to me.
I decided to get breast augmentation because I was very out of proportion. I was a 36 AA and had two bris breasts (phonetic) that were almost unbearable for me to look at. I was very self-conscious, even with my own husband.
I spent way too much time comparing myself to other women and never felt adequate as a woman myself.
While the recovery was much more difficult than I expected, I had no complications, and my only regret is that I did not do it sooner. I can actually go through a full day without ever once comparing myself to anyone else or wishing I had something it seems I should have had in the first place.
I feel complete, like a real woman. I am not self-conscious at work or in my personal life, and I love to put on my clothes in the morning knowing that they will fit right.
I did this for me and only me, and I am so very glad I took the time and money to do something that pleases me so much. I am not ashamed or embarrassed in any way. In fact, I'm proud of myself for being strong enough to admit that I could look at myself, see something I wanted to change and change it.
The next comments that I'm going to read are from a woman with saline implants telling another woman what she would want to tell her if she was considering having this surgery.
If I could tell women anything about my experience with saline implants, I would tell them this is major surgery and not to be taken lightly or with a cavalier attitude. Expect that they won't last a lifetime and that they will eventually need to be replaced. Know that just as natural breasts are seldom perfect, neither are implanted breasts.
If you expect to see improvements rather than perfection, you will most likely be satisfied with your results.
Now, this last story I'm going to read is a favorite of mine because I just think it's hysterical.
Women like myself are constantly asked why we're so vain. Why do we choose vanity? People fix their teeth. They get braces. They get dental implants. No one seems to care.
This woman's response to this was: I was born legally blind in one eye, and it was crossed. I got it straightened a little ten years ago. Nobody ever questioned that or said I was being vain. It was like it was okay for me to fix my eye so other people didn't have to be subjected to its ugliness.
Most people acted like I had purposely offended them with my cockeye and told me I really should have it fixed. I used to literally get beat up in school because of it. Growing up in the Bronx was cruel. Some people would say it was unique or even sexy, and that would make me feel better.
Now, imagine if we were all allowed to walk about topless. People have been insulted if they were forced to look at my breasts because they were so ugly. They would be begging me to fix them and telling me I should get implants. I would have really gotten my butt kicked on a daily basis.
You just can't please them. I really don't care what other people see as right or wrong. This is my life. So I will keep my cockeyes and my implants, and I don't care what anyone else says or thinks.
People really need to learn how to live and let live and stop being so rude and judgmental. It just gets tiresome.
As you can tell from some of the stories that I've read and those that are discussed on my Web site each day, women today are informed about the real risks and the issues surrounding breast implants. Visitors no longer come to my Web site just asking how much will the surgery cost. Instead they now are asking about smooth, round, textured, anatomical, what is rippling, what is the contracture rate, what is the failure rate; they know what the issue are.
Today women overwhelmingly know what they are talking about and know what it is they are choosing, and I'm happy to be a part of that each day.
I have enclosed in your booklet a printout of the index of questions on my form from a typical day so that you can see the types of questions that women are asking.
In closing, I think that it's vital that I leave you here today with one general theme. It does not and should not matter to you or anyone else why I wanted breast implants or why millions of women want to have breast implants. We are not here to judge whether women should be entitled to want to improve on oneself, and it should not matter if it is for breast cancer reconstruction or simply to augment one's appearance.
What is important is that women should be allowed with informed consent to have this surgery. What you may see as the failure of an implant, such as the potential for rippling, hardening, or the need for replacement, informed women see as acceptable risks in the process where the emotional and psychological benefits outweigh the risks.
Women know the risks about breast implants, and to the extent that they do not, they can be and want to be well informed. If women know the risks and are willing to take the risks, they should be allowed to do so, and I don't think anyone should take that away from them.
I hope that what I've said here today has been helpful.
Thank you.
CHAIRMAN WHALEN: Are there any questions from the panel?
(No response.)
CHAIRMAN WHALEN: Thank you, Ms. Cummings.
Next, Ms. Lowder from the Toxic Discovery Network.
MS. LOWDER: Good morning. Thank you for this opportunity to speak to each one of you.
I wish my experience had been like the last lady and the letters she read, but mine was not. In 1984, I chose to have saline breast implants put in in Charlotte, North Carolina, after my plastic surgeon told me unequivocally that they would last a lifetime, and I did question. Actually I had not been there for implant surgery. I had been there due to an accident and needed a scar revised, and he brought it up, and consequently I ended up -- it was my choice.
But informed choice I think is one of the key components here.
After I was implanted in 1984, in July of 1984, it didn't take but a few months and I was in the hospital in very serious condition, and that was the beginning of what has been a downward spiral for the last 23 years.
I have been in the hospital for untold surgeries. I have gone through a hysterectomy. The implants were removed in 1984 shortly after the discovered a chest wall tumor just above the left one, and they finally agreed with me that there was a problem. I was leaking a grayish-black matter, and then the doctor got in there, he discovered that I had fungus and large black particulate matter.
Now, I'm not saying that every implant has this kind of a problem. I don't know, but I do know and I can tell you that I experienced it, and what ensued, what happened after that was a nightmare.
I ended up with a total hysterectomy the same day that they removed the implants. They discovered that I was filled with tumors that I had not had before.
I need to backtrack a little bit right now. I had been an Olympic contender ice skater. I was a dancer, ballerina. I was an equestrian. I played the piano. I was a very happily married woman with two very young boys, very active, healthy boys. I had whatever in this world wants. I had a loving home and a family.
That surgery on December 5th, 1984, where they removed the implants and the hysterectomy, was just obviously just prior to Christmas. On Christmas morning, the two boys and I were waiting at the Christmas tree for my husband to come downstairs, and he came down with one bag in his hand, and he said with regret that he was really sorry, but he just didn't want the responsibility anymore. He didn't want to be married to somebody who was so sick. So he left.
I have gone through countless surgeries. It's too many to even go through. I, in fact, go home from here to have a couple more tumors removed from my abdominal area and for a third time a cell tumor out of my hand.
The seizures, the MS-like condition can only be handled where morphine -- I take 60 milligram os morphine daily just to get through. Fortunately my boys are now grown, and they've been educated, and they're on their own, and I thank God for that because I don't think I could go through it again.
My experience was not what you hear some of these women sharing about, oh, the wonderful side of implants, and maybe there is a wonderful side. I can't address that. I didn't experience it, and the women I talked to on almost a daily basis have not experienced it.
I was not informed. I don't know what it would take to have doctors explain what the real problems can possibly be or what people can expect from implants, but what I do know is that it is an elective surgery, and until we have an assurance that people like myself are not going to go in expecting nothing but good things and come out with a total disaster, maybe it is chemical sensitivity. I don't know, but I think we need more answers before we can just unequivocally, indiscriminately open the doors and say anybody that wants an implant, come get it because there are too many that are unsuspecting like I was.
Today I am in total financial ruin. I lost my home. I had to close my business that I loved. Excuse me.
I was a commercial designer. Not too many people you talk to can honestly say they love what they do, and I did. I loved every moment of it, but the day that I was -- pardon me -- driving from Sandy Springs in Georgia to Cumming, Georgia to meet with a builder on a major highway, I had a seizure. The neurologist and my other doctors had been trying to convince me that it was time to back away from my career.
Well, that day I had no choice. When I said that I thank God that my boys are grown. They were robbed. They were robbed of a mom that was a happy, healthy, well adjusted person. Instead what they have to remember is a mom not knowing whether or not when they came home from school I was going to be in the hospital, whether I was going to be in bed or whether I would be able to cook dinner for them that night.
When I say this has been a nightmare, it really has, and I don't think you people sitting up here want to open that can of worms or continue to allow it to be open until there is some recognition of what has and what is going on.
There are too many people. I hear the same stories day after day after day. I have what is typically known as ANDS. It's like MS, along with a whole host of other things, and they're too long to even go into.
I wrote them all down, and I thought that sounds like a laundry list. There's no point in getting up here and reading off to you what's wrong with me today. I hate it. That much I can tell you.
I came to know a woman by the name of Kathy Keithley Johnston with Toxic Discovery Network going on three years ago now. She had started from pure love in her heart a nonprofit organization to help women who were and had gone through situations like I've had, and she's been there, and she has continued to be there for me.
As I close, I want to read a statement from Kathy who has had to close the doors of TDN, but before I do, one other thing I want to mention to you. I purposefully have not named the manufacturer of my particular implants. The reason you don't hear as many of these stories as you could is because six years ago now the manufacturer that was involved with me decided to pay me while I was still involved in the global settlement, and my part in that was I had to sign an agreement, a contract not to disclose and not to repeat what was in the contract or anything about my story. I had to remain silent. I could not tell anybody the nightmare that I had gone through or that this manufacturer was paying me $3,300 a month, and they did for four years.
They stopped paying me in November two years ago now. My father, my brother, and my oldest son are helping me stay afloat. That's a hell of a note for somebody who was as proud as I've always been.
I'm sharing that story with you because, about the manufacturer, for one reason. I question why I was being paid to be quiet. I had saline implants. I had the same saline implants that they've had a number of problems with, a lot of problems with.
I'm not going to be their conscience. The story will come out, but I'm not here today to try to run them into the ground. I'm here to talk to you, the FDA, about a product that I don't think is safe.
I just want to close with a comment from Kathy Johnston who has selflessly given of her time, their money, and her love. Kathy is an R.N. and president and Medical Director of Toxic Discovery Network, and she wanted me to read this quote, and her comment was, "I want it read loud and clear."
The right to choose is meaningless without the right to know, and I think that's pretty poignant.
And with that I thank you for giving me the time.
CHAIRMAN WHALEN: Would you entertain a question, Ms. Lowder?
DR. BURKHARDT: Hi. I have two questions. The first is that you referred to the global settlement in relation to your saline implants. It was my understanding that the global settlement had to do with the silicone gel implants, but you had saline implants, and you were part of the global settlement?
MS. LOWDER: That is correct.
DR. BURKHARDT: The second question is that you've obviously had an enormous amount of difficulty for which I think any of us must feel great empathy and sympathy, but it was not really clear in your presentation to me why you related that to your implants.
MS. LOWDER: Because it has been directly tied together. I have, and I apologize that I didn't tie it together.
I have silicone -- even though I had saline implants, I have silicone in my lymphatic system, in my brain, in every tumor that has been removed that they have checked since 1994. I have silicone, and my first question was: well, how can I have silicone when I had saline implants?
The answer to that is the outer casing is silicone.
DR. BURKHARDT: Thank you very much.
MS. LOWDER: Thank you.
CHAIRMAN WHALEN: The next speaker is Ms. Lynda Roth from the Coalition of Silicone Survivors, and I would remind each of the speakers to please answer for us the questions at the beginning of their presentation that have been posed by the FDA.
I paid my own way to this meeting. I came of my own volition, and sadly I will not be reimbursed.
I have no financial ties to industry or any group or individual in the health professions. I am included as a claimant in the current Dow Corning bankruptcy settlement. I did receive a settlement from Mentor for a whole $1,519. That was from almost dying.
I derive no income from anything related to breast implants. In fact, it has cost me many thousands of dollars to help others with the situation.
Ladies and gentlemen on the panel, I'm a social worker with MSW and the leader of a support network for women with breast implants. I'm here today to represent the many women who are unable to come.
There are numerous reasons for their absence. Among them, the inability to afford a trip; illness; and their feelings that they could not speak eloquently enough to get their points across.
Many are embarrassed that they made this medical decision only to become ill and become a burden to their families and friends. They hide their shame.
Some fear the legal repercussions of being public while legality still exists of these devices. I'm here today to tell you my experiences with these women and with saline filled breast implants.
Our network has existed since 1990 and has about 5,500 members. About 25 percent of those women who have had only saline filled silicone implants. A few of these women do not have problems, but they are concerned. The vast majority have medical problems caused by their implants.
As saline filled implants become more popular, the percentage of calls coming from women with these breast implants has mushroomed. In the last three years, our calls have consisted of more and more saline implantees, nearing 50 percent today.
Our network provides information free of charge throughout the world to those who cannot afford to pay for it, and we do provide a newsletter that some people pay for.
We are incorporated as a 501(c)(3) nonprofit organization.
Silicone is not biologically inert. It may be chemically inert. The silicone in a shell contains many chemicals which react when placed in a biological setting. Some of these chemicals are known to be harmful to the body.
I am sure you have a list of all the contents of the shells of these devices. I urge you to read about the harmful effects of each. They are not inert devices.
Biochemical reactions can and do occur. When implants are removed, often scar tissue remains. Some of the harmful chemicals that slough off the shell will remain in the chest, causing further reactions.
Foreign bodies are known to cause reactions. The calcium deposits that form in scar tissue resemble cancerous tissues on mammograms. Screening for cancer is much more difficult with any implant.
Women who have had cancer are known to have a suppressed immune system. I am one such woman, and although at the time the implant seemed like a great idea, it was probably the biggest mistake of my life. It almost cost my life.
