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Do the benefits of transvaginal mesh outweigh its risks or should use of the product be confined to randomized trials until until more robust clinical data are available?
By Vincent Lucente, MD, MBA, and Carlos Roberts, MD
Dr. Lucente is Medical Director, Institute for Female Pelvic Medicine and Reconstructive Surgery, Pennsylvania; Chief of Gynecology, St. Luke’s University Health Network, Bethlehem, Pennsylvania; and Clinical Professor, Obstetrics and Gynecology, Temple University Hospital, Philadelphia, Pennsylvania.
He reports receiving consulting fees from AMS, Coloplast, and Medtronics, receiving fees for promotional services from Astellas and Shionogi, and performing contracted research for Allergan, AMS, and Coloplast.
Dr. Roberts is Vice-Chairman, Department of Obstetrics & Gynecology, York Hospital, York, Pennsylvania.
He has no conflicts of interest to report with respect to the content of this article.
In more than 25 years of experience as a pelvic reconstructive surgeon, I (Dr. Lucente) have practiced, published, evolved, and gained perspective. After completing a prospective randomized controlled trial (RCT) that favored the abdominal route of pelvic reconstruction1 and listening to colleagues review and critique my paper, the fact that the abdominal group received a mesh augmentation sank in. Through my experience with the transvaginal tape (TVT) procedure,2 which began in 1998, I had become confident in the transvaginal placement of mesh via a trocar-based delivery system. The innovation of transvaginal mesh (TVM) for pelvic organ prolapse (POP) expanded on the surgical principles of TVT. TVM for POP is an attractive surgical alternative without the technical challenges of traditional laparoscopy or the significant cost associated with robotically performed abdominal sacral colpopexy (ASC).
Surgeons’ skills vary widely and teaching newer techniques is challenging. It is crucial to master new surgical techniques to optimally and safely execute TVM procedures.
In 1997 Sackett defined evidence-based medicine as the use of clinical expertise combined with current best evidence to make decisions about patient care.3 But when we hear the term “evidence-based” we often ignore the component of clinical expertise. In 2009, Vintzileos elegantly discussed reality-based medicine versus evidence-based medicine. He also described the components of evidence-based medicine, highlighting the variation of clinical expertise among providers.4 The opinion expressed in this commentary is grounded in reality-based medicine with careful consideration of evidence-based medicine.
The routine use of mesh in repair of abdominal wall fascial defects for hernia repair is based on the well established superior success rates when compared to suture-based repairs. If suture-based repair of dense regular connective tissue on the ventral, non-dependent surface of our upright abdominal-pelvic cavity requires mesh augmentation, there is no doubt that surgical repair of the pelvic floor, which is composed of mostly loose regular and irregular connective tissue, necessitates the use of mesh to achieve durable high success rates.
Beyond the differences in the connective tissue matrix and the force loads experienced by the abdominal wall and the female pelvic floor, one must also consider the degenerative effects of aging with loss of spinal curvature and decreasing neuromuscular function of the levator ani group.5 Biomechanical and physical challenges to the pelvic organ support system experienced by older patients today exceed those experienced by women of a similar age in the past.6 Obesity, physically demanding occupations, and recreational physical activity are just a few demographic and environmental factors that challenge the long-term durability of suture-based native tissue repairs.
Properties that facilitate host tissue integration while minimizing inflammation include the chemical composite of mesh filaments, mesh structure, pore size, rigidity, elasticity, burst strength, thickness, and overall density.7,8 Although some believe that too small a pore size (<10mm) poses an absolute barrier for the “entry” of the neutrophils or macrophages to properly survey the mesh construct where bacteria (<1mm) could survive unchallenged, recent 3-D scanning electron microscopy casts doubt on this.9 This may help explain why postoperative surgical site infections are relatively uncommon after TVM procedures.
The importance of deterioration in the host tissue in response to the effect of stress shielding created by the increased stiffness of the implant has been well described.10 Although new lighter-weight synthetic polypropylene implants appear to be promising, a prosthesis that meets all the criteria of the ideal transvaginal implant does not yet exist. Level I evidence supporting the improved success rate of TVM compared to suture-based native tissue is not yet robust, although it is growing.
A 2008 Cochrane review of demonstrated that the placement of graft “inlays” or TVM significantly reduced the risk of recurrent prolapse.11 Several studies since 2008 have also supported the success of mesh-augmented transvaginal reconstruction over suture-based repair of native tissue.
