Transvaginal Mesh: An Overview
The use of transvaginal mesh for the treatment of pelvic floor disorders has received a great deal of attention in the media over the past several years. In 2008 (followed by an update in 2011), the FDA issued a public health notification to alert health care practitioners to the “complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences.”
Unfortunately, the data on which the FDA based their notification was misleading and nonspecific. Although the FDA saw a rise in the number of complications with mesh devices over a given period of time, that was not measured against the total number of mesh procedures conducted in the U.S., which influences the percentage of complications. In addition, the FDA did not consult physicians who specialize in Female Pelvic Medicine and Reconstructive Surgery (FPMRS) prior to writing the notification.
The fallout from their statement has been tremendous. Lawsuits have been filed against the companies who produce transvaginal mesh. More troublesome is the fear it has instilled: the fear in patients who have already undergone mesh procedures and fear among patients who could greatly benefit from treatment using mesh.
What is transvaginal mesh?
Transvaginal mesh is a broad term that applies to any piece of mesh that is placed into the vagina through vaginal incisions to either support the urethra and prevent leakage of urine due to stress incontinence or to support the top of the vagina or uterus in the case of uterine or vaginal prolapse (where the top of the vagina or uterus is falling down and towards the opening of the vagina).
Transvaginal mesh is made from large-pore polypropylene – a “thermoplastic polymer” – and is permanent. Once placed in the body, the surrounding tissue grows into the mesh within 1-2 weeks, holding it in place. Different mesh devices are on the market currently to treat prolapse and incontinence. As a result of the awareness of potential complications associated with these devices, any company that produces a mesh device is now required to complete a 522 Postmarket Surveillance study to confirm the safety of their product.
Why do we use transvaginal mesh?
Many studies, as well as our own clinical experience, have proven the benefits of transvaginal mesh. Midurethral slings used to treat stress urinary incontinence have a 90% success rate at 10 years (the longest study that has ever been done) with minimal associated complications.
Transvaginal mesh is also used to treat prolapse by adding durability to the repair. Some studies have shown a high recurrence rate with native tissue repairs and for those patients at high risk for recurrence, mesh may help prevent prolapse from returning.
The abdominal approach is another way in which mesh is used to repair prolapse. Through an abdominal or laparoscopic incision, mesh is placed on the vagina and attached to a strong ligament along the inside of the tailbone. This is called a sacrocolpopexy and often considered the “gold standard” for prolapse repair. Furthermore, this particular surgical approach and associated polypropylene mesh was not included in the FDA notification.
What can go wrong?
As with any surgical procedure, complications can occur with the placement of transvaginal mesh. The complication that is specific to vaginal mesh is exposure of the mesh. Given the use of newer mesh products and different methods for placement, exposure of mesh is usually very low, 1%-2%. Another complication that can occur is shrinkage of the mesh resulting in vaginal scarring or pain. In the hands of a competent surgeon, the complication rates are low and when they do occur, they can be treated and resolved.