Ex workers for breast impant maker critize them...story from news

[Guest guest]

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.

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The allegations are contained in a 2003 lawsuit against the Mentor

Corp., 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, C. Karjanis and

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 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.