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Senators question breast implant data

This article was originally published in The Gray Sheet

Executive Summary

Sens. Dianne Feinstein (D-Calif.) and Olympia Snowe (R-Maine) urge FDA in an Oct. 20 letter to consider "all data collected" by silicone gel breast implant developer Mentor, "whether or not it was originally required" for approval, based on allegations from a former Mentor employee that the company withheld or misrepresented data related to gel leaks. Mentor's Memory Gel silicone breast implants are pending FDA approval; the firm received an "approvable" letter in July 2005 (1"The Gray Sheet" Aug. 1, 2005, p. 18). Public Citizen appealed for a criminal investigation into the whistleblower's claims on Oct. 12 (2"The Gray Sheet" Oct. 16, 2006, p. 5)...

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