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Clinical Practice Guidelines on Vaginal Graft Use From the Society of Gynecologic Surgeons

Murphy, Miles MD, MSPH

doi: 10.1097/AOG.0b013e318189a8cc
Original Research
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OBJECTIVE: To develop guidelines regarding whether graft or native tissue repair should be done in transvaginal repair of anterior, posterior, or apical pelvic organ prolapse.

METHODS: The Society of Gynecologic Surgeons formed a work group to develop evidence-based guidelines. Published data from 1950 to November 27, 2007, from the companion systematic review were reviewed to develop guidelines on biologic and synthetic graft use compared with native tissue repair in vaginal prolapse repair. The work group formulated guidelines based on its overall assessment of the evidence. The approach to grading the quality of evidence and the strength of recommendations was based on a modification of the Grades for Recommendation Assessment, Development, and Evaluation system.

RESULTS: It is suggested that native tissue repair remains appropriate when compared with biologic graft use. Nonabsorbable synthetic graft use may improve anatomic outcomes of anterior vaginal wall repair, but there are trade-offs in regard to additional risks. The group suggests issues that should be included in the preoperative counseling of patients in whom clinicians propose to use a vaginally placed graft.

CONCLUSION: Based on the overall low quality of evidence, only weak recommendations could be provided. This highlights the need for practitioners to fully explain the relative merits of each alternative and carefully consider patients’ values and preferences to arrive at an appropriate decision. Future research is likely to change the estimates in the net benefit and risk and the confidence around these assessments.

Clinical practice guidelines for the potential use of transvaginal grafts compared with native tissue repairs for pelvic organ prolapse are provided. Supplemental Digital Content is Available in the Text.

From the Society of Gynecologic Surgeons Systematic Review Group.

See related article on page 1131.

*For members of the Society of Gynecologic Surgeons Systematic Review Group who worked on this article, see the Appendix online at www.greenjournal.org/cgi/content/full/112/5/1123/DC1.

Supported by the Society of Gynecologic Surgeons, who provided administrative and financial support for the Systematic Review Group’s meetings and consultants (www.sgsonline.org).

Corresponding author: Miles Murphy, MD, MSPH, the Institute for Female Pelvic Medicine & Reconstructive Surgery, 1010 Horsham Road – Suite 205, North Wales, PA 19454; e-mail: milesmurphy@comcast.net.

Financial Disclosure Dr. Murphy has consulted for Ethicon Women’s Health & Urology (Johnson & Johnson, New Brunswick, NJ) and Boston Scientific (Natick, MA). Potential conflicts of interest for others involved in the study: Matthew Barber: American Medical Systems (Minnetonka, MN) (research support); Oz Harmanli: Boston Scientific (Natick, MA), American Medical Systems, and Bard (Covington, GA) (consultant); Lior Lowenstein: Pfizer (New York, NY) and Astellas/GSK (Toyko, Japan) (research support); James Lukban: American Medical Systems (consultant, speaker, preceptor); Miles Murphy: Ethicon Women’s Health & Urology (Johnson & Johnson) and Boston Scientific (consultant); Holly Richter: Pfizer (research support); Joseph Schaffer: Cook Medical Inc. (Bloomington, IN) (research support) and Astellas/GSK (speaker); Karl Tumussino: Astellas (advisory board), Gynecare (Ethicon Women’s Health and Urology; Johnson & Johnson) (preceptor, speaker), and Eli Lilly & Co. (Indianapolis, IN) (speaker); Thomas Wheeler: Pfizer (speaker).

