|August 2011 · Vol. 23, No. 8
Transvaginal mesh placement for POP tied to adverse events
Transvaginal mesh tied to more risks than other surgical approaches in pelvic organ prolapse surgery
The U.S. Food and Drug Administration has warned health care providers and patients that transvaginal surgical placement of mesh to repair pelvic organ prolapse (POP) may be riskier than other surgical approaches, with no greater clinical benefit.
More than 100,000 POP repairs used surgical mesh in 2010, with approximately 75,000 of those performed using a transvaginal approach, according to the FDA. In 2008, the agency issued a safety communication regarding the increased risk of adverse events associated with transvaginal placement of mesh, which has continued to increase since that time. The agency received 1,503 adverse event reports associated with mesh used for POP repair between 2008 and 2010, five times as many the FDA received between 2005 and 2007.
The agency also conducted a review of scientific literature published between 1996 and 2010 and found that transvaginal POP repair with mesh was associated with additional risks as compared with transvaginal POP repair with stitches alone, with no additional clinical benefit. According to the FDA, the most frequently reported complications from surgical mesh used to repair POP include erosion, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Also, additional surgeries or hospitalization to treat complications or to remove the mesh have been reported.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
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