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Sylvia M. Botros, MD and repair: Senior Research Fellow, Evanston Continence Center, Evanston Northwestern More success with mesh? Healthcare, Northwestern University Feinberg School Graft materials have been used for years in other types of of Medicine, Evanston, Ill . Can they reduce the high failure rate of prolapse repairs? Peter K. Sand, MD Director, Division of ; Director, Evanston Continence Center; Professor of Obstetrics and Gynecology, CASE Symptoms point to yet Evanston Northwestern type of material, attachment sites, and dura- Healthcare Medical Group, another prolapse recurrence tion of follow-up. Level I evidence that aug- Evanston, Ill mented repairs have a clear benefit over tra- A 52-year-old woman® Dowdenpresents with aHealthditional Media repairs is sparse. bulge and pressure in her . She Advocates of graft materials argue that has undergone 2 prior reconstructive native tissue is already compromised— .Copyright TheFor first was personal a vaginal use onlyhence, the prolapse—making surgical failure , anterior and posterior likely.1 They claim graft materials help repair, and sling; the second was an strengthen repairs, especially in the case of abdominal procedure that included a . They also point out that adjuvant IN THIS ARTICLE sacrocolpopexy and paravaginal repair. materials have been used in burns, plastic A reveals a surgery, and orthopedics for more than 10 ❙ A complex web recurrent 4th-degree cystocele that years and are generally well tolerated. Their of support protrudes 2 cm beyond the hymenal ring. success in hernia repairs prompted their con- The vault and posterior compartment are Page 35 sideration for the . well supported, and the patient reports no incontinence, a fact confirmed by A pervasive problem, urodynamics testing. She asks that you but only 10% to 20% seek help do everything in your power to prevent Roughly 1 of 2 parous women lose pelvic further recurrence. support as they age, but only 10% to 20% How do you proceed? seek medical care, with a lifetime risk of surgery for (POP) of his patient ultimately underwent 11% by age 80.2 ❙How successful anterior colporrhaphy and vaginal With women living longer than ever are adjuvant T paravaginal repair using a decellular- and remaining active later in life, this per- ized dermal cadaveric implant. She was still centage is likely to rise. Unfortunately, few materials? doing well 1 year later, with no recurrence. alternatives to surgical treatment exist, and Page 40 Despite success stories like this one, the the reoperation rate for recurrence is 29%, use of graft materials to repair cystoceles according to a 1995 review.2 If surgical and rectoceles is controversial. One reason management is the only hope of cure, how is the difficulty of interpreting published can we lower the 29% recurrence rate? data, since studies lack uniformity in tech- Graft materials may provide part or all nique, patient characteristics, graft shape, of the solution.

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Cystocele and rectocele repair: More success with mesh? ▲

❚ Elements of prolapse A complex web of support Anterior compartment Central and/or lateral defects can occur in the anterior compartment. Lateral (paravaginal) defects indicate that the endopelvic has sepa- rated from the arcus tendineus . Lateral defects can be repaired vagi- nally or abdominally. One study3 found that 67% of women with anterior wall prolapse had para- vaginal defects, but no randomized trials have evaluated the clinical benefit of repairing these defects, compared with tra- ditional colporrhaphies. Ischial spine Central defects involve site-specific defects Arcus tendineus and/or general attenuation of the endo- pelvic connective tissue. These are usually Fascia of the repaired vaginally. pelvic diaphragm Recurrence rates for lateral and central defects range from 3% to 70%.4-8 Two large series of vaginal paravaginal repairs noted the following recurrence rates: • Shull et al6 found a recurrence rate of In the normal pelvis, support of reproductive organs depends on a 7% to the hymenal ring or beyond. complex web of muscles, fascia, and connective tissue. To ensure 7 success, prolapse repairs should correct any separation or • Young et al observed a recurrence rate attenuation of tissue and preserve or enhance tissue resilience. for lateral defects of 2%, with recurrence IMAGE: RICH LaROCCO rates as high as 22% for central defects. In a comparison of 3 techniques for vaginal repair of central defects, using Recurrence rates. Site-specific repairs are strict criteria to assess anatomic outcomes, thought to minimize complications such as Weber et al4 found recurrence rates of 54% . However, few studies have to 70%. Other studies show symptomatic compared the efficacy of site-specific recurrence rates of 3% to 22% for cysto- repairs with that of traditional colporrha- celes.5,8 phies. At our institution, women who With grafts, both paravaginal and central underwent traditional colporrhaphy had defects can be repaired. Vaginal para- fewer recurrences than controls (33% vs vaginal repairs are not popular due to the 14%), with no differences in postoperative technical difficulty involved. With the use symptoms such as dyspareunia, constipa- of grafts, however, both paravaginal and tion, and .11 central defects can be addressed simultane- Graft materials of questionable benefit. In ously with relative ease. the posterior compartment, these materials have not been shown to be beneficial, com- Posterior compartment pared with traditional or site-specific Defects in the posterior compartment are repairs. Sand et al12 found no benefit for less likely to recur. Reported success rates repairs in which absorbable Vicryl mesh range from 80% to 90%.9,10 was imbricated, but this randomized trial Posterior compartment defects include may have lacked sufficient power to show general attenuation of Denonvillier’s fascia statistical significance. Large cohorts or a tear anywhere along the fascia or any would be needed to show significant bene- of its attachments. fit of meshes in the posterior compartment. CONTINUED

