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The FDA’s Regulation of Silicone Breast Implants

U.S. Congress, Report of the Subcommittee of Human Resources and Intergovernmental Relations of the House Committee on Government Operations, 1993

The FDA’S Regulation of Silicone Breast Implants

I. Introduction

Under the Rules of the House of Representatives, Rule X, 2(b)(2), the Committee on Government Operations is authorized to “review and study, on a continuing basis, the operation of Government activities at all levels with a view to determining their economy and efficiency.” The committee has assigned this responsibility, as it pertains to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to the Human Resources and Intergovernmental Relations Subcommittee.

Pursuant to its authority, the subcommittee conducted an investigation of the safety and effectiveness of silicone breast implants, the regulation of those devices by the FDA, and research support by the NIH.

On December 18, 1990, the subcommittee conducted a hearing on the FDA’s regulation of silicone breast implants. The hearing included testimony from the following FDA witnesses: Walter Gundaker, Acting Director, Center for Devices and Radiological Health; Mr. Robert Sheridan, Director, Office of Device Evaluation; and Dr. Joseph Arcarese, Director, Office of Training and Assistance. Other witnesses included Dr. Nir Kossovsky, assistant professor of pathology and laboratory medicine at the University of California at Los Angeles; Dr. Frank Vasey, professor of medicine at the University of South Florida; Dr. Pierre Blais former senior scientific advisor for the Department of National Health and Welfare of Canada; Dr. Norman Anderson, former Chair of the FDA panel that reviewed the breast implant issue in 1988-90; Mr. Thomas D. Talcott, an engineer specializing in silicone implants for 20 years at Dow Corning; and Mr. Robert Rylee, vice president of Dow Corning Wright. Implant patients Sybil Goldrich, co-founder of Command Trust Network; Rosemary Locke of My Image After Breast Cancer; and Janet Van Winkle, founder of the American Silicone Implant Survivors (AS IS), also testified. Officials of three other manufacturers, Mentor, McGhan, and Surgitek, declined the subcommittee’s invitation to testify.


Read the original article here.

Testimony of Linda MacDonald Glenn at the FDA on Silicone Gel Breast Implants

Linda MacDonald Glenn, Women’s Bioethics Project, April 2005

My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women’s Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in healthcare and technology.

I am a biomedical ethicist, attorney, educator, and long-time patient advocate. I spent 20 years as an attorney, a prosecutor, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman’s Bioethics Project scholar. I have no financial conflict of interest.

“Tell me what you don’t like about yourself.” This catchphrase is the opening line to the controversial TV drama “Nip/Tuck” that sums up a plastic surgeon’s attitude towards his patient. The implication is that plastic surgeon can fix what you don’t like about yourself.

And while we’re not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman’s choice; in other words, “Let us help you feel better about yourself.” But, as I will follow up and explain, the FDA’s summary of the manufacturer’s own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today. Issues of long-term safety and truly informed consent are the primary concerns.

In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up with a slogan, “Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.

The slogan “The right to choose” implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.

Mentor’s own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.

To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.

The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long-term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.

Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn’t even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long-term safety are established.

Thank you for your thoughtful consideration in listening today.

Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies

Marcy Gross, State of Maryland Women’s Health Promotion Council, April 2005.

I am Marcy Gross, a consultant who specializes in women’s health issues. I am a member of the State of Maryland Women’s Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women’s Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six-year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long-term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short-term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third — and this is a change from the past — the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don’t know when.

I would assert that if this were an NIH-funded research study, it’s unlikely it would go forward.

Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor.

FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions

The FDA released a new report entitled Update on the Safety of Silicone Gel-Filled Breast Implants on June 22, 2011. The FDA summarized the report as showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.” However, the FDA admits that we don’t have as much safety information as we need, and that the implant companies haven’t done a very good job of doing safety studies.

After reviewing the research, we conclude that most of the studies that were conducted by Mentor (Johnson & Johnson) and Allergan are completely inadequate to provide safety information to patients. These studies of 40,000 women for each manufacturer’s study were required as a condition of the approval of silicone gel breast implants in 2006. The goal was for the FDA, patients, and doctors to find out more about the risks of silicone gel breast implants over time. They were intentionally large so that the risks of relatively rare complications, such as autoimmune diseases, could be evaluated. Several years into the studies, most of the patients have dropped out. Only about half of the Allergan augmentation patients stayed in their studies, and most of the Mentor augmentation and reconstruction patients dropped out of the studies. As a result, the studies cannot provide meaningful information about safety for those patients.

