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

patients if mesh is being used.

The FDA recommends that patients:

  • Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
  • Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
  • Those who have had POP surgery but don't know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

The FDA also announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity. The panel will discuss the risk of transvaginal POP repair, clinical studies that may be necessary to address risks and benefits of this type of surgery, and the FDA's interim recommendations for health care professionals and patients.

"Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight," Maisel said.

Today's safety communication is limited to the transvaginal placement of mesh to repair POP. It does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.

For more information:

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/u
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SOURCE U.S. Food and Drug Administration
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