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Risk factors for recurrent prolapse Soft polypropylene meshes such as • Poor tissue (assess tissue quality before Gynemesh and Atrium are commonly used and during surgery) permanent materials, and polyglactin 910 • Impaired healing is an absorbable material (TABLE). • Chronic increases in intraabdominal pressure due to obstructive pulmonary Classification of synthetic materials disease, asthma, or • Type 1 grafts are totally macroporous • High-grade cystocele (>75 µm), which allows fibroblast, • Age 60 or above13 macrophage, and collagen penetration Patients with these conditions may with angiogenesis. Examples include benefit from the use of adjuvant materials Prolene and Marlex meshes. in the anterior compartment. • Type 2 mesh is microporous (<10 µm in Note that women who have had recur- 1 dimension). This prevents penetration rences after earlier repairs may experience of fibroblasts, macrophages, or collagen. repeat recurrence. Gore-Tex is an example of a Type 2 mesh. • Type 3 mesh is macroporous (>75 µm) ❚ Advantages of grafts with multifilamentous or microporous Using graft materials, the surgeon can repair components. Examples include Mersilene all vaginal defects faster and with less effort. (braided Dacron mesh), Teflon (polyte- In the anterior compartment, a graft can be trafluoroethylene [PTFE]), Surgipro placed and anchored bilaterally from arcus (braided polypropylene mesh), and to arcus tendineus, and posteriorly to the MycroMesh (perforated PTFE patch). level of the spine, recreating level I support. • Type 4 mesh has a submicron pore size Graft materials also offer the potential to that prevents penetration. Examples treat stress concomi- include Silastic, Cellgard (polypropylene tantly using different shaped materials. Two sheeting), and Preclude pericardial mem- authors have already described their success brane/Preclude dura-substitute.1 performing this type of repair.14 2 other important properties are composi- Nevertheless, great care and considera- tion of fibers (multifilamentous materials FAST TRACK tion should be devoted to actual and theo- commonly have interstices less than 10 Women whose retical short- and long-term risks, many of microns) and flexibility (which has a bear- which have not been fully elucidated. ing on erosion of the material).1 prolapse recurs Once a successful material is identified Bacteria can penetrate pores smaller are more likely or developed, it may decrease operating time than 1 µm, whereas polymorphonuclear to have yet another and morbidity in vaginal surgeries. It may white blood cells and macrophages need a recurrence also reduce the higher hospital costs normal- pore size larger than 10 µm, and capillary ly associated with abdominal procedures. ingrowth requires a size larger than 75 microns. Thus, Type 1 offers the advantages of larger pore size and monofilamentous interstices to allow for capillary ingrowth. ❚ Types of graft materials There are 2 types of materials: synthetic or biologic. Synthetic materials can be further classified into permanent or absorbable. ❚ Which material is best? The most widely used biologic materi- Although the literature is difficult to inter- als include allografts such as human freeze- pret because of the diversity of studies dried or solvent-dehydrated fascia lata and other factors, some findings are worth (Tutoplast), decellularized human cadaveric noting: dermis (Alloderm, Repliform), porcine der- • Tutoplast and Alloderm appear to have mal xenografts such as Pelvicol or Intexene, the best tensile strength, maximum load and bovine pericardial implants (Veritas). to capacity, and microscopic architec-

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▲ Cystocele and rectocele repair: More success with mesh?

TABLE How successful are adjuvant materials in cystocele and rectocele repairs?

