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Managing Mesh and Graft Complications

Beri Ridgeway, MD; Matthew D. Barber, MD, MHS

Minimally invasive procedures using mesh and grafts to repair pelvic organ prolapse and stress urinary incontinence provide excellent anatomical results, but associated complications may leave the patient with a whole new set of symptoms that may require further surgery.

Synthetic mesh and biologic grafts are increasingly used in the surgical management of stress urinary incontinence and pelvic organ prolapse. Synthetic mesh—typically loosely woven polypropylene—has well established safety and efficacy in many procedures, including sacral colpopexy and tension-free vaginal tape (TVT). More recently, mesh and grafts are being used in transvaginal prolapse repairs to either augment standard vaginal prolapse procedures or as part of a commercially available prolapse kit. High-quality data on the safety and efficacy of transvaginal mesh placement are relatively scarce. One review concluded that the data are insufficient to permit a complete assessment of anatomic or symptomatic efficacy of graft use in transvaginal prolapse repair.1 However, outcome and complication data are rapidly accumulating, such that several randomized, controlled trials have demonstrated improved anatomic outcomes with anterior vaginal synthetic permanent mesh placement compared with anterior colporrhaphy using native tissue, but with similar subjective outcomes and higher complication rates.2,3 Data on the transvaginal placement of synthetic mesh or biologic graft in the apical and posterior compartment are lacking.1 Despite the paucity of consistent data, the use of permanent synthetic materials, including mesh kits, is rapidly expanding. Given this trend, it is important that the gynecologic surgeon be familiar with common complications and their management.

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COMPLICATIONS

Complications related to graft and synthetic mesh include erosion, infection, dyspareunia, fistula, and chronic pain. Rates of these complications vary greatly and are inconsistently reported. Erosion of synthetic mesh and biologic graft materials has been reported since the products were introduced for abdominal sacral colpopexy. Sacral colpopexy reviews report a mean rate of mesh erosion between 3.4% and 9%.4 However, these rates are material dependent as studies using polypropylene mesh for abdominal sacral colpopexy report very low rates of erosion (0.5%), whereas those using multifilament or coated polyester mesh report higher erosion rates (3% to 23.8%).5 Synthetic mesh placed vaginally (as opposed to abdominally) also confers a higher risk of erosion.6 Additional reported risk factors include concurrent hysterectomy and tobacco use.7 Erosion of biologic graft or synthetic mesh placed transvaginally in the anterior wall has been reported at up to 17.1%.8 When synthetic mesh is placed transvaginally in the posterior vaginal wall, erosion rates have been reported as high as 12%.9

The emergence of prepackaged minimally invasive procedural kits for the vaginal placement of synthetic mesh or biologic graft to correct pelvic organ prolapse has led to the more widespread use of transvaginal mesh and graft. Insertion of these materials involves the blind passage of trocars through small perineal incisions into the obturator foramen and ischiorectal fossa. Data on complications associated with these kits are limited, but mesh erosion rates of 3% to 12% at 3 to 12 months postplacement have been reported.10-12 The largest series describing short-term complications in 289 women notes an erosion rate of 10%.11

Complications such as fistula, de novo dyspareunia, and chronic pain are not routinely recorded except in case reports and small series.11,13 Nonetheless, these problems are increasingly common in a referral practice. In October 2008, the FDA issued a public health notification regarding serious complications associated with transvaginal placement of surgical mesh, citing some 1,000 reports of complications over 3 years.14 The most frequent complications included erosion through the vaginal epithelium, infection, pain, urinary problems, and the recurrence of prolapse and/or incontinence. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to pain, including dyspareunia. Although the notification concerned the use of mesh for both pelvic organ prolapse and stress urinary incontinence, there are considerably more data on the latter. Erosion rates after midurethral sling procedures (eg, TVT) are 1% or less.15 The FDA emphasized proper preoperative patient counseling covering the permanent nature of the mesh, the possibility that some complications may require additional surgery with no guarantee of outcome, and the potential for resulting decreased quality of life (eg, dyspareunia, scarring, narrowing of the vaginal wall) (eTable).

