In reporting these guidelines, the group followed the recommendations on standardized reporting of clinical practice guidelines proposed by the Conference on Guideline Standardization.7
Before publication, these guidelines were verbally presented at the 34th Scientific Meeting of the Society of Gynecologic Surgeons in April 2008 in Savannah, Georgia. As part of the public vetting process, it was announced at this meeting that the original draft of the manuscript would be placed on the SGS Web site for more than 2 weeks in an effort to solicit input from members of the SGS and other interested gynecologists. In addition to verbal comments from the audience at the meeting, seven physicians wrote to the SRG with comments on the manuscript that had been placed on the Web site. Finally, an expert in clinical research and four leading experts in the surgical treatment of POP who were not members of the SGS-SRG were invited to review. Reviewers’ comments were incorporated for the drafting of the final version of the manuscript before submission to the journal.
Recommendations on the Use of Vaginal Grafts Based on Graft Type and Site
Biologic Graft Use in the Anterior Compartment
The systematic review revealed four comparative studies on the use of biologic graft use in the anterior compartment. Two randomized controlled trials (RCTs)8,9 demonstrated conflicting results with regard to anatomic outcomes of anterior wall biologic graft. Two retrospective studies10,11 demonstrated no difference in anatomic outcomes, but these were underpowered for this outcome measure. Three studies8–10 reported symptomatic outcomes including pressure, bulge, or lower urinary tract symptoms. No differences were found between women in whom anterior wall biologic graft was used and those who had anterior colporrhaphy without graft.
Six studies reported graft erosion after anterior wall biologic graft use. Erosion rates between 0% and 13.5% were reported.8–10,12–14 A single study noted infection and surgical failure of anterior wall biologic graft in one of 19 patients (5%).15 Additionally, one study reported postoperative febrile morbidity in 11% of 36 patients.14
From a historical perspective, native tissue repair can be considered the default or standard of care. Insufficient data exist to conclude whether anterior wall biologic grafts offer any overall advantages or disadvantages compared with anterior vaginal wall repairs without graft. Graft-related complications such as graft erosion and infection are rarely reported but do occur in association with biologic graft implanted in the anterior vaginal wall. There are uncertain trade-offs with the use of anterior wall biologic graft.
It is suggested that native tissue repair remains appropriate in anterior vaginal wall repair when compared with biologic graft (Weak).
Synthetic Graft Use in the Anterior Compartment
The most commonly used absorbable synthetic graft material is polyglactin 910 (Vicryl mesh, Ethicon, Somerville, NJ). The first randomized trial of use of this graft with anterior colporrhaphy was published in 2001 by Weber et al16 and compared standard anterior colporrhaphy to colporrhaphy augmented with polyglactin mesh and to ultralateral anterior colporrhaphy. This trial randomly assigned 114 patients with stage I through IV anterior vaginal prolapse, and 83 (73%) patients returned for follow-up. They found no difference in success, but they also failed to meet their desired sample size based on a prospective power calculation.
One other randomized trial17 that compared the use of polyglactin mesh to traditional anterior colporrhaphy did not employ an overlay technique but rather used the mesh as a “bulking material folded into the anterior colporrhaphy stitches.” Sand et al17 excluded anterior vaginal wall prolapse associated with paravaginal defects and randomly assigned 161 women with anterior, posterior, and apical compartments to receive mesh or not; 143 (88.8%) women were available for follow-up at 1 year. The proportion of the patients with anterior compared with posterior compared with both compartment mesh placement was not reported. The trial had a 43% recurrence rate of anterior vaginal wall prolapse to the midvaginal plane in participants without mesh compared with a rate of 25% in the mesh group (P=.02).
No urinary or sexual function differences were noted between arms in either study. There was one (4%) mesh erosion in the Weber study and none in the Sand study. There is conflicting data with respect to anatomic outcomes of anterior absorbable synthetic mesh in the anterior compartment and uncertain trade-offs with its use.
It is suggested that native tissue repair remains appropriate in anterior vaginal wall repair when compared with absorbable synthetic graft (Weak).
The most commonly used permanent, synthetic graft material used in repair of the anterior compartment is currently polypropylene. The first comparative study of polypropylene mesh using Marlex (BardVascular System Division, Billerica, MA) was published by Julian in 1996.18 The population of this nonrandomized study included only 12 women in the control group and 12 in the treatment (graft) group. Inclusion criteria included two or more postsurgical recurrences of severe anterior vaginal wall prolapse. At 2-year follow-up, four prolapse recurrences (two grade 2, two grade 3) were noted in the control group and none in the treatment group (P<.05). Three (25%) patients in the treatment group had graft-related complications, including two graft exposures and one 3-mm area of granulation tissue over the graft.
