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.

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.

Audrey Sheppard, April 2005

I have no financial conflicts.

For four years, 1996 through ’99, I directed the FDA Office of Women’s Health. As a result of my professional involvement with silicone breast implants, I regard sharing my perspective an ongoing responsibility. I hold the agency and you in high regard and am optimistic about your making scientifically sound judgments.

My role at OWH, nearly a decade ago, requested by and partnering with the Center for Device Leaders, was to champion and obtain full funding to conduct what became the critically important FDA rupture study. Its findings have resulted in a better understanding of the frequency of these devices rupturing over time.

You will be briefed — and there has been reference to it already — on the results. Suffice it to say that over time more than 65 percent of women in the study were found to have at least one ruptured implant and over 21 percent had silicone gel outside the capsule in one or both breasts. The latter finding is particularly concerning since the effect of silicone on the tissues and in development or progression of disease remains unknown.

After leaving the agency five years ago, I have advised and assisted women’s health and other women’s nonprofits and projects and from this vantage point will share three requests. One, follow the science.

Even the company’s data, which you know will put on the best face, will not dispute a significant rupture rate nor other consequences of having these devices for years. These are not lifetime devices and, as such, without regular and too frequent resurgeries are not safe and effective, as intended.

Two, pay close attention to FDA’s own documents and data. A number of documents on the CDRH Web site, including — and I have the names, but you can find them. These themselves are damning information that is based on scientific research, decades of experience, tens of thousands of adverse event reports. And it also includes disconcerting photographs.

Please don’t discount this body of material with the argument that the devices are much improved today. Make certain there is data to prove it.

And, number three, please believe your own eyes and ears when you see the dozens of sincere women whose health has been compromised standing before you. Of course, you will also hear from those who are highly satisfied. Their experience does not provide reason enough to open implants to wide use for augmentation, even by teenage girls.

To summarize, the health and well-being of some of America’s women and girls will be affected, even if they won’t know it for years to come, by your decisions.

Judy Norsigian, Our Bodies Ourselves, April 2005

I am Judy Norsigian. I am the Executive Director of Our Bodies, Ourselves, also known as the Boston Women’s Health Book Collective, a nonprofit public interest, women’s health, education, and advocacy organization. For 35 years, we have advocated for women’s health from an evidence-based and consumer perspective, most notably through our major publication, Our Bodies, Ourselves. We have no financial ties to either of the manufacturers or their competitors.

Our organization’s interest in breast implants goes back to the mid 1980s, when the late Esther Rome, my coworker, began to work with hundreds of women, both locally and nationally, who believed that breast implants caused some serious problems. Many of these women were initially happy with their implants but later developed debilitating conditions after five or ten years or more. Even today, many women continue to have problems with more recent models. And we still do not have adequate data that would allow women to make informed choices about using these devices.

As we and others have said before, we do want choices, but we want safe choices. Since the October 2003 panel that addressed the safety of silicone gel implants, studies in mammography and platinum suggest new challenges for women with silicone gel implants.

A study published in the January 2004 JAMA issue found that breast implants interfere with mammography, missing 55 percent of breast cancers in women with breast implants, compared to 33 percent in women without implants. This fact alone provides a compelling reason for the FDA to weigh carefully the risk-benefit issues regarding these products.

Silicone breast implants have also been found to contain platinum. A study published in the July 2004 issue of Analytical and Bioanalytical Chemistry found very high levels of platinum in silicone gel as well as the encasing materials, implant elastomer, double lumen, and foam, materials that are in direct contact with the chest wall of patients.

Much media coverage has suggested that there are many studies showing that breast implants are safe, but the largest, best designed studies do show increased risks. Even the Breiting, et al., study of Danish women noted substantial problems that call for further research. When read carefully, this study is anything but a stamp of approval for silicone breast implants.

Scientists at the FDA and NIH are among those who have called for more research to answer many of the key questions that have been raised repeatedly at FDA hearings. You should be joining them.

All assertions to the contrary, we simply do not have adequate data on such conditions as fibromyalgia. Our recent experiences with premature drug and device approval underscore how critical it is to take a cautious approach.

