Confirming The Safety Of Silicone

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Many of you readers know that silicone implants were approved by the Food and Drug Administration (FDA) in November of 2006. What you may not know is that the approval was conditional on the manufacturers conducting post-approval studies to evaluate the long-term performance and safety of the implants.

A new report released by the FDA confirms much of what was already suspected about silicone-gel-filled breast implants at the time of their approval. The main points to take home from the report are that silicone-filled breast implants are safe but they aren’t meant to be permanent. About 20 percent of implant recipients in standard cases will need to have them removed/replaced within 10 years, and half of breast reconstruction patients will need their implants replaced in that time. Basically, the longer a woman has a breast implant, the more likely she is to experience complications ranging from wrinkling and infection to capsular contracture (or hardening around the implant) and rupture.

The FDA recommends implant recipients should submit to routine check ups and MRIs, used to detect changes and subtle ruptures, to prevent more serious complications and also to pay attention to symptoms such as wrinkling, asymmetry and breast pain, as these can be signs of complications. Has anyone had to have her implants replaced? What was the experience like?

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