The surgical placement of mesh via the vagina to repair pelvic organ prolapse may be riskier for the patient compared to other surgical procedures, the FDA (Food and Drug Administration) has warned doctors. The FDA adds that other options carry less risk than this transvaginal surgical procedure.

The FDA informs that even though there is greater risk with transvaginal surgery, there is no evidence of improved quality of life or greater clinical benefit.

Pelvic Organ Prolapse, often referred to as POP is when the pelvic organs, such as the uterus, bowel and bladder drop from their normal position, they may bulge or prolapse into the vagina. This occurs because the internal structures that support them become too weak.

A POP is not life-threatening, however it can cause serious discomfort among women, as well as disrupting their defecatory, urinary and sexual functions. A POP can undermine the patient’s quality of life.

Surgery can be done either by entering through the abdomen or the vagina (transvaginally). A surgical mesh can be introduced to strengthen the support.

William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, said:

“There are clear risks associated with the transvaginal placement of mesh to treat POP. 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.”

In the USA last year, over 100,000 surgical procedures to correct POPs were performed using surgical mesh, three-quarters of which were done transvaginally.

In 2008, the FDA warned about adverse events linked to the transvaginal placement of mesh. The number of reported cases of adverse events has continued to rise since 2008. The FDA received 1,503 reports of adverse events from 2008 to 2010; 400% more than during the 2005 to 2007 period. Some of the reports, however, did not specify whether the procedure was done through the abdomen or vagina.

Common adverse events associated with the surgical mesh placement include:

  • Bleeding
  • During the surgical mesh procedure, organs become perforated
  • Erosion – the mesh protrudes out of the vaginal tissue
  • Infection
  • Mesh becomes exposed
  • Pain during sex
  • Pain
  • Urinary problems
  • Further surgeries to deal with complications, or to take the mesh out

FDA scientists reviewed published scientific studies which compared non-mesh to mesh surgeries between 1996 and 2010. They found that women who underwent transvaginal POP repair with mesh had a higher risk of adverse events compared to those who underwent POP repair with stitches alone. There was no evidence of greater clinical benefits for mesh than non-mesh surgeries.

The FDA says that doctors should:

  • Acknowledge that in the majority of cases non-mesh procedures are effective
  • Be aware that the mesh is a permanent implant, which can make subsequent surgical repairs harder to carry out, placing the patient at extra risk of complications
  • Understand that abdominally placed mesh for POP repair tends to have a lower risk of complications, compared to going in through the vagina
  • Make sure that the patient is told about the risks and benefits associated with the available procedures

An FDA advisory panel is meeting on September 8th and 9th, 2011. They will discuss the efficacy and safety of surgical mesh used to treat POP and SUI (stress urinary incontinence).

Maisel said:

“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.”

The FDA says that today’s announcement is specific only to the transvaginal placement of mesh to treat POP, and not SUI, or mesh that is placed by going in through the abdomen.

Written by Christian Nordqvist