Controversies in the Management of Mesh-Based Complications




Since the introduction of the synthetic midurethral sling, several transvaginal mesh delivery systems have been developed for treating stress incontinence and pelvic organ prolapse. Widespread use of these “kits” has introduced a new dilemma of mesh-specific complications that female pelvic surgeons must manage. Differing treatment techniques have been described and controversy exists as to which method is preferred for vaginal mesh extrusion, mesh perforations, pelvic pain, and dyspareunia. This article addresses the differing management strategies for mesh complications after reconstructive surgery and highlights the available literature on the success of each option.








  • Multiple options for managing mesh complications after pelvic reconstructive surgery are described in the literature, but the paucity of supportive data creates a challenge for the patient and pelvic surgeon electing a treatment.



  • Expectant management or topical estrogen therapy for vaginal mesh extrusion has reported success in 37% to 42% of patients.



  • Mesh in the bladder or urethra can be managed endoscopically using various tools; however, success is often less than 50%.



  • If conservative measures or endoscopic approaches fail, timely definitive management with open suprapubic, transvaginal, or laparoscopic techniques is appropriate.



  • Pure transvaginal techniques for extrusions and urethral and bladder perforations have been described with good outcomes and earlier convalescence than major abdominal operations.



Key Points


Introduction


Unsatisfactory success rates and relative morbidity of native tissue repair for stress urinary incontinence and pelvic organ prolapse encouraged innovative investigation into augmenting repair with synthetic and biologic grafts. The success of the tension-free transvaginal tape introduced by Ulmsten and Petros in 1995 spurred widespread development of transvaginal synthetic mesh delivery systems to treat incontinence and pelvic organ prolapse. The first synthetic mesh repair system for pelvic organ prolapse was approved for use by the U.S. Food and Drug Administration in 2001, and since then many of these “kits” have been marketed. Use of these novel methods by pelvic surgeons opened an unsuspected Pandora’s box of mesh-specific complications to the field. Management of these sequelae varies between surgeons, and most published data are limited to case reports and small retrospective series. This article focuses on the differing management options for treating synthetic mesh complications after incontinence and prolapse surgery.




Types of mesh-based complications and reported incidence


A variety of adverse events associated with the use of synthetic mesh in female reconstructive surgery have been reported in the literature. This article focuses on mesh-specific complications after midurethral slings, transvaginal mesh delivery systems for pelvic organ prolapse, and sacrocolpopexy. The discussion is limited to complications in which the “correct” treatment choice is controversial, and focuses on terminology established by the International Continence Society and International Urogynecological Association, highlighting alternatives in management of mesh exposure, extrusion, prominence, perforation, contraction, pelvic pain, and dyspareunia.


Synthetic midurethral slings have an overall reoperation rate of 1.8% to 5.4%, partly because of complications such as mesh extrusion, pelvic pain, dyspareunia, and urethral and bladder perforations. Bladder perforation rates have been reported as high as 12%, occurring in 2.7% to 3.9% of cases in randomized controlled trials. Bladder perforations were identified in 4.7% of bottom-to-top retropubic slings compared with 8.5% of top-down approaches and in only 0.3% of transobturator slings. In a contemporary review of a large insurance-based cohort, trocar bladder perforation occurred in 1.4% of cases, although these results may be limited by underreporting. The number of missed trocar perforations that present with delayed complications is more difficult to define. Mesh has been identified in 14% to 27% of symptomatic patients presenting with delayed complications after synthetic midurethral slings. Intraoperative urethral perforations occur rarely and are reported in fewer than 1% of sling operations. Delayed presentation of urethral extrusion or missed perforation is reported in 0.3% to 1.0% of patients. Vaginal extrusion of mesh occurs in approximately 3% of cases. The reoperation rate for vaginal mesh extrusion after synthetic midurethral sling is reported to be 0.8%.


