Avoiding and Managing Synthetic Mesh Complications After Surgeries for Urinary Incontinence and Pelvic Organ Prolapse

In 1998 synthetic midurethral slings became commercially available in the United States. These procedures were robustly compared with suspension procedures, and pubovaginal slings were found to be much less invasive with comparable long-term outcomes. These slings have stood the test of time and would be considered by most to be the “gold standard” for the surgical treatment of stress urinary incontinence (SUI) (see Chapter 55 ). In 2001 the first transvaginal mesh kit, for repair of pelvic organ prolapse, became commercially available.

Although abdominal sacral colpopexy with synthetic mesh (see Chapter 41 ) is a well-accepted and proven procedure, a variety of vaginal procedures with synthetic and biologic mesh were described and advocated in certain women with prolapse.

Wide adoption of vaginal mesh use occurred between 2005 and 2010 mostly because of the marketing of commercially available mesh kits. Consequently, in 2008, after more than 1000 voluntary reports of safety problems in the Manufacturer and User Facility Device Experience Database (MAUDE), the U.S. Food and Drug Administration (FDA) released a public health notice regarding complications and adverse events associated with the use of mesh in prolapse and stress incontinence procedures. In 2011 the FDA released a safety communication that updated the pelvic health notification and concluded that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare” and “it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional nonmesh repair.” The FDA further recommended that vaginal mesh surgery should be selected only after weighing the risks and benefits of surgery with mesh versus all surgical and nonsurgical alternatives. In 2016 the vaginal mesh devices used to correct pelvic organ prolapse were changed from a class II to class III device by the FDA, thus requiring they go through a premarket analysis by performing 522 postsurveillance studies for associated safety and efficacy. In July 2018, the FDA ordered the manufacturer of mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse in the posterior compartment (rectocele) to stop selling and distributing their products. In April of 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. Synthetic mesh products for the treatment of SUI and sacrocolpopexy were not affected by this FDA order.

Historically a variety of biologic tissue has also been available for utilization, including autologous grafts, allografts, and xenografts. Currently very little transvaginal mesh is being used to augment vaginal prolapse repair. However, more than 10 million women have had some sort of transvaginal mesh kit placed, and thus a full understanding of how these kits were placed is beneficial to the surgeon who needs to manage any complication related to the mesh placement.

Mesh-Related Complications After Sacrocolpopexy

Sacrocolpopexy is an abdominal, laparoscopic, or robotic procedure that involves attaching a Y-shaped graft (usually synthetic mesh) to the anterior and posterior vaginal wall and securing it to the anterior longitudinal ligament of the sacrum (see Chapter 41 ). Mesh complications after abdominal sacrocolpopexy are fairly rare and primarily center on mesh or suture erosion into the vagina ( Fig. 56.1 ). The rate of erosion after abdominal sacrocolpopexy ranges from 3% to 10%.

A variety of risk factors have been identified for mesh and suture erosion after sacrocolpopexy. One study found three identifiable risk factors: (1) concurrent hysterectomy, which increased the erosion rate from 4% to 14%; (2) the use of expanded polytetrafluorethylene (ePFTE; Gore-Tex; GORE Medical, Newark, N.J.), which has a fourfold higher risk (19% vs. 5%) of mesh erosion when compared with those with non-ePTFE mesh; and (3) smoking, which was associated with a fivefold increase in risk of mesh erosion.

Managing mesh erosion after sacrocolpopexy may require only observation and topical estrogen; however, in my experience, it almost always requires surgical excision. Surgical management of mesh erosion after sacrocolpopexy can be technically challenging, partially due to the usually high location within the vaginal canal, the amount of mesh used in the procedure, and the ingrowth of tissue into the mesh, making surgical dissection difficult. Vaginal and abdominal routes for mesh excision have been described. In my experience, most mesh exposures, assuming there is no infection or pelvic abscess, can be successfully managed vaginally with a technique of sharp dissection of the exposed mesh away from surrounding tissue, with aggressive downward traction on the mesh. The mesh is cut away as high as possible, and the vaginal defect is closed ( Fig. 56.2 ). Vaginal entrance into the peritoneum significantly facilitates successful removal of the mesh and also allows resuspension of the vaginal apex if necessary.

Mesh Complications After Synthetic Midurethral Slings

Vaginal Extrusion

Vaginal extrusion occurs in approximately 3% of cases of synthetic midurethral slings ( Fig. 56.3 ). Symptoms of vaginal erosion can be discharge, bleeding, patient/partner dyspareunia/hysparunia, and recurrent urinary tract infection. Most data on the management of vaginal mesh extrusion come from small case series involving both surgical and nonsurgical treatments with varying success rates. Topical estrogen is a reasonable initial treatment for women with small extrusions; however, subsequent mesh excision is often necessary. Excision of exposed mesh can occur in the office setting or operating room, with the important questions being timing of excision and how much mesh to excise. On the basis of my experience, office-based management is most often successful when the erosion is less than 1 cm in size, it is easily visible/accessible with office instrumentation, and the patient has healthy vaginal tissues. Local anesthesia is necessary before any attempt at office-based trimming or epithelial reapproximation. I prefer 1% lidocaine without epinephrine. Sterile gloves and instrumentation should be used, and in addition to an assistant, instruments commonly needed include a speculum, scissors, forceps with teeth, a needle driver, and suture. Excision of a portion of the mesh in the office can be done, but often, mobilization of vaginal epithelium around the mesh with reapproximation using suture in a tension-free manor is also necessary.

Fine surgical scissors (Metzenbaum) should be used to mobilize the vaginal epithelium around the area of erosion. If mesh is going to be excised, a right-angle clamp is placed between the mesh and underlying tissue and gently opened to elevate the sling away from the tissue. It can then be trimmed and the vaginal epithelium around the eroded tissue should be mobilized, with the goal of closing the defect with well-vascularized, healthy vaginal epithelium. The rate of recurrent SUI after vaginal excision of eroded mesh is 30% to 50%.

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