Although saline implants are less ideal for many women, they do provide a reasonable alternative while we await the findings of further research. And such research must include women with implants for a minimum of ten years, not an average of ten years.

Women’s health and lives depend upon a careful assessment of these devices. We urge the panel to require adequate safety data to be collected before any decision to approve their use, especially in light of industry’s current marketing strategy of targeting younger women, whose long-term health status may depend upon your recommendation.

Thank you very much.

Marcy L. Gross, State of Maryland’s Women’s Health Promotion Council, October 14, 2003

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

Good morning.

I am Marcy Gross, a health policy consultant and member of the State of Maryland’s Women’s Health Promotion Council.

I retired last November after 25 plus years at HHS, most recently in the position of Senior Advisor for Women’s Health at the Agency for Healthcare Research and Quality (AHRQ). During part of my tenure at HHS, I also participated in the former Secretary’s ad hoc Working Group on Silicone Breast Implants.

I give you this brief resume to establish my familiarity with the issues you have under consideration today, but am here speaking entirely as a private citizen, and base my remarks on my own personal views and on information available to the general public.

One legacy of my 6 year tenure at AHRQ is a good appreciation of the need for women and policy makers to have a strong evidence base for making decisions on health care issues. My concern today is that an adequate evidence base for the premarket approval of silicone gel-filled breast prostheses does not exist, and that the short-term assurances drawn from the applicant’s study will override acknowledgment of the troubling gaps in research on long-term risks.

I can see from the information posted on the panel’s web site for the hearing that FDA’s background work has been exhaustive, encompassing extensive literature and statistical reviews, assessment of the toxicology and chemical testing, and extensive consideration of clinical data. All this data and more will come to you again over the next two days.

But, the basic facts are simple, and have not varied in the 12 plus years since silicone implants were pulled from the market:

1. The studies available on the health aspects of silicone gel implants are short-term analyses, often involving mere handfuls of mice studied over the course of a few weeks in the case of toxicology and chemical testing; and, in the case of Inamed’s Core Study, involving patients studied over a two-three year period.

2. Yet, even these short term assessments indicate that the rate of ruptures and other complications which lead to re-operations remains high, unacceptably high in my view: 20 percent plus for patients using implants to augment their figure, and 45 percent plus for reconstruction patients.

Thanks to our longer life span, breast implants will stay in a woman’s body for the rest of her life, which can be 50 years or more, or so many women are told. Even when it is acknowledged that they will have to be replaced, women are given a time line of 10 to 20 years. Thus, a two-three year study simply doesn’t offer the kind of assurance of safety needed to understand the health implications of accepting an implant. It is a set-up for future medical problems for the women who have this type of device implanted, especially when retrospective studies show that by 10 years, most women with silicone gel implants will experience at least one broken implant. At least these women know they have a problem and seek further surgery: Silent ruptures are also a documented and recurring problem.

Sometime in the next few days, I feel certain that you will hear someone say that none of the several important studies of possible health risks of implants has shown that they cause a health problem. You may even hear it said that, well, we use silicone in many other implanted devices such as heart valves, knee joints, etc, so why should silicone from breast implants be different?

My response is that having bubbles or globules of migrating gel floating through a human body, into and around organs, is, on its face, a health risk. As for the silicone in other implanted devices: one doesn’t expect bits of a heart valve to break off and migrate to a patient’s brain, liver, or other organs. Further, patients who get knee or hip joint replacements are routinely warned that a small number of patients will have an immune system reaction to silicone fragments shed by newly implanted joints.

There is no health imperative behind the push to reintroduce silicone breast implants. On the contrary, they are used in an elective, cosmetic procedure that often causes serious health complications associated with ruptures and the surgery itself. Although there are other options available to breast cancer patients that carry fewer risks, for some, access to silicone gel implants is felt as important to their recovery. We know that this will make them more vulnerable to future illness and complications and will obscure future cancer screening procedures. But, again, we lack the kind of long-term studies that would allow their choice to be fully informed.

