Statement by Marcy L. Gross

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

October 14, 2003

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.

Statement by Susan L. Cunningham

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

October 14, 2003

My name is Suzy Cunningham and I came here at my own expense.

My biggest concern is that these implants rupture, and there is still no medical information on how to recognize a rupture and what to do about it. It is a frightening experience to be so sick and not have a clue what is wrong with you. Many women can’t afford an MRI to check. And, even if they find out their implants are ruptured, many don’t have the money needed for surgery.

My own experience began after I had breast-fed both of my children and my husband was no longer happy with my appearance. He suggested implants and arranged for a consultation with a respected plastic surgeon. I had concerns, but the surgeon said the implants would last a lifetime.

I was fairly pleased with the results but it didn’t last long. I began to experience loss of nipple sensation and numbness. Then I experienced capsular contracture in the right breast. On top of all that, I found out that my husband had been having an affair for some time and I decided to terminate the marriage of 18 years.

As the years went by, I was plagued with sinus and respiratory problems. I remarried, but my health continued to decline. Finally, in l993, I consulted my plastic surgeon. As he wrote in his notes “I reassured her concerning this and advised her to leave her implants in place unless there are further difficulties because they look very good.”

My body was wracked with joint pain. I was diagnosed with Raynaud’s and suffered from constant muscle spasms. My breathing and chest pain were severely affected and I had been in the emergency room several times. Finally, tests indicated “fairly remarkable changes” in my immunological system “characterized by an unexplained decrease in the total CD-4 or helper cells.”

I was getting sicker and experienced a fatigue so devastating that I would weep from the smallest effort. My concentration was zilch and I started having huge gaps in my memory – Like pulling out of my driveway and then wondering where I was going or what I was doing in the car.

It was frightening and became worse. Finally, I was forced to quite a career that I loved . At this point it became necessary to sell the family home.

I was praying for answers and help finally came from a family member, a cousin who had just finished medical school but had become too sick to work. She told me that she had had ruptured implants and symptoms like mine.

I sought out Dr. Feng whose practice was 120 miles away. She informed me that at least one implant was ruptured. They were removed in l995 and I promptly noted relief in the chest pain I had been experiencing for years. Within a few months my blood work returned to normal except for IgE levels and a positive antihistone antibody, which took an additional two years to return to normal.

My overall physical condition has taken a few years to improve. I still suffer from fibromyalgia- like symptoms though attacks are less frequent and of shorter duration. At the ripe old age of 6l, my mind is much sharper and my body much stronger than it was just a few years ago. My infections have become infrequent, which is good because I find myself pretty resistant to antibiotics.

Today I live a life far different than one I could have lived if it were not for ruptured implants and their devastating effects. My husband and I have been through a terrible time but our marriage has endured and become stronger. However, I am certainly not the involved wife, mother and grandparent I had hoped to be, and I am now on disability, which was granted on silicone rupture and related problems. It was a very black day for me to finally accept the fact that working is no longer an option for me.

I am not looking for pity because I have been blessed with many other things in my life. But if there is anything I could do to help other women to avoid the devastating effects of ruptured or leaking implants, then I have to try. That’s why I am asking you to not approve silicone gel implants until the company provides long-term safety data proving that leaking silicone and autoimmune diseases can be avoided. The company’s application for silicone gel breast implants was rejected in 1991. They had 12 years to collect data, but only collected three. They will only do better research if approval is denied until they do.

Ms. Cunningham presented her testimony to the FDA on October 14, 2003.

Statement by Sherry Henderson

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

October 14, 2003

My name is Sherry Henderson and I am from Bossier City, Louisiana.

I had fibrocystic breast disease and precancerous cells, which resulted in a double mastectomy and reconstructive surgery with implants. During my first year of implants I had chest pain and headaches; within the next three years I had hair loss, muscle spasms, irritable bowel syndrome, reflux muscle pain, and rashes.

By the eleventh year, a sonogram verified a silent rupture and I had my third surgery with a tram flap; that was a six-hour surgery.

