Breast Implants

U.S. FDA approves silicone gel-filled breast implants after in-depth evaluation

Published in Medical Letter on the CDC and FDA, December 24th, 2006

After rigorous scientific review, the U.S. Food and Drug Administration (FDA) 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 products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, California, and Mentor Corp., Santa Barbara, California.

"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, MD, director, Center for Devices...

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Source: Medical Letter on the CDC and FDA (2006-12-24)

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