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Review Article

Synthetic Mesh in the SurgicalRepair of Pelvic Organ Prolapse:Current Status and Future DirectionsTristan Keys, Lysanne Campeau, and Gopal Badlani

In light of the recent Food and Drug Administration public health notification regarding complications associated withtransvaginally placed mesh for pelvic organ prolapse (POP) repair, we review recent literature to evaluate currentoutcomes and complication data, analyze the clinical need for mesh on the basis of genetic and biochemical etiologiesof POP, and investigate trends of mesh use via an American Urological Association member survey. Mesh-basedtechniques show better anatomic results than traditional repair of anterior POP, but subjective outcomes areequivalent. Further research and Level I evidence are required before mesh-based repair of POP can be standardized.Adequate surgical training and patient selection should decrease complication rates. UROLOGY 80: 237–243, 2012.

ublished by Elsevier Inc.

Approaches to the surgical management of pelvicorgan prolapse (POP) have undergone severalparadigm shifts over the last few decades. Inno-

vative technologies are being incorporated into treat-ment methodologies, specifically in the arena of surgicaldevices. Subsequently, there has been a concerted effortto improve surgical outcomes while keeping patientsafety paramount. This, unfortunately, has led to signif-icant controversy in the surgical treatment of POP. It wasinitially believed that synthetic mesh for augmented re-pair would provide an effective tool in the surgeon’sarmamentarium against severe and/or recurrent disease.The advent of commercialized kits, however, has led towidespread use of mesh to treat incontinence and pro-lapse. Many believe their introduction into clinical usehas been too rapid, and that sufficient clinical evidenceto garner Food and Drug Administration (FDA) approvalis lacking. The controversy surrounding the rise in re-ported complications associated with prolapse repair isevidenced by the FDA Safety Communication Update.1

To help gain insight into current trends of syntheticpolypropylene mesh use for POP repair, we review themost recent literature regarding efficacy of mesh-basedrepairs in randomized controlled trials (RCTs), geneticand biochemical factors supporting its use in stress uri-nary incontinence (SUI)/POP repair, and complicationsassociated with mesh use, differentiating between com-

Financial Disclosure: The authors declare that they have no relevant financialinterests.

From the Department of Urology; and Institute for Regenerative Medicine, WakeForest University School of Medicine, Winston-Salem, NC

Reprint requests: Gopal Badlani, M.D., Department of Urology, Wake ForestUniversity School of Medicine, Medical Center Boulevard, Winston-Salem, NC

27157. E-mail: gbadlani@wakehealth.edu

Submitted: April 3, 2012, accepted (with revisions): April 6, 2012

Published by Elsevier Inc.

plications resulting from surgical technique vs the mesh.We also analyze American Urological Association (AUA)members’ responses to a questionnaire on their educationand use of mesh, as well as correlate lessons from mesh usefor abdominopelvic hernia repair.

MATERIAL AND METHODS

A PubMed search for RCTs and meta-analyses in English since2007 was performed. In addition, landmark publications before2007 are included, as well as a review of epidemiology, thegenetic causes of POP, and general surgical hernia repair withmesh. Key words include POP, synthetic mesh, complica-tions, genetics, hernia. Ninety-five articles were consideredin the process; on the basis of subject relevance, only 45 areincluded in the review. We also performed an Internet surveyof AUA members regarding their training and use of syn-thetic mesh.

Epidemiology of POPA recent investigation has demonstrated POP’s associationwith age. Nygaard et al2 performed a cross-sectional analysis of1961 women participating in the 2005-2006 National Healthand Nutrition Examination Survey (NHANES). Their evalua-tion revealed an overall prevalence of symptomatic POP, de-fined as sensation of vaginal bulging, to be 2.9% in women over20 years old, with a prevalence of 3.8% for ages 40-59, 3% forages 60-79, and 4.1% for ages �80. Wu et al3 used thesenumbers and population projections from the 2000-2010 USCensus Bureau to estimate that as many as 9.2 million womenwill have symptomatic POP by 2050. In another population-based study, the Reproductive Risks for Incontinence Studyrecruited 2001 women from a Californian health maintenanceorganization from 1999-2003. In this cohort, Rortveit et al4

report a 5.7% prevalence of symptomatic prolapse, defined assensation or visualization of vaginal bulge, with 47% of these

women experiencing moderate to severe distress.

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Although disease prevalence is important, perhaps a bettermarker for severity is the need to undergo surgical treatment forsymptom relief. In a landmark study, Olsen et al5 retrospec-tively evaluated 395 women who had surgery for prolapse orincontinence in 1995 and observed that a woman has an 11.1%lifetime risk of undergoing an operation for these complaints.Furthermore, they noted that 29.2% had previously undergonea traditional repair. Unfortunately, the authors did not performsubgroup analyses; thus the utility of this study is limited whenconsidering prolapse alone. Shah et al6 specifically examinedrates of POP surgery in United States women by analyzingICD-9 codes from the 2003 National Hospital Discharge Survey(NHDS), revealing a surgical rate of 18/10,000 women. Age-group analysis found rates of 24/10,000 for ages 40-59, 31/10,000 for ages 60-79, and 17/10,000 for ages �80.

Providing evidence-based counseling to patients requiresclose monitoring of surgical outcomes. Part of the debate sur-rounding mesh use has been the lack of consistent or clinicallypertinent outcomes measurements. Weber et al7 randomizedwomen with anterior wall prolapse to three different repairtechniques. On the basis of the definition from the 2001 Na-tional Institutes of Health Workshop on Standardization ofTerminology for researchers in Pelvic Floor Disorders (pelvicorgan prolapse quantification [POP-Q], points Aa and Ba � -2cm with or without symptoms), they found surgical repairfailure ranging from 54-70%. Using an updated and “clinicallyrelevant” definition of success, Chmielewski et al8 reanalyzedthe data, reporting a recurrence of only 12% in the standardcolporrhaphy group. This definition was based on a recommen-dation by the Pelvic Floor Disorders Network to include symp-tomatic and anatomic criteria along with absence of reopera-tion in the outcomes measurements.9 This emanated from the

ARE trial by Barber et al,9 in which surgical success of abdominalacrocolpopexy ranged from 19.2-97.2% depending on the defini-ion. Furthermore, the CARE trial demonstrated that anatomicuccess alone did not correlate with patient assessment of globalmprovement, whereas patient-reported lack of symptomatic vag-nal bulge was associated with improvement. In the Pelvic Organupport Study, Swift et al10 evaluated a diverse group of 1004omen presenting for routine gynecologic visits for presence ofrolapse, finding that 24% had stage 0 POP-Q, 38% stage I, 35%tage II, and 2% stage III; none had stage IV. Although percentagef symptomatic patients is not reported, they did observe a corre-ation between increasing degree of prolapse and bother. Thistudy is limited, however, in that it under-reports severe cases,kewing their analysis of symptomatic disease.

Genetic and Biochemical Factors Underlying POPThe individualized approach to surgical repair of POP requirescareful consideration of all possible contributing factors to thecondition, along with ongoing or future insults. A genetic studyusing the Swedish Twin registry demonstrated that geneticcontribution accounted for 43% of the variation for POP.11

Familial studies have also shown that women with a familyhistory of prolapse and hernia were at a higher risk of develop-ing POP.12,13 The familial predisposition may be explained byenetic alterations. POP has also been linked with chromosomeq21, an area with genes for proteins highly expressed in mus-le.14 More recently, six loci on different genes were found toave single nucleotide polymorphisms (SNPs) associated withOP in 115 case group participants.15

Epigenetic regulation of the extracellular matrix (ECM)

likely plays a strong role in pelvic floor support.16 The pelvic

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oor is an anatomic arrangement of smooth and skeletal mus-les, ligaments, and fascia. Substances like collagen and elastinrovide extraordinary compliance and elasticity in the ECM ofascia and ligaments. Collagen synthesis and breakdown rendershe ECM a very dynamic structure through a constant processf remodeling. Candidate gene and case-control studies haveocated high-frequency SNPs in women with prolapse for genes,uch as LAMC117 and MMP-9.18 More than 20 different types

of MMPs are largely responsible for collagen breakdownthroughout the body. The interstitial and neutrophil collage-nases (MMP-1, MMP-8, MMP-13) cleave fibrillar collagen, andthe gelatinases (MMP-2 and MMP-9) degrade the denaturedpeptides. These mutations alter ECM metabolism, increasingpredisposition to pelvic floor disorders.

A strong genetic predisposition in a woman with an initial orrecurrent clinical presentation of POP should be taken intoaccount in the surgical decision making process. These patientsmay possibly have a weaker pelvic floor with disorganized tissuerepair, thereby favoring the use of mesh. This holds true espe-cially for severe anatomic disease because there is significantlyhigher risk of prolapse recurrence after traditional surgical re-pair without mesh in women with stages 3-4 prolapse.19 Byontrast, their inherent altered ECM metabolism may increaseheir likelihood of complications like erosion, although theiterature does not suggest or disprove this.

Several studies suggest a correlation between the develop-ent of POP and other acquired diseases involving connective

issue laxity, such as hiatal and inguinal hernias.20,21 The evo-lution of synthetic mesh use can be observed in abdominopelvichernia repair where treatment with synthetic biomaterials hasbecome standard practice.22 Treatment efficacy is significantlyimproved with the incorporation of mesh, and it has beenwidely accepted despite the uniquely associated complications.Similar to controversies over mesh for POP repair, there are nodefinitive conclusions regarding which of the many productsmay be most efficacious and safe.23 Although trials to answersuch questions are underway, synthetic mesh will remain one ofthe primary treatment options for hernias.