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Data Supplements

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Pelvic organ prolapse (POP) is the herniation of the pelvic organs to or through the vaginal opening and can be described as anterior (cystocele), posterior (rectocele), and apical (enterocele), or commonly, a combination of defects. Although minimal, asymptomatic prolapse does not require intervention; symptomatic women can be managed nonsurgically (pessaries and/or behavioral therapy) or surgically. Surgery for prolapse is common. A women has an 11% lifetime risk of undergoing surgery for prolapse or incontinence: one third of surgeries performed are for recurrence.1 Methods of repair vary, and data to guide surgical decision making regarding route of repair are limited. A 2005 Cochrane review reported better apical support success and less dyspareunia with abdominosacrocolpopexy than with sacrospinous ligament fixation, a vaginal procedure, but with an overall increase in morbidity.2 However, only three studies were evaluated in this review. In an attempt to minimize morbidity and improve anatomic success rates, many gynecologists continue to perform transvaginal repair of POP with a variety of techniques, with and without graft augmentation.3 Graft augmentation that bypasses the use of native tissue support is gaining rapid acceptance, especially since the advent of trocar-placed grafts.

Expert opinion varies widely regarding the usefulness of graft augmentation of transvaginal repair of POP. This practice guideline is not meant to serve as a guide to abdominal compared with vaginal graft use. It is intended as an aid for gynecologists performing transvaginal prolapse repairs to understand the quality of evidence for or against using graft augmentation in the anterior, posterior, or apical compartments of the vagina.

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MATERIALS AND METHODS

The Society of Gynecologic Surgeons (SGS) is a select member group of more than 250 physicians representing both private practice and academic faculty—all involved in the teaching and practice of advanced gynecologic surgery. Scientific meetings are held annually, with presentations and discussions of papers based on research in anatomy, physiology, surgical technique, or clinical results of gynecologic surgery by members and invited guests.

In 2007 the research committee of SGS formed a Systematic Review Group (SGS-SRG) to develop these and future guidelines. The SGS-SRG comprised members of the SGS and methods consultants with expertise in the conduct of systematic reviews and guideline development from Tufts Medical Center. The membership of the SGS-SRG includes a diverse group of surgeons whose practice patterns include varying degrees of abdominal and vaginal graft use for prolapse repair as well as native tissue repairs. Their experience level ranges from that of current fellows in female pelvic medicine and reconstructive surgery programs to that of surgeons with decades of pelvic floor repair experience.

The clinical practice guidelines are based on a systematic review on the use of vaginal graft compared with native tissues repair in the treatment of vaginal prolapse conducted by the SGS-SRG. The full description of methods and findings of this systematic review can be found in the companion publication to these guidelines.4 Briefly, a literature search was performed in MEDLINE of publications on vaginal graft use from 1950 to November 27, 2007. Each qualifying study was graded for quality.

Grading of the quality of evidence and the strength of the recommendations followed an approach that was modified from the system proposed by the Grades for Recommendation Assessment, Development, and Evaluation (GRADE) Working Group.5 The GRADE system grades the quality of evidence for each outcome of interest, taking into account study design, methodologic quality, consistency across studies, and directness of evidence. It then considers “the balance between benefits and harms” and assesses the overall quality of evidence across all important outcomes. When formulating a recommendation, it incorporates the applicability of the data to the target practice setting and the baseline risk of the target population. Finally, a grade for the strength of the recommendation is assigned based on the quality of the supporting evidence, the size of the net medical benefit, and other considerations such as values and preferences applied in judgments.5 Although cost is a consideration that can affect the strength of a recommendation, it was not formally considered in this guideline.

The quality of evidence is graded as “high,” “moderate,” “low,” and “very low”; medical benefit is categorized based on risk and benefits of the intervention (see the Box). The strength of each recommendation was graded as “strong,” “moderate,” or “weak” (Table 1). These levels of strength of recommendation differ from those proposed by GRADE, which uses only two levels: strong and weak (or discretionary). The moderate strength of recommendation was added to better distinguish between recommendations based on moderate quality evidence and recommendations based primarily on the work group’s opinion in the face of low or very low quality evidence. This alteration to GRADE has been successfully implemented for international guidelines on kidney disease.6

Figure

Figure

Table 1

Table 1

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.

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RESULTS

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).

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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).

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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).

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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.

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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.

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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.

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DISCUSSION

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.

Table 2

Table 2

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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.

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