I was fortunate to see a doctor who had studied implanted women for over twenty years. I was diagnosed with several diseases, included Lupus likeness, rheumatoid arthritis, fibromyalgia, myositis, organic brain syndrome, high blood pressure, and autoimmune diabetes. I’m on disability.

I would like to ask the FDA to have the implant makers do at least ten years of research. They should be required to pay for a national implant registry, and require all women in it to have yearly screening examinations for local and systemic complications. Let unbiased researchers do the screening.

The Inamed research shows very high complication rates and an increase in fatigue and other symptoms in just the first two years after getting implants. But, to know the real consequences, we must have longer research.

Breast implants are not life-saving devices. If they are not safe, they should not be approved.

I live in pain every day and I pray that my grandchildren and nieces will not have to go through the pain I have gone through. The higher rate of brain and lung cancer, more suicides, and the study linking leaking implants to fibromyalgia are warnings that silicone gel should be made less available, not more available.

We are tired of all the suffering. There are young women becoming 100% disabled and the government is finally coming after the manufacturers. If the FDA refuses to approve this defective product, the implant makers would do better research and develop safer implants.

In the past, the FDA ignored hundreds of thousands of adverse reports sent to them dating back to the 1970s. Breast implant women have copies of these reports and would gladly provide them for anyone to see. These reports documented horrible health problems and unbelievable complications with these devices.

Please make the right decisions for the sake of women who trust your opinion and whose lives depend on that trust.

Testimony of Shannon Scott during the Public Comment of the FDA Advisory Panel for Silicone Gel Breast Implants in April 2005.

My name is Shannon Scott. I have no conflict of interest.

In 2002, I received silicone gel implants through Mentor’s adjunct study. To be in the study, a patient must have a deformity, have had a mastectomy, or a problem with implants that need to be replaced. The goal of the study is to evaluate short-term complications. I wanted implants for augmentation. Dr. Deniz Gocken of San Diego stated that I was eligible for reconstructive surgery in the adjunct study, even though my only deformity was a nearly invisible blemish on my left breast.

I was in perfect health prior to augmentation. Three months after I began developing pain within my breasts, the implants started to harden. A plastic surgeon performed a procedure in which he squeezed them to break up the scar tissue.

In January of 2005, I was told by Mentor’s patient service representative that closed capsulotomies are not to be performed. This procedure can cause the implants to rupture.

Dr. Gocken is still a part of the adjunct study. He has refused to provide me with any future medical care. I was told that I would receive monitoring and medical treatment as needed through the adjunct study for the next five years. This has not happened.

Since the implants, I have had muscle, joint aches, severe chest pain, limited range of muscle motion, migraines, rashes, swollen lymph nodes, fatigue, sensitivity to light, and considerable memory loss.

I am now bedridden approximately 95 percent of the time. And due to the pain, I need assistance in even the most minor aspects of my life, such as brushing my hair or even getting dressed. I cannot afford the thousands of dollars it will take to have my implants removed.

This study is supposed to be monitored by the FDA. I did not receive informed consent. The doctor did a forbidden procedure that could have ruptured my implants, and now I can’t afford to get them taken out.

I question how the FDA can allow this to happen to women. Dr. Gcoken’s medical records in my case are incomplete and inaccurate. If Mentor is not provided data, such as in my case, you can assume that the clinical trial study data is also incomplete and inaccurate.

How many cases like mine occur? How many people are too ill or have been misdiagnosed or ended up committing suicide? Is the statistical data in these studies?

It is my hope to prevent other young women, young healthy women, from experiencing this nightmare. Thank you for your time.

Testimony of Dawn Miller during the Public Comment of the FDA Advisory Panel for Silicone Gel Breast Implants in April 2005.

I am Dawn Miller. I am from Massachusetts. I have no conflicts of interest.

I had silicone breast implants in 1990 at the age of 20 as a part of a correction for congenital deformity of my rib cage. It was recommended by my surgeons that I have implants at age 16. I waited until age 20 because I felt I really needed to explore the safety of the devices prior to surgery.

