Category Archives: Other Testimonies About Breast Implant Complications

Lisa Rohland


Mesa, Arizona

I’m Lisa Rohland, a Surgical Technologist and First Assistant for the past 24
years from Mesa, Arizona and founder of the Arizona Breast Implant Illness
and Information Facebook page. In just eight months, I’ve helped over five
hundred sick women connect with each other and find qualified explant
surgeons.

Informed consent is the most important conversation patients have with their
surgeons. We must improve the consent procedure for breast augmentation
with implants.

Few patients are health literate. The consent form used by the ASPS is
written at a collegiate level. Reading this thirteen-page form took me 1 hour
and 48 minutes.

At this meeting in 2002, a video-based informed consent process was
suggested that permitted a woman to scrutinize the data from the skeptical,
not the supportive. This is technologically possible now more than ever.
Risks like fatigue, hair loss, migraines, memory loss and autoimmune
disorders may have been minimized in the consent process or the implant
handbook that I never received. I remember my surgeon saying, “These
risks really NEVER happen.” Then he had me sign and initial a single page
consent form acknowledging I “understood” ALL of my risks. I loved my
new saline implants but quickly became ill. I spent years apologizing to my
children with tears in my eyes that I wished I could be the mother they
deserved.

I’ve listened to the testimony of multiple women within the last year that
were part of implant studies. I continued to hear that as soon as adverse
events were reported, patients would receive a letter that they had suddenly been dropped from their study, or were just never contacted again. Several
women were removed just two years into their ten-year study.
We’ve recently learned that women reporting adverse events directly to the
FDA had their data placed into a repository. As a result, all that
information has still not been made public- not to patients, not to doctors,
and not to the media. Transparency regarding adverse events and the
chemicals contained in these implants is essential for women to make
informed decisions.

Patients need to be told about all potential risks to allow for autonomy in
the informed consent process. Otherwise, it is the surgeon and the
manufacturer making the decision on behalf of the patient, regardless of
how small that risk may be.

I would like to help you form an Advisory Committee on informed surgical
consent. This committee should have equal members of physicians,
patients who have been harmed like myself, and members of the FDA, and
other governing bodies. All surgeons should use an independent, engaging
and interactive, web based informed consent by 2020 and review and
update it annually. FDA, you have failed surgeons and patients and this is
your opportunity to make it right. Do your job.

Lisa testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

Nancy Gallegos


California

Hello,

Thank you for allowing me the chance to share my story with your respected panel. My name is Nancy Gallegos. I traveled here from Fresno, Ca. at my own expense, so I have no conflict of interest.

I decided at the age of 24 to get my breast implants. I was young, very vulnerable, and just knew this would change my confidence for the better! Self-esteem was all I wanted.

So I was implanted with Allergan Textured Saline Implants. And if I might add, I am still sick with these today. One might say, “But you look just fine”. For me, this is just a mask. Internally I am suffering.

My health issues started 6 years ago. For many years, I lived symptom free. Until 2013, when all things came crashing down.

The once upbeat, motivated, very confident woman had now turned into a woman who could not get up off her couch, drive her daughter to school, or pass a mandatory test at her job in order to stay employed.

My husband used to describe me as an independent, motivated, and extremely outgoing. Anyone that knows me would say the same. Now he sadly feels this illness has consumed my life. My illness is all I talk about. And he would like the old me to come back! Even though he supports me, I know I’m not the same person he married 10yrs ago.

Today I am asking for proper informed consent. I feel we should be provided very crucial information before implanting, and at that point, the patient can make their own decision whether or not they would like to proceed. One thing I might add is, it’s very difficult going to see your physicians because we are so ill & they have no idea what Breast Implant Illness is. Therefore, many incorrect diagnosis are given with medication prescribed that has no effect.

I myself deal with depression, weight gain, joint pain, insomnia, auto immune disease, Vitamin D Deficiency, anemia, high blood pressure, memory loss, and much much more. I am so thankful a friend directed me to the Breast Implant Illness page, because now I felt like I belong somewhere. These women are dealing with the same issues I have been crying about for years! This page has given me insight as to what no doctor has been able to explain or diagnose. I am a woman in my 40’s that has to walk around with a pill box everywhere I go! Numerous medications with no ultimate effect.

I cannot wait to explant! However, the cost to remove my implants costs almost double what I paid to get them in. Health insurance makes it near impossible to cover. Why do I pay thousands of dollars on an expensive PPO Insurance, yet get denied coverage for explant when i’m extremely ill. I just want my health back!