Why Can’t the Studies Provide Meaningful Information About Breast Implant Safety?

There are three major problems with the breast implant studies submitted to the FDA.

#1. Most studies lost track of most patients, so that the results can’t tell us what “most women” will experience. The complication rate for “most women” could be much higher or much lower.

#2. Most of the studies didn’t ask patients about the kinds of health problems that many women with implants experience. And, the studies stop at 10 years, whereas many of the worst complications occur after more than 10 years.

#3. Some of the studies rely primarily on questionnaires filled out by the patients, rather than medical records or medical examinations. In medical research, medical examinations or medical records are considered much more accurate ways to evaluate a person’s health than questionnaires.

The FDA report includes several studies that the companies conducted and submitted as a requirement of FDA approval. The FDA has not stated how many of the studies relied on information from medical examinations and how many relied on questionnaires filled out by the patients. However, we know that the largest studies, which should be the most important ones, rely on questionnaires. The “Core” studies of breast implants have some good 8-10 year information about local complications (such as implant breakage) for breast cancer patients but very limited information about augmentation patients. Information is especially lacking for women with Mentor implants.

Studies that are called the “Adjunct studies” lost track of most of their patients and can’t provide useful information about complications of any type.

The Patients Did Not Stay in the Studies

The largest studies—the ones with more than 40,000 patients each conducted by Mentor and Allergan—have reported the first two or three years of data. Mentor already lost track of 79% of all their patients after three years. Allergan lost track of almost half their augmentation patients in their first two years, and 25-31% of their reconstruction patients in the first two years. These studies are supposed to continue for 10 years. Usually, if patients drop out of a study after 2 or 3 years, they won’t participate in the study after that. For that reason, a study that lost even 25% of their patients after only 2 years are likely to lose more than half by 5 years, and the majority by 10 years.

When even a third to a half of the patients drop out before the research is completed, it is impossible to say with confidence what percentage of women will need additional surgery or have health problems after getting breast implants. In research, this problem is called missing data or “loss to follow-up.” In most of the studies that the companies conducted, most of the patients did not provide follow-up health information in the years that the study was supposed to measure complications. Did the companies lose track of the patients because the patients no longer stayed in touch with their plastic surgeon? Did patients stop going to the doctor because their implants were removed? Were they “lost to follow-up” because they died or got very sick? Or are they so happy with their implants and their lives that they didn’t want to be bothered going back to the plastic surgeon or filling out questionnaires? The huge number of patients who are “missing” from many of these studies, and especially the Mentor studies, are such a problem that these results would not be publishable in any peer-reviewed journal.

Is the Safety Information Provided Accurate and Comprehensive?

Some women have told us that when they reported health problems to their plastic surgeons, those problems were not reported to the FDA as part of the studies. We don’t know how often this happens, but complications would be under-counted whenever that happens. Patients tell us that plastic surgeons have an interest in staying in touch when the patients are satisfied, but not when patients are having problems. This could result in many women with implant problems being “lost to follow-up,” and those health problems would therefore not be counted in the study results.

Another problem with these largest studies is that they rely on questionnaires that patients fill out online for payment. A patient that wants to receive the payment ($10 or $20) might fill out the questionnaire very quickly, and not necessarily carefully. And, even if the patient does her best to fill out the questionnaire accurately, she may not know the answers to some of the questions about diagnoses of a long list of diseases, most of which the patient may never have heard of and some of which are almost impossible to pronounce.

In addition, It seems that some of the studies did not ask about many of the complications that women with leaking implants have complained about in testimony before the FDA, such as joint pain, hair loss, and other autoimmune symptoms. By focusing on the diagnosis of rare diseases rather than on symptoms that are more likely, some of the studies seem designed to result in an “implants are safe” conclusion rather than a “complications can be devastating” conclusion.

Despite these shortcomings, the FDA concluded that the studies show that many women with implants have “frequent local complications and adverse outcomes.” However, the results could have been very different if the studies did not have the three major flaws listed above.

