Jan. 8. 2003

Statement of Sidney M. Wolfe, M.D., Director, Public Citizen’s Health Research Group, Concerning FDA Non-Approvable Letter for Silicone Gel Breast Implants

As the group that petitioned the U.S. Food and Drug Administration in 1988 to ban silicone gel breast implants, we commend the FDA for the non-approvable letter it released today, concerning Inamed silicone gel breast implants. Responding to a review of the data, the strong urging of the chairman of its advisory committee chairman, Dr. Thomas Whelan, against approval and other outside pressures against approval, the FDA is wisely asking for more data upon which to judge the safety of the implants. The agency is thereby rejecting its own flawed "guidance," which encouraged companies such as Inamed to think that dangerously inadequate amounts of data could be used as a basis for approval.

The FDA decision to not approve Inamed’s silicone gel breast implants is a rejection of what would have been the most dangerous, defective medical device ever approved by the FDA despite advanced knowledge of its dangers. Although saline implants are also defective in their frequent ruptures, there is an extraordinary difference between rupture and leakage of salt water – which is immediately and safely absorbed by the body – and the spread of highly reactive silicone gel, causing local and regional scar tissue formation as well as gel migration to other parts of the body.

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To read Dr. Wolfe’s statement before the FDA’s advisory committee on silicone gel breast implants, click here.