New manufacturer of Silicone implants gets FDA approval!

Serving Bonita Springs, Estero, Fort Myers, Marco Island, & Naples, Florida

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It has been since 2007 that we have had anything new to say about silicone breast implants and the FDA. While we have been awaiting the approval of "form stable" or 'gummy bear' implants for 5 years, a Brazilian manufacturer (Silimed) has gotten approval to sell its Silicone implants in the US. The only thing it may add to our present armamnetum is caused by a curious decision by the FDA to let Silimed sell its shaped silicone implants in the US. These are currently not allowed in the US market (Mentor and Allergan have wonderful products of the same type). The decision to limit the devices to women over 22 years of age is explained by the FDA in their statement explaining that the majority of the subjects used by the manufacturer's to prove the safety of the silicone implants were over the age of 22. The logic of this reasoning escapes me since no one really believes that the implant is okay for a 22-year-old it is possibly dangerous for an 18-year-old. I believe that we can understand in 2012 that are not lifelong devices. Personally neither is my own natural Knee which will probably see a replacement within the next few years. Stay tuned for further updates as the silicone wars begin. The