The use of mesh for these 2 applications diverges, though, inthe different tissue milieu of the abdomen and pelvis. Whereasabdominal adhesions are the scourge of the general surgeon,tension-free repair of SUI/POP depends on such tissue re-sponses to anchor the mesh. Furthermore, the abdominal wall isnot subjected to the same mechanical stress as is the pelvicfloor. This has ramifications in the preclinical biocompatibilitytesting of synthetic materials because abdominal wall defects inanimal models are used to measure tissue responses. Such stud-ies cannot reliably predict how mesh will behave in vivo andthus data extrapolation to humans is limited.24 However, morestudies are emerging in which the biomechanical properties ofimplanted mesh are investigated. Woodruff et al25 performedhistopathologic examination of 5 different pubovaginal graftsexplanted from human patients, finding variable host remodel-ing characteristics for each type of graft. Although not clinicallycorrelated, this study epitomizes the importance of investigatingetiologies of local complications and functional alternations,which have efficacy and safety implications.

Outcomes from RCTs and Meta-AnalysesBetween 2007 and 2011, there were 11 published completeRCTs (Table 1) and 2 meta-analyses comparing traditionalrepair to synthetic mesh augmentation; outcome reporting var-

ies significantly. In 2007, Hiltunen et al26 randomized 201

UROLOGY 80 (2), 2012

Table 1. Reported outcomes and complications of RCTs

Author, year Published F/UPrimary Outcome: Criteria

(defect treated)ComparedProcedures n

Primary OutcomeResults(P value)

Rates of SymptomaticRecurrence

Mesh-specific Complicationsand Treatment

Re-operation for POPRecurrence

Hiltunen et al, 200726 1 y POP recurrence: �stage IIPOP-Q (anterior prolapse)

AC 104 38.5% 14 patients 17.3% anterior wall exposure78% local excision of mesh22% topical estrogen

1 patient in the AC groupSTM 97 6.7% (P �.001) 4 patients (P � .005)

Sivaslioglu et al,200827

1 y Surgical success: �stage IPOP-Q (cystocele)

AC 42 72% NR 6.9% vaginal erosion100% local excision of mesh

NRSTM 43 91% (P �.05) NR

Nguyen and Burchette,200828

1 y Surgical success: �stage IPOP-Q (anterior prolapse)

AC 37 55% 1 patient 5% incisional extrusion0% symptomatic100% local excision of mesh

1 patient in the AC groupPerigee 37 87% (P� .005) 0 patients

Carey et al, 200933 1 y Surgical success: �stage IPOP-Q at any site (anterior/posterior prolapse)

A&P 61 65.5% NR 5.6% exposure75% local excision of mesh25% topical estrogen

2 patients in the ACgroupSTM 63 81% (P � .07) NR

Lopes et al, 201034 1 y POP recurrence: Ba �0 POP-Q(uterine prolapse)

SSLF 15 44% NR 35.7% erosion20%/20% local/full excision60% topical estrogen

1 patient in mesh groupfor vault prolapseNazca 14 57% (P � .8) NR

Iglesia et al, 201035 3 mo. POP recurrence: �stage IIPOP-Q (apical /anteriorprolapse)

VC 33 70.4% NR 15.6% erosions60% local excision of mesh40% topical estrogen

NRProlift 32 59.5% (P � .28) NR

Nieminen et al, 201029 3 y POP recurrence: �stage IIPOP-Q (anterior prolapse)

AC 97 41% 26 patients 19% exposure70% local excision of mesh30% topical estrogen

8 patients in AC groupSTM 105 13% (P �.0001) 9 patients

Withagen et al, 201130 1 y POP recurrence: �stage IIPOP-Q (recurrent prolapseat any site)

CR 97 45.2% 4 patients 16.9% exposure65% asymptomatic35% local excision of mesh65% topical estrogen

4 patient in CR groupProlift 93 9.6% (P �.001) 0 patients

Maher et al, 201136 2 y Surgical success: �stage 1POP-Q at any site (vaultprolapse)

LSC 53 77% 1 patient 2% 3 patients in mesh groupProlift 55 43% (P �.001) 4 patients 9%

Altman et al, 201131 1 y Surgical success:1. �stage 1 POP-Q2. No vaginal bulge sensation

(anterior prolapse)

AC 182 34.5% 38% Total exposure rate NR3% had revision of mesh

1 patient in AC groupProlift 186 60.8% (P �.001) 25% (P � .008)

Vollebregt et al, 201132 1 y Surgical success: �stage IIPOP-Q (cystocele)

AC 56 41% NR 4% exposure100% local excision of mesh

3 patients in AC groupAvaulta 58 91% (P �.001) NR

AC � anterior colporrhaphy; A&P � anterior and posterior colporrhaphy; CR � conventional repair; F/U � mean length of follow-up; NR � not reported; STM � surgeon-tailored mesh; VC � vaginalcolpopexy.