This FDA panel will be making a decision that affects the lives and pocketbooks of women involved quite substantially. There are substantial, emotional issues involved in the decision and results. Implants are also an expensive procedure, especially when the cost of care for complications, re-operations, infections and other medical side affects are added in. Some 225,000 to 250,000 new procedures were done last year. If costs of surgery are estimated as $5,000 each, the total cost approximates $1.2 billion dollars. While much of this is paid for by the patient, the cost for reconstructive procedures after cancer surgery is most often covered by insurance, as are some of the costs for any follow-up treatments needed.

What is the policy recommendation here? FDA found the middle ground 12 years ago. And while I would still prefer not to see the 4-fold increase in implants that has since occurred, at least the current policy sends a strong cautionary signal to women with choices. That should not change until we are more confident that these implants are safe for long-term use. That will take more time and more research, the kind of research that should have been initiated 10 years ago.

I thank you for your time and attention this morning. I see that your agenda runs well into the evening, and I wish you luck–and stamina.

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. For more information about Marcy’s national contributions to women’s health, click here.

California

I am Beatrice R. I had hoped to be there in person, but my flight was canceled due to the hurricane. Thank you for showing this video instead.

I am currently a single mother, a photographer, and a multimedia consultant. I speak four languages and I was raised in Europe. I live in San Diego.

In 2005, I wanted a minor nipple procedure, to correct a cosmetic problem caused by breastfeeding. Two surgeons advised implants. Dr. Minniti in Beverly Hills convinced me that the implants were safe and that once they were in, I would never have to worry about them for the rest of my life, unless of course I had a capsule, and in that case he’d break it, a minor office visit.

The study documentation was presented to me for signing for the first time at the pre-op. appointment. I had no time to read the over a dozen pages, but I was reassured that all women were part of the trial and it was a mere formality. This is the Adjunct study referred to by the FDA.

Please note that no one ever followed up at any time, despite my sending many emails regarding my ailments to both FDA and Mentor.

Because I am the athletic type, I chose small implants. Without my consent, the surgeon implanted me with the whopping 450cc, about twice the size I wanted. I was a teacher and felt ridiculous and deformed after the surgery. I stopped going to the gym because even with two sports bras I could no longer run and men were obsessing with my chest size. My chest muscles were deformed because they were cut deeply to adjust to these enormous implants. I can never do any sports that put strain on my chest, which is most sports.

This is a point I’d love the FDA to pay attention to, as surgeons may use implants that are not the ones agreed on, but these details are not in writing.

The larger implant size was a problem, but not as big as a problem as the severe immune reaction I had to the implants.

Within days after the surgery, the skin on my arms and forearms felt very sore and sensitive, and a strange pain seemed to come and go at different locations in my body. Ankles and knuckles were the worst. The pain would take my breath away, and never stopped, day or night. The pain killers, anti inflammatory and muscle relaxant, prescriptions, nothing helped.

Nights were exhausting, trying to get comfortable and get more than 3 hours of sleep at a time. I had to lay down in bed either on my back or sideways and having to rotate continuously because the arms would go numb. After only a few hours of sleep I’d be awake and pacing around at home.

I had a burning sensation on my upper lip at all times. My eyes were dry in the morning and feeling like sand and very painful. Some days one eye would go completely blurry and a few hours later it seems like I had perfect vision. My hair started to fall off and I gained 15 pounds in just a few months.

I saw many specialists, who ran every possible test. One year after getting the implants I had a sinus infection that developed into bronchitis and lasted for months. I did three rounds of antibiotics and developed staph on my neck, which triggered an asthma attack and sent me to the emergency room. This is all documented with my doctors. The school wanted to fire me because I kept missing work.

One day the pain in my left ring finger was so strong that I had to go to the emergency room to get X-rays. They couldn’t figure out what was wrong. At times, pain would shoot in my right foot, and this was very dangerous while I was driving.

At times the gums in my mouth were pulsating at the root of my teeth. It felt like removing teeth would be relief. My labia were painful, my feet arches would get stiff and I’d feel a throbbing pain at the joints. Then the symptoms got worse. My vertebrae started to make loud popping noise upon waking up.

