Mentor Hid Defects ... stashed defective parts ...

Ilena Rose · medicine forum Guru Joined: 05 May 2005 Posts: 813

AP picked up this story and there have been over 64 publications who
have printed it so far ... including Business Week!

Bravo to all involved!

The original NY Times version I have reprinted below.

Excerpt from AP story:
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.

Ex-employees of breast-implant manufacturer say company made ...
570 News, Canada - 7 minutes ago
.... 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 ...

Ex-workers criticize breast implant maker
BusinessWeek - 13 minutes ago
.... 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 ...

Ex-employees of breast-implant manufacturer: company made ...
Belleville News-Democrat, IL - 26 minutes ago
.... 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 ...

Ex-Workers: Company Hid Breast Implant Info
FOX News - 49 minutes ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
WRAL.com, NC - 2 hours ago
.... 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 ...

Enter a Category
New York Newsday, NY - 2 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Columbus Ledger-Enquirer, GA - 3 hours ago
.... 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 ...

Ex-employees of breast-implant manufacturer say company made ...
Macleans, Canada - 3 hours ago
.... 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 ...

Ex-employees of breast-implant manufacturer say company made ...
CJAD, Canada - 3 hours ago
.... 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 ...

Ex-employees of breast-implant manufacturer say company made ...
Canada.com, Canada - 3 hours ago
.... 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 ...

Ex-employees of breast-implant manufacturer say company made ...
Canoe.ca, Canada - 3 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Seattle Post Intelligencer, WA - 3 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Contra Costa Times, CA - 3 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Kansas.com, KS - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Monterey County Herald, CA - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
In-Forum (subscription), ND - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Macon Telegraph, GA - 4 hours ago
.... 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 ...

Ex-employees: Breast-implant maker hid info
Newsweek - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Duluth News Tribune, MN - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
San Luis Obispo Tribune, CA - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Biloxi Sun Herald, MS - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Kentucky.com, KY - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Miami Herald, FL - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Lodi News-Sentinel, CA - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
San Jose Mercury News, CA - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
The State, SC - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Bradenton Herald, FL - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Akron Beacon Journal, OH - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Centre Daily Times, PA - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Fort Worth Star Telegram, TX - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Fort Wayne Journal Gazette, IN - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Fort Wayne News Sentinel, IN - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Charlotte Observer, NC - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Washington Examiner, DC - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Tallahassee.com, FL - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Petoskey News-Review, MI - 4 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Kansas City Star, MO - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
San Francisco Examiner, CA - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
WJLA, DC - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Carlisle Sentinel, PA - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Natchez Democrat, MS - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Tahlequah Daily Press, OK - 4 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Daily Inter Lake, MT - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
North County Times, CA - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
CBS News - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Daily American Online (subscription), PA - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Appeal-Democrat, CA - 5 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Sacramento Bee (subscription), CA - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Worcester Telegram (subscription), MA - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
ABC News - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
The Ledger, FL - 5 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
Albany Times Union, NY - 5 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
MLive.com, MI - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Times Daily, AL - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker - Yahoo! News
SierraTimes.com - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
MSN Money - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Forbes - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Los Angeles Times, CA - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Newsday, NY - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Washington Post, DC - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
Lexington Dispatch, NC - 5 hours ago
.... 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 ...

Ex-workers criticize breast implant maker
BusinessWeek - 5 hours ago
.... 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 ...

Ex-Workers Criticize Breast Implant Maker
WTOP, D.C. - 5 hours ago
.... 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 ...

Implant Maker Hid Defects, Workers Said
New York Times, NY - May 21, 2005
.... ill. The suit was dismissed. The depositions were provided to The
New York Times last week by Kim Hoffman, the plaintiff. Josh Levine
....

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, John 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. Diana 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. Richard 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, Cynthia 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.

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