Myrl Jeffcoat myrlj@jps.net

MS. STANSELL: I was supposed to have five minutes.

CHAIRMAN CHOTI: Please go ahead. Yes.

MS. STANSELL: Okay. Thank you.

My name is Anne Stansell, and I have no conflicts of interest. I represent a support group of about 45 women, all with experiences similar to mine. One, Ann Palmer, a cancer survivor, was in the Mentor study. When her silicone implants ruptured at about two years, she was dropped from the study. And her record at Mentor and, thus, presented to you tomorrow shows no adverse effects. Ann Palmer died of breast implant complications in 2001.

I was diagnosed with breast cancer when I was 39. I underwent a mastectomy, radiation therapy, and breast reconstruction with silicone implants. Four doctors recommended that I get silicone implants. At the time there was no research on silicone breast implants in cancer survivors. But none of the doctors told me that. Not one of them told me about the risks, the fact that they can rupture and leak silicone and other chemicals into my body.

Because of these chemicals in my body, I now get severe headaches when I am exposed to any common household products with phenolic disinfectant, such as Lysol.

After six years, I started to get sick with joint pain, muscle pain, skin problems, dry mouth, and dry eyes. My eyes are so dry that it has caused a retina to tear. These are all autoimmune symptoms.

I was also diagnosed with an autoimmune symptoms called Grave's disease. After fighting cancer, the new illnesses caused by my implants, I then had to fight with my insurance company to have the implants removed. You see, the law states that they must provide implants for mastectomy patients. There is no law that says insurance companies must replace them in case of rupture or remove them in case of adverse effects.

When my implants were removed, half of one of them was gone. This is not surprising given that Inamed's own data shows that 20 percent of reconstruction patients experience ruptured implants within just three years. Studies have shown that silicone can leak into the scar capsule and the lymph nodes, even when the implants haven't yet ruptured.

After I had the implants removed, I started to slowly get better. This is also typical. I have read a study by National Cancer Institute researcher Dr. Noreen Aziz which shows that most women with implants who have rheumatological symptoms get better when their implants are removed and not replaced. If their implants were replaced, most got worse.

I am not fully recovered, unfortunately. In addition to continued fatigue, the many surgeries to put in and remove my implants had left me with such chest tenderness that I cannot have anything more than a soft t'shirt on my chest. Now prosthetics even are out of the question.

This controversy has been going on for 15 years. The whole new generation is now being seduced into believing these products are safe when they are not.

No significant improvements have been made in silicone breast implants in the last 15 years. This is the same product with new advertising and new hype. Just because these manufacturers have created a market for their products with advertising and TV makeover shows does not mean the product is safe.

If you want to help breast cancer patients, please insist on long? Term safety data before approving this product. You owe it to us older women who have suffered for years and years and to the young women who will suffer for many years if you approve this product.

Thank you.