Women who have suppressed immune systems should not be exposed to products that are known immune system suppressants. The manufacturers of saline that goes into these implants are on record as stating their solution is not meant for long term implantation into the human body. It is a dated solution, and one that cannot be guaranteed to remain sterile.
Generally the date is less than a year from the time of the implantation. Sterility is only as good as the conditions of the operating room and the cleanliness of the medical persons involved.
In addition, sterility is never 100 percent, even with the modern ways we have to sterilize medical devices.
Implants are microporous. They exchange fluid with the body. Anything in the implants can get into the body and vice versa.
We all have bacteria and fungi in our bodies. This leads to the incubation of nightmarish microbes that cause serious damage.
Saline implants can and do rupture, often. Besides the risk of the original surgery, women are exposed to repeated surgeries for years to come. The FDA reportedly has over 25,000 claims of injury from these saline filled devices. We have heard that our government is here to protect us. What have they done about these claims?
Some of the most common problems reported to us are deflation of the implant, often within a few weeks after surgery; hard, painful breasts; shifting of the implant so that it has to be surgically moved back where it belongs; body aches, joint pains; loss of energy; unexplained rashes often on the chest and neck; burning, twitching and weakness of muscles; and short-term memory loss.
Many women report significant hair loss all over their bodies, including eyebrows and eyelashes, and this problem usually reverses with implant removal.
Women also report skin and nipple necrosis. Testing often reveals antibodies to silicone.
I would like to specifically address the studies that the manufacturers have conducted, the so-called five year studies. First, I want to mention the lack of informed consent.
Product label inserts are not often given to the women. Women often have these implants placed without hearing a word about the possible problems. They report being given papers to sign when they have been prepped for surgery and have been given a sedative. They report being given papers to sign after the surgery before they are fully recovered from anesthesia.
I have heard from more than a dozen symptomatic women in the last three years who have never been contacted by their plastic surgeon after implantation with saline implants, despite the fact that they were told they were in a study about the safety of these devices.
These women's symptoms remain unreported. If I had heard from this many and other group leaders have heard from at least this many, how many others remain unreported?
These women are all part of a study being done by McGhan or Mentor. The plastic surgeons that insert the implants are collecting the data. This greatly reduces or eliminates any scientific validity of the study.
Another problem is that a study that only goes on for five years can hardly define risks that may take 20 to 30 years to discover, as in the case of asbestos. We know for a certainly that women with silicone implants often do not show symptoms for at least six to eight years. For some it is 15 years or more.
What possible value can a biased study, one in which not all the plastic surgeons follow up with patients and that only goes for five years, have?
This certainly calls into question the accuracy of the data of these studies that you will hear at this PMA meeting.
These saline filled silicone implant studies need to be followed by unbiased researchers for at least 20 years before we can know what damage they will do to many of the recipients.
I have heard doctors joking about these studies, stating that they are a study in name only. I seriously doubt that any of these doctors who make money from placing implants are going to come here and admit that these studies are not scientifically valid.
A survey of all women implanted should be done to find out how many had problems and how many have reported these to their plastic surgeons. This should not be done by manufacturers of implants or the plastic surgeons. The FDA should closely monitor these studies and check the accuracy of the information regarding these.
Women call our network with illnesses after a few years after implantation stating that they have never heard from their plastic surgeons. When they do finally call their surgeon complaining of symptoms, they are told that these symptoms could not possibly be from the implants.
I have heard from one of these women again recently, and after four years she had not once heard from her California plastic surgeon, despite the fact that she was told she was enrolled in a study. She finally called his office to report problems and was told that her problems were not of the type implants cause.
I'm including the E-mail of one woman who contacted me less than three weeks ago. She had her saline implants for four months and was already symptomatic. When she contacted her plastic surgeon, he told her it was not due to her implants.
She has persisted, and he has removed them, but with great reluctance. I do not believe this is an uncommon problem. From the reports I get from women and other support group leaders, this is an extremely common situation.
Those of us who speak out are called fanatical, hysterical women. I am a serious, practical, intelligent, and educated woman. I am dedicated to informing people on this issue.
If this meeting is not a serious effort to evaluate the safety of implants, but instead a rubber stamp to please the manufacturers by approving their products, then I ask that you make absolutely certain that all women are at least a week before the surgery given the important information about side effects. They need to be informed of the wealth of information available. They need to be given this without bias or comments by the physician.
Often concerns are just waved away with a sweep of the hand and a statement that "we don't have any problems with this." That's exactly what happened to me.
My group members report this same paternalistic response from their plastic surgeons. Maryland is a good example of informed consent law. The state has an excellent policy of informed consent regarding implants, but unfortunately the doctors do not comply.
There's an increasing problem with younger and younger women desiring on getting breast implants. The age range is from 13 to 17 years of age. Although some few plastic surgeons refuse to implant women so young, most can and do take these young women, children, as patients. They are not yet old enough to understand the lifetime of surgeries and problems that may occur, yet they are having implants placed in their body.
Ethically and morally these women should not be candidates for surgery. Their parents need to be truly informed of all the problems. Often these young women's bodies are not finished with development. Yet they're being exposed to surgeries.
You will hear about the social aspects, the self-esteem issues, the self-worth issues, and the feel good issues, "about myself now" reports here today. Many, many of the results are just the opposite.
The emotional pains are tremendously high. Women commit suicide to escape the pain. Increasing numbers of women are being granted disability. The taxpayers are paying for this. I know women who had saline implants in the '70s, and they are on disability. I'm grateful often that I'm not in their shoes.
The last point is that women have to sign away their rights to ever sue the manufacturers of these devices now. They have to sign a waiver saying they will never sue if they get implants. If they are so safe, why are we having to sign away our rights to ever sue?
The manufacturers know these devices are not safety.
In conclusion, I thank the panel for your time, and hope that you will make the decision to require more study on saline implants before any approval so that women of this country and, indeed, the world will benefit from this hearing.
Thank you.
CHAIRMAN WHALEN: Would you entertain a question?
MS. ROTH: Sure.
CHAIRMAN WHALEN: Dr. Dubler.
MS. DUBLER: Thank you for your testimony.
You said that you were dedicated to informing women, and I wonder what sorts of information do you think they should have. Should they have the data on the package insert? Should they have the raw data from some of the studies that have been conducted?
How would you go about informing them?
MS. ROTH: Maryland has an excellent brochure that has quite a number of pages. I would ask that you look into that and find out exactly what they have done, but in informed consent, information is no better than the doctor who is giving it out, and regretfully, most doctors do not give informed consent to their patients.
Now, the FDA has had currently understood risks of saline filled breast prostheses, which I have here, for years. There's a thing on the back that says "signature," "date," "witness." These are not being filled out. These doctors are not giving these to the patients, and if they do give them anything, they wave it away and say, "Oh, this is just a formality. We don't have any problems with these," which is exactly what happened to me.
MS. DUBLER: So are you suggesting that the materials be given out, that are given out by physicians, be composed by other people?
MS. ROTH: Oh, absolutely, and that the plastic surgeons be informed that they are not to discount this information because patients truly have a right to informed consent.
And I do have a picture here that was sent to me by one woman. She wants it back, of a saline breast implant that was removed from her body. So I would like to give you this information and share this picture.
CHAIRMAN WHALEN: The next speaker is Ms. Eileen Swanson from Survivors of Salines.
MS. SWANSON: Good morning. My name is Eileen Swanson, and I am here to tell you of my experience with saline implants and the experiences of that of my support group members, Survivors of Salines.
To answer your questions, because I am on disability and have low income, I accepted the offers of small donations for this trip from several other breast implant survivors. I also received an honorarium to participate in the workshop yesterday from the National Center of Policy Research for Women and Families, a nonprofit research center.
I have no financial ties with industry or health professional societies. I'm a claimant in the Dow Corning bankruptcy, and the answer to four is I derive no income from surgical procedures using breast implants or from treating patients with complaints they believe are related to breast implants.
My Web site and support group, Survivors of Salines, is entirely supported by me and the information is provided free of charge.
I was implanted with Mentor leaf valve (phonetic), smooth shelled, saline breast implants in July of 1989 for reconstruction following Stage 2 breast cancer on the right and prophylaxis on the left. Other than my cancer diagnosis, I was healthy and active.
The right implant deflated in the recovery room before I even woke up. It went straight downhill from there.
Another surgery followed, a saline only tissue expander a few months later, then a new set of Mentor saline textured surface implants two months after that.
In the following months I suffered from local complications: infection on both sides, swollen lymph node, pain, redness and swelling on both sides, rash and skin tags on my chest and under arms, burning chest pain which persists to this day, Baker III contractures, and a cluster of lumps on the left mound which mammography indicated was a crease in the implant. The lumps were later biopsied and found to be fibrocystic changes in my tissue.
Systemic symptoms began suddenly the third week of April 1990 and included widespread, constant pain, morning stiffness, frequent cramps, diarrhea, nausea and vomiting, ceca symptoms, severe headaches, bladder pain, frequency and incontinence, extreme neck pain attacks which leave me bedridden, abnormal fatigue, difficulty in concentrating and short term memory loss, chemical sensitivity, and a sleep disorder which I was told was called fragmented sleep.
I was explanted in May of 1991. I had a brief reprieve, but then my condition deteriorated. The scar tissue capsules imbedded with microscopic fragments of silicone were left in my chest underneath the muscle. Doctors tell me that surgery to remove them now would likely mean scraping my ribs and possibly doing more harm than good.
In September of '93, four years after implantation, my condition worsened. I developed numbness, paraesthesias, and burning pain in my legs and feet, arms and hands and face. These caused me to stumble and fall easily, shuffle my feet and drop things, have difficulty breathing, difficulty swallowing, sudden onset inability to speak, disorientation and dizziness, and balance difficulties.
You can imagine with all of these symptoms I've named so far what it's like to live on a daily basis.
I lost my photography business in 1994 because I could not hold my camera, move the props or backdrops, or even remember the technical details of my trade.
I lost my marriage, my health insurance, my home, and I live in the attic bedroom in my mother's home. I'm on SSI and Medicaid now. I used to be an active Army wife, full-time mother of three, a community volunteer. I enjoyed cross-country skiing, bicycling, hiking, and bicycling, in addition to working full time.
Now I'm lucky if I can walk around the corner to church on a really good day.
Board certified doctors have diagnosed fibromyalgia, with all of the symptoms that are defined by the American College of Rheumatology criteria.
My current neurologist says that despite normal EMG, she feels I clearly have a neurological problem in my legs, at least in my legs.
My current rheumatologist states that he believes I have more than fibromyalgia due to the abnormal blood work which he says indicates inflammation, such as elevated ANA, C reactive protein, retic count and CPK.
From the time I was 39 years old, nearly ten years ago, my life has been an agonizing struggle to do the everyday things most people take for granted. I have adverse reactions to nearly all medications we've tried, even herbs and homeopathic remedies and even food. So treatment and pain management remains an extreme challenge.
In 1998, I founded Survivors of Salines, which is an Internet saline implant support group, because I wanted to educate women about the risks. I have heard my story repeated in countless women who have written to me who have had saline implants. They have similar symptoms and similar difficulties in obtaining effective medical treatment.
Women like me who have had only saline implants, never gel, tell me they're experiencing deflations, rippling of the implant shell, infection, contractures, multiple surgeries, joint pain, fatigue, hair loss, irritable bowel syndrome, bladder pain, tremors, memory loss, chest pain, sleep disorders, fibromyalgia, lupus, neuropathy, scleroderma, and allergic reaction to silicone.
I'm sorry.
Women who have replaced silicone gel implants with saline implants report that their conditions worsened after receiving the saline, often having violent reactions such as intense inflammatory response in the breast, along with the other symptoms they have already had.
Most of these women tell me that their symptoms are debilitating, and many are on disability. Women seeking to be implanted often tell me that their doctors did not even advise them of the risk of local complications. They are frequently not aware that the shell is silicone, much less that it can shed microscopic fragments, and they are always shocked when I tell them that sterile saline has a shelf life after which time it has been shown to support microbial growth.
I am requesting that the pre-market approval applications for saline filled silicone breast implants be denied because the following have not been accomplished: standardized testing for allergy to silicone for all saline implant patients.
Salastic (phonetic) allergy was documented in 11 percent of patients in a study of endolymphatic subarachnoid shunt failures in 1998. According to the American Society of Plastic Surgeons, the silicone shell of the saline implants parallels the material that makes up other medical devices.
Second, a national registry of saline implanted women by a government agency, information from which is made available to saline implant patients, to include numbers of women implanted, symptoms experienced, and treatments available.
The plastic surgeon is often the sole source of information for a prospective implantee and may have little incentive to advise breast implant patients of possible complications since they earn an average of $3,000 from an augmentation or a reconstructive procedure.
Instead of the current climate of denial, there should be early detection of breast implant related symptoms, whatever they might be.
And third, studies and tests involving women who have saline implants and are sick. This is not a novel concept. It happens all the time when a new illness becomes known, such as Legionnaire's Disease in 1976. The CDC intervened and discovered a new bacteria.