From the evidence-based literature and the experience of surgeons who have safely performed TVM for several years (yet have not had the resources or opportunity to publish their results) it is obvious and not surprising that mesh-augmented repairs provide durable anatomical benefit. The concern remains, however, that this benefit may not be worth the inherent risk associated with TVM use. The only truly unique risk associated with TVM surgery is that of mesh exposure or extrusion. Fortunately this adverse event is often only mildly symptomatic or asymptomatic and eventually curable in 95% of patients.12
Postoperative de novo dyspareunia has been reported as a result of all pelvic reconstructive surgeries although the rates widely vary. Among surgeons skilled in TVM surgery, de novo dyspareunia rates are similar to both native tissue repairs and ASC.
In one study, when patients who developed dyspareunia after TVM were surveyed, 94.7% responded that overall the TVM surgery had improved the quality of their lives, and they would have it done again.13 So perhaps the real question is whether we can truly minimize complications associated with TVM-augmented repairs.
Variation in surgical skill levels when performing TVM is a much greater determinant of patient outcomes than are mesh properties or delivery systems. Several studies have highlighted this fact.14-17 In one multicenter RCT comparing trocar-guided mesh based repair to conventional repair involving 22 surgeons, the exposure rate ranged from 0% to 100%.14 The same mesh and delivery system was used throughout the study. The obvious conclusion is that the wide variation in exposure rate is more of a function of variation in surgeon expertise.
I often hear the argument that because surgeons are “experienced” the reported suboptimal results can’t be related to insufficient skills. But in the case of more innovative procedures that require expertise in new and different techniques, we must discard the notion that experience equals expertise. For TVM procedures this expertise includes full-thickness vaginal wall dissection, careful and proper sizing, safe and accurate trocar placement, and proper mesh tensioning or setting.
Although there is one comparative trial reporting TVM exposure rates similar to ASC rates,18 overall the reported TVM exposure rates are indeed higher than ASC. If the same mesh is being placed in exactly the same anatomical space as for an ASC performed at the same setting as a hysterectomy (both involving vaginal incisions), the question is, why? Correct placement of the mesh into the true vesicovaginal space is technically easier with a transabdominal route than with a transvaginal approach.
Surgeons are very familiar with the proper planes of dissection from the abdominal route to enter the vesicovaginal space and have the visual guidance to help avoid bladder injury. Transvaginal entrance requires that the surgeon dissect completely through the full thickness of the vaginal wall. If the surgeon uses a “splitting” dissection technique instead of achieving a full thickness dissection, the mesh exposure rate will be higher.
Several authors have recognized suboptimal dissection during surgical trials, noticing that exposure rates decreased over time (despite the use of the same material), implying that the learning curve of the surgeon is a key factor.14
Critical in our development of proper surgical dissection of the vaginal wall was routine utilization of precise hydro-dissection into the true vesicovaginal space. We have found that use of a Tuohy needle, commonly employed for the placement of epidural anesthesia, is helpful with placement of the dissection fluid. The periscope shape of the needle tip provides tactile feedback. The 10-mm silver/black hash marks provide visual reference. The surgical steps of sharp and blunt dissection “follow” the space created by hydro-dissection.19
During sharp dissection it is imperative that gross visible fat or adipose tissue be seen and “followed.” The presence of this adipose tissue is the only absolute confirmation of entrance into the true vesicovaginal space. By using this technique we have reduced our postoperative vaginal mesh exposure rate to 2%–3%.20 Over the past 2 years, we have continued the same dissection technique but have utilized even lower-density meshes (18–21 g/m2) and our exposure is now <1%. Small exposures are often asymptomatic and resolvable in the office setting.12
The most clinically challenging adverse event, and most troublesome to the patient, is the onset of dyspareunia. Fortunately, many patients experience an overall improvement in sexual health after undergoing TVM surgery for POP.13,21 The surgeon’s experience in performing TVM has also been shown to correlate with the incidence of dyspareunia.16
There are several factors that can contribute to the development of postoperative dyspareunia. Setting of the mesh itself is perhaps most important. The mesh must be properly sized to the patient’s anatomical dimensions. It should be delivered to attachment sites that are relatively void of muscle volume (ligaments, fascia, or tendinous insertions).
Lastly, there should be no tension within the mesh. We have found it beneficial to simulate vaginal inward displacement, as with coital penetration, while adjusting the mesh setting to minimize the risk of any restriction of the mesh setting onto the vagina itself.