MATERIAL NO. IN RECURRENCE SITE OF FOLLOW-UP (SIZE IN CM) AUTHOR STUDY RATE (%) ATTACHMENT (MONTHS) COMPLICATIONS BIOLOGIC MATERIALS Alloderm 3x7 patch Chung29 19 16 Pubocervical 28 None with concomitant sling fascia Intexene 6x8 with sling Gomelsky 70 9 stage II Arcus tendineus 24 1 wound et al 200420 4 stage III fascia pelvis separation Solvent-dehydrated Gandhi et al 76 patch vs 21 vs 29, Overlay 13 None cadaveric fascia lata 200521 72 no patch respectively patch with sling (P=.23) Alloderm 3x7 trapezoid Clemons et al 33 41 stage II Arcus tendineus 18 None 200322 3 symptomatic fascia pelvis SYNTHETIC MATERIALS WITH CONCOMITANT SLINGS* Marlex Nicita 44 0 Arcus tendineus 13 1 vaginal 10x3x5 199823 fascia pelvis erosion Polyglactin 910 Sand et al12 80 mesh vs 25 vs 43 stage Insert in the 12 None absorbable mesh 80 no mesh II cystoceles, anterior and respectively posterior (P=.02) colporrhaphy suture line Polyglactin 910 Weber et al4 26 with mesh + 58 vs 54 vs 70 Overlay 23 None absorbable mesh standard repair; stage II, 24 with ultra- respectively lateral repair; (P=.58) 33 with standard repair SYNTHETIC PERMANENT GRAFTS WITHOUT CONCOMITANT SLINGS Marlex trapezoid Julian 199619 12 with 0 vs 33, Arcus tendineus 24 3 vaginal 12 without respectively fascia pelvis erosions Mixed-fiber mesh Migliari and 12 25 Pubourethral 20 None (polyglactin 910 and Usai 199924 and cardinal polyester 5x5) Prolene (Atrium) Dwyer and 64 anterior 6 grade II Tension-free 29 8% vaginal O’Reilly25 50 posterior erosion 1 Gynemesh 6x15 de Tayrac 87 7 stage II Tension-free 24 8% vaginal et al 200526 2 stage III erosion Prolene mesh patch Milani et al 32 anterior 6 stage II Fixed to 17 20% anterior, 200527 31 posterior endopelvic 63% posterior connective dyspareunia; tissue 13% vaginal erosion (anterior); 1 pelvic abscess (posterior) Prolene mesh Natale et al 138 3 Tension-free 18 9% vaginal (double-wing shape) 200028 erosion 7% dyspareunia 1 hematoma *Absorbable and permanent.