What Does the Breast Implant Safety Issue Tell Us about the FDA Post-Market Studies and Safety Data?

Once a medical product is approved, its manufacturers have no incentive to do required post-market studies properly. Silicone breast implants are just one example of how the FDA’s reliance on post-market studies to determine product safety can lead to inadequate safety data that have no practical value for a patient trying to decide whether to use a medical product. Most women considering silicone breast implants can have no way of knowing how likely they are to experience serious complications when studies are so poorly conducted.

What should the FDA do differently? It’s time for the FDA to acknowledge that studies done before approval are likely to be much better than the ones done afterwards. The FDA should require better information before approving a product, and should rescind approval if a company fails to provide adequate safety data after approval.

What Do Women Considering Breast Implants Need to Know about Implant Safety?

The FDA reminds us in this report that “breast implants are not lifelong devices.” Many patients need additional surgery and perhaps need to have their implants removed within a few years. They report that about half the reconstruction patients (those who get implants after cancer or trauma) need to have their implants removed (and possibly replaced) within 8-10 years. The FDA reported lower rates of removal (1 in 5 patients) in 8-10 years for augmentation patients, but are those lower numbers credible? We think that they are not credible because so many of the augmentation patients were not in the study after 8-10 years. We don’t even know if the women whose implants were removed were intentionally dropped from the study because they no longer had breast implants.

The FDA report also reminds us that breast implant complications are common. “The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), re-operation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.” If a silicone gel implant leaks or ruptures, the silicone gel can migrate to the lymph nodes or organs where it can’t be surgically removed.

The FDA notes that “preliminary data” does not show a link between breast implants and autoimmune or connective tissue disease. “However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far,” the FDA admits. Although the FDA did not mention it, research indicates that autoimmune problems often decrease after breast implants are removed.

We recommend that women considering implants always make sure they have at least $6,000-8,000 saved to remove problem implants, in addition to the cost of the initial surgery. The FDA cautions women to “assume that you will need to have additional surgeries.” We have heard from many women who had serious health problems and were unable to remove their implants because they did not have enough money for surgery. While breast augmentation surgery is sometimes available on an installment plan, implant removal surgery is not.

Women considering implants can follow the link to read more information about breast implant safety.

What Do Women Who Have Silicone Gel Breast Implants Need to Know?

The FDA reminds women with silicone gel breast implants to get an MRI three years after getting their implants, and every other year after that. The FDA warns, however, that this procedure “is costly and may not be covered by your insurance.”

The FDA also tells women that “The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications.”

The FDA states that “…Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.”

“At this time, the FDA is recommending that healthcare professionals and women who have silicone gel-filled breast implants do the following:

  • Follow Up.  Women should continue to routinely follow up with their healthcare professionals. This includes getting routine MRIs to detect silent rupture.
  • Be Aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.
  • Pay Attention to Changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report online at or by calling 800-332-1088.
  • Stay In Touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.”
    Women with silicone gel breast implants can follow the links to read more about silicone breast implant problems and what to do if your implant breaks.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff

Statement of Dana Casciotti, MPH, PhD at the FDA on Breast Implants

Dana Casciotti, MPH, PhD, Cancer Prevention and Treatment Fund, August 2011

I am the public health research director of the Cancer Prevention and Treatment Fund, a nonprofit center that uses research findings to improve prevention and treatment strategies. Our nonprofit does not accept money from pharmaceutical or device companies so I have no conflicts of interest.

My perspective today is as someone trained in public health at Johns Hopkins and previously worked at the National Cancer Institute. I am very familiar with clinical trials and research methodology.

You have already discussed how poor the follow-up was on the implant studies. I was disappointed that an FDA official implied yesterday that most of the post-market studies were fine, and only a few were not.

I completely disagree. It was not just the Mentor large study that was so outrageous after only 3 years, and Allergan barely kept half their augmentation patients after only two years.

The Adjunct studies were even worse, only 16-23% of the women were still in the studies after 5 years. The Core Studies were slightly better, but Mentor had only 58% of their patients at 8 years, and that is not acceptable in any of the places where I have conducted research.

Our nonprofit has talked to many women who have had serious problems with their breast implants, and I am talking about recent patients, not patients from 20 years ago. But, many of these patients have already missed work because of their illness and couldn’t take the time to be here this week. Some told us that their kids are going back to school this week, and they need to be there. Others didn’t even hear about this meeting in advance, it wasn’t exactly highly publicized to the general public.

