FDA warns of risks of using mesh to repair pelvic organ prolapse

Transvaginal placement of mesh to correct pelvic organ prolapse (POP) may carry greater risk than other surgical options, the United States Food and Drug Administration warns health care providers and patients in an updated safety communication issued July 13. The procedure shows no evidence of providing greater clinical benefit than other procedures, the FDA says.

Of approximately 100,000 POP repairs using surgical mesh performed in 2010, about 75,000 were transvaginal. The most often reported complications include exposure of the mesh or protrusion from vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation during surgery, and urinary problems. Additional surgeries or hospitalization to treat complications or remove the mesh have also been reported.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” says William Maisel, MD, MPH, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “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.”

Increasing concerns about adverse events linked to transvaginal mesh placement prompted the FDA to issue a safety communication in 2008. Reports of adverse events continued to increase, rising to 1,503 between 2008 and 2010-5 times the number received by the FDA from 2005 to 2007 (reports don't always distinguish between transvaginal and abdominal placement). An FDA review of scientific literature published between 1996 and 2010 found no evidence of greater clinical benefit with mesh than nonmesh procedures.

An outside panel of experts in obstetrics and gynecology will meet on September 8 and 9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI). The latest safety communication addresses only transvaginal placement of mesh to repair POP, not abdominal placement nor the safety and effectiveness of mesh to treat SUI.

The American College of Obstetricians responded to the FDA safety communication with a statement that the College “shares the FDA’s concerns and encourages patients and physicians to review the FDA white paper” describing the health risks associated with using surgical mesh to treat POP.

The white paper is at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm#.