Current status of silicone breast implants.

The current status of the silicone breast implants which have recently come under scrutiny by the FDA and received much unfavorable media coverage is reviewed. The gel-filled breast implants which in 1976 were "grandfathered" by the FDA have now been required to provide scientific evidence of safety and effectiveness by July 9, 1991. The possible risks of silicone breast implants include capsular contracture, interference with early tumor detection by routine mammography, development of sarcomas in laboratory animals (no human cases are reported), silicone gel leakage and connective tissue disease. In the less frequently used polyurethane covered implants, the degradation of the polyurethane to diaminotoluene (TDA) has caused liver cancer in laboratory animals, yet at present, this type of implant has been voluntarily removed from the market by the manufacturer. After reviewing the available evidence, the American Society of Plastic Surgery still considers silicone breast implants reliable and safe.