FDA investigates claims by ex-Mentor engineer
This article was originally published in The Gray Sheet
Executive Summary
The Mentor whistleblower who alleged his former employer decided against upgrading the patches on its Memory Gel implants to reduce silicone oil leakage says he spoke with FDA's Office of Criminal Investigations unit Dec. 19. The engineer, who requested anonymity, said a criminal investigator spoke with him at FDA's offices in Dallas for over an hour about the charges he first reported to the agency in August 2005 (1"The Gray Sheet" Dec. 12, 2005, p. 8). In addition to the claims about Mentor's decision not to update the patches on the Memory Gel, the former employee alleges that the company has not accurately reported the rupture rates of the implants. FDA has not contacted Mentor about an investigation, the company said in a statement. "All rupture complaints have been submitted and reviewed as part of the premarket review process," the firm says...