http://www.sagamore.iupui.edu/33_12/viewPoints/lettEdit_fdaSilicone.html
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