In our case, it would seem to be common sense to test not only for reaction to the silicone shell, but also for bacteria and fungi which have been shown to grow and reproduce in no longer sterile saline, even though it is the FDA's position that saline filled implants are less risky because they release only salt water when they rupture, and not silicone gel.
I am asking you to protect future generations of women in a way that I was not. It never occurred to me that my doctor would place an object in my body that was not approved for use in the human body.
There is no proof that saline breast implants are safe, and isn't that what should have happened before they were ever placed in women's bodies?
Breast implants are not life saving, nor do they restore function in any way. Please do not allow women to continue being used as guinea pigs.
Thank you.
CHAIRMAN WHALEN: Thank you.
Our next speaker, we're going to go slightly out of order and go back to an individual consumer. So this will be a five minute address maximally to us rather than a ten minute address. And this will be Ms. Lisa LaCivita.
I'm sorry I couldn't make it at my predetermined time. I'll be very brief.
My name is Lisa LaCivita, and I am a woman that chose to have breast augmentation, and in coming here I had none of my travel or accommodations paid for. I don't have any financial ties to the industry. I'm not party or witness to any lawsuits involving implants.
However, I am an anesthesia provider, and I do derive income from surgical procedures involving breast implantation. I think that you should know that.
But I'm here as a consumer advocate for a women's choice to have breast implantation, and I really believe that whether it's for reasons of vanity or self-esteem or to correct gross disfigurement that results from necessary surgical procedures, that it should be a woman's choice to have breast implantation.
It's the responsibility of the FDA to determine the safety of the products that we are implanted with and the responsibility of the patient's surgeons to discuss the risks and the benefits of the surgical procedure.
Then it's the responsibility of the patient to make an informed choice and to give informed consent to proceed.
I'm a nurse anesthetist that works in a cosmetic surgery center, and for the last ten years we've done about 250 cases a year, about 90 of which are breast augmentations with saline implants. During that time, we have not had any difficulty with patients, and the data that you have is part -- we participated in the data that was contributed.
But we haven't had any patients come back and ask that their implants be removed. The most common risk or adverse event that we have seen has been mild capsular contracture, and even then patients may come back and have their implants removed, have a capsulectomy, and then have the implants put back in, but none of them have chosen to have them removed and to remain so.
So in conclusion, I'm just here to urge that you not take away a woman's right to make informed choices when considering breast implantation.
Thank you very much.
CHAIRMAN WHALEN: Thank you.
Returning then to the consumer group list, so back to ten minute presentations maximally, we have next Ms. Susan Sherr from the National Coalition of Cancer Survivors.
MS. SHERR: Good morning. In response to all four of your questions, the answer is no.
My name is Susan Sherr, and I thank you for this opportunity to speak to you, to this committee this morning.
I'm speaking today as a representative of the National Coalition for Cancer Survivorship, and I will correct that in the record, NCCS. It is the only patient led organization advocating on behalf of survivors of all types of cancer.
But I also am speaking today as a 22 year breast cancer survivor and one who has had personal experience with both reconstructive surgery and with breast implants.
I have previously testified before the FDA when silicone implants were being reviewed, and in 1998, on behalf of the Cancer Leadership Council before the IOM Committee reviewing the safety of silicone implants.
I mention this because NCCS' position and that of most of the major cancer organizations has essentially remained the same since 1991, and that is that evidence based science be the determinant in your reviews, questions, deliberations, and findings.
There will be several organizations and individuals testifying about the importance of options particularly for breast cancer survivors and on the topics of quality of life, mammography screening, and an informed consent. So I will not address these issues in my remarks.
Unfortunately, the silicone implant issue is one that has been contentious and litigious, and one that has pitted woman against woman, created a media frenzy that has led to fear and misinformation in the general public. We do not want to see this replicated with saline implants.
As an organization representing survivors of all types of cancer, all ages and both sexes, it is especially important to us that the FDA factor in the ramifications of faulty or non-science based decision making be it for a drug, a biologic, or a medical device.
By this I mean the implications for manufacturers of other drugs, biologics or devices leading to the potential loss or reduced development of new products, thus affecting patients and their treatment options.
It should also be understood that although this hearing is about saline implants, and NCCS is primarily concerned with the outcome for cancer survivors, we are also concerned that the process by which a decision is reached be thorough, thoughtful, balanced, and not subject to hype, emotion, or possible bad publicity that the FDA might receive.
Unlike the environment when silicone gel PMAs were being considered, there is considerable information and data available about the safety and efficacy of saline filled implants. In studies conducted throughout Europe, China, and the United States, contracture, rupture, under inflation, over inflation, texture, microbial growth, and even noise following surgery have been reviewed.
We are appreciative of the role of the FDA in protecting all citizens of the United States from unsafe and harmful products, but we do not need the FDA to take a paternalistic position. Women who are well informed are perfectly capable of making good decisions, and women who have already dealt with a diagnosis of breast cancer may be inclined to accept more risk than the average person. They should have this right if nothing dangerous or unexpected is presented in the PMA data.
It is also important that the FDA include the patient experience as a body of evidence when making its evaluation, both pro and con, and that the established, respected, and reasonable patient-consumer advocacy community be more involved in the process.
Thank you.
CHAIRMAN WHALEN: Thank you.
Next is Ms. Sybil Niden Goldrich of the Command Trust Network.
MS. GOLDRICH: Good morning. Command Trust Network has paid my way here. I do not receive any grants from any industry people. I am -- I have been appointed by the federal district court to represent women on certain panels in MDL 926. I am the consumer representative to the Tort Claimants Committee on the Dow Corning bankruptcy.
I get no money from performing surgical procedures.
I'm grateful for this opportunity because we're at a very critical juncture in the long unresolved debate over breast implants, and I'm going to repeat today some of the very same remarks I made to this panel 12 years ago when I first spoke.
Unfortunately, the issues that I raise today must again be addressed.
I thought to myself, gee, I've last longer than a lot of implants.
(Laughter.)
MS. GOLDRICH: The FDA continues to be caught in a situation where virtually all classes of implanted medical devices, including breast implants are sold to millions of Americans without full and open analysis of the risks versus the benefits.
Last year 130,000 saline filled implants were sold in the United States. I've been a consumer advocate for more than a decade and have had the occasion to speak to many women with saline implants. Believe me when I say that a large percentage of them are surprised and even shocked to learn that the safety of saline implants has never been formally approved by the FDA.
They are also keenly disappointed to learn that the manufacturers were under no obligation to begin collecting safety data until 1993, 20 years after saline implants were first marketed. Much of the industry data that will be presented to this panel, therefore, will be of very limited value. It is not possible to evaluate the long term risks of saline implants when the data is only on a short term basis.
Moreover, the two findings from the PMA data that were released prior to this conference are disturbing in their face. In the first instance, I refer to a recently published comment from Dr. Bruce Cunningham, who was the lead researcher on the PMA studies. He has reported that the failure rate for saline implants was five percent per year. At that rate, after five years, one in every four saline implants will have failed. After ten, half will have failed.
This was on the WebTV article.
A woman who has double implants is essentially guaranteed to have one of them fail within ten years. Of course, the failure rate between the five year mark and the ten year mark may be worse. We don't know. We don't know because there's no data available from that time period.
Secondly, I refer to an industry study that was cited in last years Institute of Medicine report. Based on an observational survey of 2,855 women who received saline implants during 1995 and 1996 from McGhan Medical Corporation, it appears that women with saline implants must return to the hospital at a much more alarming rate than women with silicone implants.
With silicone implants, one in four women need additional surgeries within the first five years, according to the Mayo Clinic. According to the McGhan data, however, one in three breast cancer survivors had to return to the operating room within the first 12 months with all of the inevitable risks and expenses involved in those procedures.
The McGhan study divided women into two categories: post-mastectomy reconstruction and augmentation. Of the cancer survivors, 35.9 percent suffered infections, deflation, contracture, or other problems that necessitated removal of their implants.
For augmentation patients, the rate for the same set of problems was 18.9 percent. Although it seems that one in four saline women need new surgery within the first five years after receiving -- altogether it seems that one in four will need new surgery within the first five years after receiving implants. In other words, the rate for saline implant patients is approximately five times higher than for silicone implants.
But we can't really know this for sure, again, because it's only a one year study. I urge the panel to make every effort to consult with medical professionals and other knowledgeable experts to obtain all of the available evidence before making a final decision.
Bioethical concerns are very important. Because breast implants are under the category of a cosmetic rather than a life saving device, most women assume that the risks are minimal or nonexistent. They had better be prepared to accept a higher risk in the case of a brain shunt or a heart valve, but not for breast enhancement.
Therefore, I recommend that this panel, the panel members, attempt to elicit the answers to the following questions:
One, what is the threshold of safety that must be achieved before cosmetic devices are made available for general marketing?
Two, how does the safety standard for cosmetic devices differ from the standard for life saving devices?
Parenthetically I might add: has the FDA ever approved a medical device that is not a life saving device when it has as high a failure rate as breast implants?
Also, how long should the surveillance period be to enable scientists to measure epidemiological results?
My medical concerns. Slick advertising, most women today are misled into believing that breast implants have been proven safe. It is important that you make the following determinations.
What is the rate at which women with saline implants experience capsular contracture, infections, loss of nipple sensation, skin numbness, skin rashes, or bacterial contamination?
What is the rate at which saline implants deflate or rupture?
What is the time period for these rates?
What is the rate at which saline implants interfere with mammographic tests for breast cancer?
Informed consent. Women who decide to undergo implant surgery only after a limited knowledge of the risks, later many of them say, "If I'd only known, I would have said no," but then it's too late. Most patients are not unduly upset if unpleasant information is provided at the outset.
What upsets them far more is when any level of truth is withheld and when only half truths are provided. I urge that the panel press hard to resolve the following.
What level of information is necessary to permit consumers to make an informed consent decision about breast implants?
How will women be notified in detail about potential risks, complications, and the longevity of devices prior to implantation?
Will the package labeling include specific data about the rates and time periods of all medical complications?
Will photographic examples of medical complications be made available to women to enable them to visualize the potential risks?
Will the package inserts be provided in duplicate so one can be kept in the surgeon's files and the other be given to the patient?
How will women be informed that their implants may interfere with mammograms and self-exams for breast cancer?
The last thing I want to approach are long term studies. The Institute of Medicine recommended last year that a standardized system, some type of registry be set up to help collect even more extensive information about the frequency, causes, management of medical complications of breast implants.
I asked for that in 1988. The following questions fall fully on the FDA to address.
Number one, should the FDA establish a monitoring system by which the implanted devices are tracked and retrieved upon removal for further study?
Should they be a chain of custody set of documents?
Should breast implants be registered in the national registry by model number and serial number?
Should consumers be informed of the model number and serial number of their individual implants?
Should they be issued a permanent wallet size card marked with all permanent information about their implants? How does that protect their personal privacy?
If a certain model of implant is deemed defective, what's your recall procedure? Who's going to pay for the cost of the recall?
Adequate information was not available to me when I got my breast implants after breast cancer. I've had persistent health problems after my surgery. I've had two implant replacement operations.
The article I wrote for Ms. magazine in 1988 brought widespread public attention to this issue and ultimately led the FDA to the moratorium for the devices in 1992. What I said then and what I will reiterate now: the patient's interest is the only valid interest in this equation and only it must be served. A product that is merely not unsafe should not be placed in the general marketplace. The American public expects and deserves that the FDA approve only those products that can truly be called safe.
Please don't fall off that very fine line that separates the two.
Thank you.
CHAIRMAN WHALEN: Thank you.
Question? Ms. Brinkman.
MS. BRINKMAN: Yes. Ms. Goldrich, you made some good points. I can't write fast enough. So --
MS. GOLDRICH: I spoke too fast.
MS. BRINKMAN: -- is there a possibility that some of the lists of points that you would like the FDA to consider, such as labeling and other issues that you made, just a brief list of what those are?
MS. GOLDRICH: I will be very happy to supply them to the panel and whatever group the panel chooses to write these documents. I did serve on an early advisory committee on writing the informed consent documents, but that committee was manned by manufacturers and plastic surgeons, and at the very end of that committee process, it was decided that the support groups were not even to be listed as an information source.
I hope that we have gone well beyond that in the last 12 years and that we can get some really solid answers to my questions. I'll supply them to you.
CHAIRMAN WHALEN: Dr. Burkhardt.
DR. BURKHARDT: Ms. Goldrich, I was listening as carefully as I could, but I think I missed some statistics that you reported from the Institute of Medicine Report.
MS. GOLDRICH: Yes. I have to go back to those.
DR. BURKHARDT: Did you say that 19 percent of patients who had augmentation with saline implants had their implants removed within one year?
MS. GOLDRICH: Yes, I did. I think I did say that.
DR. BURKHARDT: And that's in the report?
MS. GOLDRICH: Yeah, it is.
DR. BURKHARDT: Thank you.
CHAIRMAN WHALEN: Any other questions?
Yes, I'm sorry.
MS. DUBLER: You mentioned at one point the package insert.
MS. GOLDRICH: Yes.
