Pam Noonan-Saraceni
I was diagnosed with breast cancer and had a mastectomy at the age of 25.
I waited 5 years before I decided to have reconstructive surgery. I played tennis, jogged, and taught aerobics. But the prosthesis often shifted or fell out of my bra when I perspired. So, as a well-educated woman, I did my homework on breast implants prior to choosing the plastic surgeon to perform my reconstructive surgery. However, I was told that they would “last a lifetime” and “complication were rare”.
Within 3 months of the initial reconstruction, I was back on the operating table. My body had formed a capsule around the implant and the implant had shifted up under my collarbone. The searing pain at that time was causing my shoulder to become immobile.
My symptoms began slowly. At first I attributed the fatigue, aches, and pains to just getting older. (I was only 36 years old!) This was 6 years after I had been implanted.
Then I got a severe case of the flu, and 6 weeks later I was still so fatigued that my life was being drastically effected. I had GI problems, sleep disorders, night sweats, chronic fatigue, myalgias, and joint pain.
Before I had the implant removed (10 years after the initial reconstruction), I was again wearing a partial prosthesis over the implant. Capsular contracture had again become a problem and I was misshapen and lopsided. The explantation was the 5th surgery at my breast site.
I never fully recovered. I have gone to various doctors and specialists and have been given a list of various possible diagnoses. Atypical Connective Tissue Disease is number one, but that diagnosis was made quite a bit later, not within the first 10 years.
To date, my out of pocket medical expenses exceed $40,000. My husband and I are self-insured. The insurance policy that we took out carried an exclusion. I was not covered for any illness or disability related to the reconstructive surgery. Apparently the insurance companies understood that there are health risks associated with breast implants and they are not willing to bear the financial costs.
There is not a miracle cure for me. But I hope that by telling you what happened to me, you will understand why better research on breast implants is so important.
Kathleen Van Fossen Nye
My name is Kathleen Van Fossen Nye and I am from Reading PA. I am not well enough to travel to this meeting so I thank you for the opportunity to have my words read before this panel.
I first got breast implants after undergoing a bilateral mastectomy at the age of 22 at the U.S. Naval Hospital in Portsmouth, VA.
My experience with implants is like a history book on breast implants, because I started with some of the early implants and those were repeatedly replaced as newer models became available.
I beseach you to make sure that well-designed and implemented long-term studies are conducted on all breast implants that are sold. Then make these studies available to the public on the internet so women can read them for full disclosure.
When I was 22, the doctor claimed I was lucky to live when reconstruction was available with silicone breast implants. He said before the implants I would have walked around with a sunken chest. He also said they would never sag, that I would be the sexist old lady in the nursing home. In addition, they would self-seal if I was stabbed in the breast.
I wasn’t so lucky, after all. My original breast implants had to be cut off my chest wall, because the mesh backing from the implants grew into the chest wall. The implants had become as hard as rocks.
I was told that the new silicone gel implants were greatly improved and would not get hard. In addition, if for any reason they do get hard, all the doctor had to do was squeeze the breast until they break the scar tissue capsule.
Claims of being able to break the scar capsule were not true. After 5 years of squeezing the hardened breast, I could no longer take the pain. My doctor told me it was my fault because I had no breast tissue. However, he told me that the new Meme implants were covered with polyurethane foam that would stay soft and never get hard, so he was going to use these new and improved implants.
When asked about the safety of the foam, I was told to trust the doctor because he knew what was best for me.
And yet, the new implants also got hard. The old Meme implants were removed and I had surgery to get a new set of Meme implants.
For 3 years I was weak and sick and after visiting three different doctors complaining of pain and lumps on the edge of the implant, two doctors told me it was scar tissue. The third doctor said to give me peace of mind he would remove the lumps. The implants were removed and the 3 lumps were biopsied.
Foreign material was found in two of the masses. The mass that was sandwiched between the other two was cancer.
After chemo and radiations treatments I had two expanders and I was implanted once again, against my wishes.
Within 3 months, I developed necrosis and the implant pushed itself up and out through my skin.
My physical health has suffered greatly. I have had over 25 breast related surgeries, including 6 sets of implants and 4 single silicone implants, 2 expanders, and 4 individual saline for the left breast.
I now have lupus and many other health problems.
I have given my history to show you that there is always great optimism about the newly designed implants, but as the years go by, the optimism gives way to reality and those old implants are always replaced with new ones, until those new ones become the bad old implants that need to be replaced.
It is 49 years and about 3 generations of women since Drs Cronin and Gerow implanted the first breast implants. If the manufactures’ make safety claims, they should back them up with studies that really provide accurate long-term data, not biased samples where half of the patients are missing and we don’t know if the half that are missing are healthy or terribly sick.
Anne Stansell
My name is Anne Stansell and I live in New Mexico. I wish I could be there today, but I hope you will listen to my story.
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 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. Here is a photo of me with my half empty implants.
They couldn’t remove all the silicone from my body, but even so I began to get better almost immediately. My family noticed the difference even before I did.
I’m still recovering, and I can work some now.
When I heard about the new post-market studies, I saw that the complication rate was high, but was surprised that the complication rate wasn’t even higher. 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.
