FDA Public Health Warning: Vaginal Mesh Use

In October 2008 the FDA issued a notification regarding complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

This is a mouthful, however it relates to the frequently used polypropylene or xenograft (animal or human tissue) pieces of material, to strengthen the weakened vaginal wall.

The FDA describes the problems they have encountered on their website.  Click here. 

The main problem is exposure of the mesh, which means, some part of the mesh is not covered by vaginal tissue. Dependent on the material used, this mesh exposure can be removed or delayed healing awaited with the help of vaginal estrogen. Vaginal estrogen is used to prevent the complication of mesh extrusion also.

I agree that mesh extrusion can be encountered by every surgeon using vaginal mesh implants. A significant amount of women prefer a mesh extrusion over their vaginal organs hanging out. The mesh, not being covered by vaginal tissue is often treatable in the office, or with a small outpatient surgery.

Remember not everybody with pelvic organ prolapse will need surgery, there are other treatment options. Also not everyone requiring surgery will need transvaginal mesh placement.

The FDA describes problems with pain, recurrence of prolapse, urinary problems and perforation of organs during insertion.

Even though it is stated in the medical community that “the only surgeon who has never had a complication does not operate”, it is well known that experience with the procedure diminishes the risk of complications.

Sometimes vaginal scar formation can not be controlled, however most patients who had pain after mesh placement that were referred to me, had their mesh placed too tight, by inexperienced surgeons. The good news is, I was able to relieve all of them from their pain and their prolapse has not returned.

It needs to be remembered that transvaginal mesh placement is not the best procedure for all and some women may be better off with a laparoscopic sacrocolpopexy ( the use of mesh with the help of a scope placed through the belly button) or a vaginal repair without mesh.

It needs to be emphasized that the use of mesh is permanent and as with any procedure there are downsides.

The general failure rate of pelvic organ prolapse repair is 30%. It has been scientifically proven that the use of mesh for a condition of prolapse called cystocele (bladder prolapse), diminishes the rate of recurrence.

What to do if you have pelvic organ prolapse and your surgeon has discussed the use of mesh? The FDA website describes questions that you should ask your surgeon pertaining to the need for the mesh, experience of the surgeon and how the surgeon will deal with possible complications.

The best recommendation I can give to you is to go on the FDA website and choose your surgeon wisely. Ask questions and make sure your surgeon is an urogynecologist or gynecologist/urologist with extensive experience with the use of vaginal mesh. If you are postmenopausal use your vaginal estrogen as prescribed.

Dr. Sprock is fellowship trained in urogynecology and has an extensive experience in the use of mesh. She is at the forefront of development of new techniques for vaginal prolapse repair and has worked closely with industry in the development of some mesh products, to improve the outcome. She continues to improve techniques and products and has instructed hundreds of surgeons in the safe use of vaginal meshes to improve the outcome of pelvic organ prolapse repair.