Myrl Jeffcoat myrlj@jps.net

EXECUTIVE SECRETARY KRAUSE: Are you Christianne Corbett?

MS. CORBETT: Yes, I am.

EXECUTIVE SECRETARY KRAUSE: Okay.

MS. CORBETT: Yes. Good morning. My name is Christianne Corbett. I am the Program Coordinator at the National Council of Women's Organizations, NCWO. NCWO is am umbrella group for 200 women's groups. And I am speaking on behalf of the over ten million women nationwide that NCWO represents.

NCWO is very concerned about the safety of medical products used by women. The key question for this FDA advisory panel is whether silicone gel breast implants are safe, whether the benefits outweigh the risks.

In my testimony, I will focus on what we know and don't know about long term safety. We know from hearing testimony of the women at the 2003 panel meeting and again today that many of these women were very happy with their implants for the first few years. But after seven or more years, especially after their implants broke and started to leak, many women reported serious problems.

Local complications are the best established problems. These complications can be short lived, like most infections, or can be devastating. Chronic pain is very difficult to live with.

Having breasts that are hard as rocks is not a goal for most women. And if things go wrong and implants have to be removed, then what happens?

I have some photographs that I want to share with you. The photograph up right now is a photograph of a 29-year-old woman who had her implants removed after 7 years. She had capsular contracture that was so painful that she decided to have her implants removed. This photograph is from the FDA website.

Here is another woman -- you can go to the next slide -- who wasn't so lucky. This woman's ruptured implant had leaked into her healthy breasts. And when the silicone was removed, that is all that was left of her breasts.

Now let's look at some long?term studies of diseases. The National Cancer Institute looked at thousands of women who had implants for at least eight years. They found women with implants were twice as likely to die from brain cancer, three times as likely to die from lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.

FDA's scientists did the best study of the health of women with ruptured silicone implants. All the women in their study had breast implants for at least six or seven years. So some had implants that had been leaking for several years. They found that women with implants that leaked outside the scar capsule were significantly more likely to report fibromyalgia and several other painful connective tissue diseases.

Dow-Corning paid for another study on ruptured implants, referred to as the Danish study in the FDA review that was provided to you. Unfortunately, the Danish study included only 23 women with implants that leaked outside the scar capsule. They found that those women had more pain and other problems than women whose implants were not leaking, but because of the small sample size, those differences were not statistically significant. The study is not conclusive because the number of women with extracapsular leakage is

much too small.

Implant makers often say that there are more than 100 studies of women with implants and that these studies prove that implants are safe. When they say this, they tend to ignore the studies that don't agree with them, which tend to be the studies of women who had implants the longest, such as the FDA and the NCI studies.

Most of the studies that the implant makers quote as proving safety were funded by Dow?Corning. Almost all of the studies in the often quoted Institute of Medicine report, including the Mayo Clinic study and the Harvard study, were funded by Dow-Corning. And, like the Danish study I mentioned, they tend to have rather small samples. And most studied women who had implants for a short period of time. For example, the Mayo Clinic study included only 749 women with breast implants, and only 375 of them had had implants for more than 7 years.

Autoimmune diseases take years to develop and be diagnosed. And the sample would have to be larger to adequately study diseases that are so rare in young women. You don't have to take my word for it. The authors point that out themselves.

Listen to the testimony you will hear from the women today. It took years for them to develop diseases after getting their silicone implants. First, they had symptoms that they didn't take very seriously. When they were tired or their joints hurt or they had trouble concentrating, they thought that perhaps they just weren't getting enough sleep or they were working too hard.

Those are the same symptoms reported by Inamed in their patients who had implants for only two years. They aren't sick or diagnosed with diseases like rheumatoid arthritis, but it will take at least a few more years to find out if they will be.

One more thing is that almost all of the women in the core studies are white. Women of every racial group got breast cancer, but only six African American women and five Asian American women are in the Inamed reconstruction study. Race is an important issue because African American women are more likely to get autoimmune diseases than white women.

In conclusion, not enough research has been done on large diverse samples of women that proves that silicone breast implants are safe in the long term. Because of this, on behalf of the National Council of Women's Organization and the ten million women NCWO represents, I urge you to vote against the approval of silicone breast implants.

Thank you.