Similar types of mesh complications occur after prolapse repair. Vaginal mesh extrusion rates range from 2.7% to 11.3% after transvaginal mesh delivery systems according to large retrospective cohorts. Randomized controlled trials comparing mesh repair and native tissue repair report extrusion in 11.7% to 16.9% of patients. The rate of bladder perforation, either dissection-related or trocar-related, is between 0.6% to 0.73%. Bowel and rectal perforations occur less commonly, and postoperative vesicovaginal fistulas occur in 0.29% of cases.


In randomized controlled trials, the rate of de novo dyspareunia was found to be 8.0% to 9.1% in patients receiving mesh, although no statistical difference was found compared with native tissue repair. An observational cohort of 294 women found de novo pelvic pain in 5% and de novo dyspareunia in 26% of patients after transvaginal mesh. In this study, pain and dyspareunia before surgery were independent risk factors for postoperative symptoms. Several studies report lower rates of dyspareunia in patients with mesh repair than in those with traditional repairs. Symptomatic mesh contraction varies greatly between studies, reported as low as 0.4% and as high as 11.7%.




Types of mesh-based complications and reported incidence


A variety of adverse events associated with the use of synthetic mesh in female reconstructive surgery have been reported in the literature. This article focuses on mesh-specific complications after midurethral slings, transvaginal mesh delivery systems for pelvic organ prolapse, and sacrocolpopexy. The discussion is limited to complications in which the “correct” treatment choice is controversial, and focuses on terminology established by the International Continence Society and International Urogynecological Association, highlighting alternatives in management of mesh exposure, extrusion, prominence, perforation, contraction, pelvic pain, and dyspareunia.


Synthetic midurethral slings have an overall reoperation rate of 1.8% to 5.4%, partly because of complications such as mesh extrusion, pelvic pain, dyspareunia, and urethral and bladder perforations. Bladder perforation rates have been reported as high as 12%, occurring in 2.7% to 3.9% of cases in randomized controlled trials. Bladder perforations were identified in 4.7% of bottom-to-top retropubic slings compared with 8.5% of top-down approaches and in only 0.3% of transobturator slings. In a contemporary review of a large insurance-based cohort, trocar bladder perforation occurred in 1.4% of cases, although these results may be limited by underreporting. The number of missed trocar perforations that present with delayed complications is more difficult to define. Mesh has been identified in 14% to 27% of symptomatic patients presenting with delayed complications after synthetic midurethral slings. Intraoperative urethral perforations occur rarely and are reported in fewer than 1% of sling operations. Delayed presentation of urethral extrusion or missed perforation is reported in 0.3% to 1.0% of patients. Vaginal extrusion of mesh occurs in approximately 3% of cases. The reoperation rate for vaginal mesh extrusion after synthetic midurethral sling is reported to be 0.8%.


Similar types of mesh complications occur after prolapse repair. Vaginal mesh extrusion rates range from 2.7% to 11.3% after transvaginal mesh delivery systems according to large retrospective cohorts. Randomized controlled trials comparing mesh repair and native tissue repair report extrusion in 11.7% to 16.9% of patients. The rate of bladder perforation, either dissection-related or trocar-related, is between 0.6% to 0.73%. Bowel and rectal perforations occur less commonly, and postoperative vesicovaginal fistulas occur in 0.29% of cases.


In randomized controlled trials, the rate of de novo dyspareunia was found to be 8.0% to 9.1% in patients receiving mesh, although no statistical difference was found compared with native tissue repair. An observational cohort of 294 women found de novo pelvic pain in 5% and de novo dyspareunia in 26% of patients after transvaginal mesh. In this study, pain and dyspareunia before surgery were independent risk factors for postoperative symptoms. Several studies report lower rates of dyspareunia in patients with mesh repair than in those with traditional repairs. Symptomatic mesh contraction varies greatly between studies, reported as low as 0.4% and as high as 11.7%.




Management of mesh complications after synthetic midurethral slings


Vaginal Extrusion


Differing treatment options for the management of vaginal mesh extrusion are described in the literature, and most outcomes data are derived from small case reports with varying success. Thus, a dilemma is created for the surgeon managing these complications. Described methods range from observation alone, use of topical estrogen or antiseptics, systemic or topical antibiotics, office-based trimming of the extruded material, and operative excision. Adding to the conundrum, the duration and frequency of medical therapy are not proven, the appropriate time to intervene for treatment failure is not known, and the amount of mesh to excise has not been standardized.