My immune system was completely out of control but none of the doctors could figure out what to do to help me. Then the brain. Driving home from L.A. one night, I no longer knew if I was in Italy, in France, or in the United States. This was incredibly scary, I was losing my mind. Everything was getting worse. Soon, I had to systematically walk up and down every row of cars in a parking lot to find where I had parked.

Over the next 20 months, I visited 12 specialists and met with three surgeons to discuss getting my implants removed. Waking up in the morning, I would look at my front door and feel completely overwhelmed, in tears, by everything I needed to do to get ready for work — simple steps as showering and getting dressed, brushing my hair, my teeth, and out into the world. This was like climbing the Kilimanjaro.

I felt like a woman in her 80s, at the end of her life. A vaginal ultrasound revealed I had three ovarian cysts, two fybroids and a mass that had to be operated right away. So now I had to postpone getting my implants removed until that surgery was completed.

Fearing the worse, I made a video on Youtube telling my unfortunate guinea pig experience, for other women to find support and stay away from the damaging silicone. To my surprise dozens and dozens of women responded to my video. Women from all over the country and the world told me of the exhausting suffering, health deterioration and complications, lack of funds to see doctors and run tests, and the frustration of their families not being able to help them.

I am angry that the FDA allowed these potentially dangerous implants on the market, with studies that were not really aimed at collecting scientific evidence of safety. The silicone gel includes heavy metals and potentially dangerous chemicals, and each label should include all the ingredients, just like with the food industry. The FDA should also require that the labels should also include examples of the patient’s potential expenses for lab testing, the loss of time from work, and harm to one’s quality of life.

At today’s meeting you are supposed to decide what research needs to be done. The FDA has stated that serious health problems are rare with breast implants, but I can tell you that is not true. Based on my experiences, neither the plastic surgeons nor the implant companies can be trusted to do this research objectively. Certainly, neither reported my serious health problems to the FDA.

Beatrice submitted her story to be read at the FDA Advisory Committee Meeting on breast implants in August 2011.

New Jersey

I was diagnosed with Stage II breast cancer in May 1988, after which I had a modified radical mastectomy. In July of 1989, the doctors (including a cancer researcher) determined that I was at high risk for a second primary tumor in the other breast, and I made the decision to have a prophylactic contralateral mastectomy with implants. I opted for saline-filled, because by then there was some talk of silicone gel-filled implants leaking.

Two Mentor saline smooth-shell leaf valve implants were surgically implanted in my chest cavity in July of 1989. The right one deflated in the recovery room. My left side had difficulty healing and there was a lot of swelling, including a swollen lymph node on the left side. I experienced a dizzy spell that required a brain scan. The results of the brain scan were normal, even though my “breasts” were extremely painful after the implant surgery.

In January 1990, the right implant was replaced with a Dow tissue expander, saline implant only. It was filled weekly with saline over a period of around 8 weeks, which was a very painful process requiring Valium and/or Tylenol with codeine. Then a 3rd surgery replaced both my right and left implants with Mentor saline Siltex implants, with textured shell. They hardened almost immediately, and again I had difficulty healing. There was a lot of oozing and swelling. The left side swelled up all the way to my collarbone, and remained swollen until the saline implant was explanted. At one point the implant could even be seen through my wound.

In less than a month, I suddenly became ill with symptoms of widespread joint and muscle pain, stomach cramps and diarrhea, overwhelming fatigue, hair loss, morning “stiffness” so severe that I could barely get out of bed, and a sleep disorder that I later learned is called “fragmented sleep.”

My plastic surgeon told me that my symptoms were similar to those of silicone gel implant patients. She also told me, for the first time, that the shells of my saline implants were made of silicone. I decided that I wanted the implants out, but by then I had different doctors at the military hospital (my husband was in the military), and they refused. I waited for six months until I was finally explanted in May of 1991. Small incisions were used to deflate the implants of saline and then the shells were pulled out. By the time I got the implants removed, I could not even do stretching exercises, and as a result, my photography business was nearly at a standstill.

