Testimony of Judy Norsigian at FDA on Silicone Breast Implants

Judy Norsigian, Our Bodies Ourselves, April 2005

I am Judy Norsigian. I am the Executive Director of Our Bodies, Ourselves, also known as the Boston Women’s Health Book Collective, a nonprofit public interest, women’s health, education, and advocacy organization. For 35 years, we have advocated for women’s health from an evidence-based and consumer perspective, most notably through our major publication, Our Bodies, Ourselves. We have no financial ties to either of the manufacturers or their competitors.

Our organization’s interest in breast implants goes back to the mid 1980s, when the late Esther Rome, my coworker, began to work with hundreds of women, both locally and nationally, who believed that breast implants caused some serious problems. Many of these women were initially happy with their implants but later developed debilitating conditions after five or ten years or more. Even today, many women continue to have problems with more recent models. And we still do not have adequate data that would allow women to make informed choices about using these devices.

As we and others have said before, we do want choices, but we want safe choices. Since the October 2003 panel that addressed the safety of silicone gel implants, studies in mammography and platinum suggest new challenges for women with silicone gel implants.

A study published in the January 2004 JAMA issue found that breast implants interfere with mammography, missing 55 percent of breast cancers in women with breast implants, compared to 33 percent in women without implants. This fact alone provides a compelling reason for the FDA to weigh carefully the risk-benefit issues regarding these products.

Silicone breast implants have also been found to contain platinum. A study published in the July 2004 issue of Analytical and Bioanalytical Chemistry found very high levels of platinum in silicone gel as well as the encasing materials, implant elastomer, double lumen, and foam, materials that are in direct contact with the chest wall of patients.

Much media coverage has suggested that there are many studies showing that breast implants are safe, but the largest, best designed studies do show increased risks. Even the Breiting, et al., study of Danish women noted substantial problems that call for further research. When read carefully, this study is anything but a stamp of approval for silicone breast implants.

Scientists at the FDA and NIH are among those who have called for more research to answer many of the key questions that have been raised repeatedly at FDA hearings. You should be joining them.

All assertions to the contrary, we simply do not have adequate data on such conditions as fibromyalgia. Our recent experiences with premature drug and device approval underscore how critical it is to take a cautious approach.

Although saline implants are less ideal for many women, they do provide a reasonable alternative while we await the findings of further research. And such research must include women with implants for a minimum of ten years, not an average of ten years.

Women’s health and lives depend upon a careful assessment of these devices. We urge the panel to require adequate safety data to be collected before any decision to approve their use, especially in light of industry’s current marketing strategy of targeting younger women, whose long-term health status may depend upon your recommendation.

Thank you very much.