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ture similar to the original tissue.15–17 8. Macer GA. Transabdominal repair of cystocele, a 20-year experience, compared with the traditional vaginal approach. However, these qualities were docu- Trans Pac Coast Obstet Gynecol Soc. 1978; 45:116–120. mented prior to implantation in vivo. 9. Cundiff GW,Weidner AC, Visco AG, Addison WA, Bump RC. An anatomic and functional assessment of the discrete • Slings appear to help prevent cystocele defect rectocele repair. Am J Obstet Gynecol. 1998; recurrences, according to a study by 179:1451–1456. 18 10. Paraiso MF, Ballard LA, Walters MD, Lee JC, et al. Pelvic Goldberg et al. support defects and visceral and sexual function in women • A fascial patch had no benefit when treated with sacrospinous suspension and pelvic reconstruction. Am J Obstet Gynecol. 1996; 175:1423–1430. placed as an overlay in the anterior com- 11. Abramov Y, et al. Site-specific rectocele repair compared partment in a randomized, controlled trial with standard posterior colporrhaphy. Obstet Gynecol. (involving 162 women) by Sand et al.12 2005;105:314–318. 12. Sand PK, et al. Prospective randomized trial of polyglactin • Marlex. One group of women with recur- 910 mesh to prevent recurrence of cystoceles and rectoce- rent prolapse underwent synthetic graft les. Am J Obstet Gynecol. 2001;184:1357–1362. 13. Whitesides JL, Weber AM, Meyn LA, Walters MD. Risk fac- (Marlex) augmentation with bilateral tors for prolapse recurrence after vaginal repair. Obstet ATFP attachment, while the other group Gynecol Surv. 2005;60:164–165. 19 14. Kobashi KC, Mee SL, Leach GE. A new technique for cysto- had anterior colporrhaphy only. None of cele repair and transvaginal sling: the cadaveric prolapse the women who received grafts had fur- repair and sling (CAPS). . 2000;56:9–14. 15. Lemer ML, Chaikin DC, Blaivas JG. Tissue strength analysis ther recurrence, while 33% of the control of autologous and cadaveric allografts for the pubovaginal group did. However, 25% of the women sling. Neurourol Urodyn. 1999;18:497–503. 16. Choe JM, Kothandapani R, et al. Autologous, cadaveric, and with the graft had vaginal erosions. synthetic materials used in sling surgery: comparative bio- • Polyglactin 910 had a protective effect mechanical analysis. Urology. 2001;58:482–486. when embedded in the plication, accord- 17. Scalfani AP. Biophysical and microscopic analysis of homol- ogous dermal and fascial materials for facial aesthetic and 12 ing to Sand et al. However, it had no reconstructive uses. Arch Facial Plast Surg. 2002;4:164–171. benefit when used as an overlay to a tra- 18. Goldberg RP, et al. Protective effect of suburethral slings on 4 postoperative cystocele recurrence after reconstructive ditional repair in a study by Weber et al. pelvic operation. Am J Obstet Gynecol. 2001;185:1307–1312. The discrepancy may be related to small 19. Julian TM. The efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal sample size; the study by Weber et al was wall. Am J Obstet Gynecol. 1996;175:1472–1475. powered to detect only a 30% difference. 20. Gomelsky A, Rudy DC, Dmochowski RR. Porcine dermis interposition graft for repair of high grade anterior compart- However, these studies suggest that it is ment defects with or without concomitant pelvic organ pro- not only the type of graft that is impor- lapse procedures. J Urol. 2004;171:1581–1584. FAST TRACK tant, but how it is used or attached. 21. Gandhi S, et al. A prospective randomized trial of solvent dehydrated fascia lata for the prevention of recurrent anteri- Synthetic grafts In general, synthetic grafts may have slight- or vaginal wall prolapse. Am J Obstet Gynecol. tend to have ly higher success rates, whereas biologic 2005;192:1649–1654. 22. Clemons JL, Myers DL, Aguilar VC, Arya LA. Vaginal para- materials appear to be better tolerated. vaginal repair with an AlloDerm graft. Am J Obstet Gynecol. slightly higher Prospective, comparative trials of 2003;189:1612–1618. success rates; 23. Nicita G. A new operation for genitourinary prolapse. J Urol. these materials are desperately needed. ■ 1998;160:741–745. biologic grafts 24. Migliari R, Usai E. Treatment results using a mixed fiber mesh in patients with grade IV cystocele. J Urol. 1999; tend to be better REFERENCES 161:1255–1258. 1. Cervigni M, Natale F.The use of synthetics in the treatment 25. Dwyer PL, O’Reilly BA. Transvaginal repair of anterior and tolerated of pelvic organ prolapse. Curr Opin Urol. 2001;11:429–435. posterior compartment prolapse with Atrium polypropylene 2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. mesh. BJOG. 2004;111:831–836. Epidemiology of surgically managed pelvic organ prolapse 26. de Tayrac R, Gervaise A, Chauveaud A, Fernandez H. and urinary incontinence. Obstet Gynecol. 1997;89:501–506. Tension-free polypropylene mesh for vaginal repair of ante- 3. Richardson AC, Lyon JB, Williams NL. A new look at pelvic rior vaginal wall prolapse. J Reprod Med. 2005;50:75–80. relaxation. Am J Obstet Gynecol. 1976;126:568–573. 27. Milani R, et al. Functional and anatomical outcome of ante- rior and posterior vaginal prolapse repair with prolene 4. Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior mesh. BJOG. 2005;112:107–111. colporrhaphy: a randomized trial of three surgical tech- niques. Am J Obstet Gynecol. 2001;185:1299–1304. 28. Natale F, Marziali S, Cervigni M. Tension-free cystocele repair (TCR): long-term follow-up. Proceedings of the 25th 5. Porges RF, Smilen SW. Long-term analysis of the surgical annual meeting of the International Urogynecological management of pelvic support defects. Am J Obstet Association. 2000;22–25. Gynecol. 1994;171:1518–1526. 29. Chung SY, et al. Technique of combined pubovaginal sling 6. Shull BL, Benn SJ, Kuehl TJ. Surgical management of pro- and cystocele using a single piece of cadaveric dermal lapse of the anterior vaginal segment: an analysis of sup- graft. Urology. 2002;59:538–541. port defects, operative morbidity, and anatomic outcome. Am J Obstet Gynecol. 1994;171:1429–1436. Dr. Botros has no financial relationships relevant to this article. Dr. 7. Young SB, Daman JJ, Bony LG. Vaginal paravaginal repair: Sand receives grant/research support from Boston Scientific, one-year outcomes. Am J Obstet Gynecol. 2001; and is a consultant and speaker for American Medical Systems 185:1360–1366. and Boston Scientific.

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