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FDA: Surgical Placement of Mesh to Repair Pelvic Organ Prolapse Poses Risks
Date:7/13/2011

safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.  The reports don't always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems.  Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:

  • Recognize that in most cases, POP can be treated successfully without mesh;
  • Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
  • Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
  • Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform
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SOURCE U.S. Food and Drug Administration
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