Three subsequent comparative investigations of nonabsorbable synthetic graft used in the anterior compartment have been reported.19–21 Only one of these compared traditional anterior colporrhaphy to colporrhaphy with graft. This trial by Hiltunen et al20 of 202 women with symptomatic anterior vaginal wall prolapse to the hymen or beyond randomly assigned 97 women to standard anterior colporrhaphy and 104 to colporrhaphy reinforced with low-weight monofilament polypropylene mesh (Parietene light, Sofradim Co., Trevoux, France). They excluded women with an apical defect indicating concomitant vaginal fixation. A 3–4-cm by 4–5-cm body of mesh was placed in between the mucosa and the fibromuscular layer of the anterior vaginal wall after it had been plicated. Four short arms extending from the body of the mesh were placed into narrowly dissected tunnels along the inside of the inferior rami of the pubic bone, penetrating the fibromuscular layer of the obturator space but not penetrating the membrane. The mesh was not fixed by suture in 60% of cases; in the remaining cases it was fixed with one to three stitches of absorbable suture.
At 12-month follow-up, recurrences were seen in 38.5% of the control group compared with 6.7% of the mesh group (P<.001). A higher rate of postoperative stress incontinence occurred in the mesh group (23% compared with 10%, P=.02). Eighteen (17.3%) mesh exposures occurred in the graft group.
These studies found a number of complications associated with the use of synthetic graft in the anterior compartment. When considering these studies in conjunction with the case series of anterior compartment mesh use, the following adverse outcomes have been reported: infection, hemorrhage, mesh erosion, dyspareunia, incontinence, bladder injury, voiding dysfunction, and ureteric obstruction. Overall, the rate of mesh erosion/exposure ranges from 0–24.5%.22,23 In summary, there are trade-offs between using nonabsorbable synthetic mesh or native tissue in anterior compartment repair.
It is suggested that nonabsorbable synthetic mesh may improve anatomic outcomes of anterior vaginal wall repair, but there are significant trade-offs in regard to the risk of adverse events (Weak).
Biologic Graft Use in the Posterior Compartment
Most studies of biologic graft use in the posterior compartment have investigated the use of porcine dermis or porcine small intestine submucosa. Only three studies have compared a vaginally placed biologic graft to a traditional repair in posterior vaginal wall prolapse surgery. A single RCT evaluated the efficacy of biologic graft on anatomic and functional outcomes.24 The other two studies were comparative cohort studies, designed to evaluate inflammatory response of the graft25 and postoperative sexual function.26
The current data suggest that anatomic outcomes are not improved with a biologic graft, and may be worse. Paraiso et al24 randomly allocated 106 women with posterior vaginal wall prolapse to one of three surgical techniques: posterior colporrhaphy, site-specific repair, or site-specific repair augmented by porcine small intestinal submucosa (Fortagen, Organogenesis, Inc, Canton, MA). After one year, the failure rate was higher in women who received a biologic graft–augmented repair (12 of 26, 46%) than in women who received site-specific repair only (6 of 27, 22%) or traditional posterior colporrhaphy (4 of 28, 14%; P=.02). Altman et al25 placed a cross-linked porcine dermal graft (Pelvicol, CR Bard, Covington, GA) into the rectovaginal space as a “replacement layer” rectocele repair in 17 women with Pelvic Organ Prolapse Quantification (POP-Q) stage II or greater posterior vaginal wall prolapse, and compared them to 15 “age matched” historical controls who had received a posterior colporrhaphy for similar indications. At 6 months, the failure rate was similar between the biologic graft and the traditional repair. In the study by Novi et al26 of 100 women who underwent surgery for POP-Q stage II or greater posterior vaginal wall prolapse, 50 women received a “replacement layer” cross-linked porcine dermal graft (Pelvicol) by a urogynecologist, and 50 women received a site-specific repair by a colorectal surgeon. Sexual function at 6 months was compared; anatomic outcomes were not evaluated.
In regard to symptoms, functional, defecatory, and sexual outcomes are similar with and without biologic graft use. Paraiso et al24 reported that functional failures were not significantly different between groups. Defecatory dysfunction improved significantly in all three groups. Regarding sexual function, significant improvement in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) scores from baseline to 1 year after surgery were reported for each treatment group (P<.001 for each), with no differences between groups. Novi et al26 reported that participants undergoing posterior vaginal wall repair with porcine graft scored significantly better (higher) on the PISQ 6 months after surgery when compared with site-specific repair (101.3 compared with 89.7, P=.01).
