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Silicone gel-filled breast implants approved.(products from Mentor Corp. and Allergan Inc. gets approved)

Publication: FDA Consumer
Publication Date: 01-JAN-07
Format: Online
Delivery: Immediate Online Access

Article Excerpt
After rigorous scientific review, the Food and Drug Administration has 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 Corp.,...

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...Allergan formerly Inamed Corp., of Irvine, Calif., and Mentor Corp. of 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 of the FDA's Center for Devices and Radiological Health after the approval in November...

NOTE: All illustrations and photos have been removed from this article.



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