Outcomes for expectant management and treatment with topical therapies such as estrogen differ among studies. Four patients with vaginal mesh extrusion in a cohort of 90 retropubic slings were all treated expectantly without any topical estrogen or antibiotics. The area of extrusion was 0.5 to 1.0 cm and all resolved spontaneously with epithelialization after 6 weeks. In a series involving both prolapse and sling mesh, failure with conservative methods was reported in 63%. Success has not been reproducible and definitive treatment with mesh excision is often recommended.


Office-based trimming and operative excision with approximation of the vaginal epithelium are preferred management options, particularly if conservative therapies have failed. The questions to answer are the timing of intervention and the amount of mesh to excise. One should ensure adequate tissue quality before reconstruction, and any evidence of infection, inflammation, or atrophy must be addressed. Addition of vaginal estrogen cream before surgical reconstruction may enhance tissue quality. Once the decision has been made to surgically intervene, the choice of office-based excision or surgical exploration depends on the amount and location of the mesh extrusion and its accessibility to the surgeon; involvement of adjacent organs; and patient comfort. The amount of mesh to excise also depends on the size and location of the extrusion, involvement of adjacent structures, and symptoms. In managing asymptomatic extrusion or focally symptomatic extrusion, excision of enough material to allow tension-free approximation of vaginal epithelium is necessary to prevent dehiscence or recurrence. Leaving protruding edges of mesh may increase this risk. Care must be taken to not excise more than necessary, because maintenance of continence is key. Tijdink and colleagues report a 36% recurrent stress incontinence rate after excision for mesh extrusion. This finding approximates published incontinence rates after sling incision for obstruction, reported at 21%.


Surgical excision is often an ambulatory procedure well tolerated by most patients, and has shown good outcomes. Marcus-Braun and colleagues report on 104 mesh removal operations, of which 44 were for vaginal extrusion. After 6 months’ follow-up, only five patients underwent intervention for recurrence, yielding an 88% success rate. This series, however, includes both synthetic mesh slings and mesh prolapse repair. High success with these techniques applies to type I mesh, such as lightweight large-pore polypropylene. Earlier series involving different classes of synthetics have lower success and higher complication rates. Sometimes, infection is present and the entire foreign body must be removed for healing to occur. With type I polypropylene, this is less likely and partial excision is highly successful.


The authors’ experience with expectant management and topical estrogen therapy often yields less-than-satisfactory results. However, use of vaginal estrogen cream before planned resection of extruded mesh may improve the vaginal tissue quality if atrophic vaginitis is present. Referrals to the authors’ tertiary practice have often yielded failed conservative measures and their preferred management is operative excision in an ambulatory surgical center. After proper surgical preparation, exposure is obtained with a weighted speculum and elastic hooks with or without a ring retractor. The surrounding vaginal epithelium is injected with 0.5% lidocaine with 1:200,000 epinephrine to facilitate dissection.


Vaginal epithelial flaps are created by incising the epithelium adjacent to the extrusion site in a direction perpendicular to the mesh. However, the incision is tailored on a case-by-case basis, and horizontal, inverted-U–shaped, or circumferential incisions may be used. Using a combination of sharp dissection with Metzenbaum scissors and blunt dissection with a Kittner, vaginal flaps 1 to 2 cm in length are created on both sides of the extrusion. A blunt-tipped instrument such as a Kelly clamp or Mixter right angle forceps is passed between the mesh and underlying fascia adjacent to the urethra. The clamp is carefully opened to raise the synthetic mesh off the underlying fascia and the sling is incised. Each cut edge is grasped with an Allis clamp for traction and dissected free from the underlying fascia with a combination of sharp and blunt dissection. Care is taken to keep the dissection on the mesh and not wander into deeper tissue. Pointing the tips of the Metzenbaum scissors toward the mesh helps avoid inadvertent urethral or bladder injury. The mesh is transected with a curved Mayo scissor once it has been dissected free from the underlying fascia. Enough mesh is excised to provide at least a 1-cm margin from the edge of the extrusion. The edges of vaginal epithelium are then approximated with a running 2-0 polyglycolic acid suture after copious irrigation.


