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MENTOR SUSPENDS SILICONE BREAST IMPLANT STUDY INVESTIGATOR

This article was originally published in The Gray Sheet

Executive Summary

MENTOR SUSPENDS SILICONE BREAST IMPLANT STUDY INVESTIGATOR after FDA issues a warning letter to the physician that raises "significant questions about the conduct" of his study. In the March 9 warning letter, FDA cites Dennis Nigro, MD, North Coast Center for Ambulatory Surgery, Encinitas, California, for failing to follow the protocol for the second phase of FDA's silicone gel- filled breast implant study program, and for not obtaining informed consent from patients. Nigro also failed to submit certain reports of adverse incidents and maintained inadequate records, FDA alleges. FDA inspected Nigro's study between Aug. 18, 1993 and Jan. 19.
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