Former Mentor Employee Claims Firm Could Reduce Silicone Implant “Bleed”
This article was originally published in The Gray Sheet
Executive Summary
A former engineer for Mentor says the company decided against upgrading its Memory Gel silicone breast implants with patches capable of decreasing silicone oil leaks, or "bleeds.
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Public Citizen Seeks Criminal Investigation Of Breast-Implant-Maker Mentor
Public Citizen has asked FDA to begin a criminal investigation into allegations that silicone-breast-implant-manufacturer Mentor failed to disclose potential safety problems with its implants, currently under review by the agency
Public Citizen Seeks Criminal Investigation Of Breast-Implant-Maker Mentor
Public Citizen has asked FDA to begin a criminal investigation into allegations that silicone-breast-implant-manufacturer Mentor failed to disclose potential safety problems with its implants, currently under review by the agency
FDA investigates claims by ex-Mentor engineer
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...