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eTABLE. FDA Recommendations for Management of Complications Associated With Transvaginal Placement of Surgical Mesh14

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MANAGEMENT

Mesh or graft erosion is unique to graft placement. Treatment options consist of observation, estrogen cream, outpatient or hospital excision, and total removal of the mesh or graft (Figure 1). If the patient is asymptomatic and not sexually active and the erosion is less than 3 mm, or if the use of vaginal estrogen is contraindicated, the authors will consider observation at 3 and 6 months, and every 6 to 12 months thereafter. In these cases, the erosion rarely heals spontaneously, but also rarely progresses. However, most patients are treated with vaginal estrogen, despite a lack of data documenting improved healing. Given the known effects of vaginal estrogen on the vaginal epithelium and blood supply, this seems a reasonable conservative option for managing small mesh erosions or exposures. A typical regimen calls for 1 g of vaginal estrogen nightly for 2 weeks, and then 3 times weekly thereafter. Systemic absorption is minimal, especially after the first 2 weeks.16 The patient should be assessed 6 to 8 weeks after initiating treatment, and can continue the regimen if improvement is noted. Some physicians use intravaginal metronidazole gel or other intravaginal antibiotic ointments to manage small mesh erosions, but data on efficacy are lacking.

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FIGURE 1. Algorithm for the treatment of mesh erosion.

If the erosion persists despite estrogen use or if vaginal estrogen is contraindicated, mesh excision is appropriate (for detailed description of the author’s technique, visit www.femalepatient.com). This can be accomplished in the office if the erosion is less than 5 mm. The area is injected with local anesthetic, an Allis or tonsil clamp is used to grasp the mesh or graft, and the exposed portion is excised sharply. The edges of vaginal epithelium are trimmed, and reapproximated using absorbable suture. If the patient cannot tolerate this procedure in the office or the exposure exceeds 5 mm, a hospital setting is preferable. In these cases, the mesh is excised as described previously, and the edges of the vaginal epithelium are mobilized to create a 5- to 10-mm circumferential flap and then reapproximated. Care should be taken to avoid putting tension on the repair or narrowing the vagina. Postoperatively, the patient should use vaginal estrogen until the area is well healed.

If mesh excision fails; the exposure exceeds 1 to 2 cm; or infection, fistula, or chronic pain is present, the majority of the mesh should be removed. Although this can be technically difficult, the authors’ experience suggests that it can be done safely with few complications and adequate relief of most symptoms.13 If the mesh was originally placed using a completely transvaginal approach, it may be possible to remove the mesh in its entirety. If trocars were used to place the mesh (eg, with a kit), it may be neither possible nor prudent to remove the arms of the mesh as they pass through the ischiorectal fossa and/or obturator space. In these cases, as much of the mesh can be removed as possible through a vaginal approach while leaving the mesh arms in place.

In the authors’ technique for transvaginal mesh removal, the vaginal epithelium is opened with a scalpel, and flaps are developed with sharp dissection. The mesh edge is identified and grasped with Allis clamps to provide traction (Figures 2-4). The bladder or rectum is separated from the mesh using sharp dissection with scissors and gentle, blunt dissection to peel away the underlying tissue. It may not be possible to remove all of the mesh, especially the lateral portions of the mesh arms. If recurrent prolapse is present, it can be corrected at this time using native tissue. The authors do not advocate placement of mesh or graft to treat recurrent prolapse at the time of mesh removal.

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FIGURE 2. The vaginal epithelium is opened with a scalpel and flaps developed with sharp dissection.

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FIGURE 3. The bladder or rectum is separated from the mesh using sharp dissection with scissors and gentle, blunt dissection with a peanut dissector, finger, or sponge to peel away the underlying tissue or vaginal skin.

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FIGURE 4. Once a mesh edge is identified, it is grasped with Allis clamps to provide traction. This traction is also valuable in visualizing the lateral mesh arms.

