Mesh, graft, or standard repair for prolapse surgery?
Authors: Cynthia Brincat, Linda Brubaker
Journal: The Lancet (2016)

As reconstructive pelvic surgeons sought to reduce anatomical and symptomatic recurrence of transvaginal prolapse, the concept of incorporating an augmenting material was adopted. With this idea, similar to mesh-based hernia repair, health-care professionals aim to decrease anatomical recurrence of prolapse and thereby decrease the need for reoperation. In the PROSPECT study in The Lancet, Chiaris Glazener and colleagues1Glazener CMA Breeman S Elders A et al.Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentred, randomised controlled trials (PROSPECT).Lancet. 2016; (published online Dec 20.)http://dx.doi.org/10.1016/S0140-6736(16)31596-3Google Scholar have made progress in answering a clinically relevant question: using two parallel-group randomised controlled trials, the investigators assessed augmentation of transvaginal prolapse surgery with synthetic absorbable or non-absorbable mesh (type 1 monofilament macroporous polypropylene) or biological grafts (porcine acellular collagen matrix, porcine small intestinal submucosa, or bovine dermal).1Glazener CMA Breeman S Elders A et al.Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentred, randomised controlled trials (PROSPECT).Lancet. 2016; (published online Dec 20.)http://dx.doi.org/10.1016/S0140-6736(16)31596-3Google Scholar The pragmatic design involved 65 surgeons across 35 UK sites, allowing considerable generalisability with a low risk of bias. The effective randomisation strategy included patients undergoing either primary or secondary repairs, further expanding the relevance of these results. Although current evidence, including that of this study, suggests that only a few women with anatomical recurrence or persistent symptoms undergo reoperation, the timeline for anatomical recurrence needs more study.1Glazener CMA Breeman S Elders A et al.Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentred, randomised controlled trials (PROSPECT).Lancet. 2016; (published online Dec 20.)http://dx.doi.org/10.1016/S0140-6736(16)31596-3Google Scholar, 2Chmielewski L Walters MD Weber AM Barber MD Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success.Am J Obstet Gynecol. 2011; 205: 69.e1-69.e8Summary Full Text Full Text PDF PubMed Scopus (96) Google Scholar, 3Gotthart PT Aigmueller T Lang PF Ralph G Bjelic-Radisic V Tamussino K Reoperation for pelvic organ prolapse within 10 years of primary surgery for prolapse.Int Urogynecol J. 2012; 23: 1221-1224Crossref PubMed Scopus (16) Google Scholar If prolapse recurrence occurs shortly after a reconstructive surgery, it is probably related to the limitation of the previous surgical approach;4Culligan PJ Murphy M Blackwell L Hammons G Graham C Heit MH Long-term success of abdominal sacral colpopexy using synthetic mesh.Am J Obstet Gynecol. 2002; 187 (discussion 1481–82.): 1473-1480Summary Full Text Full Text PDF PubMed Scopus (182) Google Scholar however, recurrence of the prolapse years after the initial surgery is probably related to intervening factors such as physiological ageing or other health conditions.5Unger CA Barber MD Walters MD Paraiso MF Ridgeway B Jelovsek JE Long-term effectiveness of uterosacral colpopexy and minimally invasive sacral colpopexy for treatment of pelvic organ prolapse.Female Pelvic Med Reconstr Surg. 2016; (published online Sept 16.)https://doi.org/10.1097/SPV.0000000000000313Crossref Scopus (12) Google Scholar Generally, the goal of surgeons is to make every reasonable effort to address anatomical support to reduce symptoms, while recognising that no perfect correlation exists between anatomical recurrence and symptom presence.6Nygaard I Brubaker L Zyczynski HM et al.Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse.JAMA. 2013; 309: 2016-2024Crossref PubMed Scopus (348) Google Scholar Thus for patients and their reconstructive surgeons, an important unanswered question has been whether an augmenting material improves surgical outcomes—eg, does it reduce anatomical recurrence, patient symptoms, or reoperation? If there is an advantage, is it offset in any clinically meaningful way? In Glazener and colleagues' study, the primary outcomes of participant-reported prolapse symptoms (via questionnaire) and condition-specific quality-of-life scores at 1 year did not differ between the standard repair group and either the group with standard repair augmented with synthetic mesh, or the group with standard repair augmented with a biological graft. Similarly at 2 years after surgery, neither synthetic nor biological augmenting materials improved surgical outcomes. The augmenting materials used in this study do not provide any advantage compared to native-tissue transvaginal reconstructive surgery. The pragmatic nature of this