I had a brief reprieve, but the illness continued. The pain was unrelenting, and at times so excruciating that I was bedridden and disoriented. My doctors shrugged their shoulders. They had no idea what to do for me.

In 1993, I was diagnosed with fibromyalgia and assured by my rheumatologist that some medication for sleep, followed by increasing amounts of exercise would easily manage the disorder. Having been athletic and very active my whole life, I was ecstatic.

But it did not work out that way. The medication made me so drowsy that even a quarter-dose made me too sleepy to work the next day. I was forced to stop taking it after a few weeks. Aerobic exercise was a distant memory. My rheumatologist had no suggestions for another medication at that time.

In April 1994, I had extreme fatigue, incredible pain, and was suffering from memory loss. I was forced to close my photography business. I realized that I was having difficulty remembering the myriad of details that photography requires.

Sometime in 1994, I learned that in order to insure maximum removal of the silicone, the scar tissue capsules have to be removed. Unfortunately, mine were not. Because the capsules are located under my muscles, I am told that to remove them now could do more harm than good. There are no guarantees that they can be removed fully intact. There is a possibility that the doctors would have to scrape the capsules off my ribs.

In 1997, duodenal ulcers were added to the myriad of problems that I already had. Therefore, most medications (pharmaceuticals, OTCs, and alternatives) and foods are now off limits. I have tried 5 medications for sleep, 6 for ulcers, and 7 for pain. Right now, I can only take Klonopin (chewed), for sleep or pain.

I have every symptom that is listed as being associated with fibromyalgia in the ACR classification. Irritable bowel, Raynaud’s, and cognitive dysfunction, along with the other symptoms I have described.

My marriage ended in divorce. I am on disability and live with my mother in her attic bedroom. I have a friend who recently returned to work following being similarly ill from implants. It cost her $40,000-$50,000 in treatments that are not covered by insurance. I have little hope of being able to do those things since I have no money. I do not expect to receive much from Dow. I received very little from Mentor.

I had 5 saline implants. They were supposed to be safe. I try to tell myself that maybe I would have become ill anyway, however, I have no family history of this sort of illness. And if it is not residual silicone that makes my chest burn constantly, then what?

Many of us pray that our government and the medical community will finally recognize what is making us ill, and do something to help us. I cannot tell you what a relief that would be.

Most of my doctors still are unable to help me, and do not recognize silicone-related illnesses. I have even been laughed at by a rheumatologist because I suggested that my implants had made me ill. Another doctor told me that it was strictly a lawyer-driven, hysterical-women, greed issue. Which, of course, would account for why I live on $560 a month, and why I gave up my dream profession to live this way!

I just want to get well. I just want my life to stop being such hell with no end in sight.

This is Ms. Swanson’s testimony before the FDA Advisory panel on March 1, 2000.

North Carolina

I was diagnosed with a precancerous tumor in 1987, and after a lumpectomy I used McGhan silicone gel implants.

I developed aches and pains, eye problems and a general feeling of unwellness within 2 years, and was diagnosed with fibromyalgia in 1992.

I saw over 60 medical doctors in North Carolina, Florida, Texas, Connecticut and New Jersey, who could not give me a definite diagnosis for my illness.

I became blind in my left eye and my health rapidly deteriorated. I’ve been bedridden with dozens of symptoms since June 1993. I have been diagnosed with MS and lupus. I was hospitalized for 10 days at St Mary’s Hospital, in Connecticut, where they found lesions on my brain and spinal cord, and an ANA of 180.

I was then transferred to a different hospital where I spent another 53 days getting stabilized and prepared for explantation. My implants were removed in 1993, and the right implant was leaking. I was hospitalized a total of 180 days within a one year period due to illness and toxicity from breast implants. I was explanted on my birthday, September 22, 1993, and felt better within 24 hours.

I spent $300,000 on treatments not covered by insurance and re-location to Houston, TX for 18 months. Gradually, my health has improved and most of my blood work is back to normal. I have not developed new lesions on my brain or spinal cord. My brain fog improved greatly after explantation, but depression is still a huge factor. I can’t handle stress of any kind. However, I no longer have a diagnosis of fibromyalgia.