If dyspareunia develops, directed therapies to resolve the pain should be employed as soon as possible. If there is no palpable mesh banding or bulking (which may require surgical revision or resection), tender or hypersensitive scar areas can be injected with a combination of steroids and an intermediate-acting anesthetic.
If the pain is relieved but keeps recurring, careful injection into the scar with a neurolytic solution of 5% NaCl can be performed. For patients whose mesh was implanted under tension, or was folded, bunched, or otherwise sub-optimally placed, creating a palpable mass or ridge, resection/removal is necessary.
We have also found transvaginal suppositories containing muscle relaxants (diazepam) to be helpful in alleviating pelvic muscle spasm.
Both the literature and our experience clearly establish the need for a long-term durable surgical treatment for POP. The success criteria for our pelvic reconstructive surgeries must be stringent, both anatomically and functionally. Unfortunately, suture repair of native tissue carries a high failure rate approaching nearly 40% even when performed by experts.22 Reconstructive surgery using mesh augmentation has been clearly demonstrated to offer patients a higher success rate for defects involving both anterior or anterior/apical compartments.
Transvaginal placement offers a minimally invasive and more cost-effective approach than transperitoneal, especially when compared to robotically performed ASC. True expertise in TVM procedures is paramount to achieving a very low complication rate. Likewise, one must be knowledgeable and skillful at administering interventions to bring adverse events to resolution.
1. Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996;175(6):1418–1422.
2. Ulmsten U, Henriksson L, et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J. 1996;7(2):81–86.
3. Sackett DL. Evidence-based medicine. Semin Perinatol. 1997;21(1):3–5.
4. Vintzileos AM. Evidence-based compared with reality-based medicine in obstetrics. Obstet Gynecol. 2009;113(6):1335–1340.
5. Mattox TF, Lucente V, et al. Abnormal spinal curvature and its relationship to POP. Am J Obstet Gynecol. 2000;183(6):1381–1384.
6. Drutz HP, Alarab M. POP: demographics and future growth prospects. Int Urogynecol J. 2006;17(1):6–9.
7. Griffis K, Hale DS. Grafts in pelvic reconstructive surgery. Clin Obstet Gynecol. 2005;48(3):713–723.
8. Brown CN, Finch JG. Which mesh for hernia repair? Ann R Coll Surg Engl. 2010; 92(4):272.
9. Van Goethem E, Guiet R, et al. Macrophage podosomes go 3D. Eur J Cell Biol. 2011; 90(2):224–236.
10. Feola A, Abramowitch S, et al. Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh. BJOG. 2013;120(2):224–232.
11. Maher C, Baessler K, et al. Surgical management of POP in women. Cochrane Database Syst Rev. 2010;4(4).
12. Crosby EC, Abernethy M, et al. Symptom resolution after operative Management of complications from TVM. Obstetrics & Gynecology. 2014;123(1):134–139.
13. Lowman JK, Jones LA, et al. Does the Prolift system cause dyspareunia? Am J Obstet Gynecol. 2008;199:707.e1-707.e6
14. Withagen MI, Milani AL, et al. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a RCT. Obstet Gynecol. 2011;117(2, Part 1):242–250.
15. Altman D, Väyrynen T, et al. Anterior colporrhaphy versus TVM for pelvic-organ prolapse. N Engl J Med. 2011;364(19):1826–1836.
16. Abe H, Rahn DD, et al. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011;22(7):789–798.
17. Barski D, Otto T, Gerullis H. Systematic review and classification of complications after anterior, posterior, apical, and total vaginal mesh implantation for prolapse repair. Surg Technol Int. 2014;24:217–224.
18. Maher CF, Feiner B, et al. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. AJOG. 2011;204(4):360-e1.
19. Lucente V, Murphy M, Saiz C. Vaginal prolapse repair: suture repair versus mesh augmentation: a urogynecology perspective. Urol Clin N Am. 2012;39(3):325–333.
20. Murphy M, Lucente V, et al. (2012, October). Outcome incidence: A retrospective series of over 1000 patients following TVM surgery for POP. Oral poster. AUGS 33rd Annual Meeting, Chicago IL.
21. Bhatia N, Murphy M, et al. (2010, April). A comparison of short term sexual function outcomes for patients undergoing the TVM procedure using the standard polypropylene mesh vs a hybrid polypropylene/poliglecaprone mesh. Oral poster. SGS 36th Scientific Meeting. Tucson, AZ.