When I finally decided on reconstruction, an 80 cc silicone implant was implanted on my left side and a 200 cc silicone implant was implanted on my right side, filling in the cavity of my chest wall and creating a normal-appearing breast.

I consulted with four plastic surgeons prior to my surgery. And they informed me that silicone was essentially synthetic sand, a building block of life and completely inert in the human body. I was told that it would take a severe physical trauma to rupture an implant.

In August of 2002, I experienced permanent hearing loss in my left ear and problems with my equilibrium. In January of 2004, I began to have heart arrhythmias. I never associated either of these conditions with my silicone implants.

Two years later, in August 2004, my sister heard a news report that scientists found high levels of platinum in some women who had silicone implants. Women with these platinum levels were experiencing neurological problems that included hearing loss.

At this time I contacted the manufacturer of my implants, Inamed Corporation, and inquired about my implants. I was told, and I quote, that “The same materials, silicone elastomers for the shell and silicone gel, are used in the fabrication of the Style 40 devices today.”

Very concerned, I sent a sample of my urine to the scientists who performed the platinum testing on breast-implanted women. My urine tested positive for high levels of platinum.

My implants were removed last November. My surgeon told me that my left implant was ruptured and leaking and my right implant appeared to be intact. Free silicone was found in the skeletal muscle and connective tissue taken from both my right and left sides.

Platinum is a well-known neurotoxin, as reported in the literature. The hearing loss, equilibrium problems, and heart arrhythmias I experience very closely resemble that experienced by those exposed to platinum through chemotherapy.

I had silicone implants for 14 years. At no time did I suspect a rupture. This is consistent with the FDA’s study that showed that most women with implants will have at least one ruptured implant within ten years. And, just like me, the women in that study never knew they had a ruptured implant.

The fear, the outrage, and the sadness are with me still. These same feelings are shared by my family and friends, who support me through this. It has been devastating to learn that the same implants that have caused me harm are being considered for reintroduction to the open market.

The industry’s four-year studies are completely inadequate because they do not provide any information about the long-term safety of these products. I urge you to recommend that the FDA not approve these PMAs.

Testimony of Ed Brent during the Public Comment of the FDA Advisory Panel for Silicone Gel Breast Implants in April 2005.

My name is Ed Brent. I am representing my wife, P. J. Brent, and our children.

My wife had silicone breast implants for ten years. She had no problems at first but became increasingly ill. On May 29th, 2000, my wife committed suicide. She left behind seven children. On behalf of my wife and my seven children, I urge this panel and the FDA not to approve silicone breast implants unless there is clear evidence that the implants being sold now are safe for long-term use, meaning ten years or more.

Several studies have shown higher rates of suicide among breast implant patients. And a National Cancer Institute study found that women with implants were four times as likely to kill themselves as other plastic surgery patients.

The implant makers think the explanation is that women with breast implants had lower self-esteem before they got their implants, but there is no reason to think that women who decide to get implants have lower self-esteem than women who decide to get liposuction, nose jobs, or any other plastic surgery.

My wife was not a woman with low self-esteem. She was a vibrant, loving wife and mother. P. J. loved the way she looked the first few years after her implants. Then she began to get sick, and her joints hurt, her fingers would swell. She had lupus-like symptoms and was diagnosed with fibromyalgia.

P. J. breast-fed two of our daughters after getting implants. Both are seriously ill. My daughter Catherine, who is with me now, was diagnosed with chronic inflammatory demyelinating polyneuropathy as well as esophageal motility disorder. She spent years in leg braces, and now the leg braces have been replaced with a wheelchair.

Our daughter Christine also has esophageal motility disorder and leg weakness as well. In contrast, our five children born before my wife got breast implants are perfectly healthy.

After P. J. committed suicide, an autopsy was performed. Large amounts of platinum were found in her body. And a doctor at the CDC after seeing the amount of platinum in P. J.’s body said she could not have been in her right mind.

