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Pelvic Mesh for Incontinence May Carry Added Risk for Women: FDA
Date:7/13/2011

xual intercourse and urinary problems. Reports were also found of the mesh becoming exposed or protruding from vaginal tissue, or organ perforation from tools used during the surgical placement of the mesh.

More than 100,000 mesh procedures for the treatment of pelvic organ prolapse, 75,000 of which were transvaginal, were carried out in 2010 in the United States, the FDA stated.

The FDA also looked over data from 1996 to 2010 pitting mesh surgeries against non-mesh surgeries and found that the former seemed to carry heightened risks but no greater clinical benefit.

Based on their findings, the agency is urging health-care providers to remember that pelvic organ prolapse can be successfully treated without the use of mesh, with potentially fewer complications or adverse events. The agency urges patients who have had the procedure to check in regularly with their doctors, especially if pain or bleeding develops.

In a statement, the American College of Obstetricians & Gynecologists (ACOG) said it "applauds" the agency move. "The College shares the FDAs concerns and encourages patients and physicians to review the FDA's White Paper that describes, in detail, the health risks associated with the surgical mesh products when used to treat pelvic organ prolapse," the ACOG said.

The FDA plans to convene an independent panel of experts to meet and discuss the issue in early September. "Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for [pelvic organ prolapse and stress urinary incontinence] repair, including any changes that would improve our oversight," Maisel said.

More information

Find out more about pelvic organ prolapse at the University of Michigan Health System.

-- HealthDay Staff

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