The US Food and Drug Administration revealed that it has approved Allergan's new silicone gel-filled breast implant, Natrelle 410.
The implants can be used to increase the breast size of women over 22 years of age and can also be used in rebuilding breast tissue in women of any age. The FDA said that the silicone gel in Natrelle 410 implants are a lot firmer than Allergen's previous Natrelle models though the studies conducted by the company did not compare the safety of the new model with older implants.
Advertisement"The data we reviewed showed a reasonable assurance of safety and effectiveness. We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness", FDA's medical device director, Dr Jeffrey Shuren said.
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