MS. DUBLER: And I wonder, again, if you're suggesting that the package insert is appropriate to go to all patients. The struggle in informed consent construction has been to alert the consumer, the patient, to the material risks and those on which the patient should focus.
Do you think that the package insert will help that process or perhaps hinder it?
MS. GOLDRICH: I find it interesting that for many years I have asked for the manufacturers to package the product in such a way that the package insert is on the outside of the box rather than on the inside of the box.
The box is opened in the operating room. It doesn't even do the doctor any good there. I do believe that the package insert should be supplied to a patient.
When you buy a bottle of medicine in the pharmacy, they give you this big, fat thing stuck to the side. It's the package insert. There's no reason we shouldn't have it, and we should also have supportive documents to explain that package insert, but to keep it from somebody makes that person think that you're keeping a secret.
There can be no secrets about this product. The package insert should be made in duplicate. The doctor should be required to write that he has read this new package insert. They change them all the time. Whenever they lose a lawsuit they change the -- they up the ante and change the package insert, and the patient should be given that package insert.
Let her go home and read it at three o'clock in the morning when the questions some. What am I doing? Should I do this? Is this healthy for me? Am I safe?
I think it's only reasonable. The more information you get, the better, and I don't think in the long run a lot makes it more confusing. I think what happens is you see certain issues repeated over and over again, and then they're repeated, they hit home. People understand.
Anything else?
CHAIRMAN WHALEN: Thank you.
MS. GOLDRICH: Thank you.
CHAIRMAN WHALEN: Next is Ms. Cynthia Pearson from the National Women's Health Network.
MS. PEARSON: I'm Cynthia Pearson. I'm the Executive Director of the National Women's Health Network.
The network is an independent member supported organization dedicated to using a science based analysis to safeguard women's health rights and interests.
We accept no money from pharmaceutical companies, medical device manufacturers, or trial lawyers.
And in answer to the four questions, we have no travel expenses. We have no ties with anyone in industry or professional societies. We're not involved in any lawsuits and derive no income from clinical services.
Some of the panel members and FDA staff remember that the FDA has been actively involved as a voice for women consumers throughout the long history of FDA's consideration of the regulatory status of breast implants. For nearly two decades we have advocated for the agency to first classify these devices as requiring study, and then to require the manufacturers to provide data demonstrating the safety of these devices.
We're pleased that the day has finally arrived when this panel is meeting to evaluate data that have been collected on saline filled breast implants and make a determination about their safety.
We're also pleased to have the opportunity to speak here. Unfortunately we've been forced to prepare this statement in something that's a vacuum, as you see that most of the public speakers are speaking in advance of the data presentation.
Because of this we'll make our remarks in a way that just give our general impression, but hope to have some opportunity to participate tomorrow after data have been presented.
We believe, based on what we know as of this morning, that saline filled implants have not yet been tested in an adequate way to demonstrate that they are safe for anyone. There's no long term data available showing what happens to women with implants after five to ten years.
This deficiency is particularly frustrating in light of the fact that women have been using these devices for more than 30 years. This use has been based on their belief that the products wouldn't be available if they weren't known to be safe.
The women are out there, and we know as well as you do the deficiencies of retrospective studies, but they were a potential source of collecting data on the long term effect, the effects of long term sue of implants, and the fact that this opportunity has been ignored makes us question whether for some reason the manufacturers don't want the answer to that question.
But the women want the answer to that question, especially because of what we are beginning to know in a very scientifically valid way about the short term experience and safety record of the implants. We've heard some reports this morning of PMA information that have been discussed publicly that don't sound so wonderful, you know, a steady, constant breakage rate, a reoperation rate.
These are serious and painful health problems, even setting aside the question of whether there are larger systemic effects.
These complications are not contested. Everyone on both sides of the issues agrees, acknowledges that they occur, although the data that establish the frequency with which they occur are only beginning to be made public.
Similarly, in addition to the hardening of breasts and infections, the breakage rate is a common problem; the need to undergo another surgery. This means that women, if the average age of implants is still in the early 30s, although it may be dropping because of the growing popularity of implants inserted when women are teenagers. Women might require reoperations every five years. I'm just guessing, or every ten years for the rest of their life.
This is a serious consideration that individual women must weigh and face, but we believe that the panel has to also weigh and face as to whether a product with that kind of regular failure rate can be considered to be approved for certain groups of people.
We are specifically concerned because of our long history of work on breast cancer issues and with the new in the '90s wave of breast cancer specific survivor groups about the affect of implants on women who receive them following mastectomy.
It appears, based on what we know this morning, that relatively few of the women studied for the somewhat short term effects of saline implants, received their implants for reconstruction after mastectomy.
It's not improbable. There is a biological plausibility to the question of whether or not breast cancer survivors may be at increased risk for some health problems caused by implants as compared to other women.
There might be health problems. It's possible that there could be health problems that are specific to breast cancer survivors, but we won't know that question, the answer to those questions, unless the FDA and you give the advice to the FDA to require that the manufacturers look at that question, and the answer will take what it takes to answer any scientific and clinical question like this: trials with adequate sample size to determine an effect.
We heard results of meta analyses. We heard a guesstimate of what percent of women were in those meta analyses and in a statement that we should infer that the women had no risk -- in this case it was of connective tissue disorder -- because the overall group had no risk, but we all know, even we in the consumer world, that if there weren't enough women with saline implants to answer that question, the fact that they don't affect the overall outcome doesn't prove that you've answered any question about the impact on their health.
So I'm deeply troubled, and as our breast cancer specific groups -- I know that the agency has received a letter from Breast Cancer Action in San Francisco expressing this concern, that there is this possibility that any of these implants could be approved for use in reconstruction after mastectomy without adequate studies.
We are more than anything concerned with the lack of long term follow-up. It's been 15 years since your predecessors on this panel first recommended to the FDA that the manufacturers conduct studies and provide sound data assuring the safety and effectiveness of these devices.
It's been 12 years since the FDA accepted that recommendation and informed the manufacturers that such data would be required, and it has been eight years sine this panel found the available data wanting and engaged other research bodies in trying to stimulate needed research.
There's absolutely no excuse for us not to have solid data on the long term effects of these devices in year 2000.
Another concern we have is the loss to follow-up rate. We don't know what it is now. We haven't seen the studies that you reviewed in advance and will be presented this afternoon, but loss to follow-up, it's a frightening prospect for us out in the consumer world.
If the loss to follow-up is higher than average in the type of trials you're used to seeing, we would wonder based on the anecdotal reports of women in support groups who say they've talked to this woman, that woman and another woman who either has never been followed up or who has had her surgeon assume that her reported complications are not related to her device. We would be worried about selective loss to follow-up, and we hope that the FDA would have -- the FDA staff will be able to report to us later this afternoon that as they've examined the case reports and the manufacturer's submissions very carefully, that they've looked at and verified the procedures that have been used for follow-up.
So we hope that you'll give that really serious attention this afternoon and tomorrow.
And to wrap up, I'd just like to say as the representative of a consumer group that works on a multiplicity of women's health issues, we know that the term "FDA approved" carries great weight with the public. These implants currently have the sort of aura of approval just because they've been in existence and been used so widely for so long.
But if the panel votes to recommend approval for any of the saline filled breast implants being considered today, women will even more so believe that these devices have been proven to be safe.
Women count on the FDA to protect their health, and we believe and urge you to consider that approving a device such as this, without long term safety data and without data that specifically demonstrated safety in the populations in which it will certainly be used would be a betrayal of that trust that women place in the FDA.
We urge you to take these concerns into consideration as you evaluate whether the data before you are sufficient to warrant approval.
Thank you.
CHAIRMAN WHALEN: Dr. Burkhardt?
DR. BURKHARDT: If you don't mind, a question. One thing I did not -- could not follow. I was unable to follow your apparent criticism of the statistical studies, many of which we'll rely on specifically in regard to meta analysis.
Can you explain that to us?
MS. PEARSON: Yes. Before the FDA acted in the early 1980s -- excuse me -- the early 1990s to restrict access to silicone gel filled implants, they were by far the most common type of breast implant used.
The meta analysis, like all of the previously published studies for the most part included the general population of users identified in a variety of ways, but unless the study was -- a particular study was designed specifically to include women with saline filled implants, their study population would reflect the general population, which was more than three-quarters women with silicone gel filled implants.
Dr. Ory said that when he was asked what is the relative risk of I believe it was connective tissue disease after using -- in women with saline filled implants as compared to a woman with no implants at all, he said that the overall risk is close to one. The risk for women with silicone gel filled implants is close to one in those studies which separated them.
So since those two risks are both one, we can infer that the relative risk for women using saline must be close to one.
My point is if there weren't enough women with saline filled implants in those studies to come up with a population size that has the power to find a relative risk of something like connective tissue disorder, which is relatively rare in the general population, the fact that the inclusion of some few number of women with saline filled implants did not change the grand total relative risk does not tell you one way or another whether or not those women are affected by their implants.
I believe, and I think you'll have your hands on more of the numbers to know specifically, and you'll have saline specific studies submitted by the manufacturer, but I believe that until now the majority of published studies don't have the sample size of users of saline filled implants to answer very many questions at all.
DR. BURKHARDT: Can you think of any reason one would suspect the incidence of systemic problems to be greater with the silicone implants -- with the saline implants than with the gel implants?
MS. PEARSON: Not necessarily, but as a representative of a consumer organization, I believe that these devices should be held to the same standards that they would have been held to if they came to the agency after the device amendment passed in 1976.
The fact that they existed before '76 allowed the situation to emerge that we have now, where we have decades of use, and I believe that you would only ask that question if you had the opinion based on clinical experience in decades of use that you know something about saline filled implants.
We would like the opinions that have been believed up until now to be verified by trials of the size and design that can get the answer to those questions.
DR. BURKHARDT: Thank you.
MS. PEARSON: Another question?
(No response.)
MS. PEARSON: Thank you very much.
CHAIRMAN WHALEN: Thank you.
Next we'll hear from Ms. Martha Murdock from the National Silicone/Saline Implant Foundation.
MR. HAYTON: I'm Ron Hayton. Martha was sick this morning so I got volunteered.
We have no connection with the manufacturers, no money except from my regular job.
I'd like to discuss a few issues for the panel to consider when making recommendation for PMA -- thank you. I would like to discuss a few issues for the panel to consider when making recommendation for PMA approval of saline breast implants.
Thank you for providing an opportunity to do so.
First, I'd like to quote a couple of paragraphs from a recent article published January 24th of this year, copyrighted by Healthion Web, M.D. I chose this article because of these types of comments repeatedly.
The article states regarding the advisory hearing, underlying the meetings are very clear indications that the FDA is in favor of approving saline filled implants, products that while available for a quarter of a century have never been approved by the agency.
A decision to formally approve silicon gel implants which are more controversial than saline implants will come later, but all indications are the FDA is favorably disposed to approving them as well.
The article further states a recent letter sent by the FDA to a member of Congress declared that the agency feels that there is a need not only for saline implants, but also for silicone gel implants, at least for reconstruction follow breast cancer surgery.
Saline filled breast implants are not adequate for all women, the letter stated. There continues to be a public health need for silicone filled implants.
The letter was sent to Representative Thomas Bliley, Republican from Virginia, Chairman of the Commerce Committee which oversees FDA activities.
As you see, the buzz is that the PMAs will be approved. The FDA implies that Congress wants implants to remain on the market because they are a medical necessity. They fill a public need, and women should have the right to choose what she does with her body as long as she gives informed consent.
I'm sure you'll hear these statements many times by those who wish to keep breast implants on the market. I am in agreement with most of these general concepts, but I think there are a few things to consider.
It is my hope that what Congress wants is for the FDA to fulfill its duty to provide protection to the consumers that only safe, effective products will be marketed in the United States. It has become increasingly obvious that failure rates for breast implants is much higher in companies' reports. Recently published research indicates 25 to 30 percent women will need additional surgery in five years. Putting that into perspective and relating it to human beings, that means of 150,000 women a year receiving breast implants, 45,000 women will have to endure additional surgery with all of the risks and expenses involved with any surgery.
I ask you as American consumers: do we wish to set a standard that a 30 percent failure rate of a product in five years is acceptable? Is this a standard that is acceptable to the FDA?
In 1993, FDA Commissioner David Kessler stated that a five percent failure rate was not a failure rate that the FDA could accept for this device.
Dr. Laurie Brown, a FDA researcher, has done a comprehensive study on the rupture rate of silicone implants. It's been done for quite some time, but has not been published. I suspect that that is because she has found unbelievably high failure rates for these devices.
I believe the FDA has an obligation to make this data available to the public and certainly to this panel. Although Dr. Brown's research reported failure rates exclusively for silicone implants, one could easily conceive failure rates for saline implants would be the same or higher.
Saline implants are manufactured with the same silicone bag or shell as silicone implants. Additionally, they have valves that have been known to leak and fail at unbelievably high rates.
And finally, because sometimes are under filled, the risk of crease fold failures is increased.