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OUTCOMES

Until recently, all studies of mesh excision were limited to the treatment of erosion and infection after abdominal sacral colpopexy and intravaginal slingplasty.17,18 It was found that transvaginal mesh excision with or without endoscopy after prior abdominal sacral colpopexy is safe, less invasive, and has less morbidity compared with the abdominal route.17 Although excision of mesh using the vaginal approach was often successful in these series, some cases required multiple procedures. Complications related to intravaginal slingplasty required aggressive mesh excision to treat pain, dyspareunia, significant vaginal erosion, infections, abscess, fistulae, intravesical/rectal erosions, voiding/ defecatory dysfunction, and recurrent pelvic organ prolapse.18 Follow-up showed that symptoms were greatly alleviated or resolved.

In a large series on complications related to mesh prolapse kits, 97% of women with mesh erosion were symptomatic, and all were initially managed conservatively with estrogen.11 However, all patients eventually needed mesh excision, with 13% undergoing more than 1 procedure and 7% requiring total removal of the mesh (0.7% of all cases). Severe complications related to mesh prolapse kits such as infection, fistula, large erosion, and chronic pain have also necessitated extensive mesh removal. Smaller series on mesh excision describe encouraging outcomes, with most patients improving.13 In light of the authors’ experience and the published data, removal of the majority of mesh seems prudent in cases of erosion recurrence, large erosion, fistula, chronic pain, and infection. Some surgeons advocate release of the mesh arms without mesh excision for patients who have chronic pain without associated erosion following a procedure utilizing a mesh prolapse kit.

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CONCLUSION

The use of mesh and graft in pelvic reconstructive surgery is increasing. Although recent randomized, controlled trials report superior anatomic outcomes with transvaginal mesh, this must be balanced against a unique set of complications frequently requiring reoperation.19 Management of these complications using mesh excision is often successful in treating even the most serious problems.

Neither author reports any actual or potential conflicts of interest in relation to this article.

Note: Additional content pertaining to this article can be seen online at www.femalepatient.com, including a step-by-step guide to the authors’ technique for transvaginal mesh removal, and FDA recommendations for management of complications associated with the placement of surgical mesh.

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Beri Ridgeway, MD, is Fellow, Obstetrics, Gynecology, and Women’s Health Institute, Cleveland Clinic, Cleveland, OH. Matthew D. Barber, MD, MHS, is Vice Chair of Clinical Research, Obstetrics, Gynecology, and Women’s Health Institute; and Associate Professor of Surgery, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH.

References

1. Sung VW, Rogers RG, Schaffer JI, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008;112(5):1131–1142.
2. Nieminen K, Hiltunen R, Heiskanen E, et al. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(12):1611–1616.
3. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008;111(4):891–898.
4. Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004;104(4):805–823.
5. Govier FE, Kobashi KC, Kozlowski PM, et al. High complication rate identified in sacrocolpopexy patients attributed to silicone mesh. Urology. 2005;65(8):1099–1103.
6. Visco AG, Weidner AC, Barber MD, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol. 2001;184(3):297–302.
7. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008;199(6):688.e1–688.e5.
8. Hiltunen R, Nieminen K, Takala T, et al. Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2007;110 (2 Pt 2):455–462.
9. de Tayrac R, Picone O, Chauveaud-Lambling A, Fernandez H. A 2-year anatomical and functional assessment of transvaginal rectocele repair using a polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(2): 100–105.
10. Fatton B, Amblard J, Debodinance P, Cosson M, Jacquetin B. Transvaginal repair of genital prolapse: preliminary results of a new tension-free vaginal mesh (Prolift technique)? a case series multicentric study. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(7):743–752.
11. Abdel-Fattah M, Ramsay I; West of Scotland Study Group. Retrospective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG. 2008;115(1):22–30.
12. Collinet P, Belot F, Debodinance P, Ha Duc E, Lucot JP, Cosson M. Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(4): 315–320.
13. Ridgeway B, Walters MD, Paraiso MF, et al. Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol. 2008;199(6):703.e1–703.e7.
14. US Food and Drug Administration. FDA Public Health Notification: Serious Complications Associated with Transvaginal Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. October 20, 2008. www. fda.gov/cdrh/safety/102008-surgicalmesh.html. Accessed March 11, 2009.
15. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002;81(1):72–77.
16. Santen RJ, Pinkerton JV, Conaway M, et al. Treatment of urogenital atrophy with low-dose estradiol: preliminary results. Menopause. 2002;9(3):179–187.
17. South MM, Foster RT, Webster GD, Weidner AC, Amundsen CL. Surgical excision of eroded mesh after prior abdominal sacrocolpopexy. Am J Obstet Gynecol. 2007;197(6):615.e1–615.e5.
18. Baessler K, Hewson AD, Tunn R, Schuessler B, Maher CF. Severe mesh complications following intravaginal slingplasty. Obstet Gynecol. 2005;106(4):713–716.
19. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol. 2009;113(2 Pt 1):367–373.

