Several queries regarding silicone implants have been asked recently in regards to breast reconstruction. Basically, silicone implants have always been able to be used for reconstructive purposes. They were taken off the market for a time period for aesthetic reasons, but re-approved in the last few years for this purpose.
The FDA approved Allergan Corp. and Mentor Corp.’s silicone breast implants and have since returned these devices to the U.S. market. 14 years after the FDA restricted access to the silicone implants, they have been placed back on the market after extensive studies for safety concerns. They were off the market for this reason from 1992 until November 2006.
The approval letter stipulated a number of conditions that the manufacturers needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the United States. These letters came after an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment.
Breast augmentation is now the most common aesthetic surgical procedure, according to ASAPS and ASPS statistics. About 380,000 and 58,000 women had breast augmentation and reconstruction, respectively, last year, according to ASPS. Both breast augmentation and reconstruction have been proven in numerous studies to have psychological and physical benefits for women who choose these procedures.
Silicone implants have been proven safe for reconstructive and augmentation purposes and the research behind these implants are excellent. Overall, excellent results are obtained from such implants with the health concerns already addressed and complications of such should be discussed with your plastic surgeon.
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