Myrl Jeffcoat myrlj@jps.net

MS. HOWE: You've got two Massachusetts people together here. Thank you for this opportunity to testify. My name is Genevieve Howe, and I am a member of the board of Massachusetts Breast Cancer Coalition.

The coalition defines breast cancer as a political issue and challenges all obstacles to eradication of the disease. All board members are volunteers for the coalition, and it does not accept financial or any kind of support from pharmaceutical companies or any sources that profit from cancer or contribute to environmental pollution. I have no financial conflict of interest in this issue.

Although reconstruction after mastectomy represents only about 20 percent of breast implant surgeries, the devices play a significant role in the lives of the 215,000 women diagnosed with breast cancer each year.

I would like to address three concerns about silicone gel?filled breast implants: one, health risks due to lower sensitivity of screening mammography; two, the very high rate of resurgeries and other complications, especially in reconstruction patients; and, three, the reluctance of organized plastic surgery and breast implant manufacturers to accurately inform women about the nature and magnitude of the risks involved in reconstruction with silicone implants.

Researchers generally agree that augmentation implants significantly reduce the ability of radiologists to analyze breast tissue in mammography, even when using special techniques.

Two sound studies, Miglioretti, et al.; and Brinton, et al., found that women with implants who were later diagnosed with breast tumors did not present with higher stage cancers. However, as Brinton accurately points out, there are major differences between women who undergo breast augmentation and those who don't.

Women who choose augmentation tend to be younger, to have a smaller breast size, and less glandular tissue mass, and to have their first child at a younger age than the adult female population as a whole. Each of these factors associated with lower breast cancer risk, particularly younger age.

In my written testimony, I have included a statement on conflicts of interest by researchers making the improbable claim that silicone breast implants can lower women's risk of developing breast cancer.

In their own data, both Inamed and Mentor find very high rates of moderate, severe, or very severe complications within three years. These complications are much more frequent in reconstruction patients than augmentation patients.

Inamed reports one or more resurgeries in 21 percent of augmentation patients and 39 percent of post?mastectomy patients. That seems very high to me. Four out of ten have one or more repeat surgeries within three years.

Mentor's application shows resurgeries within 3 years on 15 percent of augmentation patients and on 26 percent of post-mastectomy patients. Other local complications are also frequent. And many patients have more than one type of complication. Inamed lists 21 types of moderate, severe, or very severe complications, 6 of which were each experienced by 20 percent or more of reconstruction patients.

In both of the pending applications, the manufacturers tend to minimize the risks in patient information. For example, Inamed projects rupture risk as linear without acknowledging deterioration in device materials over time. And the company underestimates the decline in MRI sensitivity and specificity. Mentor's glowing measures of satisfaction include fewer than half of their original 251 reconstruction patients.

Organized plastic surgery has opened up a new dot.org Web site, breastcancersafety.org, claiming we place patient safety above all else. The site's overview page links to a letter sent to this panel by 12 breast cancer advocacy groups, at least several of which have received contributions from plastic surgery organizations and/or breast implant manufacturers.

Given the plethora of biased information and research and the lack of long?term prospective studies, it is difficult to imagine women being able to make truly informed decisions on silicone implants.

Judith Brady is a 67-year-old cancer activist in San Francisco. Both of her breasts were reconstructed with silicone implants following a double mastectomy nearly 25 years ago. She has been living with these implants ever since and considers them to be "a ticking time bomb," to quote her, in her body.

When I asked her what advice she would offer to women considering silicone implants, she said that, as far as reconstruction goes, "choose a plastic surgeon with great care."

As for women considering breast augmentation, she said, "That I think should be clearly avoided. In fact, I think doctors who do this surgery should be strung up." That is not a response we advocate, but my point is that our male-dominated culture too often pressures women to risk pain, suffering, and great expense simply to fit in.

We urge the FDA to deny the pending applications for widespread use of silicone implants. We fear that a lack of caution by FDA in this matter could lead to further unnecessary pain and suffering on the part of women and additional years of costly litigation.

Thank you very much.