Silicone Gel-Filled Breast Implants Approved By FDA
FDA today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The decision was made after rigorous scientific review. The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.
"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA.