Mentor Corporation Misled FDA, Harmed Women, Lawsuit Alleges

SEATTLE, WA, Jan 24 (MARKET WIRE) --
Mentor Corporation, one of the world's leading medical device manufacturers,
misled the U.S. Food and Drug Administration (FDA) to win approval of its
"ObTape"
medical product, which led to severe medical complications and multiple
corrective surgeries in four women, according to a lawsuit filed in federal
court today.

Thousands of other women could unknowingly be suffering complications from
ObTape, a "transobulator sling" surgically implanted in women to relieve the
symptoms of Stress Urinary Incontinence (SUI). SUI is an involuntarily leakage
of
urine due to increased abdominal pressure, usually from coughing, sneezing or
exercise. It afflicts an estimated 14 million, mostly older, women.

"Because problems with ObTape are relatively unknown in the general
medicalcommunity, we need to get the word out so that women can get appropriate
treatment.
One of my clients, for example, was diagnosed and treated for vaginal
infection for nearly a year before learning that the source of her problem
was ObTape," said Matthew Metz, attorney for the plaintiffs.

Studies have found that up to 20 percent of women who received ObTape may
suffer from complications, typically caused when the ObTape painfully protrudes
into the vaginal wall. An estimated 50,000 women worldwide have received
ObTape. Other slings by other manufacturers have failure rates between 0 and 5
percent, studies indicate.

Surgical removal of ObTape is the primary treatment for correcting
problemsand multiple surgeries are often required.

Mentor stopped marketing ObTape in March 2006, but never recalled the
product. One of the women in the lawsuit had ObTape implanted in August 2006
because her doctor was never notified of the high rates of complications
associated with ObTape.

The lawsuit against California-based Mentor was filed in the U.S. District
Court
for the Central District of California on behalf of Suzanne and Stanley Crews
of Sammamish, WA; Jean and Richard Tommaselli of Virginia Beach, VA; Suzanne and
John Pennington of Lake Dallas, TX; and Carolyn Diane Scharf of Deltona, FL.

The complaint alleges that the four women needlessly suffered significant
pain and
multiple surgeries because Mentor obtained approval to bring ObTape to market
by making misrepresentations to the FDA concerning ObTape's design, manufacture,
safety and efficacy.

Mentor won approval of ObTape from the FDA on the grounds it was
"substantially equivalent" to slings already on the market while during
thesame time applying for a U.S. patent on the grounds ObTape was a new and
unique product, Metz said. The FDA allows an expedited approval process that
does not require clinical trials for medical devices substantially equivalent to
products already on the market.

Ms. Crews, and her husband, previously filed a lawsuit against Virginia
Mason
Hospital in Seattle, WA, alleging that its doctors implanted ObTape without
fully informing her of the risks, that the doctor who implanted the tape
failed to disclose her financial relationship with Mentor and that the
complications she suffered from ObTape were misdiagnosed by Virginia Mason as a
vaginal infection.

For more information about the lawsuit visit
http://www.metzlaw.net/index.php?id=12

For more information contact:
Joe Quintana
206-726-9830 (office)
206-931-3320 (mobile)
Email Contact

Copyright 2008, Market Wire, All rights reserved.

-0-