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FDA's silicone vote not binding
To the Editor:
Thank you for your excellent editorial. After spending two days at the FDA's meeting on silicone
breast implants on October 14-15, I too was amazed at the corporate indifference to women's health.
Unfortunately, many of the plastic surgeons were equally indifferent, insisting that implants were
safe despite the heartbreaking testimony of women who had traveled at their own expense to tell
their stories.
The 9-6 vote recommending approval is not binding. Of the 15 panel members who voted, most of those
who voted for approval were plastic surgeons or breast surgeons – clearly they had a conflict of
interest. Even so, those voting in favor demanded additional research to determine whether the
implants are safe. Those voting against approval included a toxicologist, radiologist,
epidemiologist, statistician, cancer surgeon, and dermatologist. They stated that the company
should prove that the implants are safe before the FDA approves them.That happens to be what the
law requires.
The next step is for the FDA to decide whether or not to approve silicone gel implants for the
first time.Unfortunately, the press coverage was unclear on that point. We have heard that plastic
surgeons are already telling patients that silicone gel implants are now FDA-approved. They are
not. They are still restricted, and the 9-6 vote is relatively close, making it unclear what the
FDA will do.
There are many reasons to be concerned. In the short term, breast implants can cause pain and often
require additional surgery within three years. The greatest health risk of silicone gel implants is
that they break, usually within ten years. If they leak inside the body, the silicone can get into
the lungs, lymph nodes, and possibly brain. Nobody knows how that will affect health, but a study by
the FDA found that women with leaking implants were more likely to have a painful autoimmune disease
called fibromyalgia. Also, when the silicone gets into the breast area, it can be very difficult to
remove, and many women have been deformed as a result.
For science-based information about the risks of breast implants, please see
www.breastimplantinfo.org
Diana Zuckerman, Ph.D., is Presidnet of the National Center for Policy Research for Women & Families
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For more info on the FDA debacle, the Dow Bankruptcy and links to other studies and implant related
sites, please visit:
www.BreastImplantAwareness.org