In closing, I ask you today, to please listen & know we are women in a world of struggle. I would hope that if you had a wife, child, or family member crying out for your help, and they too have breast implants, please listen and know these implants are making women deathly ill, and changing our lives entirely!

Thank you.

Nancy testified at the FDA Advisory Committee on breast implants in March 2019.

Robyn Towt


My name is Robyn Towt. I am a breast cancer survivor. I was diagnosed in 2017 and I had a double mastectomy and reconstruction with Mentor Silicone breast Implants. I did not have chemotherapy or radiation treatment, nor did I take hormone therapy drugs, I only did surgery. I was feeling just fine until the implants were put into my body, they made me horribly ill. I’ve had three cancers in my life of 46 years and having breast implants were worse than all three cancers put together. I suffered the entire time that I had them in with the following symptoms:

headaches/migraines, heart palpitations, difficulty breathing, difficulty swallowing, skin rashes, hair loss, joint pain, extreme fatigue, physical therapy 3 times a week, anxiety, choking feeling, chest pain, burning pain, red eyes, chronic inflammation, dizzy/lightheaded, insomnia

I went back to my surgeon 4 times and she said it wasn’t from my implants, and that my implants are safe. I also wasn’t given the patient information brochure prior to getting my implants. ALL of the health issues that I was experiencing are outlined in that booklet. If I had that booklet, I would have been able to determine the cause of my failing health much sooner.

Another breast cancer lady shared with me how her implants made her sick, leaving her bedridden and unable to work. Her story resonated with me and sounded remarkably similar to mine. So I removed them after just 4 months and every single symptom has resolved. I then became a member and administrator of the FB group Breast Implant Illness and Healing by Nicole.

Over 75,000 women in our group have had a similar experience. In a recent survey of over 2,300 women, 83% said they were not given the patient information brochure, 83% said they did not feel they understood all the risks at the time, and 97% said they weren’t given enough time to make an informed decision. This is not acceptable.

I work closely with the AZ Society of plastic surgeons. The four board members of that society told me that they don’t give the booklet to every patient because they only get a couple of booklets in each shipment of breast implants. I also contacted

a mentor rep who confirmed that only a few booklets are given with each shipment, but the surgeons can request more and they will be provided. Part of the premarket approval agreement between the breast implant manufacturers and the FDA in 2006 was that EVERY single patient was to get that patient information booklet.

None of this information is new. The FDA has been hearing all of this…FOR DECADES. These same stories of sick women pleading for help. Women are not being properly informed and breast implant manufacturers are not being held accountable. Something needs to be done to remedy this situation. It is very difficult to be optimistic about solving this problem when the SYSTEM has COMPLETELY FAILED us for DECADES.

SOMETHING needs to change, this is a global women’s health crisis.

In March 2019, the FDA released that the implant manufacturers have clearly violated the conditions of their PMA. I implore the FDA to revoke the premarket approval that was given to the breast implant manufacturers in 2006. There should be consequences for these violations, otherwise the safety studies will never be completed and women will continue to suffer.

In the meantime, in order to protect women and give them proper information to make an informed medical decision, I am suggesting implementing the following…for FULLY INFORMED CONSENT.

  • Mandatory Patient Information booklet
  • Mandatory Patient/Doctor Checklist (see attached)
  • Mandatory Chemical Ingredient list
  • Black box Warning Statement including ALCL and autoimmune
  • Mandatory testing explant patients for ALCL at implant manufacturers expense
  • Continuing education for surgeons on how to properly remove implants
  • NBIR to include explant patients retrospectively, following and monitoring symptoms pre and post explant.
  • Health Care Provider Letter to physicians, clinicians and surgeons stating that breast implants cause autoimmune diseases
  • IMMEDIATE BAN AND RECALL of all textured breast implants
  • Funding for awareness of Breast Implant Illness and ALCL

For the breast implant manufacturers I suggest…

  • Compensation and reimbursement for explants of theTHOUSANDS of women who have suffered autoimmune and health issues and CANCER from implants that were deemed “safe”. The manufacturers need to be held accountable.

Robyn testified before the FDA Advisory Committee on breast implants in March 2019.

Julie


Quebec, Canada

My name is Julie and I’m from Quebec Canada.

I had Mentor smooth cohesive gel implants from 10 years.

When I decided to get breast implants, I knew every surgery had risks and that

implants could rupture or cause contracture.

But my surgeon said that the newest generation of implants were impossible to rupture, and  the cohesive gel would never leak.

Implants transformed me from an athlete with a full-time job to a full-time patient.

3 weeks after getting implants I noticed the first changes in my health.