Another paragraph from this article states that in the letter to Bliley, FDA said that it believes that women can evaluate risk versus the benefits of breast implants for their personal situation if they are well informed about the rate of infection and other local complications that can occur.
The agency cited a study in the New England Journal of Medicine published March 1997 that found infections occurred in 2.5 percent of the women undergoing implants; other local complications, including rupture, pain, and disfigurement. All of these may lead to medical interventions and repeat surgery, the letter stated.
In the letter to Chairman Bliley, the FDA conveniently left out the information from the same study which stated that approximately 25 percent of the women studied required additional surgery in the first five years, and the reconstruction patients had higher complication rates than cosmetic patients.
One thing you don't hear much about is the companies that have numerous problems with their manufacturing processes. It is evidenced by FDA Form 483 inspection reports for both Mentor and McGhan since the moratorium in 1992 for most breast implant manufacturers prior to the moratorium.
Inspection reports reveal quality control problems, the under reporting of complications, and the inability to validate manufacturing processes of these devices. In fact, the FDA had to resort to issuing a consent decree against Mentor in 1998 just to get them to comply with the law as good manufacturing practices, and to insist the company validate its manufacturing processes.
The bottom line is companies are having problems proving their devices are safe and effective. Former company employees have reported company data may be misleading and problems with devices are not adequately addressed and corrected. Could it be they can't prove the products are safe and effective?
A thorough investigation would probably shed light onto why company data is significantly different than published data regarding complications.
I urge the panel members to review FDA 483s and their EIR reports for the past 15 years for each company submitting a PMA before recommending approval. I am providing you with samples for your review.
I'd like to briefly address the issues the manufacturers and breast implant advocates argue for PMA approval, along with my responses to these statements. Additionally, I'd like to provide you with a copy of Mentor's PR plan titled "Mentor v. the World," which may give you an indication of where some of these myths may have originated.
Myth number one, breast implants are medically necessary.
Response: breast implants are not medically necessary. They are not required for body functions.
Myth two, breast implants fulfill a public need.
I believe it could be argued that breast implants fulfill a public desire for reconstruction patients, but there is not a public need for those who simply -- for cosmetic reasons. Surprisingly, only 15 to 20 percent of the women who have received breast implants do so for reconstruction.
These people may be willing to take the risk for what they perceive as a benefit they may receive and are entitled to make their own choice, if and only if they are given all of the information. Would you choose a breast implant from a company who has been cited for repeated violation of good manufacturing practices, or if you knew they were undergoing criminal investigation, or if you knew by having breast implants or if you've had breast implants many health insurance companies will deny you coverage?
CHAIRMAN WHALEN: Mr. Hayton, I'll have to ask you to come to a conclusion, please.
MR. HAYTON: I thought I had ten minutes.
CHAIRMAN WHALEN: Indeed, you do, but that light is flashing.
MR. HAYTON: Oh. Well, I'll just leave it at that then, and I'll give you the copies of PMA.
CHAIRMAN WHALEN: Are there any questions?
No response.)
CHAIRMAN WHALEN: We'll, just for planning purposes, have one more speaker and then we'll break for lunch and reassemble after for the conclusion of the public speakers.
Before lunch, we'll have Ms. Ann Fonffa from the Annie Appleseed Project. She's not here.
Ms. Margaret Volpe from Y-ME.
MS. VOLPE: Thank you for allowing me to present this statement to the advisory panel.
My name is Margaret Volpe. I am a breast cancer survivor and a breast implant recipient. I have no financial ties to manufacturers or health care providers, and I'm not being reimbursed for my appearance here today.
I am a volunteer representing Y-ME national breast cancer organization. We are based in Chicago and have chapters nationwide. We believe that no one should face breast cancer alone. So we operate a 24 hour national 1-800 number, hot line in Spanish and in English, and provide peer support and educational programs.
Y-ME is committed to providing support and accurate information to empower individuals touched by breast cancer so that they can select the most appropriate options for themselves in conjunction with their health care provider.
When I was diagnosed with breast cancer in 1995, I faced the fears, anxiety and depression common to those diagnosed with a life threatening illness. Because of the size and location of my tumor, I had to have a mastectomy.
I chose to have a tissue expander inserted into my chest when I had my mastectomy. This was followed by an implant placed under the pectoral muscle in February 1996 once I'd completed chemotherapy.
It was very important to me to have reconstruction, not have to worry about how clothes would fit, to feel whole again, for my family and me not to be constantly reminded of my breast cancer, and to get on with my life.
And I have had no problems or complications with my implant since my surgery.
Now, let me tell you why I selected an implant for my reconstruction. Now, I know I have ample tissue on my abdomen to be eligible for tram flap reconstruction. However, I knew I didn't want to have to endure the major abdominal surgery and painful recovery period required for the surgery, and I also wanted to keep those muscles intact.
I have several friends who did not have this option at all. They were told they were too thin to have the needed tissue for the tram reconstruction. Even the latissimus dorsi, or back flap reconstruction, usually requires an implant.
By doing nothing and settling on an external prosthesis, my friends and I would be reminded daily of the mutilation to our breast. Each woman who has had a mastectomy must be allowed to pursue the best option for her, including breast implants.
At present, if a woman has had tram reconstruction on one breast, she is unable to have a second tram reconstruction at a later date if she should develop cancer in the other breast. It is imperative that we continue to have a choice, and for many of us, implants are the only option we have.
Y-ME and I believe the availability of saline implants is very important to women who face breast cancer. It is the only uncomplicated option left for women who desire an implant as part of their breast reconstruction after the FDA restriction in 1992.
It was very difficult for me to get the textured reverse, double lumen implant I received in 1996 because of FDA restrictions that required me to be in a clinical trial. I am on a patient registry.
In addition, the informed consent I signed in order to participate in the implant study was much more lengthy and detailed than the informed consent I signed to have the potentially deadly stem cell rescue in a clinical trial at Johns Hopkins.
This panel must stick to the science when evaluating saline breast implants. Do not allow yourselves to get diverted and sidetracked by special interests that may have litigation more on their minds than health issues.
The National Academy of Sciences' Institute of Medicine report has been issued, and the science is clear. The IOM conducted an exhaustive and definitive review of all existing research and found that there is no evidence that silicone breast implants cause cancer or disease.
This report also found the same result for saline breast implants. The U.S. court's National Science Panel and several European government scientific panels issued similar findings. W-ME emphasizes the need for a wide range of treatment options as each woman, each woman must be able to choose the option that best fulfills her needs.
One of W-ME's main messages to women and families seeking our help is to fully understand the risk and benefits of any medical choice, including the usual surgical risks. We have worked with FDA to produce accurate information and used the FDA breast implant information booklet when counseling women.
And when it comes to the implant itself, women should understand that no medical device lasts forever. Shunts, heart pacemakers, even artificial knees and joints have an expected life span and possible local complications.
And women should be aware of potential rupture and the need for replacement. Adequate informed consent is a key part of the process. Doctors should discuss the issues of risk and benefit in detail with their patients.
Saline implants do have a silicone shell, but from the exhaustive research on silicone implants, pointed out by the IOM report, we also know that there is no convincing evidence that silicone produces an immunologic response. The IOM report states that such diseases or conditions are no more common in women with breast implants than in women without breast implants.
In closing, W-ME would like to work with FDA on informed consent and labeling issues that will be required if the FDA approves the PMAs. I urge the committee to act based on the science alone.
Breast cancer is a devastating disease. In the effort to resume our lives, breast cancer survivors have the right to select appropriate and effective medical therapies or devices.
Thank you very much.
CHAIRMAN WHALEN: Thank you.
Ms. Volpe, I perhaps didn't hear it. Did you at the beginning identify any financial relationships of your organization?
MS. VOLPE: As I said, I'm a volunteer.
CHAIRMAN WHALEN: And W-ME receives no funding from any manufacturers of implants?
MS. VOLPE: I believe that they have funding provided in the past by some, and our funding is public knowledge and can be --
CHAIRMAN WHALEN: Right, but we do ask each of the speakers to identify that so that if there can be any potential bias, those four questions need to be answered, and one of those would be if your organization receives funding from any manufacturers. So that is, indeed, the case.
MS. VOLPE: I believe in the past it has been.
CHAIRMAN WHALEN: Thank you.
Are there any questions of the panel members?
(No response.)
CHAIRMAN WHALEN: Thank you.
As I stated, we're going to break for lunch. I have right now about 12:05, and we'll take 45 minutes. So please reassemble at a time sufficient so that we can begin business at ten minutes to one.
(Whereupon, at 12:03 p.m., the meeting was recessed for lunch, to reconvene at 12:50 p.m., the same day.)
A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N
(12:56 p.m.)
CHAIRMAN WHALEN: If everyone could take their seats, please, we'll try to resume. If everyone could please be seated, we'll resume the continuing public comments from consumer groups and consumer information providers.
And the next identified speaker if she's present is Ms. Stansell, who is here from the United Silicone Survivors of the World.
MS. STANSELL: I'm Anne Stansell from New Mexico.
The question is who's paying for this trip. My husband and I are.
Now, I need to explain something. We both work only part time due to health reasons. My trip all the way from New Mexico costs about $1,000. That's a lot of money for a couple that only makes about 24,000 in a year. I'm stating these figures to let you know how very important it is for all of us to tell you that we are sick from breast implants. So please take this seriously as we do.
The answer to the next question is -- are you a party to a pending lawsuit? -- I am a claimant in the Dow bankruptcy court. Dow is offering a settlement, which means I will probably end up getting $1.98, and my lawyer will get two thirds of that.
The answer to the other questions is no.
I'm speaking to you as a leader of a group of women in New Mexico in a similar situation. There are some of their photographs so they can be here in a way.
Ninety percent of the women in our group in New Mexico are cancer survivors. Many have saline filled silicone shell breast implants. None of us had all the facts when we made the decision to get the breast implants. None of us realized we had a choice.
It was presented to me as all part of the treatments. My doctor said, "You have cancer. You need mastectomies, radiation, and breast implants." There was no discussion. No facts were presented to me other than breast implants are perfectly safe and will last forever. This experience is commonly shared by others in our group.
If they should ever leak, we'll just replace them, the doctor said, as if it's as easy as changing hair styles.
No one told me that breast implants rupture often. No one told me about infections. No one warned me about other complications causing a need for 14 more surgeries or procedures. No one warned us that saline would get rancid and grow fungus. No one warned us about capsular contracture until a plastic surgeon pounded on our tender chests with both fists.
If I had had all the facts, I would never have chosen breast implants, "chosen" being the key word. It should be presented to a cancer patient and all others as a choice, and one can only make an intelligent choice if one has all the facts.
Furthermore, the group of cancer surviving women I represent here before you wants me to tell you that breast implants are not medically necessary. We did not need breast implants to get over cancer. Implants are not life saving devices. They are life damaging devices.
We have been robbed of our survival to live a healthy life to a mature old age. We should have been warned by the FDA that they knew nothing about the device being surgically implanted. I guess there is some warning on a thing called "package insert."
Now, think about it a moment. "Package insert." It is wrapped inside the sterile package. It is not opened until the patient is under anesthesia. I don't read well under anesthesia.
In closing, we need to know when is enough. ASPRS (phonetic) tells us that 80,000 women of child bearing age received saline filled silicone shell breast implants in 1999. Many will file Medwatch forms of adverse reactions as many of us already have.
What number is enough? When does it stop? Is it ten percent, 20 percent? What's it going to take? Is it 50 percent?
Even ten percent is too much.
I charge the FDA to validate now the clinical trials the manufacturers have submitted. Check into selected patient follow-up. Check into patient intimidation by giving up their rights to sue.
Thank you.
I give the remainder of my time to Dr. Blais.
CHAIRMAN WHALEN: Are there any questions?
(No response.)
CHAIRMAN WHALEN: Thank you.
Is Dr. Blais here? I have been told that he is not here.
PARTICIPANT: He's here.
CHAIRMAN WHALEN: All right. While we see if he'll arrive, are any of the following here? Ms. -- unfortunately we had no timer, but it was about five minutes left -- Ms. Fonffa, Ms. Mullen, Ms. Williams. None of those are available? Ma'am?
PARTICIPANT: (Inaudible.)
CHAIRMAN WHALEN: Yes. Actually that's going to be a little bit delayed from 12:50. We're following sequence, but you will be called.
Is Dr. Puckett available?
DR. PUCKETT: Good afternoon. I'm Dr. Lin Puckett, professor and head of the Division of Plastic Surgery at the University of Missouri Health Sciences Center in Columbia, Missouri. I'm also President of the American Society of Plastic Surgeons.
The Educational Foundation of the ASPS has received undirected research funds from both Mentor and McGhan. These have been used for implant research. Both of them are also exhibitors at our national meeting, along with about 350 other exhibitors.
My travel and hotel expenses are being paid by the American Society of Plastic Surgeons. I have no ties to the manufacturers myself. I'm not involved in any lawsuit involving breast implants. As a part of my broad based practice of plastic surgery in the academic environment, I perform breast implant surgery both for reconstructive and cosmetic reasons. I, therefore, derive a portion of my income from this type of surgery.
