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This article was originally published in The Gray Sheet

Executive Summary

A determination as to whether the breast implant maker may have violated federal securities laws is requested by House Commerce Committee Chairman Thomas Bliley in an April 3 letter to the Securities and Exchange Commission Enforcement Division. The issue relates to a recent Mentor public statement denying the firm is the subject of a criminal investigation by FDA based on "allegations of serious irregularities in breast implant studies" (1"The Gray Sheet" March 27, p. 14). Mentor has publicly denied the investigation is based on these particular allegations, contradicting FDA assertions. Bliley made the request since Mentor's denial apparently caused the firm's stock to rebound sharply after initially falling up to 50% upon an initial news report in the March 23 USA Today. FDA's General and Plastic Surgery Devices Advisory Panel recommended at a March 1 meeting that Mentor's saline filled breast implants should remain on the market (2"The Gray Sheet" March 6, p. 3). FDA has indicated that it will make its decision on Mentor's PMA by May 12

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