FDA Questions Vaginal Mesh Implants

In the wake of numerous reports of serious complications as well as no evidence that the meshes actually provide the medical benefit for which they are marketed, the FDA is re-assessing the trans-vaginal sling or mesh that has been used to treat urinary incontinence in women.
The vaginal mesh is designed to improve pelvic organ prolapse wherein a woman’s bladder, uterus, or rectum slips out of place. Not only was the vaginal mesh unable to provide release for pelvic organ prolapse, the medical mesh was shown to potentially cause serious complications such as tissue erosion and vaginal shrinkage.
“We are reassessing our regulatory options for this product,” said Dr. William Maisel, a chief scientist for the agency’s medical devices arm. Maisel said options include requiring clinical trials to be conducted and changing the classification of vaginal mesh implants to require formal pre-market approval applications. “We feel that the routine use of mesh for transvaginal POP treatment is not necessary.”
The situation is serious enough that the FDA has called for a September meeting of outside experts to assess the situation including a potential vaginal mesh recall. It’s estimated that some 75,000 receiving the vaginal mesh last year. The medical device was approved for use in 1996 to treat female incontinence and in 2002 the vaginal mesh was approved for treatment of pelvic organ prolapse.