The ASPS represents 5,000 Board certified plastic surgeons in the United States and Canada. It is the largest organization in the world of surgeons certified by the American Board of Plastic Surgery. Our members have provided care for most of the more than one and a half million women who have chosen breast implant surgery over the past 30-plus years.
As physicians, we know the women who have benefitted from breast implant surgery, but who may be uncomfortable speaking about this very personal subject in this public forum. We are their advocates.
The FDA determined in 1992 that there is public health need for silicone filled breast implants. Women's request for silicone or saline filled implants dropped off temporarily due to the concerns of the early 1990s. However, since 1995, we've seen a resurgence of interest in and demand for breast implant surgery.
The majority of breast implant procedures performed today is the silicone inflatable shell or saline filled breast implant due to the clinical study restrictions on silicone gel filled implants. Today only three companies market the saline implant in the United States.
Important research data has emerged in recent years on both gel and saline filled implants. Because the outside envelope that is used for both gel filled and saline filled implants is a silicone elastomer shell, the study findings on gel implants to a great extent also apply to saline filled implants.
In 1997, the prestigious Institute of Medicine of the National Academy of Sciences undertook a major study of silicone breast implants funded in part by the FDA and referred to several times this morning. The IOM's key findings released in June of '99 concluded that silicone implants do not cause major disease. Breast feeding does not pose a health threat to infants. Silicone implants do not harm the developing fetus. Radiation does not hurt implants and vice versa, and that breast implants have improved over time, reducing local complications.
It further reported that implants do not weaken the immune system and that, in general, silicone as present breast implants is safe.
The findings of this landmark study are reassuring for women and physicians. They confirm the positive clinical experience of plastic surgeons over the years and the high level of satisfaction reported by women with implants.
The study also recognizes the problems that can occur in women with implants. These include the possible need to replace implants, local complications, and the potential need for additional surgery.
These factors are relevant for both silicone gel filled implants and saline filled implants.
The latest data on these potential problems specific to saline filled breast implants will be presented subsequently at this hearing. Data from a recent University of Minnesota multi-center, retrospective study of 450 patients with saline filled breast implants with a minimum follow-up of ten years shows a deflation rate of 5.8 percent for implant models currently in use. This would be a failure rate of less than one percent per year, and this is in contrast to the interpretation of these statistics quoted earlier today.
Deflation of a saline filled breast implant is generally harmless but carries the risk associated with additional surgery for replacement. While these risks are not insignificant, they must be viewed in the context of the patient's overall risk-to-benefit ratio.
The Minnesota study, designed in consultation with the FDA, found that patient satisfaction with saline filled breast implants is extremely high. Ninety-three percent of patients, most of whom received implants for cosmetic breast enlargement, reported that they were satisfied or very satisfied with their surgery. Ninety-six percent said they would make the same choice again.
Extensive scientific studies today document the safety of silicone implants and the high level of patient satisfaction. Much of the past controversy surrounding breast implants has focused on claims of a link between silicone and autoimmune diseases.
While a saline filled breast implant contains only sterile saltwater solution, its shell is made of a silicone elastomer. As recently as August of '99, the FDA stated in the Federal Register that no definitive link between immunologic or connective tissue disorders and saline filled breast implants has been found.
Further, after comprehensive evaluation of the evidence for association of silicone breast implants with human health conditions, the Institute of Medicine concluded in June of '99 that there is no definitive evidence linking breast implants to cancer, immunologic diseases, neurological problems, or other systemic diseases.
What then constitutes the major risks associated with saline filled breast implants? Besides deflation, there is the risk of capsular contracture, tightening of the natural scar tissue that forms around the implant, and it can cause breast firmness.
The occurrence of capsular contracture is unpredictable, and if severe may require corrective surgery. In the Minnesota study, only four percent of patients rated their reconstructed or augmented breasts as hard, while 24.5 percent said their breasts were slightly or moderately firm.
While the ideal of implant surgery is a soft, natural feeling breast, some degree of firmness may be well tolerated by the patients, as evidenced by the high rate of patient satisfaction recorded in that same Minnesota study.
A concern associated with breast implants is the possibility that the devices may interfere with the early detection of breast cancer. Mammography of the implanted breast requires special techniques and additional X-ray views. However, recently published University of Southern California study of breast cancer diagnosis and survival among 3,182 women with breast implants in Los Angeles County showed the stage of cancer diagnosis was virtually identical to that of all breast cancer patients in L.A. County.
In addition, the five year survival rate was consistent with rats established by the National Cancer Institute. There is no evidence that implants cause breast cancer. In fact, two major studies have shown a lower than expected incidence of breast cancer in women with breast implants.
Plastic surgeons have seen first hand how a woman's quality of life can be tremendously improved by these devices. Every plastic surgeon can provide numerous stories about women whose self-confidence flourished after augmentation mammoplasty.
We also know first hand of many mastectomy patients who have expressed that they have only felt themselves to be recovered from their breast cancer experience when their bodies were restored with breast reconstruction.
The responsibility that our patients bestow on us as plastic surgeons when we perform breast implant surgery is taken very seriously. We believe that women should be fully informed of the potential risks and benefits of implants and should have the right to choose implants to restore their breasts following cancer, trauma, or deformity, or to achieve a satisfying breast appearance through augmentation.
Women who would wish to have breast implant surgery are often made to feel that the procedure is frivolous and poses unnecessary risk. Yet studies have confirmed that most of these women experience improvements in self-esteem and body image and quality of life.
We must also remember that there is no alternative currently available to breast implants. Autogenous procedures to reconstruct the breast require extensive surgery and may not be an option or are impractical for many patients. Autologous tissue transfer for breast enlargement could not be justified.
We believe that breast implants fill a significant health need, and we will continue to work to insure that women have access to this procedure and the right to make their own informed choice to proceed or not. The research findings of the recent years have significantly restored women's faith in breast implant safety and efficacy.
Thank you.
CHAIRMAN WHALEN: Thank you, Dr. Puckett.
Are there any questions from the panelists?
(No response.)
CHAIRMAN WHALEN: Thank you, sir.
DR. PUCKETT: Thanks.
CHAIRMAN WHALEN: Before proceeding to the next speaker, I'm told that one of the speakers who could not be here, Ms. Mullen from the Women's Information Network against Breast Cancer, that Ms. Brinkman will read a statement that was submitted by her.
MS. BRINKMAN: Thank you. I was just given this. So this in no way reflects any bias on my part.
This is from Elizabeth Mullen --
CHAIRMAN WHALEN: As you're starting, do know of any financial arrangement that that organization has?
MS. BRINKMAN: I don't even know who she is. So --
CHAIRMAN WHALEN: Thank you.
MS. BRINKMAN: I do not.
It's from Elizabeth Mullen, President, CEO of Women's Information Network Against Breast Cancer, written testimony.
I very much appreciate the opportunity to submit my written testimony to you for consideration. I had hoped to be here today in person, but was unable to make the trip from California due to circumstances beyond my control. My remarks will adhere to the ten minute oral testimony limit.
I am founder, President and CEO of the national, nonprofit organization Women's Information Network Against Breast Cancer. The acronym is WINABC.
As such, I am representing WINABC for the purposes of this testimony and would like to communicate from the perspective not only of an advocate, but also as a breast cancer survivor who has had a mastectomy and immediate post reconstruction latissimus dorsi with a saline filled breast implant, and finally as a woman who cares deeply about the issue being addressed today and throughout this week: the availability of saline filled implants and a woman's right to choose.
Oh, she goes on to say at the bottom, "And I have in no way been reimbursed for addressing this panel." She says her organization has received grants from a few pharmaceutical companies, Glaxo Wellcome. "I am not a witness or party to a pending lawsuit, and my income is not derived from breast implants."
My perspective as a breast cancer survivor and as a woman. I was diagnosed with breast cancer nearly seven and a half years ago at the age of 33. Judging from the size of my tumor, my physicians estimated that the malignancy had been there for seven to ten years.
Breast cancer had not been on my physicians' radar screens, nor had it been on mine. I quite simply did not fit the profit of a woman with breast cancer, or so it seemed.
Wrong assumptions had been made regarding my health status, and as a result, when I was finally diagnosed with breast cancer, my treatment options were limited. Due to the size and location of the tumor in my breast and the size of my breast in relation to the size of the tumor, I opted for breast conserving surgery. I would have, in essence, ended up with a partial mastectomy.
Due to these factors, there was consensus that a mastectomy was my best surgical option. I was, to say the least, fraught with sadness and fear over the prospect of losing my breast, facing chemotherapy, and the prospect of dying within two to three years. I was overwhelmed, confused, and numb. Being misdiagnosed for several years robbed me of some very important choices.
I was fortunate that my surgical oncologist called in a plastic and reconstructive surgeon for my initial surgical consult. My first glimpse of hope in the painful days following my diagnosis was learning that breast reconstruction was an option for me.
The prospect for my waking up after surgery without a breast was devastating to me. When my plastic surgeon explained that I could have an immediate breast reconstruction, my outlook began to improve, and I began to regain my strength of spirit.
Because of many factors, I was not a good candidate for a tram flap reconstruction. So reconstruction with an implant was my best option, my only option, as it turned out.
I remember making love with my husband for the last time before my mastectomy and reconstruction. It was so bittersweet. What would it be like after surgery? There were so many unknowns.
I share this with you because the personal and intimate perspectives of all women all too often get bypassed in forums such as this.
Just as the science is critical, as you consider the efficacy of saline filled breast implants, so, too, is the conscience, body, mind, and spirit of individuals who choose to have surgery with implants, be it for cosmetic augmentation or breast reconstruction.
How do you quantify hope, self-esteem, body image, sexuality? How do you hope self-esteem and a positive self-image impact of a 33 year old woman fighting for her life after breast cancer surgery, or as a teenage young lady with a chest defect following reconstruction to correct the anomaly, or a 50 year old woman who has never been comfortable with her AA size breast, who following breast augmentation experiences a new sense of womanhood?
I urge you to keep this human and humane outlook in mind.
I am blessed to be married to the one and only true love of my life, my high school sweetheart. I have known Ken since I was 16 years old. We always knew that we would get married, and for years we had the name of our first child all picked out, Semantha Ann Mullen, SAM for short, SAM, a daughter we never knew. Because of my chemotherapy protocol, Ken and I will never be able to have children together. Although we never had been warned about it, chemotherapy threw me into permanent menopause. I never had a choice in the matter.
Choice, one word that means so much. When a woman faces the diagnosis of breast cancer, she experiences a range of feelings that often include loss of control and grief over the possible loss of a breast.
But the good news is women have choices, including important choices in breast reconstruction. Limiting these choices by limiting or eliminating the availability of saline filled breast implants would be a tragic and devastating blow to women.
What's at stake here today and throughout this week is a woman's right to choose, and here is where my perspective shifts from that of an individual patient and a women who has experienced first hand the positive impact of breast reconstruction with an implant to that of a woman's health advocate, working to insure equal access to quality health care for individuals.
My perspective as an advocate and CEO of WIN Against Breast Cancer: "knowledge is the antidote to fear."
I founded the WIN Against Breast Cancer following my own experiences with breast cancer. The WIN organization was established to provide patients with the information and resources that they need to make to make confident and informed health care decisions. We place particular focus on helping women and men understand their treatment options and empowering individuals with the even knowledge about their choices and health care.
Choice and knowledge, informed decision making are at the core of WIN's organization, mission and goals. WINABC strives to provide individuals from all cultural and socioeconomic backgrounds with responsible, unbiased information about breast health, breast cancer, and personal health responsibility.
WIN was also founded to be a catalyst for change in partnership and to serve as a conduit by which individuals and organizations can be linked to one another in areas of common interest and purpose.
I will leave the science to the scientists and the clinicians, but I'd like to highlight a few key points regarding the great implant debate.
The device. Breast implants have been studied for 20 years and have been under intense scrutiny for a large portion of that time.
The science is sound and ongoing.
Product information. I have been able to see first hand and experience first hand the improvements that have been made in the product development with respect to saline filled breast implants over the years.
I started off this portion of my remarks with a quote about knowledge, another important development with respect to the devices under consideration by this panel: saline filled breast implants. Is the improvement in provider and consumer education? The bottom line: we fear what we do not know and understand.
As an advocate who has worked with hundreds of women over the years and dozens of providers, I can report first hand that what I referred to is myth conceptions are oftentimes tragic barriers to women seeking life saving breast cancer screening and treatment services.
I cannot count the times women have called our organization following a sound byte on the news about, quote, the dangers of implants or the, quote, deadly side effects of Tamoxifen or the, quote, long term, ineffectiveness of lumpectomies.
Hype destroys hope. Misinformation leads to disintegration of health. Overstated? Unfortunately not.
Women often fear the prospect of losing their breast to cancer more than chemotherapy or the disease itself. The fear is a barrier to women examining herself or seeking screening and treatment services. Oftentimes and tragically, women will ignore a palpable lump for years and present in the clinic with open sores on their breast in late stage disease because of the fear of losing a breast.
