Fw: letter to the editor published on implants

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----- Original Message ----- From: Zuckerman

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Sent: Monday, November 03, 2003 8:49 PM

Subject: letter to the editor published on implants

This letter to the editor of a campus newspaper is our effort to get the word out to the young women considering implants.

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

Zuckerman, Ph.D., is Presidnet of the National Center for Policy Research for Women & Families