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Posted at 07:00 AM ET, 07/14/2011

FDA: Complications from mesh for pelvic organ prolapse ‘not rare’

The U.S. Food and Drug Administration issued a statement Wednesday about the use of synthetic mesh in transvaginal surgery to repair pelvic organ prolapse. In addition to updating concerns about the mesh’s safety and efficacy in correcting prolapse, the agency said that, contrary to its stance in its 2008 report on the matter, complications from use of the mesh in treating prolapse are “not rare.”

Prolapse occurs when tissues that hold pelvic organs (including the bladder, uterus, rectum, bowel and the top of the vagina after hysterectomy) weaken, allowing those organs to bulge into the vagina and sometimes past the vaginal opening. More than one pelvic organ can prolapse at the same time. The condition, which often results from childbirth, affects an estimated 30 percent to 50 percent of women, though only about 2 percent experience symptoms related to the condition. Those symptoms can include difficulty urinating or defecating and discomfort or pain during sex.

Though mesh has a history of safe and effective use in hernia surgeries, its use in treating vaginal prolapse has proven problematic. Among many potential complications, the most common is that the mesh, which is implanted sling-wise in the vagina, can erode, causing discomfort, particularly during intercourse. In this report, the FDA identifies a new complication, in which the flexible mesh contracts, causing vaginal shortening, tightening and pain. The paper notes that such complications are less common when the mesh is inserted via the abdomen than when inserted through the vagina.

No specific brand of mesh was singled out as especially problematic.

The paper provides a list of questions for patients to ask their doctors before agreeing to prolapse surgery using mesh; they include, “Why is surgical mesh being chosen for my repair?”

Learn more about prolapse, its treatment and the problems with mesh in this video.

By  |  07:00 AM ET, 07/14/2011

 
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