22. Barber MD, Brubaker L, et al. (2014). Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial. JAMA. 2014;311(10):1023–1034.
NEXT: The case against mesh use >>
By Andrew I. Sokol, MD, and Ladin Yurteri-Kaplan, MD
Dr. Sokol is Associate Director, Minimally Invasive Surgery, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, Associate Professor of Ob/Gyn and Urology, Georgetown University School of Medicine, Washington, DC.
He has no conflict of interest to report with respect to the content of this article.
Dr. Yurteri-Kaplan is Co-Director of Female Pelvic Medicine and Reconstructive Surgery, MedStar Franklin Square Medical Center, Baltimore, Maryland.
She has no conflict of interest to report with respect to the content of this article.
The past decade has been a tumultuous time in the field of pelvic medicine and reconstructive surgery. Much attention has focused on the use of vaginal mesh for pelvic organ prolapse (POP) repair. The issue has been hotly debated in both the lay and medical literature. With approximately 240,000–290,000 transvaginal POP surgeries performed annually in the United States, this debate is anything but trivial. Vaginal mesh “kit” procedures were developed with the intent of improving anatomical cure rates for native tissue vaginal prolapse repairs. At the heart of the idea was the notion that failure and reoperation are common after POP repair, with an oft-quoted reoperation rate of 29.2%.1 However, this is likely an overestimation, since the reoperation rate in that commonly cited study was for both incontinence and prolapse, and 21% of initial surgeries were hysterectomies alone done for uterovaginal prolapse. Hysterectomy alone is inadequate for the treatment of uterovaginal prolapse.2,3
Initial case series of transvaginal mesh showed promising results, with high reported cure rates (>90%) and low complication rates.4 The kits were marketed aggressively, and adoption of the technology was rapid.5 According to 2010 data from the US Food and Drug Administration (FDA), 25% of all POP surgeries in that year used transvaginal mesh.6 Many of the early adopters became paid preceptors for the manufacturers of the devices, holding weekend training courses to “certify” surgeons in the performance of these techniques. Some of these physicians made handsome profits teaching the techniques, consulting with the companies, and participating in speaker’s bureaus. In fact, a recent Wall Street Journal article reported that some of the biggest proponents of vaginal mesh kits made hundreds of thousands of dollars working with the device manufacturers.7 Investigators with industry relationships performed many of these early studies, potentially leading to bias in outcomes. A study evaluating the effect of blinding on outcome assessors in pelvic reconstructive surgery trials found that, on average, unblinded examiners (usually the surgeons themselves) report a 15% higher rate of success than their blinded counterparts.8
The rapid growth of the use of vaginal mesh for POP repair was paralleled by increasing reports of mesh-related complications. The FDA’s Manufacturer and User Facility Device Experience database tracked increasing reports of transvaginal mesh complications (eg, erosion, pain, and visceral injury), malfunction, and death,6 resulting in the release of a public health notification in 2008. In response to a 5-fold increase in adverse event reports during the next 3 years, the FDA released a Safety Communication in 2011. In April 2014, the FDA proposed orders to reclassify surgical mesh for transvaginal POP from a moderate-risk device (Class II) to a high-risk device (Class III), an order that will require rigorous testing of new mesh products against native tissue repairs prior to release.9
Over the same time period, randomized controlled trial (RCT) data began to emerge. One RCT comparing native tissue to vaginal mesh repairs performed at 3 high-volume centers with fellowship-trained, “certified” surgeons was stopped early after a predetermined erosion threshold of 15% was exceeded in the mesh arm of the trial.10 To date, vaginal mesh has shown benefit only in the anterior compartment, without proven benefit in apical or posterior compartment prolapse.11 According to the Cochrane review, traditional anterior repair is associated with higher rate of anatomic recurrence (RR 3.15, 95% CI 2.50–3.96) compared to polypropylene mesh repairs.11 However, studies show no difference in total reoperation rates for prolapse. To the contrary, evidence shows a higher overall reoperation rate with transvaginal mesh versus native tissue repair when used for multi-compartment prolapse-mostly due to mesh-related complications.12,13 In a review of complications and reoperation after apical repairs, vaginal mesh had a higher reoperation rate (8.5%) compared to native tissue vaginal repairs (3.2%).13 This was similarly noted in the Cochrane review for multicompartment treatment of prolapse. The reoperation rate after transvaginal polypropylene mesh repair (11%) was higher than after native tissue repair (3.7%) (RR 3.1, 95% CI 1.3–7.3).11
Moreover, no studies show quality-of-life differences between mesh and native tissue repairs, and quality of life may be the most important factor from a patient’s perspective. Patient-centered outcomes research shows that anatomical outcomes correlate poorly with patients’ perception of success after POP surgery, and that the absence of a sensation of vaginal bulge, rather than anatomic “success” alone, impacts overall patient perception of improvement. The NIH Pelvic Floor Disorders Network now recommends that subjective outcomes be included in the definition of success for surgery.14
Proponents of vaginal mesh often use the argument that the high complication and failure rates associated with mesh-based repairs in randomized trials are related to surgeon inexperience. This same argument could be made for currently published data regarding cure rates after native tissue repairs; that is, surgical cure rates may be tied to surgeon experience. However, if only a select few around the world can achieve very high success and very low complication rates, is this technology generalizable to practicing pelvic surgeons? Even the inventors of this technology reported high long-term complication rates for mesh exposure (16%) and dyspareunia (10%).15 This led them to recommend lower-weight mesh and RCTs before widespread clinical use.
