SOURCE: Metz Law Group PLLC

January 24, 2008 14:53 ET

Mentor Corporation Misled FDA, Harmed Women, Lawsuit Alleges

Studies Suggest Thousands Potentially at Risk

SEATTLE, WA--(Marketwire - January 24, 2008) - 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 medical community, 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 problems and 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 the same 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

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