In a front page story, the Boston Globe reports, “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 Los Angeles Times reports that the “FDA says a review of industry literature and patient reports has shown little evidence that the device improves pelvic organ prolapse, in which a woman’s uterus, bladder or rectum can slip out of place.”
The AP reported, “About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence.” Between 2008 and 2010 the FDA “received more than 1,500 reports of complications from women undergoing vaginal prolapse surgery with mesh, up 500 percent from the prior three years. There were fewer complications among incontinence patients.” The FDA’s “warning applies only to mesh for prolapse. The agency is also reviewing the use for incontinence, though side effects have not been as frequent.”
The Minneapolis Star Tribune reports, “The most-common complication is when the mesh becomes exposed or protrudes from the tissue, as well as pain, infection, bleeding and urinary problems. Three deaths have been associated with prolapse repair using mesh — two bowel perforations and one hemorrhage, according to” the FDA. “Dr. William Maisel, the FDA’s deputy director and chief scientist in the device division, said there are ‘clear risks’ associated with the mesh. ‘The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications.’”
HealthDay reported, “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.
“From the American Association for Justice news release.