Tissue samples from our daughters who had breast-fed found that they, too, had elevated platinum levels. These findings were presented at a meeting of the American Chemical Society last year.

P. J. felt terrible guilt that her two daughters had been so seriously harmed by her decision to get breast implants. It was not her fault. She had no way of knowing what would happen. Most doctors did not know that there had not been any long-term studies on the breast implants.

Just two months before my wife’s death, she testified at a previously FDA meeting on breast implants. She felt the panel ignored testimony given by women with implants.

And I am here today to ask you to listen to these patients and their loved ones and do not endorse a product not proven safe for long-term use. Women and their yet unborn children may be forever affected. This is a scientific issue and a moral issue.

Thank you.

Florida

I’m a 29 year old woman who got McGhan textured saline implants in 1996 for cosmetic reasons. About a year later, the problems started. Although I’d not had health problems in the past, in 1997 I developed a number of allergies. In January of 1999, I was rushed to the emergency room with severe abdominal pain. At the time they diagnosed me with urinary and vaginal infections and sent me home. But the pain never got better and the infections never went away. I had polyps and infections. Last April my skin all over my body started to burn, it felt like burning inside my veins, and my joints were tremendously painful. I went to several doctors, and my blood work all came back as normal.

In May I went for a mammogram, which came back fine. But within three days of the mammogram, I felt horrible. I had extreme burning and a sense of strong pressure in my chest, particularly around and behind my implants. My eyes and mouth were extremely dry and soon after I noticed my hair falling out in clumps. I was so fatigued that I couldn’t even get myself something to eat and soon found myself out of work. Emotionally, this was difficult for me to deal with because I’ve always been a healthy and active person. I rarely even had a cold, even in the middle of flu season! Now, at 28, my body was falling apart.

It got worse. By July I was so weak that I could barely get up to use the bathroom or get a drink. I was diagnosed with extremely dry eyes. Since 1998, my eyeglass prescription has changed three times. Before that my prescription changed only once in 4 years. It seemed like I couldn’t remember anything anymore. I would get up from the couch to go get a tissue and by the time I got to the bathroom door, I would have no idea what I was doing or getting. I would often become cold and nothing seemed to be able to warm me up. For instance, I remember feeling like my feet were freezing and deciding to put on a pair of socks and wrap a blanket around them. Two hours later, they still felt cold. Even a heating blanket wouldn’t warm me up. My aches and pains were so awful.

Last August, I decided to remove my implants. I just wanted to feel better. When I was explanted in September, I noticed some of my symptoms going away. My hands weren’t swelling anymore, all my chest pains were gone, and although I am still really tired all the time, I began to be able to do more things for myself. I still have health problems and I still can’t work, and at the age of 29, find myself with no income and no way to take care of myself. I thank God for my family, friends and my boyfriend who have been supporting me through this, both financially and emotionally. Without their help, I would be homeless. I’m glad I’m getting better, but it’s just not quickly enough. I would have loved to come to the meeting but my health prevents me from doing so.

Shirl’s testimony before the FDA Advisory Panel in March 2000 was read by Gwen Lewis.

Pennsylvania

I am a 36-year-old mother and wife. Five years ago I decided to have saline implants put in.
My surgeon had very positive things to say about them and said they would last a lifetime unless I happened to get in a very bad car accident. And even if that did happen, and they ended up rupturing, it would be perfectly safe because they were filled with saline, not silicone. At the time, I didn’t even know they weren’t FDA approved.

As soon as I had the implants put in, my breasts became very sensitive, but my doctors kept telling me not to worry, that it was just my hormones. About two years after this, I started having memory problems to the point that I couldn’t remember things that had happened the night before. I also began having problems in my job as a medical assistant because I couldn’t remember medications and general things I knew very well. It was also a problem that I was so tired all the time. My husband and I started to get very concerned so I went to a specialist and has some different tests done. Everything came back “normal.”