Many women do not know that breast reconstruction, immediate or delayed, is an option for them. When women fully understand their options, the benefits and risks, and are given access to peer support, second opinions, and culturally sensitive, linguistically appropriate, educational materials, they are more likely to make intelligent, competent treatment decisions and more likely will comply with treatment.
And when physicians are made aware of these issues and barriers, they can more effectively communicate with their patients and improve outcomes.
I will never forget the day when I was making rounds with a surgical oncologist. I was with him as he delivered a breast cancer diagnosis to a Latino patient. The patient clearly needed a mastectomy, but because of a variety of reasons refused surgery.
On her second visit to the clinic to again discuss options, her surgeon called me in and told the patient that I had a mastectomy and reconstruction. We showed her my reconstruction, explained the procedure. The unknown of surgical outcomes was now a known. She could envision the end result of a breast reconstruction and knowledgeably and willingly agree to the surgery.
Her choice was made real and tangible. She chose treatment over fear and flight from treatment. The choice, her right to choose, saved her life. She was the rule, not the exception.
In closing, I am going back to the beginning of my remarks. I was given my breast cancer diagnosis over the telephone. The entire conversation lasted no more than three minutes, three minutes frozen in time that forever changed my life. It's a time frame that makes me uneasy not because of a bad memory, but because every three minutes another woman is diagnosed with breast cancer.
Every day women are seeking breast cancer treatment options that include reconstruction with saline filled breast implants, often their best and only -- their only reconstructive option, an option that can result in a new lease on life at a time when life seems so fragile and precarious, a choice that means hope, healing, and vitality to the all too many women confronted with a diagnosis of breast cancer every day in this country and around the world.
I will close with a favorite scripture of mine. "Where there is no vision people perish."
It is my sincere hope that your vision, insight and wisdom will result in preserving the ability of saline filled breast implants and the opportunity and right for women to choose whether or not to use these devices.
Device? Funny. As I look in the mirror, it's hard for me to consider that my feminine silhouette is attributed to a device. This device, this implant has become a part of me, and I dare say has outlived my original prognosis of two to three years by several years, for which I'm grateful on many levels. Other women deserve that chance.
Thank you.
CHAIRMAN WHALEN: Thank you for reading that.
Before proceeding to the next speaker, if there's anybody from either FDA or Holiday Inn in the room who has the password to the thermostat and could drop it a couple of degrees, I think we'd all be immensely appreciative.
The other professional society that will be address --
DR. BURKHARDT: I have a question for the chair. May I ask a procedural question at this time?
CHAIRMAN WHALEN: Oh, procedural, yes.
DR. BURKHARDT: Yeah, a procedural question.
We've heard lots of stories, individual stories for and against this whole thing. In our training session last night, the new members had a training session with the FDA. My understanding was that in our deliberations as we sit here, we are precluded by statute from considering these individual experiences and experiential reports.
CHAIRMAN WHALEN: FDA questions I'll deflect to Dr. Witten.
DR. WITTEN: In terms of when you make a recommendation about reasonable assurance of safety and effectiveness of each of the PMAs, you are to consider the data in the PMA and your scientific knowledge.
DR. BURKHARDT: Period?
DR. WITTEN: Yes.
DR. BURKHARDT: Thank you.
CHAIRMAN WHALEN: The other professional society to address us this afternoon is the American Society for Aesthetic Plastic Surgery represented by Dr. David Sarwer.
DR. SARWER: Good afternoon. My name is Dr. David Sarwer. I'm assistant professor of psychology and psychiatry in surgery at the University of Pennsylvania School of Medicine.
I'm testifying today at the request of the American Society for Aesthetic Plastic Surgery which will reimburse me for my travel expenses to this hearing. I have in the past received two small grants, one from the American Society of Aesthetic Plastic Surgery and one from the University of Pennsylvania Research Foundation to support my research on the psychological characteristics of breast augmentation patients.
However, I do not derive any salary support from these grants. I am not involved as a witness or party to any pending lawsuit related to breast implants.
Members of panel, I am here today to present information relevant to your consideration of the safety and efficacy of saline filled breast implants. My comments are from a psychological perspective and are based on my expensive -- extensive experience --
(Laughter.)
DR. SARWER: Not so most expensive -- in the area of the psychology of cosmetic surgery.
Over the last five years I have published 21 empirical papers, review articles, book chapters, and discussions on the psychological aspects of plastic surgery. There articles have appeared in both the plastic surgery and psychological literatures. Many of these papers have focused on cosmetic breast augmentation patients.
In 1999, I served as a chairman of a symposium on cosmetic surgery at the seventh annual Congress of Women's Health and Gender Based Medicine.
Finally, I've recently written a review paper which is currently under editorial review specifically focusing on the psychological aspects of cosmetic breast augmentation surgery.
Therefore, I am uniquely qualified to discuss the psychological issues related to cosmetic breast argumentation.
The popularity of breast augmentation surgery means that internists, obstetrician-gynecologists, and many other women's health care professionals are increasingly called upon to provide appropriate advice and guidance concerning this procedure.
As you are aware, breast augmentation surgery has become increasingly common with women from a variety of age, racial and socioeconomic groups now seeking the surgery.
Thus, I believe that much greater sensitivity to the psychological issues of breast augmentation is required from the medical community at large.
Over the past 40 years, numerous studies have investigated the psychological issues of breast augmentation patients. The majority of these studies were conducted with women who received silicone gel filled breast implants.
Nevertheless, with the exception of studies which have investigated the surgical complications and satisfaction rates, it may be safe to assume that the psychological motivations of women who have received both silicone filled implants and saline filled implants are similar.
Based on our published reviews of the literature, my colleagues and I believe that there has been a lack of solid data on the psychological characteristics of breast augmentation patients. While a variety of studies have been undertaken, most of them have suffered from methodological problems that limit the confidence that can be placed in their conclusions.
The results of more recent, more carefully controlled studies, which I will share with you shortly, have provided important new data in this area.
It is surprising to many people that the majority of women who seek breast augmentation are in middle adulthood, married and have children. This contradicts the frequently assumed stereotype of candidates for cosmetic breast enlargement.
The preoperative psychological status of these women has been studied through both clinical interviews and formal psychometric assessments. Clinical interview investigations have generally suggested a high degree of psychopathology in breast augmentation patients. However, these investigations have a number of methodological shortcomings which raise serious questions about their validity.
In contrast, studies that have used standardized psychometric tests generally have found little evidence of psychopathology in these women. Only one study has found greater symptoms of depression in breast augmentation candidates as compared to controls.
The methodologies used in some of these psychometric studies also have limitations.
Intuitively many women seek breast augmentation surgery because they are not satisfied with the appearance of their bodies and their breasts. While such concerns were often dismissed as trivial vanity years ago, research over the past several decades has demonstrated the importance of appearance in everyday life. Not only are more physically attractive individuals perceived more favorably than those who are less attractive. It also appears that more attractive individuals receive preferential social treatment in both interpersonal and social situations.
Given this knowledge, improving one's appearance can be seen less as trivial vanity and more as a positive, health self-care strategy. This research, however, only explains the outside view of physical appearance. It does not account for the inside view the way a person views his or her own appearance.
This internal perspective of physical appearance can be understood through the psychological construct of body image which encompasses an individual's perceptions, thoughts, feelings and behaviors about the body. Body image, particularly body image dissatisfaction, may be the most relevant construct by which to understand the motivation of cosmetic augmentation candidates.
Body image dissatisfaction is so prevalent in our society that researchers have labeled a normative discontent. One recent body image survey suggests that 56 percent of American women report dissatisfaction with their overall appearance, and 34 percent report a dissatisfaction with their breast size.
Furthermore, body dissatisfaction in women appears to have increased over the past several decades, suggesting that the recent occupational, economic, and political advances of women in this country have not helped improve their personal body images.
My colleagues and I were the first to empirically assess body image dissatisfaction in prospective cosmetic surgery patients. Across several studies, we found that women who seek cosmetic surgery as compared to women who do not seek surgery report greater body imagine dissatisfaction with the specific body feature for which they are seeking surgery.
We have also completed three studies of breast augmentation patients. These studies have replicated our previous findings, suggesting that women who seek augmentation as compared, again, to women who do not seek surgery report greater dissatisfaction with their breasts.
These studies have also provided more specific information on the nature of this dissatisfaction. For example, more than 50 percent of augmentation patients reported that they avoided an undressing in front of others and that they camouflaged their preoperative breast appearance with special brassiere or clothing.
These upsetting experiences appear to have a negative effect on self-esteem. In the most recent investigation from our group, women who sought breast augmentation reported more appearance related teasing and a greater use of psychotherapy than did controls. These results may suggest that a history of appearance related teasing may be another variable that distinguishes women who do and do not seek breast augmentation.
Further, the greater use of psychotherapy in these women suggest that they may be experiencing negative emotional consequences as a result of their breast dissatisfaction.
Studies of the psychological consequences of breast augmentation have been largely anecdotal, though the reported satisfaction rates, as we already heard today, are encouragingly high. In the absence of physical complications of surgery, interview investigations have reported that the majority of women experience psychological benefits, including improvements in body image and self-esteem following augmentation surgery.
Two recent studies have provided even more convincing evidence of the psychological benefits of cosmetic surgery. Results from the first study found that as compared to preoperative levels, cosmetic surgery of patients reported significant improvements in depressive symptoms and quality of life six months after surgery.
Results from a preliminary investigation have found similar improvements in body image, also six months postoperatively. Thus, there is now growing evidence to suggest that cosmetic surgery, such as breast augmentation, leads to improvement in at least three areas of psychological functioning: body image, quality of life, and depressive symptoms.
A recent investigation of women who had their silicone breast implants removed further underscores the psychological impact of an altered body image. Women who had their implants removed reported less satisfaction with their appearance, fewer positive appearance related thoughts, and greater discrepancy between their ideal and post explantation breast size.
Thus, it appears that removal of a breast implant, something which has occurred more frequently as a result of prior controversies over silicone safety, may have a profound effect, negative effects, on psychological functioning.
In conclusion, recent evidence supports the view that women seek breast augmentation to reduce or eliminate their personal dissatisfaction with the size and shape of their breasts. Based on what we know of the importance of physical appearance in our society, this desire should not be viewed as a manifestation of psychopathology, but as a positive mechanism for improving one's appearance and body image.
Two recent studies suggest that cosmetic surgeries, such as breast augmentation, result in measurable improvements in body image, as well as depressive symptoms and quality of life. Given that the benefits of breast augmentation surgery are more in the psychological than physical realm, more research demonstrating the psychological benefits of the procedure is clearly warranted.
However, based on the current studies, it is reasonable to assume that the vast majority of women who choose breast augmentation surgery will enjoy significant psychological benefits that would otherwise be unavailable to them.
Thank you.
CHAIRMAN WHALEN: Thank you.
I think the get the award for the best timing today because the last word was right when the red light came on.
DR. SARWER: Yeah, but I also had that slip of the tongue at the beginning.
CHAIRMAN WHALEN: Are there any questions for Dr. Sarwer?
(No response.)
CHAIRMAN WHALEN: Just so the three remaining individuals who are going to be talking to us know, we will be getting to them in time.
We have one remaining consumer group to hear from. Dr. Blais, Pierre Blais is from the Chemically Associated Neurological Disorders, and in view of Ms. Stansell's yielding of half of her time, would the timer please be set for 15 minutes?
DR. BLAIS: Thank you very much.
I differ from the other speakers inasmuch as I am not a U.S. citizen. I'm here on invitation. I'm not a member of the association, nor, for that matter, of any advocacy association.
I do not derive income from the breast implant trades, neither through implantation, explantation, health care, diagnostic, marketing, sale, or whatever.
I am here at my own expense. I have never received funding from any source with respect to this program.
I'm a former Canadian official with a position very similar to our colleagues here from the FDA. I had a similar role in Canada. I'm responsible for what may be the largest breast implant or, for that matter, general deep, long term implant study ever taken worldwide. It has lasted now 25 years to this day.
The part I wish to report today is a very small segment of this study. It concerns 250 specimens from a very large cohort of explanted devices collected between about 1989 to almost the present. Out of these, there were only a few that were suitable for the type of study according to our protocol.
The type of protocol that we had targeted was one where we would look for contamination in implants that had not failed. This is a minority of implants that are removed, and they also included a review of the mechanical issues surrounding the fabrication of implants.
We have heard today about many things. We have heard about how beneficial the implants can be psychologically, how beneficial they will be to cancer patients, the fact that they are liked by individuals who have had deformity and so on. This may be so I could agree with it. I applaud the studies. They're very worthwhile.
My interests, however, are much more mundane. I'm a scientist, and I'm also a technologist. I've studied those devices now for far in excess of 25 years. I go back to the '60s, and I have personal direct recollection from the Joseph Kennedy hearings. Those of you who are my age will remember that.
