Surgeon charged in implant study violation

A fairly prominent LA plastic surgeon has been charged with doing an end-run around the current FDA restrictions on silicone breast implants by fudging enrollment criteria in the adjunct studies and importing French-made implants via Mexico. This is disappointing but not surprising. It highlights two important things.

1. It's not worth cutting corners

2. The lunacy of the current FDA restrictions

The "compromise" imposed in the early 1990's by then FDA Commissioner, David Kessler, reserved implants for cancer patients and complex cosmetic cases. These were exactly the WRONG patients to choose if you were worried about device safety and post-operative complication rates as their expected reoperation rates are signifigantly higher then primary breast augmentation patients.

The FDA is still currently sitting on the 2005 advisory panel endorsements for Inamed & Mentor.


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