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.

Las Vegas

Only a little more than two and a half years ago, I had a normal life, and I was completely happy and healthy. I had been a straight-A college student, graduating with high honors, I had a career in management, I had found the man of my dreams, married him, and had children. I had enjoyed tremendously robust health my entire life. I was full of energy, and frequently was up doing chores or reading my favorite books, long after the others in my family had gone to bed. I hadn’t missed a day of work due to illness for over 10 years.

While others around me suffered from colds and flu, I never did. However, shortly after getting saline implants by McGhan, my life was turned upside down as my health was completely destroyed. I have spent the last 2 years of my life struggling to regain that precious health. The most important step I took was to get my saline implants taken out.

My highly respected plastic surgeon had told me that my implants would go with me to the grave and last me a lifetime. He never told me that I was risking the integrity of my central nervous system, or the functioning of my brain. He never discussed the seriousness of autoimmune diseases, or the fact that they are incurable. When I asked him if anyone ever got their implants out and why, he stated simply, because “they don’t like them”, which I now see as an evasive response. I understood that there were some risks with infection, hematoma or rupture, but I was told these were minor risks that I could handle.

However, I was wrong. The risks were much greater than he lead me to believe. My world crashed in January 1998, only eight months after getting my saline implants. My vision became disturbed. I couldn’t concentrate on anything. I would read, and not retain anything. I was extremely tired, but sleep never refreshed me. Mentally, I was laboring. My head was in a fog all the time. I was dizzy. I could barely care for my kids or my house. I had night sweats and sleep disturbances. I often bumped into walls. My hands were always cold. I had heart palpitations and muscle twitching, joint pain and tingling hands. I had never felt so sick in all my life.

Blood tests from a rheumatologist showed an autoimmune response as evidenced by an elevated rheumatoid factor, as well as a lowered C3 Complement, and macrocytosis. However, the rheumatologist was unable to come up with any diagnosis for me.

There is no doubt that the implants were harming me in a terrible, terrible way. It has now been 2 years since I was explanted, and I am almost fully back to normal, thanks to God. Almost every single one of my symptoms of illness have disappeared. I still suffer from occasional brain fog, but in light of how sick I was then, and how well I am now, I consider myself very, very fortunate.

My experiences should never, ever be considered “acceptable risks” in the evaluation of these unnecessary medical devices. My breast implant experience was the worst nightmare of my life. Ask my parents if the risks were acceptable: They had to drive over 2000 miles to come and take care of me. Ask my husband if the risks were acceptable: He had to pay thousands of dollars in unexpected medical bills, and lost me as a supporting partner in our family. He had to bear the burdens alone. Ask my children if the risks were acceptable–they lost their smiling, nurturing mother, and instead were left with a sick woman who couldn’t play with them anymore, cook their favorite dinners, bake them cookies, take them shopping, or go to the movies. Ask me, and I will ask you if you would be willing to let your wife or daughter, sister or other loved one suffer from destroyed health, loss of career, loss of income, emotional distress, financial distress and medical system abuse all for the sake of breast implants. Only heartless fools would dare to call these risks “acceptable.”

You are mistaken if you think that women will be able to correctly evaluate the risks, and make informed decisions about getting breast implants. You will not be able to give them the information they need, until long-term studies are done to determine how many women become ill, and which women are most vulnerable. That research has not yet been done, and the manufacturers’ research has not answered those questions.

I do not consider what little information my plastic surgeon gave me nearly enough to indicate “informed consent” in any way. If he had told me that there were neurological risks, there would have been no way that I would have gotten the implants. Nowhere in my research about implants was there any indication of the risks I experienced. It was only after I became ill that my plastic surgeon told me to get the FDA booklet on breast implants. Prior to that, I did not know it even existed. I was told by every plastic surgeon that I talked to that saline implants were FDA-approved.

Two weeks ago my stepdaughter asked my husband and I for $6000 for breast implants, and informed us that she knew all the risks. When I asked her to tell me what the doctor had told her, she mentioned infection, hematoma, rupture, and future surgery. She did not know the meaning of capsular contracture and had never heard of autoimmune diseases.

