Remarks by Dr. Zuckerman on Article in NY Times

[Guest guest]

Note: forwarded message attached.

Subj: Sunday's NY TIMES: Implant Maker Hid Defects, Workers Said

Date: 5/22/2005 9:52:21 AM Eastern Standard Time

From: dz@...

Dear Friends,

Here is the latest installment of the breast implant saga, in Sunday's New

York Times.

I will need to send a correction explaining that our Center does not oppose

all silicone implants, we only oppose FDA approval for implants that

are not proven safe.

Otherwise, I think it is an important article and hope that it is useful in

the debate on FDA and implants. The bottom line is: if an implant maker

has a history of lying about the risks of their product, how can FDA or

consumers have confidence that their new data are accurate.

Best wishes,

Zuckerman, Ph.D.

President

National Research Center for Women & Families

1901 Pennsylvania Ave, NW, Suite 901

Washington, DC 20006

(202) 223-4000

www.center4research.org

http://www.nytimes.com/2005/05/22/national/22implant.html?oref=login & pagewan

ted=print

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.