Oct. 15, 2003
Statement of Sidney M. Wolfe, M.D., Director of Public Citizen’s Health Research Group, on FDA Advisory Panel’s Recommendation to Approve Sales of Silicone Gel Breast Implants
We strongly urge the Food and Drug Administration to side with the six panel members who voted against approval and require much more data before reaching a decision to lift the implant ban. Waiting to collect the full 10 years of information on the thousands of women who already have had implants will be a much more public health-oriented decision than precipitously approving these unsafe devices for marketing to hundreds of thousands of women a year in what would amount to a massive experiment. By lifting the ban, the FDA will be failing to uphold the law that requires “reasonable assurance of safety” before approving such devices and will make a dangerous mockery of the informed consent process since there is not enough long-term data for women to give truly informed consent. This will be the most defective medical device, with knowledge before approval, ever approved by the FDA.