FDA issues updated safety warning on transvaginal mesh

July 28, 2011

The FDA has issued an updated safety communication warning health care providers and patients that transvaginal placement of mesh to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.

The FDA has issued an updated safety communication warning health care providers and patients that transvaginal placement of mesh to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.

"There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse," said William Maisel, MD, MPH, of the FDA. "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."

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the agency said the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007.

The most frequently reported complications from surgical mesh include erosion, pain, infection, bleeding, dyspareunia, 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 recommends that health care providers:

  • recognize that in most cases, pelvic organ prolapse 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 may result in lower rates of mesh complications compared with transvaginal surgery with mesh.

In a statement released shortly after the FDA announcement, the AUA emphasized that the warning only pertains to use of transvaginal mesh for pelvic organ prolapse, and does not concern the use of mesh for the surgical treatment of stress urinary incontinence.

"This announcement reinforces the importance of discussing the potential for these complications with prospective patients prior to performing pelvic organ prolapse surgeries that utilize mesh, and of documenting that discussion in the patient’s medical record," the AUA statement said.

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 prolapse and stress incontinence. The panel will discuss the risk of transvaginal prolapse 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.