FDA warns mesh used in surgery poses risk

FDA warns mesh used in surgery poses risk

July 14th, 2011 // 12:51 pm @

Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.

The agency warned patients and surgeons to consider other options.

The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh – manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies – for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, the agency said, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include pain ful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

“I’m in constant pelvic pain,’’ said Jill Goodwin, a New Hampshire health care worker who had mesh sold by C.R. Bard Inc. implanted in 2008 and has since suffered abdominal bleeding and pelvic nerve damage. “I have spasms all the time, and I’m limited in what I can do. Some days it’s all I can do to get out of bed.’’

Bard officials did not respond to a phone call and e-mail seeking comment.

For many of the manufacturers, the mesh is just one of many products and generates a small portion of sales. But the FDA action could lead to a flurry of new lawsuits.

Boston Scientific, which has had a string of setbacks stemming from its cardiac devices in recent years, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.

“If the product is defective when it’s used in the manner intended by the manufacturer, there’s liability,’’ said Tom Girardi, senior partner at the Girardi Keese law firm in Los Angeles, which represents about 75 patients who used Boston Scientific’s mesh. “It is unfortunate that the FDA doesn’t come to these conclusions before all these people get hurt.’’

Boston Scientific executives said yesterday that they are looking into the issue but would not say whether they plan to continue selling the mesh for vaginal surgery.

Covidien, a company incorporated in Ireland with its corporate headquarters in Mansfield, supplies mesh to Bard, which markets it to health care providers to treat pelvic organ prolapse.

“We are not selling any mesh for this indication,’’ said Covidien spokesman Bruce Farmer. “We do supply product for Bard, which they use for this indication.’


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