FDA warns about the risk of using mesh in Pelvic Organ Prolapse surgery

The U.S. Food and Drug Administration in a news release issued a safety communication to health care providers and patients saying placing mesh through the vagina “transvaginal” to repair pelvic organ prolapse poses more risks than repairing the problem using other techniques and does not come with benefits such as “improved quality of life.”

William Maisel, MD, deputy center director for science and chief scientist at the Center for Devices and Radiological Health at the FDA says:

We do notĀ see conclusive evidence that using mesh for transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh.”

In 2010, surgeons performed 100,000 Pelvic Organ Prolapse (POP) surgeries using surgical mesh and approximately, 75,000 of these surgeries were using the transvaginal procedure. POP is a condition in which the pelvic organs such as bladder, bowel and uterus drop or prolapse into the vagina.

According to the FDA, complications involved with the use of mesh include:

  • bleeding
  • painful sexual intercourse
  • organ perforation caused by surgical tools
  • infection
  • pelvic or groin pain
  • persistent vaginal bleeding or discharge
  • mesh eroding or protruding outside of vaginal tissues
  • urinary problems

When these complications occur, patients sometimes have to be hospitalized to treat the complication or to surgically remove the mesh.

Other techniques to correct the problem is through the abdomen where stitches or surgical mesh is used in the repair..

According to the FDA, surgical mesh is not the problem, but the actual application of surgical mesh in the transvaginal technique. Surgical mesh is routinely used in hernia surgery.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent patients with medical malpractice and product liability cases.

FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks
FDA News Release
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