Myrl Jeffcoat myrlj@jps.net

MS. NOONAN-SARACENI: Hello. My name is Pamela Noonan-Saraceni. I have no conflicts of interest.

On July 5th of this year, I will be celebrating my 27th year as a breast cancer survivor. However, I continue to live with the ramifications of silicone gel implants.

In 1978, when I was only 25 years old, I was diagnosed with breast cancer and had a modified radical mastectomy. I waited five years before I decided to have silicone implant reconstructive surgery. I led an active lifestyle, and I played tennis, jogged, and I taught aerobics. And I had grown tired of the inconvenience and embarrassment caused by my external prosthesis shifting and falling out of my bra.

I am a well-educated woman. And I thought I had done my homework on breast implants prior to my reconstructive surgery, but I was never advised of any health risks associated with silicone breast implants or the fact that there was a chance for additional surgeries. In fact, I was told they would last a lifetime and complications were few, if ever.

Within three months of my initial reconstructive surgery, I was back on the operating table. My body has formed a capsule around my implant, and it had moved up to my collarbone.

The searing pain at the time caused my shoulder to freeze and become immobile. The surgery seemed to help, but symptoms of physical illness began to develop after that. At first, I attributed the fatigue, muscle aches, and pain to just getting older. However, I was only 36 years old at that time.

Before I had the implant permanently removed in 1994, ten years after my initial reconstruction, I had to again wear a partial prosthesis. Capsular contracture had again become a problem. And my breasts had become lopsided and misshapen. The explanation was the fifth surgery at my breast site.

I know that almost half of breast cancer patients with implants will need one additional surgery due to serious problems that occur within three years. And that is from Mentor's own data.

To date, my out-of-pocket medical expenses are approaching $50,000. My husband and I are self-insured. And the insurance policy that we took out carries an exclusion that I would not be covered for any illness or disability related to my reconstructive surgery. The insurance company understands that there are health risks associated with the breast implants, and they are not willing to bear the financial cost.

Apparently the government also knows this. Last year the Department of Health and Human Services settled with silicone breast implant companies to recuperate the cost of caring for women made ill by silicone breast implants. How can the FDA even consider approving these devices while at the same time a sister agency sought financial compensation for harm that they caused hundred of thousands of women?

Please do not recommend approval of this product until the companies provide the long?term data needed to prove their safety. Women across America are counting on you, the FDA, to protect them.

Thank you.