I had sharp, jabbing pains constantly running through my breasts. I also had aches and pains that left me virtually unable to move my joints, and there was overwhelming heat of my own skin. Soon my right arm began hurting so badly that I went in to have it checked out. The test results confirmed that I was having a lot of spasms in my neck and problems in my back. Finally I went in to the doctor again and my ANA test revealed that I had lupus.

It’s been a little over a month since I’ve been explanted. My right breast has swelled up twice since then, and each time they had to put a large tube in it for a week to drain. I’ve been on antibiotics all month. Today the new surgeon I’m seeing got the results of my culture, and it turns out that I have two infections in there still. So I’m now on penicillin, and another strong antibiotic. The hole is still there and I have to put an antibacterial ointment on gauze and push it in with a Q-tip. I go back at the end of February to see how my infection is doing.

My left breast is healing fine. The hot skin I was having for months went completely away after explantation. I no longer get sharp, jabbing pains through my breasts, and my ANA is back to normal. I am still on celebrex and I’m not sure how long I will need to take that for my joints. I am still tired but I guess that’s normal with the infections. I am just glad that my implants are out, I have noticed improvements even with this infection. However, my memory problem is still there, but I hope in time that also changes around. Now only time will tell on the rest of my symptoms.

Karen’s testimony before the FDA Advisory Panel in March 2000 was read by Gwen Lewis.

Michigan

I am here today with an unpleasant, yet very necessary story to tell regarding my experiences with saline breast implants. Were it not considered highly inappropriate I would bare my chest to you now; for seeing with your own eyes would have a greater impact than my words. To me, they are not breasts, but two containers of saline in silicone baggies held in place by skin. Were you to see them, you would see puckers and indentations where the containers have shifted, where the solution has dissipated. Were you to touch them it would be like touching a plastic bag that moved beneath a sheath of skin. You could feel the solution slosh. You’d want to take your hand away. I wouldn’t blame you.

In 1974 I was a young model and was adamantly advised to have breast augmentation by a physician. I’d nursed my baby for about a year and he said I was much too young to have such ptotic breasts. I also had many cysts in my breasts. The doctor told me that the solution to my problems was to have my breasts replaced with silicone implants, which would last a lifetime and permanently end my pain and discomfort. I had no idea that this was the beginning of a long period of pain, suffering and decline.

I ended up having not one surgery, but 12 surgeries, attempting to remedy severe capsular contracture and deformity. I started with silicone implants, and later replaced these with several sets of saline implants. I had 1 emergency surgery to deal with a hematoma where blood was literally spurting out of my breast. I had two more emergency surgeries to deal with a near deadly staph infection.

In 1987, 13 years after my first surgery, I finally consulted specialists at the University of Michigan Medical Center, who assured me that they could solve my problems once and for all. They didn’t. I had several other surgeries, including getting my first set of saline implants in 1992. They told me saline implants were the safest kind, but my worst problems started after that surgery.

On July 18, 1995 I had my third set of saline implants put in, which were described as a new, greatly improved type of saline implant. I still had a great deal of deformity from all the previous surgeries and the infection of 1986. That was my most recent breast invasion and reconstruction. There needs to be another. My doctor tells me I have to have these implants taken out of me because my health has severely declined since 1992.

I stand before you now, a recipient of social security disability trying to live my life on $512.00 per month. I was granted disability status in 1997 when I could no longer hold down a full time job or work to support myself. I had been a relatively successful freelance writer, a highly promising student in sculpting, working also as a crisis intervention counselor for a substance abuse facility. I lost my jobs because I kept getting sick. I had to quit college. In order to survive, I had to sit in a courtroom with the Social Security Judge and listen to people talk about me as though I were one of the most inept human beings, an incapable member of society. This was a most significantly tragic day for me.

There is not a single insurance company who will insure me. I’m considered high risk because of my saline implants. This entire mess has cost well over a quarter of a million dollars. Why? Because I, like everyone else I believed saline solution encased in silicone shells did not cause problems.

