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.