Transvaginal mesh refers to synthetic mesh that is placed through the vagina. The FDA released a safety communication that relates specifically to this type of surgical mesh for the treatment of pelvic organ prolapse. Although mesh is also used to treat stress urinary incontinence and in abdominal sacrocolpopexy procedures, the FDA Safety Communication on serious complications associated with transvaginal mesh relates only to mesh placed vaginally for the treatment of pelvic organ prolapse.
History of Transvaginal Mesh:
Traditional repair of pelvic organ prolapse involves bringing together the supportive tissue between the bladder and vagina, and the rectum and vagina. This procedure, also known as anterior and posterior colporrhaphy or A/P repair, has variable success rates and often leads to a 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. Sacrocolpopexy is now considered the gold standard in prolapse treatment, as it treats the prolapse by restoring the normal anatomy of the vagina. The procedure methods have also evolved as they can now be performed from a minimally invasive approach with the da Vinci robot.
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. Just like the sacrocolpopexy, the vaginal repair utilizes synthetic mesh that is placed between the bladder and vagina and rectum and vagina. However, instead of attaching to the sacrum, the vaginal mesh is attached to the sacrospinous ligament.
Complications with transvaginal mesh
The complications mentioned in the FDA safety communication include mesh exposure, mesh contraction, pelvic pain, and painful sexual intercourse. Rates of these complications can be 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 exposure and mesh contraction. However, these symptoms are known to occur even when the mesh is not exposed or contracted. Further, these symptoms can occur during all prolapse procedures that involve the sacrospinous ligament, whether mesh is used or not. These symptoms 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?
One way to minimize these symptoms is to ensure that during surgery, 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 vaginally with a post-operative supportive device.
During the vaginal 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 1week after surgery. The diaphragm elevates the vagina while the mesh incorporates into the tissue. After 1 week, the pessary is removed and the vagina is elevated.
What are the complications associated with the vaginal mesh placed by Dr. Shashoua, and how are they managed?
Occasionally, following a vaginal repair with mesh, there can be mesh exposure. Most mesh exposures are small and are almost always at the suture line, which is the weakest area following surgery. When a mesh exposure occurs, it is usually managed in the office by excising the exposed mesh. Once the mesh is excised, the vagina can then heal.
It is important to note that the vaginal mesh should not be felt by the patient.
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 or ureteral injury, severe hemorrhage, and fistula tract formation.