Transvaginal mesh refers to synthetic mesh that is placed through the vagina. The FDA released a safety communication that relates specifically to transvaginal placement of surgical mesh for the treatment of pelvic organ prolapse. Synthetic mesh is also used to treat stress urinary incontinence and synthetic mesh is used in abdominal sacrocolpopexy. However, the FDA Safety Communication on serious complications associated with transvaginal placement of surgical mesh relates specifically to mesh placed vaginally for the treatment of pelvic organ prolapse.
History of Transvaginal Mesh:
Urogynecologists have long been searching for an alternative to the traditional Anterior and Posterior Colporrhaphy (A/P repair) in the treatment of pelvic organ prolapse. When an A/P repair procedure is done, the supportive tissue between the bladder and vagina, and the rectum and vagina, are brought together. The success of this procedure is variable and the procedure often times leads to an unacceptable shortening of the vagina.
In the mid-1960s, an abdominal alternative to the A/P repair was introduced. The procedure, now called the abdominal sacrocolpopexy, involves the elevation of the vagina to the sacrum via an abdominal incision.
Over the years, the mesh used to elevate the vagina has evolved as has the approach to the procedure. The sacrocolpopexy is the gold standard in prolapse treatment and is now done with the minimally invasive da Vinci robot. The sacrocolpopexy is effective because it treats the prolapse by restoring the normal anatomy of the vagina.
The vaginal alternative to the A/P repair has evolved more dramatically over the past 50 years. The initial procedures involved elevating the vagina directly to the sacrospinous ligament with suture.
Biologic graft material was then incorporated into the repair to increase the success rate.
However, outcomes from these repairs remained unpredictable.
Vaginal repair with synthetic mesh was then introduced and is the subject of the current transvaginal mesh controversy. The idea is to perform a transvaginal procedure that results in a repair that is similar to the sacrocolpopexy. Just like the sacrocolpopexy, synthetic mesh is placed between the bladder and vagina and rectum and vagina. But in the transvaginal approach, the vagina is elevated to the sacrospinous ligament instead of the sacrum.
Complications with transvaginal mesh
The complications mentioned in the FDA safety communication on the transvaginal placement of surgical mesh for pelvic organ prolapse include mesh erosion, mesh contraction, pelvic pain, and painful sexual intercourse.
Rates of mesh erosion and mesh contraction are minimized by placing the mesh meticulously in the correct anatomic plane. When placed correctly, the vaginal portion of the mesh is lying identically as if the mesh were placed abdominally during sacrocolpopexy.
The FDA communication explains that pelvic pain and painful sexual intercourse are the result of mesh erosion and mesh contraction. However, these symptoms are known to occur even when the mesh does not erode or contract. Further, these symptoms occur during all prolapse procedures that involve the sacrospinous ligament, whether mesh is used or not. These symptoms also are less likely to occur abdominally, where the elevation point of the mesh is the sacrum and not the sacrospinous ligament.
What can be done to minimize the symptoms of pelvic pain and painful sexual intercourse?
Another way to phrase this question is to ask how can the symptoms of pelvic pain and painful sexual intercourse following transvaginal placement of surgical mesh for pelvic organ prolapse be minimized to the rates of these symptoms encountered following sacrocolpopexy?
One way to minimize these symptoms is to ensure during surgery that the vagina is elevated to the non-mobile segment of the sacrospinous ligament. This portion of the ligament has less pain fibers than the more muscular part of the ligament.
Another way is to place the mesh in a tension free manner.
During the tension free approach, the mesh is placed in the correct anatomic plane and then a small pessary in the shape of a diaphragm is left in the vagina for 6 weeks after surgery. The diaphragm elevates the vagina while the mesh incorporates into the tissue. After 6 weeks, the pessary is removed and the vagina is elevated in an entirely tension free manner.
The most common complication following a mesh augmented vaginal repair is mesh extrusion. This occurs when small fragments of mesh are exposed in the vagina. Most mesh extrusions are managed in the office by excising the extruded mesh.
It is important to note that when mesh is placed properly, it should not be felt by the patient. If placed properly and a mesh extrusion occurs, it is almost always at the suture line in the vagina, which is the area of weakness following the surgery. This is why removal of the extruded mesh takes care of the problem.
The incidence of mesh extrusion in patients who underwent their first vaginal mesh surgery with Dr. Shashoua is less than 5%. As mentioned above, most mesh extrusions are managed by simple office excision.
There are many other risks with mesh augmented vaginal or da Vinci repairs but these risks are extremely rare in our patients. These risks include erosion of the mesh into the bowel or vagina, bowel injury, unrecognized bladder injury, severe hemorrhage, and fistula tract formation.