But history should be our guide. We know that most new breast implants seemed great at first. It isn’t until years later that it becomes obvious that the “newer safer breast implants” also break and leak and cause problems. So, it may take a few years to get a better idea about the safety of the “new cohesive gel implants” but we already know after yesterday’s testimony and from talking to many other patients that these new implants can bleed silicone into the scar capsule even when the implant is intact. And even the new implants can break.

I also want to correct some misconceptions that were reflected in yesterday’s panel discussion. The large studies done by Allergan and Mentor are not asking women to come to the plastic surgeon’s office every year. Most years, they are asking women to fill out a questionnaire, which they can do online at home. I have seen copies of these questionnaires and they are much too long. By the time women get to the questions about their symptoms on page 22 of the Allergan questionnaire, for example, they will have already answered questions about 20 connective tissue diseases, many of which they never heard of and can’t pronounce, such as eosinophilic fasciitis. They will also have answered the same 20 questions about each of their children. I have to assume that by the time they get to page 22 to answer questions about symptoms they might actually have, they are in no mood to answer the question about “dilated red blood vessels under the skin surface that appear as red marks, especially on the face, hands, and lips.” Given these questions, I think it is very unfair to blame the low response rate on the patients.

Similarly, Mentor patients have told us that the symptoms listed on their questionnaire were often confusing and difficult to answer.

I have one more thing to add. The first 2 years of the Allergan and Mentor Core studies showed that self-esteem on the Rosenberg Self-esteem scale went down in most patients with implants, and that symptoms of connective tissue diseases went up. Those data were reported at previous FDA Advisory Committee meetings. But, those data are missing from the analyses that the FDA has reported for the 8-year and 10-year Core study follow-ups. I ask the FDA to explain why.

Thank you for your time.

Epidemiology of Silicone-Gel Breast Implants

S. Lori Brown, FDA, Epidemiology, Vol 13, Supplement 3, pgs S34-9: May 2002

Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

Read the original article here.

Testimony of Margaret Dunkle at the FDA on Silicone Gel Implant Studies

Margaret Dunkle, George Washington University, 2011

I am Margaret Dunkle, Senior Research Scientist at the Department of Health Policy of The George Washington University. I also direct the Early Identification and Intervention Collaborative for Los Angeles County. Among other awards, I have received the American Academy of Pediatrics’ Dale Richmond Award for outstanding achievement in the field of child development; and Vice President Al Gore’s “reinventing government” Hammer Award.

I have testified nine times before Congress on issues affecting women, children, and families and have authored more than 100 publications on these subjects.

I am here today solely because of my interest in ensuring that medical products for women be proven to be safe and effective. I am not representing any organization. I am not being paid or otherwise compensated.

The 2006 FDA approval of silicone gel breast implants was controversial because there were so many unanswered questions about the long-term safety of implants, including when they might break and leak inside a woman’s body, and what the consequences of such leakage might be.

“As conditions of approval,” the FDA required that the two implant companies (Allergan and Mentor) each study at least 40,000 women. The FDA also required that these studies be at least 10 years long since some serious adverse outcomes might not become obvious, or even be measurable, in just a few years. And it takes both time and a large sample to identify subpopulations of women who might be at greater risk for problems, such as autoimmune reactions, or reproductive or connective tissue concerns.

It is now five years later, when the studies should be close to half done. But the data for both the Allergan and Mentor studies are not what they need to be for a study of this importance.

Why do I say this? Because of the extraordinarily high “loss” of study participants, as the following table shows.

In just three years, Mentor (now a subsidiary of Johnson & Johnson) has somehow managed to “lose” four out of five of both the silicone-implant patients and the augmentation patients enrolled in its 10-year study. Their paltry overall enrollment rate, with only 21% to 29% of patients still in the study, makes their data virtually useless in terms of assessing either safety or effectiveness.

As you can see, Allergan’s rates are better, but still likely too low to meet the study’s goals. Simply put, when you lose half or more of your sample, you cannot assume that the data for the few left in the study also represent those who were “lost.”

