FDA TRIALS

COHESIVE TRIALS

The United States FDA demands rigorous long term clinical trials before it approves any medical device for sale. The trials for the highly cohesive gummy bear implants began in 2001. During that time thousands of patients received gummy bear implants, and the results of their surgery were carefully documented and analyzed. It was on the basis of this data that the 410 and Sientra implants were approved.

The implants are now widely available with two exceptions. The first is that the Mentor CPG is still awaiting approval, so patients interested in receiving that implants must enroll in a clinical trial. The second exception is that the FDA only approved four of the twelve different shapes of 410 implants. This was not a safety issue, but rather at the time the study began only those four shapes were available. To receive any of the other eight shapes, a patient must see a surgeon who can offer these implants as part of the clinical trial.

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