WASHINGTON – Two former employees of a breast-implant manufacturer alleged the company covered up high rupture rates and workers were so fearful of bosses finding defective implant parts that they hid the parts in the ceiling.
The allegations are contained in a 2003 lawsuit against the Mentor Corp., (search) which recently won a recommendation from federal scientific advisers that the government let the company resume widespread sales of its devices under certain conditions. The suit was dismissed.
Sworn depositions by the two ex-employees, John C. Karjanis (search) and Cynthia Fain, were first reported in The New York Times on Sunday. Excerpts were distributed by the woman who filed the lawsuit, Kim Hoffman of Springfield, Mo., and by the Command Trust Network (search), a group for women with breast implants.
Karjanis, who was manager of product evaluation from 1996 to 1998, alleged some senior company officials told him to destroy reports detailing high rupture rates, saying they sought "an acceptable disposition of materials through fraudulent means." He said packaging for the implants was sometimes infested with fleas, and workers on the factory floor would stash defective parts above ceiling tiles to hide them from superiors.
Fain, who was supervisor of the company's complaint unit in the mid-1990s, said in her deposition that Mentor underreported rupture rates and that she received 6,000 complaints of ruptured implants in each of her three years at the company, which was far more than Mentor told authorities about.
Josh Levine, Mentor's president and chief executive, did not address the specific accusations but told The Times in a written statement that a criminal investigation of Mentor by the Food and Drug Administration "included allegations from these two former employees." He added the investigation began in 1998 and ended in 2002 "without any further action."
The 2003 lawsuit had been brought by Hoffman, who said she suffered extreme fatigue and neurological problems from Mentor implants in the 1990s and had them removed.
"I tried to depose some of the people who knew of bad things," she said in an interview Sunday. She questioned why a regulatory panel would recently recommend that Mentor's devices be considered safe enough to expand sales under certain conditions, given the alleged history of misrepresentation. "Where is the FDA?" she asked. "Why aren't they taking actions?"
The FDA could not be reached Sunday.
FDA advisers recommended in April that Mentor be allowed to sell its silicone-gel breast implants for cosmetic purposes again if patients sign consent forms acknowledging implant risks, if sales are made only to board-certified plastic surgeons who complete special training, and if the company keeps a registry tracking how patients fare, among other conditions.
The manufacturers Inamed and Mentor corporations want the FDA to lift a 13-year ban on most use of the gel implants. The FDA's scientific advisers concluded that Mentor had proved its devices safe enough for conditional approval, but Inamed needed to do more research. The FDA has been considering that advice as it completes its own review.
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