The Mentor rates, especially, would be laughable, were it not for the seriousness of the issues. Let me put it this way. If I can easily find my antediluvian high school classmates with a few “advanced search” clicks on Google, how can it be that these well-resourced medical-device companies cannot keep track of much younger patients that they have already enrolled and consented into their clinical trials? If the will were there, there are many sound methodological ways to ensure high rates of ongoing participation in these studies.

So, what to do about this bad situation?

The FDA’s job is to protect public health by ensuring that such things as medical devices implanted into women are both safe and effective. My five recommendations are aimed at helping the Agency do just that job.

First, rescind approval for the Mentor implants. They did not uphold their part of the bargain for the post-approval study. If they can’t competently do this research to ensure their product’s safety, they should not be putting their product into the bodies of more than a hundred thousand women every year.

Second, do not restore approval of the Mentor implants until they have at least two years of credible data with 80% or more retention of clinical-trial recipients. They could accomplish this by re-enrolling or “finding” the thousands of women they have “lost to follow up.” To ensure credibility, Mentor would need to pay an independent entity to check the validity of their data.

Third, extend the duration of both the Mentor and Allergan studies to 15 years. The FDA’s own “Update” report indicates that 10 years may not be long enough to identify long-term problems from cancer to rarely diagnosed autoimmune diseases, or to detect populations especially susceptible to adverse outcomes.

Fourth, require ongoing transparency and disclosure of the data from these studies by making public meetings such as this, and the June 2011 “Update” report, the rule, rather than the exception.

Fifth, implement a broad FDA policy to put companies on notice that there will be consequences of not doing or incompetently doing FDA-required post-approval research. Consequences could include withdrawing a product from the market, or substantial financial penalties for doing a bad job of the research, and then using that “penalty money” to fund research controlled by AHQR or independent researchers.

In conclusion, with almost 400,000 women getting breast implants each year for augmentation or reconstruction these studies need to be done right. The current situation also provides a window for the FDA to improve the incentive system so that manufacturers do not again ignore post-approval research requirements to the detriment of the public’s health.

Thank you for this opportunity to comment. And I ask that my full written statement be inserted into the meeting record.

Testimony of Anne Kasper, PhD at the FDA on Silicone Gel Breast Implants

Anne Kasper, PhD, Finding My Way, October 14, 2003

My name is Dr. Anne Kasper and I am a partner in Finding My Way, a support service for breast cancer patients in Bethesda, Maryland. I am also the senior editor and author of the book Breast Cancer: Society Shapes an Epidemic.

Breast cancer patients have more choices than ever before. While it’s important to have choices, when a woman is diagnosed with breast cancer, the choices can be difficult to make.

• Three out of four women newly diagnosed with breast cancer can choose to have a lumpectomy with radiation instead of mastectomy.

• If a woman needs or wants a mastectomy, she can choose saline breast implants, silicone gel implants, or autologous tissue transfer procedures.

How important is it that silicone gel breast implants be widely available to cancer patients? Under the current restrictions, the vast majority of women who want silicone gel implants for reconstruction are able to get them.

But, breast cancer patients tend to be cautious. They want to live long lives. However, they also are concerned about cosmesis and how they will look after cancer treatment. Many will choose lumpectomy, which allows them to keep their breasts, preserving their appearance and the sensory feelings of the breasts. Women tell us that they only want silicone gel implants if they can be assured that they are safe. Women are often encouraged to choose implants and a rosy picture is painted about the benefits of implant reconstruction. However, in our practice women are often disappointed to have reconstructed breasts that have none of the sensory, sexual, and maternal capacities of a normal breasts and that often have complications.

Many reconstruction patients who choose silicone gel implants are happy with their implants at first. Unfortunately, many women experience the kinds of complications that Inamed found, such as:

46% will need additional surgery within 2 or 3 years
25% will have their implants removed within 2 or 3 years
6% will have a ruptured implant
6% will have moderate to severe breast pain
6% will suffer from necrosis, a complication in which their skin or breast tissue dies and the wound takes a long time to heal

In the Inamed core study of breast cancer patients, only 6% of the implants broke during the first 2 or 3 years, but over time we know that percentage increases. This is much more serious than when a saline implant breaks. When silicone gel implants break, the silicone can leak into the lungs, lymph nodes, and other organs. To determine the safety of silicone gel implants, Inamed should have studied the health of women whose implants broke — especially since cancer patients have compromised immune systems. Unfortunately, they did not.