She was not fully informed. She is now, and she chose NOT to get implants.

There is no such thing as a safe breast implant. Not only are they not life-saving devices and totally unnecessary, they are dangerous to health and well-being. Studies are needed to objectively measure how many women have experiences like mine. If, after long-term research is completed, the FDA determines that there are some kinds of saline implants that are safe for most women, FDA should require mandatory disclosures of the kind of ill effects many women have experienced as a result of these implants, and warn them of the very serious nature of these problems. This should include the opportunity to meet or read stories of other women harmed by implants such as myself, and their loss of jobs, career, income, home, family and well-being, including life.

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

Nebraska

My name is Rose. I am 57 years old and live in Nebraska.

After I remarried in 1990, I thought I needed to look younger, so I opted to get silicone breast implants made by McGhan, now called Inamed. I had talked to a plastic surgeon and he told me they were safe and they would last my lifetime.

I had been working in a clothing factory for three years at the time I got the silicone implants. I loved my job and had never missed a day of work due to illness.

Within four months of getting the implants I noticed I was aching all over and had developed headaches. I went back to the surgeon and told him I thought they were making me sick. He told me I was listening too much to the media and he saw no reason to remove them. I believed him and left them in.

I became more ill and the headaches became almost unbearable. I had so much pain that I had to quit my job. I had become so ill that I was put on Social Security Disability.

In the mid-nineties my nasal passages started burning and my nose was swelling shut, in addition to the horrible headaches. My GP sent me to a neurologist who did many tests and sent me to an ENT. I ended up having three sinus surgeries. Three different doctors all told me that something was inflaming my nasal passages. They told me that if I didn’t find out what my body was reacting to, they couldn’t help me. I went to an allergist and he found no allergies.

We had our house checked for any toxins. My husband checked our vehicles. By now, I was feeling much worse –dizzy and nauseated.

Over the next few years, I went to many doctors. I went to Mayo Clinic and they told me my illness had nothing to do with my implants. I went to Virginia Mason in Seattle, and Northwestern in Chicago. Nobody could find out what was wrong with me.

The last two or three years I became so ill I am almost bedridden. My nasal passages burn all the time and my headaches are constant. My legs and feet swell and I ache all over. My feet and legs burn and hurt so badly I can hardly walk. I am dizzy and nauseated. I have lost much of my short-term memory.

Over the last few years I have became intolerant of most chemicals. I can’t consume or breathe any chemical. When I am exposed accidentally, my nose swells shut, I feel nauseous, headache worsens, and my heart acts up.

In June of this year, I finally decided I was going to die if I didn’t do something. In August I had my implants removed. My left implant was ruptured, and the plastic surgeon said most of the silicone had leaked out, migrating into my chest and into my lymph nodes. She described it as “a sticky mess.” She also removed the lymph nodes with silicone in them. At that time she told me there was probably silicone in my liver, lungs and brain. The right implant was intact. I have no idea how long the left implant had been ruptured. I saw no difference in how I looked.

Through the years I have became unable to even take care of my home. Sometimes I am not able to fix meals for my husband. I spend many days in bed. Long ago I gave up on social events. My husband tells me I am actually much worse off than I realize. It’s just a struggle to survive.

If the doctors had not told me my illness was unrelated to my silicone implants, I would have had them out many years ago, and perhaps avoided much of the silicone leakage.

I think of how in 1991 the FDA decided not to take silicone gel implants off the market. It sent the clear message that silicone gel implants were probably OK.

I feel many of us have been the guinea pigs. And I feel we have proven that silicone is not safe because the implants can leak throughout our bodies. It’s too late to do much for women like me, but let’s please save the next generation. It is your responsibility to protect us, and hopefully you can restore my faith in our FDA.

This story was prepared for testimony before the FDA in October 2003.

California

My name is Judy Kemecsei. I am 51 years old and live in Los Angeles. I had silicone breast implants in 1980. I was never told of the risks or warnings of the dangers. I asked the doctor if they were safe and he said “yes, I would not have put them in my wife if they were not safe.”

