Testimony of Becky S.

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