Another shortcoming of the Inamed research is that it included only 6 African American breast cancer patients in the core study and only 5 Asian American women. Obviously, this is not appropriate data on which the FDA could make a safety decision for all American women. Both groups have approximately the same rates of cancer as white women, and African American women are especially susceptible to autoimmune disease. These women must be studied to determine if implants are safe for them.

The bottom line, though, is that the complication rates for breast cancer patients are very high in just the first two or three years. What will these women’s lives be like in the next 5 or 10 or even 20 years? Most breast cancer patients are living long lives. Many choose mastectomy as a way to “get it over with” and “put cancer behind them.” With re-operation rates of 46% in the first two or three years, and higher rupture rates in the years to come, many women will not consider implants a satisfactory and safe choice at all.

It is unusual to ask for more than 2 years of safety data for a new product, but silicone gel breast implants are not new. Inamed is asking for approval for an implant that has not changed much if at all in more than a dozen years. If FDA had strictly enforced their restrictions on breast implants, which were established in 1992, we would have 10-year data by now, instead of 2-3 years.

If the FDA approves silicone gel implants based on the data provided, it sends the message that they are not as concerned as women have a right to expect about the health and safety of breast cancer patients, and especially women of color.

If the FDA allows silicone gel implants to remain on the market, but only as part of clinical trials, and this time requires a third party to monitor the studies, then perhaps breast cancer patients will finally get the information they need to make a meaningful choice.

Testimony of Claudia Miller, MD at the FDA on Silicone Gel Implants

Claudia Miller, MD, University of Texas Health Science Center, April 2005.

My name is Dr. Claudia Miller. I have no financial interests in this hearing, and I’m here at my own expense. I’m a professor at University of Texas Health Science Center in San Antonio. I’m an allergist/immunologist. And my research is focused on people who report chronic disabling symptoms following some environmental exposure, the symptoms you have heard about today.

I have served as a consultant to the Department of Veterans Affairs on Gulf War veterans, the EPA on sick buildings, the National Institute of Dental and Craniofacial Research on temporomandibular joint implants, where, by the way, you see similar kinds of complaints.

What unites ill Gulf War veterans, sick building occupants, and patient with implants who are having problems is the fact that following a well-defined exposure event, a subset, not every one, a subset of them, go on to lose their prior natural tolerance for a wide variety of substances that are structurally unrelated.

Thereafter, common foods, medications, alcoholic beverages, caffeine, chemical inhalants, like diesel exhaust, and fragrances you have heard about today, exposures that never bothered people before suddenly trigger symptoms in them. And these can be disabling.

This two-step disease process — and has come to be known as toxicant-induced loss of tolerance, or TILT. It does not appear to matter whether the exposure that initiated this, which is at the bottom of the right-hand slide, was endogenous or exogenous. The body’s response is remarkably similar.

We have reported on 87 individuals with surgical implants, three-quarters of them with breast implants. Sixty-nine percent reported rupture. Seventy-eight percent had one or more implants removed. Of those who had undergone explanation, less than ten percent reported their health status as greatly improved.

Using a validated questionnaire, we found that the symptom severity scores of implant recipients rivaled those of the environmental exposed groups we were studying. And there were four of those.

Compared to controls, implant recipients reported much more severe adverse responses to everyday chemical exposures as well as having problems with various foods, medications, alcoholic beverages, and caffeine.

Toxicant-induced loss of tolerance is a new paradigm for environmentally induced disease that differs from classical toxicity and allergy.

Affected individuals may be completely unaware of the intolerances resulting from this because of a phenomenon we call masking. If a person is reacting to many different things and having symptoms as a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the time, often reporting chronic fatigue or flu-like illness that won’t go away.

Recent Canadian studies show that genetic polymorphisms may determine who is more vulnerable to developing this illness. And in September I will be chairing a meeting on the toxicant-induced loss of tolerance sponsored by two NIH institutes where we’ll be discussing various aspects, clinical models, animal models, and so on, in order to understand this problem better in providing you with a questionnaire that I showed a moment ago to help physicians and researchers better understand this problem.

And I will be happy to provide you with any references. Thank you.