I went to a doctor a few years ago and told her that I didn’t have any problems with my implants but I have read that they all eventually leak. I asked “wouldn’t it be better to take them out now?” She said they look and feel great, and they are not ruptured, so I shouldn’t do anything. I left them in.

I had no health problems for 20 years, and then 3 months ago I started to feel a lot of pain in my chest, burning and having a hard time breathing, and numbness and pain down my arms. I was always very fatigued, had to stop exercising, and going to work was very difficult.

Within 2 weeks I started calling plastic surgeons to make an appointment to get them taken out. I was sure all the symptoms were related to my implants, and I thought they were leaking. I had no idea I had a full blown rupture. I spent a lot of money going from one plastic surgeon to another, and each told me that my symptoms were not related to my implants, and they wanted me to get complete physicals, tests, and mammograms.

The doctor said my breasts looked and felt great, but when he opened me up my implants were totally ruptured, it was a mess. The silicone gel went up to my clavicle and into my armpit areas. That is why I was having the pain in my chest. It is very hard for me to believe that most of the plastic surgeons don’t know that the classic symptoms I had were caused by ruptured implants.

I feel like I had a time bomb ready to explode at any minute. Mine took 23 years, but most women are a lot sooner.

The doctor got out what he could – unfortunately, it can’t be all mopped up since it is like glue.

This has changed my whole life. I had never been sick, but now I still have the same numbness in my arm. I was cut open and scraped, not to mention that the top of my breasts are indented now and my breasts will never look normal again.

If plastic surgeons had told me the truth, I would never have put in my implants. It is pathetic how plastic surgeons take out so many leaking and ruptured implants every day and then put in new ones, like changing tires on a car.

If I can make a difference by talking about what happened to me, maybe my horrific experience was worth it. Put yourself in this situation. Would you take that chance?

This story was presented on behalf of Judy as testimony before the FDA in October 2003.

Pennsylvania

My name is Kathleen VF Nye and I live in Sinking Spring, Pennsylvania.

I know from experience that silicone gel implants will adversely affect the lives of many people if they are approved based on just a few years of safety data. Not only are the women who would be implanted at risk, but also there is a trickle down effect, affecting the whole family.

Inamed says that their new and improved silicone breast implants are safe.

I would like to relate my story of new and improved silicone breast implants. My first experience was in 1968. I was 22 years old and had a bilateral mastectomy.

These new devices started to get hard after 6 months. I also started having fatigue and joint pain. In 1976, I found a doctor who would remove the implants. The replacements also hardened and had to be removed in 1981. The doctor told me there was a new and improved version and they would not get hard. I had the new and improved implant inserted in January of 1981. On February 14, 1981 the left implant had to be removed and later replaced.

This new and improved silicone implant started to harden, again at about six months. I waited three years, until I could not stand the pain any longer. Again I went to the plastic surgeon and told them to remove the implants. I did not want another set, but again I was told about a new and improved silicone breast implant. So again I had the new and improved silicone breast implant inserted in January of 1983.

I started to feel lumps around the edge of the new implant. There were three masses on the right side. The cancer was sandwiched between two masses of “foreign material,” with giant cells.

This started me on the road to more implant disasters. I had a total of 13 implants, including devices made by McGhan –a company that is now called Inamed. In the early 1990’s, the implant came through the skin and popped out on its own. Here is my photo. By 1992, after having a hole in my chest for years that would not heal, I had to have a tram flap.

I have been on disability since 1986. I have been diagnosed with asthma, fibromyalgia, abnormal liver function, depression and early Parkinson disease, among other things.

I am sure you understand my concern when I heard that the manufacturers are now trying to promote a new and improved silicone breast implant. Talk is cheap. It’s easy to call an implant “new and improved’ but you won’t know if it really is better until it has been inside a woman’s body for 5 or 10 or 15 years. I urge you to not be as naive as I was when I was told they are better than the old ones. I hope the FDA will not put these “new and improved” silicone gel implants back on the market unless they have been tested for a long enough time to really prove they are safe.

This story was presented by Kathy Nye as testimony before the FDA in October 2003.