It is the FDA’s job to approve medical implants that are safe and effective. I understand that cancer patients need some form of reconstruction, but it should be safe, not almost safe.

Meanwhile, the U.S. Department of Health and Human Services is suing breast implant manufacturers for Medicare health costs of ill breast implanted women. Where is the logic? What information that the company provided would convince me that breast implants are now safe?

This testimony was read for Ms. Shatley at the FDA hearings on October 15, 2003.

Statement by Susan Pope Helman, Ph.D.

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 15, 2003

Good Morning. I am Susan Pope Helman, Ph.D. and I am from Florida.

As I speak, pretend I am your wife or someone you love very much.

A little over 13 years ago, I was normal. I had two children and took care of my Mother who had Alzheimer’s Disease, while I worked two jobs and put myself through college. I was a productive tax-paying Mom who enjoyed golfing, swimming, bicycling and long walks in the mountains and on the beach. I never missed a day of work.

Then, September 6, 1990, I made the biggest mistake of my life. I trusted my plastic surgeon who stated silicone breast implants were SAFE, that they will last a lifetime, and I would “go to my grave with them.” I assumed they wouldn’t be available unless the FDA had determined they were safe.

Boy, how wrong that was!

Within about 6 months I started getting horrible headaches, couldn’t think “right”, and noticed I was dizzy and nauseated much of the time. I would lose my balance and feel like I was going to fall down.

I couldn’t figure out why!

The second year, all of my hair fell out. I was diagnosed with fibromyalgia. I could not concentrate, and I seemed to be in a “fog” most of the time.

When the pain would come I would thrash back and forth in bed and could not focus or see or get up.

My life was destroyed.

I lost a wonderful job, my car, my salary, my home, my productivity and sense of well-being as a person.

The illnesses began with a vengeance around 1997. Both breasts burn like they are on fire and throb with pain. I have sores, blisters in my mouth and on my hands that bleed and boils on my bottom most of the time.

I wondered why I felt so bad. I had the implants removed in 1992. The implants were in my body less than 2 years!

In 2001, I found out the reason. The capsules which contained bacteria, silicone and giant T-cells were left inside my body and continued to make me more sick.

I also found out both implants had ruptured and all of the silicone was never accounted for. The silicone had migrated throughout my body. I have had brain scans that show many lesions–I was told that I had the brain of an “old lady”–and other tests that show polyneuropathies, multiple sclerosis, lupus and autoimmune disease.

Two years ago, a plastic surgeon removed the remaining capsules and silicone that spilled out into my chest wall, as well as much of my breasts and several lymph nodes and scar tissue. She stated she “was unable to remove it all.” And Susan, “You must live like this for the rest of your life.” I continue to receive cortisone injections every three months to help control the pain.

I was treated like a guinea pig in a horrible experiment that never should have been allowed to happen!

Without the Grace of God and my husband I don’t think I ever would have made it through the whole ordeal. I have been told I will never totally recover.

If FDA approves these silicone gel breast implants, we know that women will be told the FDA says they are “completely safe”. How many more women will have to go through the problems caused by broken implants, as I did?

I really want this panel to seriously consider the experiences of women like me. If you doubt that all my problems are caused by breast implants, then just think about the ones that OBVIOUSLY are: the breast pain, the silicone throughout by entire body, the devastation of losing my own breasts because of silicone leakage.

My hopes are that you will make it clear that a company that wants to sell breast implants needs to provide at least ten years of good data before expecting their implants to be approved by the FDA.

Thank you.

This testimony was presented to the FDA by Dr. Helman on October 15, 2003.

Statement by Becky S.

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 15, 2003

I got silicone gel implants at age 33 to look more appealing after childbearing. Eight years later, I was diagnosed with an autoimmune disease.