Testimony of Cynthia Pearson at the FDA on Saline Breast Implants

Cynthia Pearson, Executive Director National Women’s Health Network, July 9, 2002

My name is Cynthia Pearson and I am Executive Director of the National Women ‘s Health Network, a nonprofit, nonpartisan organization that has been dedicated to improving women’s health for more than 25 years.

The Network has been examining the safety of breast implants for more than a dozen years, and our primary concern has been the lack of safety information. When we first became involved in this issue, there were no studies of women in the published research literature, and although almost a million women had breast implants, no breast implant had ever been approved by the FDA. Today, there are quite a few published studies of the safety of breast implants, and saline implants made by two manufacturers are approved by the FDA. Nevertheless, the Network remains very concerned because there have been more than 150,000 adverse reaction reports to the FDA for women with breast implants, and there are still no long-term safety studies.

This meeting provides the first opportunity to re-visit the FDA’s approval of saline breast implants since they were approved in 2000. The manufacturers’ studies were strongly criticized by the FDA’s Advisory Committee two years ago because of the poor quality of their research. One might expect that the manufacturers would have been grateful that their implants were approved despite the high complication rates and poor quality of the data, and would have therefore made sure that their 5-year studies were better designed and analyzed. Instead, the new studies have many of the same flaws as the previous studies, and the response rate is even worse than it was at the PMA meeting in 2000.

I will not go into details about the statistics, because that does not seem necessary. Anyone who knows anything about research, and even many who know nothing about research, know that you can’t lose 95% of your sample and still have a meaningful study. When Mentor Corp analyzed their five-year follow-up data on only 60 of the more than 1200 women who were enrolled in their augmentation study, they did a disservice to the more than 400,000 women who underwent augmentation surgery since saline implants were approved in 2000, to you as FDA Advisory Committee members, and to the FDA. There is no excuse for that kind of shoddy research — in fact, it does not deserve to be called research. It is meaningless data. The fact that Mentor improved their follow-up to 24 percent at the six-year mark shows how little attention went into their 5-year study, but even a 24 percent response rate is much too low to be meaningful.

A response rate under 50 percent raises more questions than it can answer: are the other women dead or alive? Are they healthy and happy or sick and seeking medical care elsewhere? We don’t know the answers to those questions, so the data can’t really tell us about the safety of implants.

The McGhan data are little better. Like the Mentor study, they manipulate the data to make it seem that saline implants are safer than they really are. Both Mentor and McGhan made note of the women who had both their implants removed, but they are not included in the complication rate data. Instead, they are apparently excluded from the study as if they never existed — or worse, as if they were satisfied with their implants or had the same complication rate as everyone else. Even with this highly inappropriate data manipulation, approximately one out of every three McGhan augmentation patients is described as undergoing 463 additional surgical procedures — an average of more than two additional surgeries per patient

Consumers deserve an FDA that keeps unsafe or ineffective medical devices off the market. They also deserve accurate information about the long-term safety of medical implants that are intended for long-term use. In the case of breast implants, the manufacturers have failed to conduct meaningful long-term safety studies and as a result consumers are continuing to buy implants that are FDA-approved but are not necessarily safe. All we do know is breast implants have an extremely high complication rate — higher than any medical product I can think of, with the exception of a small number of life-saving products used by patients who have no other choices. Even the misrepresentation of data does not hide that fact.

On behalf of the National Women’s Health Network, I strongly urge this Advisory Committee to speak on behalf of the millions of consumers who are not able to come to this meeting, but who look to the FDA to protect them from harmful products. If this Advisory Committee does not vehemently criticize these studies, and the manufacturers’ misrepresentation of their own research, and urge the FDA to take a stronger watchdog role, breast implants will never be improved, and accurate and informative research will probably never be conducted.

Third, the cost of reoperations and local complications associated with breast implants can be significant for both the patient and society. Many health plans do not cover the medical costs associated with cosmetic breast implant complications — forcing many patients to cover these costs out-of-pocket. For example, Aetna — one of the nation’s largest health insurers — does not cover the cost of removing ruptured saline implants in patients who have previously undergone cosmetic breast augmentation. It should be noted that in 2001, more than 62,000 breast implant removal procedures were performed in the U.S.

This statement was read by Tonia Bair, because Ms. Pearson was unable to attend the meeting.