I experienced extreme exhaustion, rapid weight gain, paralyzing brain fog, and in

tolerance to sound and heat.

Nine months after getting my implants, I was diagnosed with Hashimoto’s disease.

Later on I experienced muscle pain so severe I had to stop exercising. My hair was falling out and I was always thirsty. I was also diagnosed with asthma.

I then developed food intolerances and allergies. My throat was closing up after each bite and my gastro-intestinal issues became so severe that I had to stop working.

In 2016, I read about Breast Implant Illness. I had been searching for the cause of my health problems for 10 years and it was right in front of me: I had 2 polymer bags inside of my body. I had my implants removed in January, 2018.

A month after surgery, I sent my implants and capsules to be analyzed by Dr. Pierre Blais.

My capsules were 100 times thicker than what he usually sees and were covered with granulomas.

But the most shocking was the fact that one of my implants had a small rupture of longstanding origin that had leaked silicone OIL  into my body for years.

After my explant surgery, several of my long-term symptoms disappeared almost immediately.

Today marks 14 months since my explant surgery.

While some of my symptoms still remain, I am healthier than I’ve been in years. My implants greatly compromised my health and it may take years to recover.

I decided to create the first French-Canadian support group for women affected by breast implants. The group immediately got to over 800 members an growing very day. And these members are actually 800 patients.

I stand in front of you because women are literally dying from their implants and no one believes them.

We NEED more long-term research studies on the complications from breast implants that focus on symptoms and not just on  diagnosis.

I stand in front of you because I see women fighting EVERYDAY to get proper testing for BIA -ALCL.

Health care providers need awareness on the latest developments about diagnosis, pathology and treatment of this cancer.

I stand in front of you because every day I see women who have no clue what make or model of implants they have inside their bodies.

We NEED national registries that track all health complications and not just re-operations.

I stand before you because I know the FDA can lead the way and be the role model we need.

This meeting is FDA’s opportunity to listen to what patients are saying about their experiences with implants so that public health agencies make decisions that will help shape the future health of millions of women around the globe.

Thank you for this opportunity.

Julie testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

Dawn Criss


Alberta, Canada

My name is Dawn Criss and I am from Alberta, Canada, and I have travelled here at my own expense. I received my textured breast implants in 2008 when I was 38 years old and I was not warned of any link to diseases or cancer.

For 6 years I was healthy and working.  Then in 2014 I experienced intestinal issues, chronic fatigue, unexplained rashes and itching and massive hair loss. After months of suffering, my body shut down and I was hospitalized for blood loss and Severe Ulcerative Colitis.

In 2017, my left breast swelled up twice its size. My physician referred me for an ultrasound guided needle aspiration to test for Lymphoma and an MRI to look for rupture. Both results were negative.

Despite my negative tests, I decided to remove my textured implants and replace them with smooth. On December 2017, I had my first explant surgery and it was determined that I had double capsules. The left inside capsule and implant surface tested positive for BIA ALCL.  5 weeks later I had a second surgery to remove the outside capsules and the new implants.

Since my explant last January, all of my autoimmune symptoms have subsided. In the last year, I have had only one major flare up in which it took mere weeks to recover instead of months.

New patients need to know the risks of breast implants. The Directions for Use given to plastic surgeons lists numerous concerns such as autoimmune issues, gel movement without rupture and depression. This information is given to plastic surgeons, but NOT to the patient. Therefore, the patient cannot make a well-informed decision. Transparent, informed consent with a two paged surgeon/patient checklist and a black box warning should be a priority for all new patients.

Please understand that not all women have obvious symptoms of this cancer and some of them don’t know about this disease until it is too late. False negatives from fluid collection is a common occurrence that cannot be ignored and testing capsule tissue after explant can no longer be the only acceptable way to diagnosis. The long-term safety of all breast implants needs to be investigated.  This should include BIA ALCL as well as the autoimmune symptoms typical of breast implant illness.

While all breast implants can cause an immune response, textured ones have now been proven to cause this man-made cancer. Please! Take textured implants off the market! Continue studies through a non biased organization to obtain accurate data from our current patient population and include finding a more accurate way for testing and diagnosis that does not leave a patient at risk.  We need to be able to work together within our health care systems to make sure that no one is denied testing or treatment because of their financial status regardless if breast implants were an elective choice or not.

Cancer is a hard reality for many of us to deal with. It affects not only our bodies but our minds, our relationships, our working ability and our own sense of security. For even the strongest believers, it takes away HOPE. Cancer was NOT a choice and we sure as heck didn’t elect to get it.

Dawn testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

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.

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.