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New breast implant approved by FDA.

The U.S. Food and Drug Administration (FDA) recently approved the Natrelle 410 silicone breast implant. The implant is approved for use in women at least 22 years old to increase breast size, or to rebuild breast tissue in women of any age. This offets women who have undergone a mastectomy a new option for breast reconstruction. The FDA based its approval on seven years of data from 941 women. Most complications and outcomes were similar to those found in previous breast implant studies, including tightening of the area around the implant, uneven appearance, and infection. Allergan, Inc., the manufacturer of the Natrelle 410, is required to complete a series of post-approval studies to assess the long-term safety and efficacy of the product.

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Title Annotation:FRONTLINE
Publication:Women's Health Advisor
Date:May 1, 2013
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