Now, what I wish to impress on you is that the mention of science in the study, the retrospective study is one thing, and that may be so, but the mention of science in the context of fabrication and engineering of the implant is not here. I have never seen any evidence of intelligent engineering or science in the design, the fabrication or, for that matter, the post explantation analysis of these devices. They are articles of commerce of very low grade. They belong to technology. They do not belong to science.
Those of you who still hold the view that these things are scientific need only look at a few. I have some here. I won't bore you with that they are like, except to mention the part that I wish to draw attention to.
Virtually anything we have pulled out of patients over the last years that have not been outright broken amongst the salines were all septic, septic to a level which is unprecedented in studies on scientific implants. They were visibly contaminated with all types of flora, something that by itself should be a sobering thought for any physician who puts them in and who takes them out.
What I want to draw your attention to is a very small segment of our study which has concerned saline implants. Two hundred and forty-two implants that fall into a certain category, a subclass of saline implants, 74 that fulfill criteria of being "intact" in the surgical sense of the word, six of the users reporting problems prior to removal, such as deflation, a few of them claiming systemic complications -- I'm not competent to discuss it -- three users only involved in litigation.
Out of these 74, 12 were very old implants, what we call the Jenny Mark I, which is a unique implant introduced in 1968 with a very coarse and, by the way, highly secure valve system. These are the ones that habitually are removed without rupture. It's an interesting observation.
The others, 62 of them, bearing the same type of valve, this is what we call a forward valve or an apex valve. Those of you familiar with the trade will know what this symbols is. It is simply a hole with a diaphragm at the bottom and a plug at the top to cap it.
The early ones, the Jenny, were quite secure. The second generation which was introduced in '76 is not, nor is it designed to be, as best as I can figure out. This type of implant is designed to leak intentionally to support a claim of control of contracture. It is by itself an engineering misrepresentation. It is not a single product. It is made by nearly everyone in the trade. More than 18 different manufacturers have made it. The values all share the same process, the same problem because they all come from the same place. They are a commodity. They are an article of commerce marketed by a single manufacturer, sold to others.
Now, the other part of importance in this sub-study is that not only were the values of this design not terribly good in terms of manufacturing, but they did not even fit. The parts were not mated correctly. To put it in very vulgar terms, it was like having a cork on a wine bottle which is about five millimeters smaller than the hole, so that if you put the cork in the bottle, it falls to the bottom.
Now, I ask you as a technologist, as a scientist, as a physician, as an administrator, as a layman, as a user, what would you think of a company that presents to you with an elaborate pre-market submission claiming elaborate studies and good science and good engineering, who cannot manufacture an object to the right dimensions? What credibility will the PMA have?
Now, there are many things. I've made a formal submission, and I'm very grateful to Dr. Krause for accepting it. It will be given to you.
Unlike many others, it involves 20 recommendations on what the committee has no option but to consider if they ever find that one of the submissions complies with the terms of the requirement. I'm not saying there are any. I have yet to find one, but there could be one.
If such an implant ever appears in your files and you're required to give it assent as an approved product, then you have no option but to consider implementing the 20 recommendations that are made there, and many of them are quite surprising. They're also very old because the same recommendations are culled out of meetings that took place incidental to classification panels in 1978 right through to about 1983 and were reiterated again in the late '80s when the gel implant issue arose.
I'll just point to a few of them. If you wish to have further elaborations, I can do that personally, if an invitation.
One of the main issues that I have is that the FDA must address retrospectively warnings for users of the implants. They are exposed to risks which have never been made clear to them and have been denied. Yet they are undeniable in the light of laboratory findings.
The other issues have to do with disclosure and the clearing up of issues that are called possibilities, remote risks as opposed to inevitable, time dependent certainties.
These implants are literally replete with certainties. They are not probabilities.
And then finally I have to deal with the issue of breast feeding. In the light of any reasonable person who is briefed about breast physiology and in the light of the laboratory findings that we are getting from saline implant, there is no basis in any science, any technology, not even in psychology, that would justify breast feeding, and as surprising as it sounds, it has nothing to do with the offspring. It has to do with the very principle on why implants are put in in the first place.
If you attempt breast feeding with an implant, you will have a good chance of bringing the breast back to its pre-implantation condition, breast involution. It's all over medical texts.
The issue of the so-called selfishly oriented recommendation against breast feeding is absolute. It is a cosmetic issue and also one of risk.
Now, the issue of the offspring is secondary, but it's just as important in the ethical sense because we now have implants that are not secure in terms of integrity, which are known to be colonized by a broad range of microorganisms which have access to the breast, and the breast is fully engorged and responsible for distribution of milk precursor product to the implant.
Therefore, the implant constitutes a direct channel for transmission of an infective vector to the offspring. This concept is so old that you will find it in European texts in 1965.
Contrary to opinions expressed this morning, the saline implant is not a 1968 discovery. It's a 1960 discovery, and to make it even more embarrassing, it's a Canadian one at that. It is my Breton who has foisted this on you. It is older than the gel implant. It's been known since the beginning that they constituted a microbiological hazard that would preclude absolutely any recommendation for breast feeding.
Finally, to conserve and try to establish a record of being timely, the issue of radiography must also be addressed. It is also transparently obvious these devices, the very shell is structured and is radiopaque. As such, the uniqueness of the shell, its structure and its peculiarities, preclude any form of meaningful radiodiagnostic oncology aspect. The implant is not just a confusing factor. It is capable of generating both false positive and false negatives. Therefore, there should be an FDA recommendation with respect to deemphasizing any value of radiographic assessment for tumors.
Then last of all, I have the issue of cost. How and why did Canada governments become interested in breast implants? It had nothing to do with the health of the user, the offspring, the safety, or the cosmetic aspects, what we call efficacy. It had to do with cost.
Some of you know that Canada operates under a medicare system. In the early days of this debate, which is the late '70s, I performed a study on health care cost, which is easy to do. It's only a computer issue in Canada, as we have the record, and a very strong outcome came.
Anyone implanted consumed four times our health care resources of a corresponded age adjusted individual. I haven't done the study since. I'm scared.
Now, this has enormous implications. If you do a macroeconomic analysis of this phenomenon, you will observe that both primary and secondary health care costs of some states and incidental to Medicare/Medicaid, which does operate in some states, you find that it exceeds in some cases the actual promotion studies, the cost of promoting the technology.
Now, as a result of this, everyone, whether or not they have implants, are affected. They are affected in the sense that third party insurers, HMOs, and everyone else who is in the health care funding business is looking at breast implants with much concern for good reasons, because they attract health care procedures,a nd they attract health care costs.
One doesn't have to be the rocket scientist to figure this out.
Finally, the issue, the last issue, I made a small omission in disclosing conflict. It may not be a conflict. I have consulted for everybody, the breast implant industry, the breast implant professionals, the attorneys for defense, attorneys for plaintiffs, third party insurers, governments, you name it. I have done it, but I have not derived a living from it.
And finally, I do have an involvement as a witness, and it's a witness in Canada called a material witness incidental to a criminal investigation of the Canadian government surrounding wrongdoings in the approval process of medical devices.
Thank you very much.
CHAIRMAN WHALEN: Dr. Burkhardt
DR. BURKHARDT: Is it Dr. Blais?
DR. BLAIS: Yes, it is, sir.
DR. BURKHARDT: Thank you.
A couple of things that I couldn't understand. I'm just a little dense about this stuff, the thing that you said. You said that you had removed 74 intact saline implants.
DR. BLAIS: They're out of a group --
DR. BURKHARDT: I'm not finished yet.
DR. BLAIS: I'm sorry. I apologize.
DR. BURKHARDT: You removed 74 intact implants. Then you commented that the valve looked like it had been made to leak, and I don't understand whether the implants you removed were intact or deflated or what. What was the relationship there?
DR. BLAIS: They were intact in the sense of the word that you would use in your own operative report, Dr. Burkhardt.
DR. BURKHARDT: But were they deflated?
DR. BLAIS: They were fully inflated. Many of them were even over inflated.
DR. BURKHARDT: So they had not leaked.
DR. BLAIS: Correct. However, this is not true --
DR. BURKHARDT: That was the answer to my question. I just wanted to understand that.
Now, in terms of transmitting an infected vector to the offspring, it's my understanding, and we have an expert here who might be able to help us, that about 95 percent of lactating mother's milk is contaminated with staff epidermatis. It's a normal organism in the milk, and this is the predominant organism that is recovered from around implants.
So it's not clear to me why you think that the implant itself is a vector in transmitting that.
DR. BLAIS: Yes, it's three questions actually that you have directed, and I'm familiar with the microbiology of the breast. In fact, it's not limited to stapholocci. It includes also propioni bactiacne and many other things, the natural flora of the contaminated functional breast.
However, the organisms in those implants were not of this genus. They belonged to the mycobacteria family for reasons I can't go into, but now I show you the diagram of this valve again, and I tell you that it is not secure.
Even though the implants were inflated, which puzzled us for a time, our modeling studies showed that the valve functioned as a pump. It would take extracellular fluid occupying the intracapsular space and through the user's habitual movements, this would produce cyclic compression, and it drive fluid within the implant.
Therefore, the implant leaked not just one way,b ut in both directions and --
DR. BURKHARDT: Thank you very much.
DR. BLAIS: -- therefore, whatever is in would get out into the breast.
DR. BURKHARDT: Thank you.
DR. BLAIS: Thank you.
CHAIRMAN WHALEN: Yes, Dr. Dubler.
MS. DUBLER: On the very last page of your handout, you have a comment on publication.
DR. BLAIS: Yes.
MS. DUBLER: And how difficult it is to get these sorts of negative data published.
DR. BLAIS: Yes.
MS. DUBLER: Has the government of Canada -- has your report in any way been submitted formally and accepted by any agency of the Canadian government?
DR. BLAIS: No, Doctor. The report that you have in your hand was finished yesterday. You are privileged to have its first copy, or either cursed with having its first copy.
MS. DUBLER: Thank you.
DR. BLAIS: I have published many things. I have not and deliberately avoided publication in this area as it has been painfully difficult to collect clinical material, and that could be the object of another presentation, but it has no place here.
CHAIRMAN WHALEN: Thank you.
We have three remaining individual consumers who were segregated into this separate area this morning due to some time constraints.
First, Ms. Diane Griffith.
And these are five minute presentations, please.
MS. GRIFFITH: Mine may go about five and a half. I hope you'll bear with me. I timed this the best I could.
Well, let's see. My name is Diane Griffith, and my travel has not been paid by anyone else. I'm not Social Security disability and that's my source of income.
I have no financial ties with any organization. I am a party to the Dow Chemical/Dow Corning lawsuit, and I don't perform surgical procedures.
I'm making a statement on behalf of Dr. Arthur C. Sehalski (phonetic) of the University of Southern Illinois. He's a scientist, an immunologist and could not be with us this afternoon.
The statement is confined to issues of the structural integrity within the human body of the shell of prothesis known as silicone gel breast implants and saline filled breast implants.
The statements quoted during the next five minutes come from two sources, namely, one, the 1999 National Academy press publication titled "Safety of Silicone Breast Implants," and, two, the 1999 published, peer reviewed paper by Dr. Eugene P. Goldberg and co-authors, titled "Silicone Gel Breast Implant Failure and Frequency of Additional Surgeries."
Analysis of 35 studies reporting examination of more than 8,000 explants. In the executive summary of the Institute of Medicine's 1999 publication, the following statement appears in the second paragraph of page 3. "Precise frequencies of the rupture of gel filled or the deflation of saline filled implants are not available. The properties of these devices can affect rupture or deflation and have changed markedly over time, and particularly in the case of gel implants. It has not been possible to reliably diagnose and study rupture in an unbiased cross-section of implanted women."
Continuing, "rupture frequencies in the past have been considerable, and the rupture rate of current models has yet to be measured over the relevant periods of time."
Assuming the accuracy of the statement, of the sentence just quoted, and given the absence since this statement by the IOM committee was made of evidence to the contrary, why is the advisory committee even now considering a pre-market approval application for saline inflatable breast prosthesis.
It is not the labeling information available to the prospective saline implant recipient that establishes or certifies safety. Labeling information merely informs the prospective recipient of risks. What it does not do and cannot do is provide substantial human based evidence on the duration of the integrity of the sell within women. Is this not obvious?
Are saline inflatable breast implanted women again to serve as a test population to determine safety, to determine rate of rupture? Doesn't the evidence from the studies conducted at the University of Florida's Biomaterials Center and the Tampa Bay Cranial-Facial and Plastic Surgery Center show a direct and suitable, significant correlation of implant duration with percent shell failure?
And don't the studies of Goldberg and co-workers credibly reveal a failure rate of 30 percent at five years, 50 percent at ten years, and 70 percent at 17 years?
In 1993, the AMA Council on Scientific Affairs suggested that the shell failure rate was four to six percent, and is this not true that the FDA itself has stated that five percent rupture is "not a safety standard that the FDA can accept"? Has the FDA now changed its mind?
We would hope not.
Thank you.
CHAIRMAN WHALEN: Thank you.
Part 2 - Committee Meeting Minutes
