Surgical Mesh Used for Pelvic Organ Prolapse and Incontinence Causing Complications?

As early as October 2008, the FDA released a public health notification about problems associated with transvaginal placement of surgical mesh in the cases of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Why? At the time, there had been more than 1,000 cases (from 2005-2007) of people having suffered severe complications due to the use of surgical mesh. The problems included infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Also reported were cases of recurrence of prolapse or incontinence, and the need for additional surgeries to remove the surgical mesh.

In response, the FDA recommended physicians receive special training in placement techniques and monitor patients carefully for any problems with surgical mesh. The FDA also said patients should be informed of risks associated with the use of surgical mesh so they would understand complications then thought to be “rare” which might follow surgery and affect a patient’s quality of life.

Prior to this time, Mentor Corporation’s vaginal mesh product, known as the ObTape Vaginal Sling, used for stress urinary incontinence, was removed from the market three years after it began to be used as many women experienced severe problems. Also, Mentor’s ObTape’s product caused complications in women who suffered severe infections, extrusions and urinary tract erosions. There continued to be voluntary removals of various brands of surgical mesh from the marketplace including those manufactured by Bard Avaulta, as well as Mentor.

Recently, The Los Angeles Times (July 13, 2011) published an article by Christine Mai Duc, stating that the FDA was reevaluating the use of surgical mesh following a startling increase in the number of complaints by patients in whom surgical mesh had been used: “The review found that vaginal implantation exposes patients to a number of serious risks.” The FDA is now calling a September meeting of a panel of outside experts to determine how the FDA, the medical community and industry should proceed. According to the LA Times, “Manufacturers estimate that 100,000 women were treated for pelvic organ prolapse with surgical mesh last year.”

Once again, medical devices, in this case the surgical mesh products, thought to be substantially similar to other previously FDA-approved devices were placed in the “fast-track” approval process—without clinical trial data requirements. Under this system, vaginal mesh devices were cleared for use in treating incontinence in 1996, and for pelvic organ prolapse in 2002.