I have to get up everyday and face chronic fatigue, Reynaud’s syndrome, and moments of excruciating chest pain that has had doctors sending me to the emergency room. My immune system has been compromised. I’ve developed what is known as chemically induced asthma. I have blood in my urine and no one knows why. My muscles weakened. I get sores on my skin that don’t readily heal. I have episodes of severe depression. I’ve been told to limit the use of my arms to avoid the very real possibility of capsules forming again. I can’t even pick up my grandchildren!

My current doctor ran some tests and thinks all my health problems are implant-related. I am afraid of another surgery but I am afraid not to have these saline implants removed for fear of additional medical complications. I can’t afford to have these implants taken out but will when I can. Medicaid won’t pay for it until they pop, and when they do come out Medicaid will not pay for reconstruction of the flaps of skin I will have hanging from my chest. I have no breast tissue of my own left. It’s all disappeared, all been removed. Waiting for them to pop or form a so-called significant leak is also very scary, because no knows what will happen.

I was once a very strong and healthy woman. I raised three children alone, without the benefit of child support. Illness was not even a consideration. Now I pray every day for God to help me keep my spirits up, for I know full well it is only that plus the blessed love of family and friends which keeps me going.

So as I stand here before you, a woman of strong faith in a much Higher Power, a woman disabled with two silicone baggies holding saline solution in her chest, a recipient of Social Security at way too young an age. I want to believe in you, that you will do the right thing. I want you to actually do your best to see to it that other women do not get trapped in the morass that I have been trapped in. This is your challenge and I plead with you to do it well.

There’s very little you can do for me anymore – the damage has been done. But you can help other women. One important question to be answered today is whether the manufacturers have studied the safety of saline breast implants for women who had silicone implants prior to their saline implants. If not, then the studies can not be used to prove that implants are safe for the many women who had silicone implants removed. Another important question is long-term safety. And, for many women, there is the question of whether they could afford to have implants taken out if they have problems. You are not doing women any favor by giving them a choice that could leave them financially destitute with no ability to have a failed implant removed. That is my situation today.

Thank you for this honor and opportunity to testify before you. I am going to try once again to trust you to do your part. Please do not recommend the approval of saline implants unless you are convinced that what happened to me won’t happen again.

God bless you. Thank you.

Ms. Cloud made the above statement before the FDA Advisory Panel in March 2000

New Mexico

My name is Anne Stansell and I live in New Mexico.

I am a breast cancer survivor. I was diagnosed at the age of 39. The doctor said I needed mastectomies, radiation therapy, and breast implants. Implants were just part of the treatment, no discussion. I trusted the doctors who I felt had just saved my life.

I didn’t know that safety studies of breast cancer survivors with implants had never been done.

I was fine for the first five years. Then I became very ill. I was diagnosed with Graves Disease and fibromyalgia. My eyes were so dry that my retina tore.

My implants were taken out about two years later. I had to fight with my insurance company to get them to cover the removal.

Half of one of my implants was gone. Where did the silicone go? I don’t know.

Even with silicone left inside me, almost immediately I began to get better. My family really noticed the difference – even before I did.

I’m still recovering, and I can work some now.

I thought of my own experience when I heard about the Inamed study of breast cancer patients. I had many of the same local complications. I can’t even remember how many surgeries I needed. Silicone was found in my side, when it migrated from the broken implant.

The Inamed cancer patients also had an increase in some autoimmune symptoms during the first two years. I think my symptoms started in the third year, so it is likely that those signs and symptoms will increase over time, just like mine did.

It doesn’t do cancer patients any favor to give them the kind of choice that I was given. A choice isn’t a choice if it isn’t a safe choice.

Informed consent isn’t possible if the physicians think that FDA approval means a product is safe.

The FDA’s job is to look at the research, but I hope they will listen to the patients, too. We illustrate the data. We are the examples of what can – and has – happened to tens of thousands of women across the country.

Anne told her story when she testified before the FDA in October 2003.