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Patients say medical device backfired on them
10:38 PM PST on Monday, February 4, 2008
SAMMAMISH, Wash. – A Sammamish woman claims that a device designed to treat incontinence backfired and ended up causing her more harm than good.
At issue is the way the vice was designed, and as a result, between 17 and 18 percent of women who were implanted with it suffered complications, and many of them were forced to undergo surgery to have the device removed.
But for Suzanne Crews, even that didn’t work.
After two decades of dealing with the embarrassing problem of incontinence, a doctor told Suzanne Crews about a new type of surgery that could solve her problem. She agreed to have “sling surgery,” designed to stop the bladder from leaking.
She was part of a clinical trial at Virginia Mason that used different materials for the “slings.”
“I have known other people that have had sling surgery and to my knowledge none of them has had any complications and they are just happy as they can be. And, well, I was at first,” said Crews.
But Crews says five months later, she started having complications.
“The problem is, it doesn't allow the tissue to get through the mesh and so it's constantly like wax paper rubbing against the woman's body and that's causing infection, causing the problems,” said Matthew Metz, attorney.
The following year, Crews got a letter from Virginia Mason acknowledging that ObTape may have been causing vaginal discharge and the hospital stopped using it.
After four surgeries, the device has still not been removed entirely, and Crews is still having problems.
Last month, she filed a lawsuit against Mentor Corporation, the maker of ObTape.
Across the country, the medical company faces more than two dozen lawsuits from women who claim they have suffered serious internal injuries from a device that was supposed to greatly improve their lives.
Crews is also suing Virginia Mason alleging that doctors knew women were having complications with ObTape, yet they didn't tell her about the risks.
Virginia Mason wouldn't comment on pending litigation but they point out that patients taking part in a clinical trial sign a consent form and are informed of the risks.
Mentor Corporation removed ObTape from the market three years after introducing it. By then, the device had been implanted in more than 35,000 women in the U.S.
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