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Cover-Up of Defects at Mentor Alleged

May 23, 2005 | AP

Two former employees of breast-implant manufacturer Mentor Corp. alleged that the company covered up high rupture rates and that workers would hide defective parts in the ceiling because they were fearful that their bosses would find out.

The allegations are contained in a 2003 lawsuit against the Santa Barbara-based company, which recently won a recommendation from federal scientific advisors 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 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, a group for women with breast implants.

Karjanis, who was manager of product evaluation from 1996 to 1998, alleged that some senior company executives 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, a level that 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 New York 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 that the investigation began in 1998 and ended in 2002 "without any further action."

The 2003 lawsuit was 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?" Hoffman asked. "Why aren't they taking actions?"

The FDA could not be reached for comment Sunday.