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Did Mentor hide defective implants?
Report: Ex-employees say firm made implants prone to rupture, withheld information from regulators.
May 23, 2005: 9:09 AM EDT

NEW YORK (CNN/Money) - Two former employees of silicone breast implants manufacturer Mentor Corp. said the company made defective implants that were prone to rupture and hid the information from customers and federal regulators, according to the New York Times.

John C. Karjanis, who was manager of product evaluation for the company, said in a sworn deposition that Mentor never met basic quality standards for implant manufacturing while he was there.

Karjanis said top executives instructed him to destroy reports about the high rupture rates and poor quality of some types of implants. He also said the implants were sometimes contaminated with fleas, according to the newspaper.

He added that workers on the factory floor would sometimes store defective implant parts above ceiling tiles so managers and inspectors would not realize how often the plant failed to make the parts properly.

Cynthia Fain, who supervised the company's complaint unit, said Mentor greatly underreported rupture rates to federal authorities and suppressed a report finding that some implant models had a high failure rate, according to the newspaper.

Mentor President and Chief Executive Josh Levine would not comment on the employees' accusations, the newspaper said.

In a written statement, Levine said the company believed 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 FDA, and the investigation was closed in 2002 without any further action."

According to the Times, the investigation looked into accusations that Mentor falsified records, hid defective implants and knowingly used contaminated silicone, but no charges were filed.

In 1998, Mentor also entered into a judicial consent agreement with the FDA to correct deficiencies in manufacturing "that could potentially affect the safety and quality of the breast implants," the agency said at the time.

The agency relies on information provided by Mentor to help it decide whether to allow the use of silicone implants in cosmetic surgery, and citing a very low rupture rate reported by Mentor, a federal advisory panel voted 7-2 in April to approve Mentor's application.

FDA officials refused to comment, saying that the application is under review, the newspaper said.

Karjanis and Fain were deposed as part of a lawsuit in Greene County, Mo. The depositions were provided to the Times last week by Kim Hoffman, the plaintiff who claimed that Mentor implants had made her ill. The former employees could not be reached for comment, the newspaper said.

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