FDA approves new silicone gel-filled breast implant

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA approves new silicone gel-filled breast implant

	February 2013 http://www.fda.gov/womens FDA approves new silicone gel-filled breast implant Agency requires post-approval safety studies to assess rare events The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc. The silicone gel in the Natrelle 410 implant contains more cross-linking compared to the silicone gel used in Allergan’s previously approved Natrelle implant. This increased cross-linking results in a silicone gel that’s firmer. Cross-linking refers to the bonds that link one silicone chain to another. The clinical significance of this type of silicone gel is not known. Read more     Please share this update with your network, members, constituents, and community. FDA Office of Women’s Health  10903 New Hampshire Avenue   WO32 - Room 2333   Silver Spring, MD  20993-0002 301-796-9440

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