WEDNESDAY, July 13 (HealthDay News) -- A mesh device used to support the pelvic organs and help ease incontinence in women appears to carry more risks than previously thought, the U.S. Food and Drug Administration announced Wednesday.
In an "updated safety communication warning," the FDA said that surgical placement of the mesh through the vagina to fix a condition known as pelvic organ prolapse may lead to greater risks than other surgical methods, while not providing any greater clinical benefit.
"There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse," Dr. William Maisel, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, said in an agency news release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications."
Pelvic organ prolapse involves a weakening or stretching of internal structures that support organs such as the bladder, bowel and uterus. These organs then drop to below their normal position and bulge (prolapse) into the vagina. This can lead to pelvic pain and disruption of sexual, urinary or defecatory function, the FDA explained.
There are numerous means of correcting the problem, such as surgeries carried out through the abdomen or the vagina using traditional stitches, or using the mesh to help improve internal support of the pelvic organs.
However, the FDA says that between 2008 and 2010, the agency received more than 1,500 "adverse event" reports regarding patients who had undergone the mesh procedure -- five times as many as were reported between 2005 and 2007. Some of the most commonly cited problems included pain, infection, bleeding, pain during se
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