Breast Implant Maker Hid Defects, Workers Said

Last month, a Food and Drug Administration panel voted to approve silicone breast implants made by Mentor, a Calif.-based medical device company, back on the market for limited use. The panel rejected an application from its competitor Inamed, the Times reports, in part because Inamed reported a higher rupture rate among its implants than Mentor did. Now the Times reports two former employees of Mentor testified in 2003 sworn depositions that the company’s implants were defective and that they were ordered to cover-up their rupture rate. One whistleblower, a product evaluation manager, testified that some implants were contaminated with fleas and that the factory floor employees would often hide defective implants in the ceiling to avoid detection by inspectors. As many of you may know, my father worked extensively as a consultant in the silicone breast implant litigation of the 1990s – this kind of deception is nothing new.

Two former employees of a major manufacturer of silicone breast implants said in sworn depositions in 2003 that the company for years made defective implants that were prone to rupture and hid this information from customers and federal regulators.

One employee, John C. Karjanis, who from 1996 until 1998 was manager of product evaluation for the company, the Mentor Corporation, said some top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products “are in the customers.” He also said the implants were sometimes contaminated with fleas.

The former employees were deposed as part of a lawsuit in Greene County, Mo., brought by a woman who claimed that Mentor implants had made her ill. The suit was dismissed. The depositions were provided to The New York Times last week by Kim Hoffman, the plaintiff.

Josh Levine, Mentor’s president and chief executive, would not comment on the employees’ specific accusations. In a written statement, Mr. Levine said the company believed that a criminal investigation of Mentor by the Food and Drug Administration that began in 1998 “included allegations from these two former employees.” He added, “Mentor cooperated fully with the F.D.A., and…

Posted by anthony
Anthony Lappé is GNN's Executive Editor. He's written for The New York Times, Details, New York, Paper, The Fader and Vice, among many others. He has worked as a producer for MTV and Fuse. He is the co-author of GNN's True Lies and the producer of their Iraq...

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