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Transvaginal Mesh Removal

The authors’ technique for transvaginal mesh removal is as follows:

1. At the first clinic visit, the operative notes are reviewed. This allows for preoperative planning and provides expectations to guide initial surgical dissection. In cases of erosion related to mesh kits with anterior placement, the superior and inferior mesh arms travel through the obturator foramen to pierce the arcus tendineus fasciae pelvis and exit in the genitofemoral fold. The mesh should lie between the vaginal epithelium and the bladder. When the mesh is placed posteriorly, an additional mesh arm traverses the ischiorectal fossa to pierce the sacrospinous ligament, lying between the vaginal epithelium and rectum.
2. An examination is performed under anesthesia, and the problematic areas of mesh are identified. The mesh is usually easy to palpate vaginally and rectally. Initial cystoscopy, rectal examination, and/or proctoscopy are used to determine whether the mesh has eroded into the bladder or rectum in addition to the vagina. A Lone Star retractor (CooperSurgical, Inc.) is used to aid visualization and exposure.
3. The vaginal epithelium covering the mesh is injected with a dilute vasoconstricting agent (eg, 0.5% lidocaine with 1:200,000 epinephrine) for hydrodissection and hemostasis. The vaginal epithelium is opened with a scalpel and flaps are developed with sharp dissection as for colporrhaphy (Figure 2). Care is taken to make the flap as thick as possible to prevent “buttonholes” and tearing, which can require removal of a large portion of the epithelium and lead to vaginal narrowing. Dissection is performed as far laterally as possible to achieve adequate visualization.
4. Synthetic mesh is often interlaced with fibrotic scar tissue, whereas biologic graft tends to be encapsulated. Once the layer containing the mesh and the fibrotic overlay is identified, it is mobilized away from the bladder or rectum, starting either in the midline or laterally. Laterally, an instrument such as a right angle clamp, Kelly clamp, or tonsil clamp is used to undermine beneath the mesh-tissue layer to provide a starting point. If there is no access laterally, the mesh is incised in the midline using a scalpel, taking care to avoid the underlying bladder or rectum.
5. Once the mesh’s edge is identified, it is grasped with Allis clamps to provide traction. The bladder or rectum is then separated from the mesh, using sharp dissection with scissors and then gentle, blunt dissection to peel away the underlying tissue (Figure 3). Visceral injury can be avoided by using hydrodissection and firm traction of the mesh flap away from the bladder or rectum, and by pointing the tips of the Metzenbaum scissors toward the mesh. Such traction is also valuable in visualizing the lateral mesh arms (Figure 4). Breisky-Navratil retractors are often used to obtain adequate visualization, especially as the dissection progresses laterally.
6. Once the mesh arms are visualized, tension is used to expose the maximum amount of mesh. The mesh arms are transected at the most lateral aspect possible. Neovascularization of the mesh arms is frequently noted, requiring suture ligation. This is especially important when dissecting the posterior mesh arms, which requires entry into the ischiorectal fossa.
7. For the excision of posterior mesh, a finger placed in the rectum during dissection is used to delineate the superior, inferior, and lateral borders of the mesh and avoid proctotomy.
8. It may not be possible to remove all of the mesh, especially the lateral portions of the mesh arms traveling through the obturator foramen and ischiorectal fossa. Once excision is complete and hemostasis is achieved, the vaginal epithelium is reapproximated. If recurrent prolapse is present, it can be corrected at this time using native tissue. The authors do not advocate placement of mesh or graft to treat recurrent prolapse at the time of mesh removal.
9. On completion, cystoscopy, rectal examination, and/or proctoscopy are performed to rule out visceral injury. The vagina is packed overnight to assist with hemostasis.