Women Sue Over Device To Stop Urine Leaks

It was the promise of a quick fix that appealed to Amber Suriani.

She had just turned 40 and was very fit, but whenever she went running or practiced karate — she was working on a black belt — she leaked a bit of urine.

The diagnosis was stress urinary incontinence, and her surgeon recommended a simple procedure to plug the leak by inserting a hammock made of a strip of synthetic meshlike material, called a vaginal sling, under her urethra.

“It was supposed to be a simple ‘in one day and out the next’ kind of thing,” said Ms. Suriani, now 43, who lives in a suburb of Syracuse.

And so it seemed, at least at first. The surgery went smoothly, and the leakage stopped. But several months later, Ms. Suriani developed a persistent, painful and often bloody vaginal discharge.

She was convinced that she had cancer. It did not occur to her that the sling was the source of the problem until a piece of the meshlike tape started working its way through her vaginal wall.

Since then, she has had five operations, each one removing bits of the sling but not the entire thing; another operation is scheduled. She still has chronic discharge and says her sex life with her husband has been affected. She relies on Motrin to get through the day and a sleeping pad to get through the night.

“I feel like I’m never going to be the same again,” Ms. Suriani said, adding: “I’m beginning to feel like this has ruined my life. Not just ruining my life, as in ‘It will get better,’ but ruined, as in ‘I’m stuck with this for the rest of my life.’ I try to stay positive, but it’s getting harder and harder.”

Ms. Suriani’s lawyer, Matthew Metz of Seattle, said she was one of dozens of women suing the maker of the vaginal sling, called ObTape.

The company, Mentor Corporation, based in Santa Barbara, Calif., and recently acquired by Johnson & Johnson, stopped selling ObTape in 2006 but says there is nothing wrong with the product, which was cleared for sale by the Food and Drug Administration.

John Q. Lewis of Cleveland, a lawyer with the firm Jones Day, which represents Mentor, said that there were risks to any surgical procedure and that doctors should have warned patients. He noted that early European studies reported low rates of complications with ObTape.

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http://www.nytimes.com/2009/05/05/health/05tape.html?pagewanted=1&_r=1&r...