Mentor preparing silicone breast implant Phase III study protocol.
This article was originally published in The Gray Sheet
Executive Summary
MENTOR SILICONE BREAST IMPLANT PHASE III PROTOCOL SUBMISSION TO FDA could occur as early as September, according to the com-pany. While final details of the protocol have not been worked out, Mentor says the clinical trial will involve a small number of investigators and several hundred women who have never had breast implants. The trial -- the third and final phase of a study called for by FDA in 1992 -- will include both reconstruction and augmentation procedures.
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