Native tissue POP repairs can also result in complications. However, it is the sometimes-intractable nature of the complications of mesh-based vaginal POP repairs that is most problematic. Those treating mesh complications have seen these patients-women with pain, vaginal stenosis, and loss of sexual function. In one large multicenter review, vaginal mesh complications were typically described as severe and were usually managed surgically, with 60% requiring multiple interventions.16
To responsibly serve our patients, the benefit of adding a permanent synthetic mesh must be significantly greater than the risk. Unfortunately, current data are limited and have not yet defined the role of vaginal mesh in the treatment of POP. Until robust data are available, vaginal mesh should be used mainly in well-designed randomized trials or FDA-mandated post-market surveillance studies (“522 trials”) so that outcomes can be adequately tracked. The Pelvic Floor Disorders Registry was created by the American Urogynecologic Society to track these outcomes and will launch in 2015. This registry collects information about composite (subjective and anatomic) outcomes, patient-reported outcomes, and complications associated with prolapse repair surgery. Ultimately, this will allow physicians to determine what role vaginal mesh will play in the future of pelvic reconstructive surgery.
1. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89(4):501–506.
2. Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013;121(2 Pt 1):354–374.
3. Eilber KS, Alperin M, Khan A, et al. Outcomes of vaginal prolapse surgery among female Medicare beneficiaries: the role of apical support. Obstet Gynecol. 2013;122(5):981–987.
4. de Tayrac R, Gervaise A, Chauveaud A, Fernandez H. Tension-free polypropylene mesh for vaginal repair of anterior vaginal wall prolapse. J Reprod Med. 2005;50(2):75–80.
5. Jonsson Funk M, Edenfield AL, Pate V, Visco AG, Weidner AC, Wu JM . Trends in use surgical mesh for pelvic organ prolapse. Am J Obstet Gynecol. 2013;208(1):79.e1–7.
6. US Food and Drug Administration. Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf. Accessed September 22, 2014.
7. Wang SS. Doctors, device makers: close ties.The Wall Street Journal. http://online.wsj.com/news/articles/SB10001424052702303546204579435162509926916. Accessed September 22, 2014.
8. Antosh DD, Iglesia CB, Vora S, Sokol AI. Outcome assessment with blinded versus unblinded POP-Q exams. Am J Obstet Gynecol. 2011;205(5):489.e1–4.
9. US Food and Drug Administration. FDA issues proposals to address risk associated with surgical mesh for transvaginal repair of pelvic organ prolapse. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm. Accessed September 22, 2014.
10. Iglesia CB, Sokol AI, Sokol ER, et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010;116(2 Pt 1):293–303.
11. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;4:CD004014.
12. Jonsson Funk M, Visco AG, Weidner AC, Pate V, Wu JM. Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse. Int Urogynecol J. 2013;24(8):1279–1285.
13. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complications and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol. 2009;113(2 Pt 1):367–373.
14. Barber MD, Brubaker L, Nygaard I, et al; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114(3):600–609.
15. Jacquetin B, Hinoul P, Gauld J, et al. Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study. Int Urogynecol J. 2013;24(10):1679–1686.
16. Abbott S, Unger CA, Evans JM, et al. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014;210(2):163.e1–8.