NYTIMES: Implant Maker Hid Defects, Workers Said

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May 22, 2005

Implant Maker Hid Defects, Workers Said

By GARDINER HARRIS

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, 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

the investigation was closed in 2002 without any further action. "

The F.D.A.'s investigation looked into accusations that Mentor

falsified records, hid defective implants and knowingly used

contaminated silicone. No charges were filed.

In 1998, Mentor also entered into a judicial consent agreement with

the F.D.A., a serious regulatory step, 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, which in 1992 limited the use of silicone implants to

reconstructive surgery, usually after cancer, is now using data

provided by Mentor to help it decide whether to allow their use in

cosmetic surgery.

Citing a very low rupture rate reported by Mentor, a federal

advisory panel voted 7 to 2 in April to approve Mentor's

application. The panel rejected an application from Inamed, Mentor's

rival, in part because Inamed reported a higher rupture rate among

its implants than Mentor did. The companies, both based in Santa

Barbara, Calif., have roughly equal shares of the United States

market for silicone breast implants.

Dr. Zuckerman, president of the National Research Center for

Women and Families, a nonprofit group in Washington that opposes

silicone implants, said the depositions suggested that the low

rupture rate that Mentor has reported to the F.D.A. might not be

accurate.

" Mentor employees said under oath that their company significantly

underreported implant problems, " Dr. Zuckerman said. " Mentor's new

statistics also seem questionable. Are Mentor implants so much

better than their competitors' in terms of rupture rates, or are

they providing misleading or false information? "

The safety of silicone implants has been vigorously debated for

years. A number of women's groups say they are prone to rupture -

usually without the woman's knowledge - and cause long-lasting

health problems.

In 1999, the Institute of Medicine, an arm of the National Academy

of Sciences and the nation's most prestigious medical advisory

group, said there was no evidence that silicone implants caused

major diseases. Plastic surgeons say that silicone implants are safe

and should be more widely available to women undergoing cosmetic

breast augmentation. Most of the 250,000 breast augmentations done

in the United States each year use saline implants - plastic bags

filled with water that can slosh during activity. Patients and

doctors say silicone implants feel more natural and look better.

Dr. D'Amico, a co-chairman of the breast implant task force

of the American Society of Plastic Surgeons, called the depositions

by the former employees " old news, " and said, " Our confidence in the

data presented remains absolutely high. "

F.D.A. officials refused to comment, saying only that the

application is under review.

Mr. Karjanis, the former product evaluation manager, worked for

Mentor from July 1996 to September 1998 and left voluntarily. The

other employee, Fain, supervised the company's complaint

unit. She worked for Mentor for more than three years and was fired

in 1996 or 1997, she said. Both were deposed under oath as a result

of subpoenas.

In his deposition, Mr. Karjanis said that Mentor never met basic

quality standards for implant manufacturing while he was there and

that its supplier might have sent contaminated silicone. He also

said the implants' packaging was sometimes infested with fleas,

which came in contact with the surface of the implants.

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.

Mr. Karjanis said that while he was at Mentor, some manufacturing

executives made efforts " to get an acceptable disposition of

materials through fraudulent means. " In one example, an operations

manager tried to get him to approve implant parts that had been

poorly made.

" In reviewing the documentation, I found that the documents had been

falsified, " Mr. Karjanis said. " And in confronting him and asking

him to come back to my office, I remember his literal statement

was, 'I almost got it past you.' "

Ms. Fain said Mentor greatly underreported rupture rates to the

federal authorities. Like Mr. Karjanis, she said Mentor suppressed a

report finding that some implant models had a high failure rate.

Ms. Fain said Mentor received about 6,000 complaints of ruptured

implants in each of her three years there. In its recent filing with

the F.D.A., Mentor said that it received a total of 8,060 rupture

complaints from 1985 to September 2003.

One reason for the discrepancy, Ms. Fain said, was that Mentor

disregarded rupture complaints if patients had failed to sign a form

allowing the company to inspect their extracted implants.

Mr. Karjanis and Ms. Fain said in the depositions that they had

signed nondisclosure agreements. Neither could be reached for this

article.