Adverse events (to include blood loss, wound infection, graft erosion, and chronic pain) are similar with and without biologic graft use. Paraiso et al24 reported no patients with graft exposure or graft complications during a mean follow-up of 17.5 months nor any other differences in complication rates between the three groups.
It is suggested that native tissue repair remains appropriate in posterior vaginal wall repair when compared with biologic graft (Weak).
Synthetic Graft Use in the Posterior Compartment
One RCT evaluated the use of absorbable synthetic graft in the posterior compartment.17 This study evaluated the efficacy of posterior colporrhaphy with and without the addition of polyglactin 910 mesh. The mesh was placed cephalad to the deep transverse perineal muscles, and secured within the imbricated folds of the endopelvic fascia using polyglactin sutures that encircled the mesh. The results of this only available study show no benefit of absorbable synthetic graft in the repair of posterior vaginal wall prolapse. However, these results should be interpreted cautiously, because the study was underpowered and no complications or adverse events were reported.
It is suggested that native tissue repair remains appropriate in posterior vaginal wall repair when compared with absorbable synthetic graft (Weak).
The quality of the evidence for the use of nonabsorbable synthetic graft in the posterior wall is graded as very low. The decision for grading was based on the fact that there are no comparative studies in the literature about the use of nonabsorbable synthetic mesh for the repair of posterior vaginal wall prolapse. There are uncertain trade-offs with its use. The risk of mesh erosion/exposure in the posterior compartment is nonexistent in native tissue repair.
There are no comparative studies to guide any recommendation on the use of nonabsorbable synthetic mesh in posterior vaginal wall repair when compared with native tissue repair.
Biologic Graft Use in the Multiple Compartments
The quality of the evidence for the use of biologic grafts in multiple compartments is graded as very low. The decision for grading was based on the fact that there are no comparative studies in the literature about the use of biologic grafts for the combined repair of anterior, posterior, and/or apical compartment prolapse. There are uncertain trade-offs with its use. The risk of graft erosion/exposure in the vagina is nonexistent in native tissue repair.
There are no comparative studies to guide any recommendation on the use of biologic grafts in multiple compartment repair when compared with native tissue repair.
Synthetic Graft Use in the Multiple Compartments
There are no randomized studies of combined compartment repair with a native tissue arm or that evaluated the efficacy of absorbable synthetic graft for combined vaginal wall repair. There are uncertain trade-offs with its use. The risk of graft erosion/exposure in the vagina is nonexistent in native tissue repair.
There are no comparative studies to guide any recommendation on the use of absorbable synthetic graft in multiple compartment vaginal wall repair when compared with native tissue repair.
Many single arm studies of nonabsorbable synthetic mesh used in multiple compartments have been published. Although there is a great deal of data on the use of nonabsorbable synthetic graft use in multiple compartments, none of the studies have a native tissue comparison group. Furthermore, most studies use a trocar-guided apical support with either an anterior or posterior mesh and may not represent true multicompartment placement.
The quality of the evidence for the use of nonabsorbable synthetic grafts in multiple compartments is graded as very low. The decision for grading was based on the fact that there are no comparative studies in the literature about the use of nonabsorbable synthetic grafts for the repair of combined anterior, posterior, and/or apical compartment prolapse. There are uncertain trade-offs with its use. The risk of graft erosion/exposure in the vagina is nonexistent in native tissue repair.
There are no comparative studies to guide any recommendation on the use of nonabsorbable synthetic graft in multiple compartment repair when compared with native tissue repair.
Recommendations for Conducting and Reporting Future Research
The group’s inability to provide any recommendation of moderate or strong strength is the result of a lack of definitive comparative studies in the current literature. For the comparative studies that have been accomplished, direct applicability to the patient (ie, Directness of the Evidence) is limited by the short-term follow-up and lack of covering the breadth of clinically important outcomes when researching pelvic floor disorders. In accordance with previous recommendations of SGS,27 the 1999 National Institutes of Health (Eunice Kennedy Shriver National Institute of Child Health and Human Development) workshop examining the state of basic, epidemiologic, and clinical research addressing female pelvic floor disorders,28 and recommendations of the 3rd International Consultation on Incontinence,29 our group believes that future research should follow several basic principles: 1) outcome assessments should be made using the same measures before and after intervention; 2) both subjective and objective measures should be included, incorporating improvements and deterioration in function as well as complications of the intervention; 3) valid, reproducible measures should be used, when available; and 4) pelvic floor disorders should be assessed from multiple domains, including 1) subjective assessment of pelvic symptoms, 2) quantification of pelvic symptoms, 3) objective assessment of anatomic outcomes, 4) quality-of-life assessment, 5) socioeconomic effect, including cost-effectiveness and resource use.