In 1995, after many years of pain and ugliness, a mammogram indicated that I had a rupture on the right side. My breasts were atrociously ugly and the fact that my intention was to be more beautiful was ironic. I was also aware that something else was wrong. I was achy, tired, and I began stumbling while trying to jog. I was also having intense pain around both my breasts and under my arms, which I passed off as capsular contracture. I had a new baby around that time and he was keeping me pretty tired. Finally, after a visit to my gynecologist, and me telling him about my aches and pains and numbness and my unrelenting headache, an MRI was ordered. It came back positive for multiple plaques in my brain.

Then, I learned I had a ruptured implant and I had them both removed. I was actually relieved to be able to get them out. I was ready to go without anything until the plastic surgeon acted like it was an unspoken agreement that I would have saline implants put in during the explantation surgery. Like a dummy, I didn’t stop him. I thought that he must know how ugly I would look if I didn’t have replacement implants put back in. I acquiesced as I respected this doctor and looked upon him as a friend. He scoffed at my queries about autoimmune diseases. He said that “some women are looking to make money” and there was nothing that supported any fact that silicone implants were a cause of autoimmune diseases.

He showed me the Harvard Nurses study, saying it proved that there was no link between my implants and my illness. Little did I know that the Harvard Nurses Study included many women who had implants for just a few months or years.

I so wanted to believe him. I so wanted to be able to have implants. I wanted to think that he was right. In 1995, I had the silicone implants removed and saline implants put in. I didn’t like them, but I finally was without pain and that was a relief. In 1997, the left saline implant ruptured and deflated, and I had it replaced. Then 3 months later, the other saline implant ruptured and deflated exactly the same way. I had that one replaced too. I had begun to read up on the problems that “those women” had with their implants and it sounded very familiar. I remember wishing I had known about this before I ever got the first silicone implants, and thinking that, I am already sick and it’s too late to do anything about it. I also remember thinking that, it is now 5 years after the first allegations surfaced and there is still no proof. It was and is very disheartening to me. My common sense told me that no human or animal body could withstand the “hits” from the toxic substances in silicone without reacting to it, eventually. Yet a solid scientific link had not been discovered. I was also unaware that many stories were written with a biased trend in favor of implants. Many authors were dependent on large drug companies or medical device manufacturers for a part of their income and the reporting was one-sided and heavily in favor of silicone implants.

The ruptured silicone implants have spilled silicone throughout my chest area and under my arms. I still have silicone lumps that I must have biopsied to make sure they are silicone and not breast cancer. If the manufacturers were making any money on silicone clean-ups and autoimmune diseases, we would have had our proof long ago, along with a cure.

I used to be a Registered Nurse before the “MS-like disease” took away my mobility and my ability to think clearly under pressure. I used to have a life. Now, there are a long list of activities I can no longer do. I used to be a very active and outgoing attractive woman/mother/nurse. My hair has thinned so much that my son calls me “that creature from Tales From The Crypt.” I get frustrated easily. I stopped hugging people for fear they would feel the hard balls on my chest. Now, I have two saline implants that need to be removed as soon as possible. They are long past their “safe” date in today’s standards and a recent mammogram showed that the left one has a slow leak with loss of volume.

I went to a well-respected plastic surgeon for a consult. She found two more silicone spots in my chest and estimated that an explantation with a cleaning up of the silicone and a mastopexy would cost about $9,000.00. For an explantation alone, I would need about $7,000.00. My husband is semi-retired. Needless to say, we are not making the kind of money we used to make on a two-person income in a thriving medical community. It seems that the bills are always so large and nothing is ever left to save. We are finally selling our former home, but there doesn’t seem to be a buyer right now. My promise to myself is to take that money and immediately have my implants removed. I may never regain my strength and mobility back, but I will have peace of mind about removing the silicone-covered implants.

In the meantime, none of the women in the Dow Corning settlement have ever received a dime. They keep talking like they are going to do it, but we may all be dead by the time they ever get around to it. Meanwhile, many of us don’t have the money to get our implants taken out. I call this the “Merry-Go-Round” of implantation because once you get on it, it is very difficult to get off.

Becky S.

Becky presented her testimony to the FDA on October 15, 2003