F.D.A. Halts U.S. sales of Vaginal Mesh

The FDA in a statement yesterday has mandated that vaginal mesh to treat pelvic organ prolapse (cystoceles mainly) be removed from all hospital operating room shelves because of safety concerns. Doctors Arendt, Jacoby and Miller (all FPMRS board certified) have been implanting vaginal mesh for prolapse since 2008 and have had good long-term outcomes with low complication rates. They have no concern over the use of vaginal mesh for those patients who need mesh. If you have a vaginal mesh placed for prolapse or incontinence, and you are doing well without concerns, please be reassured you are safe from the problems being reported by the FDA.

The FDA has removed the vaginal mesh kits for prolapse based on 522 studies that were designed to compare non-meshed prolapse repairs to those with mesh in both efficacy and safety. The 1-year data, which is available to the FDA, shows comparable complication rates between the two study groups. The study is designed for 3-year outcomes, but due to FDA actions, it will not be completed.  We believe, at WUA, the use of mesh in some groups of women, will allow them to have more durable prolapse repairs, thereby allowing them to avoid multiple surgeries for recurrent prolapse in their lifetime. The FDA’s decision to pull mesh will be harmful to those women who would have benefited. Leaders in Female Pelvic Medicine and Reconstructive Surgery (FPMRS) have indicated in public statements that they support the use of vaginal mesh for prolapse in high risk patients.

WUA physicians will continue to provide alternative options to treating prolapse, such as trans-vaginal native tissue repairs, robotic sacrocolpopexy, and robotic paravaginal repairs. Please call our office to make an appointment if you have additional questions.