Although these are generic recommendations, Table 2 shows the outcomes deemed important by the group to making decisions regarding the usefulness of graft augmentation. To obtain more reliable outcome measures, validated general and symptom-specific quality-of-life instruments need to be used, and anatomic outcomes should be reported using the POP-Q system by an investigator not involved in and, when possible, blinded to the surgery.30 Standardization of the surgical procedures (including graft composition) and physician training in these procedures should be documented. Studies should state clearly whether the participants have been previously reported in published articles. The authors should mention any specific inclusion criteria, such as prior failed repair in the same compartment or severe prolapse (advanced stage 3 or 4). Data should be presented for important outcomes in subgroups of women, for example those with recurrent compared with primary repairs. We recommend at least 1 year of follow-up, but clearly, long-term studies of outcomes at 5 or more years would be preferable. However, differences in adverse event or failure data between groups should be reported as soon as a significant difference is noted. Investigators should strive for follow-up in at least 80% of the women in the investigation. Future research is likely to change the estimates in the net benefit of graft augmentation and the confidence surrounding the estimates.
Recommendations for Preoperative Counseling and Vaginal Graft Use
Balancing the potential risks and benefits of reconstructive surgery always poses a challenge for pelvic surgeons. This is particularly true for new procedures. Vaginal repairs with native tissue have been performed for decades, and although there are questions about the durability of these repairs, the risks are well-known. In particular, potential long-term sequelae are easier to predict given the long track record of these procedures.
Some studies show a decrease in recurrence of prolapse associated with the use of graft in reconstructive pelvic surgery, but others show no benefit in this regard. There is undoubtedly a paucity of randomized, comparative data to guide recommendations regarding efficacy. However, there is a known, unique risk associated with the use of grafts about which potential surgical candidates need to be counseled. The risk of erosion of grafts varies between studies, but it is a risk that does not exist with native tissue repairs. The group also recommends that patients be made aware of the relative lack of long-term data on the durability of and adverse events associated with vaginal graft use. Potential risks include chronic pain, dyspareunia, fistula, infection, and delayed graft erosion/exposure.
Balancing the risks of adverse events with the potential for improved durability associated with one procedure over another is a delicate matter; one that individual surgeons must strive to communicate as clearly and transparently as they can in the face of poor data. Physicians who choose to bring grafts into their armamentarium of vaginal reconstructive surgery must be attuned to these challenges. In order for women to give true informed consent, we as surgeons must convey the unique risks related to grafts and the lack of long-term data comparing native tissue repair to vaginal graft use to our patients.
These guidelines were prepared to help guide clinicians in choosing between the use of grafts or native tissue in transvaginal repair of pelvic organ prolapse. Unfortunately, high or even moderate quality of evidence does not exist to guide us in these recommendations. In fact, the evidence is so limited in some cases that no recommendation can be offered. Even in cases where a recommendation can be made, the quality of evidence is such that further research is very likely to have an important effect on the confidence in the estimate of effect and is likely to change the estimate itself. In regard to the trade-offs associated with vaginal graft use, most studies are underpowered to detect differences in adverse events, and the length of follow-up is insufficient to estimate confidently the long-term benefits and risks. These guidelines highlight the need for further comparative studies of vaginal graft use, preferably randomized trials with long-term follow-up. Until then, practitioners need to explain fully the relative merits of using graft compared with native tissue and carefully consider patients’ values and preferences to arrive at an appropriate decision. Counseling needs to include a discussion about the lack of long-term comparative data on safety and the potential for graft-specific adverse events.
1. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. 1997;89:501–6.
2. Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. The Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD004014. DOI: 10.1002/14651858.CD004014.
3. Weber AM, Richter HE. Pelvic Organ Prolapse. Obstet Gynecol 2005;106:615–34.
4. Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J, et al. Graft Use in Transvaginal Pelvic Organ Prolapse Repair: A Systematic Review. Obstet Gynecol 2008:112:1131–42.
5. Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.
6. Kidney Disease: Improving Global Outcomes. KDIGO Clinical practice guidelines for the prevention, diagnosis, evaluation and treatment of Hepatitis C in chronic kidney disease. Kidney Int 2008;73:S1–99.