study might cause surgical trialists to question whether any specific material has been adequately tested as a comparator to native tissue repair techniques. Yet in this trial, each surgeon was able to select the augmenting material with which they were most comfortable, a pragmatic advantage that allowed each surgeon to do their best, rather than conforming to a protocol that called for a less familiar material or approach. Although the investigators noted no improvement in patient-reported prolapse symptoms at 2 years, to have all participants undergo clinical examination again at 2 years, instead of only once at 1 year, would have been advantageous to better understand the correlation between anatomical support and reported symptoms. Women who receive augmenting materials, especially synthetic mesh, are more likely to have material-related adverse events.1Glazener CMA Breeman S Elders A et al.Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentred, randomised controlled trials (PROSPECT).Lancet. 2016; (published online Dec 20.)http://dx.doi.org/10.1016/S0140-6736(16)31596-3Google Scholar, 6Nygaard I Brubaker L Zyczynski HM et al.Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse.JAMA. 2013; 309: 2016-2024Crossref PubMed Scopus (348) Google Scholar, 7Brubaker L Richter HE Norton PA et al.5-year continence rates, satisfaction and adverse events of burch urethropexy and fascial sling surgery for urinary incontinence.J Urol. 2012; 187: 1324-1330Summary Full Text Full Text PDF PubMed Scopus (58) Google Scholar, 8Barber MD Brubaker L Burgio KL et al.Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: The OPTIMAL randomized trial.JAMA. 2014; 311: 1023-1034Crossref PubMed Scopus (55) Google Scholar, 9Wei JT Nygaard I Richter HE et al.A midurethral sling to reduce incontinence after vaginal prolapse repair.N Engl J Med. 2012; 366: 2358-2367Crossref PubMed Scopus (232) Google Scholar Although the approximate 12% rate quoted in the scientific literature is not unexpected, in transvaginal repairs, these adverse events are not offset by any outcome benefit. It is possible that augmenting materials have a benefit that is detectable only with longer-term follow-up, and this might also be true for the risk of adverse events related to these materials. The findings from Glazener and colleagues' study support the limitations of prolapse repair surgery, with persistent symptoms or anatomical support loss in too many patients.6Nygaard I Brubaker L Zyczynski HM et al.Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse.JAMA. 2013; 309: 2016-2024Crossref PubMed Scopus (348) Google Scholar, 7Brubaker L Richter HE Norton PA et al.5-year continence rates, satisfaction and adverse events of burch urethropexy and fascial sling surgery for urinary incontinence.J Urol. 2012; 187: 1324-1330Summary Full Text Full Text PDF PubMed Scopus (58) Google Scholar, 8Barber MD Brubaker L Burgio KL et al.Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: The OPTIMAL randomized trial.JAMA. 2014; 311: 1023-1034Crossref PubMed Scopus (55) Google Scholar, 9Wei JT Nygaard I Richter HE et al.A midurethral sling to reduce incontinence after vaginal prolapse repair.N Engl J Med. 2012; 366: 2358-2367Crossref PubMed Scopus (232) Google Scholar In their study, the investigators noted that more than 80% of the participants had at least one residual, postoperative prolapse symptom. Researchers in this field have the opportunity to improve surgical outcomes, as well as to better understand the origination and alternative means of addressing prolapse symptoms. Although the effort to incorporate augmenting materials did not provide any advantages, affected women still rely on their surgeons to practice high-quality, evidence-based surgery. In the absence of proven benefit for a given material or given technique, surgeons should provide counselling for transvaginal reconstructive surgery that clearly highlights the limitations of the techniques, and the absence of clear advantages for augmenting materials, as well as their attendant risks. When such a surgery has an optimum outcome, everyone is pleased; however, when symptoms persist or adverse events detract from an improved quality of life, both patients and surgeons might be discouraged. The PROSPECT outcomes highlight the need for new thinking and new strategies that can be tested in appropriately designed studies, before widespread clinical use rather than after clinical implementation. LB receives personal income from editorial royalties from Up to Date journal (as Section Editor) and Female Pelvic Medicine and Reconstructive Surgery journal (as Editor in Chief). CB declares no competing interests. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication. Therefore, follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery. Full-Text PDF Open Access