At a previous meeting, the data indicated that cancer patients and augmentation patients also had an increase in some autoimmune symptoms during the first two years after getting implants. 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. But it doesn’t seem that the post-market studies measured symptoms. It seems that they just measured diagnosed diseases.
When the FDA approved breast implants, they demanded post-market studies to find out how often these debilitating complications occur. But based on the women I’ve talked to with breast implants, it seems that the women with implant problems tend to stop going to their plastic surgeons and are therefore dropping out – or being intentionally dropped out – of the studies.
I didn’t have informed consent as a cancer patient, and from what I hear from other patients, that is still true today.
This meeting is focused on research but to do the right research, you need to listen to the patients who were harmed by implants. We illustrate the data. We are the examples of what can – and has – happened to tens of thousands of women across the country.
Carolyn Wolf
My name is Carolyn Wolf; I live in Virginia. I have paid my expenses to be here and I have no conflicts of interest.
At 41, I had subcutaneous mastectomies due to fibrocystic disease. Reconstruction was with Dow Corning silicone implants (1972).
Seven years later, small burning blisters formed on my neck. I stopped wearing neck jewelry, though allergy tests were negative. I wear no makeup. I continue to develop these blisters, and other implants report they have similar blisters.
By the 15th year, my implants had become very hard; after 17 years I was hospitalized for 3 days with all the symptoms of a heart attack, but tests showed no heart problems. I asked the internist “could the implants have caused this?” and was told “no”. In hindsight, I think this episode was the result of silicone leaking from my left implant.
Three years later, I had developed joint problems on my left side, my shoulder, elbow, knee, ankle and foot. Gradually my fingers and toes became numb.
I went for checkups every year at Walter Reed. No suggestion was ever made for an MRI until a bubble appeared on top of my right breast, about 26 years after getting implants. Because there was a long wait to get an MRI, a radiologist did an ultrasound. The report was “no cancer, everything okay”.
About a year later, I started feeling burning in my scalp; it felt like a red hot worm crawling along the part line. I also had three episodes when long strings of silicone came out of my ear.
Twenty-eight years after implantation, the left breast collapsed fully. I finally had my firstMRI, which showed both implants extensively ruptured. When the implants were surgically removed in 2000, the total material that came out would not have filled a small sized Styrofoam coffee cup. Obviously the rest had leaked or deteriorated into my body.
Because of continuing dizziness and brain fog, a brain MRI was performed in 2001. This showed more than 20 lesions on my brain. EMG tests showed much damage to my left eye, to my left arm and hand, and extensive neuropathy in the extremities. The neurologist studied a Mayo –he was no charlatan.
Three years ago I was hospitalized with Giant Cell Temporal Arteritis, with the same pain in my scalp. I have been able to control the inflammation with high doses of Prednisone.
I am diagnosed with connective tissue disease, multi-nodal thyroid chronic fatigue; fibromyalgia, PMR, asthma and COPD; MS-like syndrome with neuropathy; platinum poisoning (my platinum lever is 140, 35 times normal by CDC/OSHA standards), and Irritable Bowel Syndrome.
I am not the only woman with these kids of experiences. There are still thousands of women who have had leaking silicone breast implants in their bodies for decades. Many cannot afford surgery to remove them. Others, like me, had doctors who told them that their health problems are unrelated to their implants. In recent years, many of those doctors are saying “the FDA says they are safe and leaking silicone does not cause problems.” And many women believe the doctors, and just get sicker and sicker. Many of them just “give up” and even commit suicide – and it is NOT because they don’t have knobs on their chests.
I ask the Advisory Committee to think about how your recommendations will affect these women. Why is there no research focused on the women with leaking silicone implants and what happens to them?? The FDA did such a study 10 years ago, but the manufacturers say the newer implants are safer. But there are not studies to PROVE whether that is true, because the studies required by the FDA follow women for only 10 years.
Is the FDA willing to publicly state that silicone and platinum leaking into women’s bodies, year after year, is “perfectly safe”?
So far, the FDA keeps requiring the companies to do research, but the research if NOT getting done properly. Women are being terribly harmed as a result.
Please make sure that these research requirements are enforced.
Conclusions of Pam, Kathleen, and Anne in their Joint Testimony
So far, the post-market studies have all started studying women from the time they got implants for the next 10 years — although many women dropped out of the studies before 10 years had passed. In our experience, many women with implant problems have told us that they no longer felt welcome in their plastic surgeon’s office, so they sought health care from other doctors. We are concerned those are the women who dropped out of the post-market studies. If they are, then the complication rate is much higher than the studies are reporting.
We have heard on the news where plastic surgeons say that breast implants have been studied more than any other medical device. We don’t know if that is true, but if it is true, that is an indictment of research on other medical devices. The studies of breast implants aren’t asking the right questions. You need independent researchers, not the implant companies, to do this research.
We may not be your typical breast cancer reconstruction patients, but we have talked to a lot of women who have stories just like ours. The FDA needs to interview women like us, and ask questions about our kinds of symptoms. Then, include those symptoms in the studies that are done.
And why not find the women who were in the implant studies that started 10 years ago, and follow them for the next 10 years? Complications are much more rare at first and increase over time. So, starting with women who had implants put in 10 years ago would provide much more useful safety information than starting with women who got implants 2 years ago.