7. Shiffman RN, Shekelle P, Overhage JM, Slutsky J, Grimshaw J, Deshpande AM. Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization. Ann Intern Med 2003;139:493–8.
8. Gandhi S, Goldberg RP, Kwon C, Koduri S, Beaumont JL, Abramov Y, et al. A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse. Am J Obstet Gynecol 2005;192:1649–54.
9. Meschia M, Pifarotti P, Bernasconi F, Magatti F, Riva D, Kocjancic E. Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicenter, randomized study. J Urol 2007;177:192–5.
10. Chaliha C, Khalid U, Campagna L, Digesu GA, Ajay B, Khullar V. SIS graft for anterior vaginal wall prolapse repair—a case-controlled study. Int Urogynecol J Pelvic Floor Dysfunct 2006;17:492–7.
11. Handel LN, Frenkl TL, Kim YH. Results of cystocele repair: a comparison of traditional anterior colporrhaphy, polypropylene mesh and porcine dermis. J Urol 2007;178:153–6, discussion 156.
12. Leboeuf L, Miles RA, Kim SS, Gousse AE. Grade 4 cystocele repair using four-defect repair and porcine xenograft acellular matrix (Pelvicol): outcome measures using SEAPI. Urology 2004;64:282–6.
13. Simsiman AJ, Luber KM, Menefee SA. Vaginal paravaginal repair with porcine dermal reinforcement: correction of advanced anterior vaginal prolapse. Am J Obstet Gynecol 2006;195:1832–6.
14. Wheeler TL 2nd, Richter HE, Duke AG, Burgio KL, Redden DT, Varner RE. Outcomes with porcine graft placement in the anterior vaginal compartment in patients who undergo high vaginal uterosacral suspension and cystocele repair. Am J Obstet Gynecol 2006;194:1486–91.
15. Chung SY, Franks M, Smith CP, Lee JY, Lu SH, Chancellor M. Technique of combined pubovaginal sling and cystocele repair using a single piece of cadaveric dermal graft. Urology 2002;59:538–41.
16. Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol 2001;185:1299–304.
17. Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, et al. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Am J Obstet Gynecol 2001;184:1357–62.
18. Julian TM. The efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall. Am J Obstet Gynecol 1996;175:1472–5.
19. Deffieux X, Huel C, de Tayrac R, Bottero J, Porcher R, Gervaise A, et al. Vaginal mesh extrusion after transvaginal repair of cystocele using a prosthetic mesh: treatment and functional outcomes [in French]. J Gynecol Obstet Biol Reprod (Paris) 2006;35:678–84.
20. Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 2007;110:455–62.
21. Bai SW, Jung HJ, Jeon MJ, Chung DJ, Kim SK, Kim JW. Surgical repair of anterior wall vaginal defects. Int J Gynaecol Obstet 2007;98:147–50.
22. Ng CC, Chong CY. The effectiveness of transvaginal anterior colporrhaphy reinforced with polypropylene mesh in the treatment of severe cystoceles. Ann Acad Med Singapore 2006;35:875–81.
23. Deffieux X, de Tayrac R, Huel C, Bottero J, Gervaise A, Bonnet K, et al. Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:73–9.
24. Paraiso MF, Barber MD, Muir TW, Walters MD. Rectocele repair: a randomized trial of three surgical techniques including graft augmentation. Am J Obstet Gynecol 2006;195:1762–71.
25. Altman D, Mellgren A, Blomgren B, Lopez A, Zetterstrom J, Nordenstam J, et al. Clinical and histological safety assessment of rectocele repair using collagen mesh. Acta Obstet Gynecol Scand 2004;83:995–1000.
26. Novi JM, Bradley CS, Mahmoud NN, Morgan MA, Arya LA. Sexual function in women after rectocele repair with acellular porcine dermis graft vs site-specific rectovaginal fascia repair. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:1163–9.
27. Wall LL, Versi E, Norton P, Bump R. Evaluating outcome of surgery for pelvic organ prolapse. Am J Obstet Gynecol 1998;178:877–9.
28. Weber AM, Abrams P, Brubaker L, Cundiff G, Davis G, Dmochowski RR, et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:178–86.
29. Payne C, Blaivas J, Brown J, Hirsch M, Kusek J, Peters T, et al. Research methodology. In: Abrams, P, Cardozo L, Khoury S, Wein A, editors. 3rd International Consultation on Incontinence. Paris (France): Health Publications Ltd; 2005. p. 97–148.
30. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7.
Supplemental Digital Content
© 2008 The American College of Obstetricians and Gynecologists