Urethral Perforation or Extrusion


Urethral extrusions or perforation have been managed with transvaginal excision, endoscopic, and combined techniques. The controversy arises in determining which technique to use and what outcomes are expected. Several studies report on varying management strategies, but are limited to small retrospective case series. Pure transvaginal techniques are similar to transvaginal approaches for vaginal extrusion.


In the transvaginal technique, vaginal flaps are created over the urethra after injection of lidocaine with epinephrine. Midline and inverted-U incisions have been reported. The authors’ preference is to use an inverted-U–shaped incision to avoid overlapping suture lines in an attempt to prevent urethrovaginal fistulas. The vaginal flap dissection was described in the previous section. The mesh is isolated, a blunt instrument such as a Mixter right angle forceps is placed behind, and the mesh is incised adjacent to the urethra. When the mesh is free floating within the urethra it can be approached by incising the urethra circumferentially around the mesh on both sides where it perforates the urethra. Sharp dissection and gentle spreading of the Metzenbaum scissors will often release the mesh from the urethra so it can be pulled through for removal. Placing a small hemostat into the urethra to grasp the synthetic material may help with dissection. When the mesh is adherent to or only partially visible within the urethra, one will likely have to incise into the urethra for the length of the perforation. Once the mesh is excised, the urethra is closed and other layers of tissue are closed over it.


Another author described an innovative means of using a lighted nasal speculum within the urethra to improve exposure and sharply dissect the sling from the urethral side wall. In that series, none of the three patients required repeat excision, but all developed recurrent stress incontinence. After the mesh is removed, the urethra is debrided and closed with interrupted 4-0 or 5-0 polyglycolic acid sutures to form a water-tight closure. Additional layers of periurethral or pubocervical fascia are developed sharply and closed over the urethra. The vaginal epithelium can then be approximated with a running 2-0 polyglycolic acid suture. A urethral Foley, 14 to 16 French, is left as a drain for 7 to 14 days.


The use of an additional graft or flap in this situation, such as a Martius flap, is debated. If the patient presents with a urethrovaginal fistula, then extirpation of the mesh along with reconstruction and Martius flap interposition is often recommended. Potential adverse sequelae include recurrent stress incontinence and urethrovaginal fistula. In one series, the rate of incontinence after transvaginal excision was 83%, although others report no incidence of de novo stress urinary incontinence after surgery to correct urethral perforations. Deng and colleagues report three postoperative urinary vaginal fistulas that required a second reconstructive procedure with Martius flap interposition. If recurrent stress urinary incontinence occurs, expert opinion recommends an autologous fascia pubovaginal sling after adequate time for tissue healing.


Controversy exists regarding the use of endoscopic methods to remove mesh from the urethra. Velemir and colleagues report on a technique of pure endoscopic excision in four patients. A forceps is introduced alongside a cystoscope and used to grasp the mesh for traction. Endoscopic scissors are introduced through the cystoscope and the mesh fibers are sharply incised. In follow-up, two of these patients needed at least one additional endoscopic procedure to remove remaining mesh, yielding a 50% failure rate. Another series also reported a 50% failure rate with endoscopic management, and these patients ultimately required transvaginal removal. Doumouchtsis and colleagues applied a Holmium laser fiber to the mesh as close to the mucosa as possible. Failure in this series was high and only one of four patients was symptom-free and without endoscopic evidence of recurrence at 2 years. One patient underwent repeat laser excision, and the remaining two continued to have residual fiber extrusion at the end of follow-up. Comparison of data from each series are presented in Table 1 . Based on the available data and the authors’ experience, transvaginal excision is their preferred management for most patients presenting to their center.


Mar 11, 2017 | Posted by in UROLOGY | Comments Off on Controversies in the Management of Mesh-Based Complications

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