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postmenopausal women with anterior prolapse alone to anteriorcolporrhaphy with (n � 104) or without (n � 97) surgeon-tailored, low-weight polypropylene mesh (Parietex, Sofradim);there were no concomitant procedures for SUI. Recurrence ofdisease, defined as prolapse �stage II POP-Q, occurred in38.5% of the nonmesh group and 6.7% of the mesh group(P �.001) at 1-year follow-up. There were no significant dif-ferences between mesh and nonmesh groups in regards to sub-jective outcomes, such as pelvic pressure or vaginal bulge. Inanother study, Sivaslioglu et al27 randomized women withystoceles to either transvaginal mesh repair (n � 43; Parietex,ofradim) or colporrhaphy (n � 42), and determined the cureates as defined as prolapse �stage I POP-Q. Patients withoncomitant SUI were excluded. At 1-year follow-up, anatomicure was achieved in 91% of the mesh group vs 72% of theonmesh group (P �.05). There was no significant differenceetween groups overall in a postoperative quality-of-life ques-ionnaire (P-QoL). However, when the questionnaire was bro-en down into individual symptom complexes, the mesh groupad significantly less abnormal emptying, frequency, urgency,nd pelvic pain, and the nonmesh group reported improvedymptoms in abnormal emptying and urgency parameters only.guyen et al28 randomized 74 women with anterior prolapse to

ither colporrhaphy (n � 37) or transvaginal polypropyleneesh repair (n � 37; Perigee, AMS). A majority of patients in

ach group also had a midurethral sling placed for SUI. Theesh group had a significantly higher optimal or satisfactory

elvic support at 1 year, defined as prolapse �stage I POP-Qompared with the traditional repair group (87% vs 55%, P �005). Overall, most patients with anatomic recurrence weresymptomatic, with only 1 patient in the nonmesh group re-uiring a secondary procedure. Both groups had significantostoperative improvement in scores on 2 validated question-aires—PFDI-20 and PFIQ-7—but there was no significantifference between groups overall. Interestingly, the mesh groupid have significantly better scores in the prolapse and urinaryubscales of the PFDI-20.

In a multicenter RCT with the longest follow-up periodublished to date, Nieminen et al29 randomized 105 women to

surgeon-tailored transvaginal mesh (Parietex, Sofradim) and 97women to traditional colporrhaphy for anterior wall prolapse.Patients with concomitant SUI were excluded. At 3 yearsfollow up, the authors reported recurrence of prolapse �stage IIPOP-Q to be 13% in the mesh group vs 41% in the traditionalrepair group (P �.0001). Although the proportion of postop-erative recurrence of symptomatic bulging sensation was similarin each group (65% for nonmesh group vs 69% in mesh group),there was a significant difference favoring the mesh group ifoptimal outcome was defined as absence of anatomic recurrenceand lack of vaginal bulge sensation (82% vs 55%, P �.0001).Although no validated questionnaires were used, there was nodifference between groups in other secondary measures of globalimprovement. In a comprehensive RCT, including patientswith recurrent prolapse in anterior, posterior, or apical vaginalcompartments, Withagen et al30 observed that overall 9.6% of

omen who underwent trocar-guided, tension-free vaginalesh (n � 93; Gynecare Prolift, Ethicon) had anatomic failure

n the treated compartment compared with 45.2% of womenho had a traditional procedure (n � 97) at 1 year follow-up

P �.001). There was no difference between groups whenconsidering apical failure, but the mesh group performed signif-icantly better in both anterior and posterior compartments.

Interestingly, if the definition of failure was changed to prolapse

40

�stage II POP-Q in any compartment, failure rates increased to49% in the mesh group and 66% in the traditional repair group,but still significantly favored mesh repair (P �.05). Despitehaving better anatomic outcomes, however, there were nosignificant differences in secondary outcome questionnaires(UDI, DDI, IIQ, PGI-I). In the largest multicenter RCT com-paring traditional repair with a commercialized mesh kit (Gyn-ecare Prolift, Ethicon), Altman et al31 randomized women withystoceles to either anterior colporrhaphy (n � 182) or trocar-uided, transvaginal polypropylene mesh repair (n � 186). Therimary outcome at 1-year follow-up was defined in terms ofnatomic success (POP-Q �stage I) plus subjective successabsence of a vaginal bulging sensation) and was found in0.8% of the mesh group but in only 34.5% of the nonmeshroup (P �.001). Furthermore, the mesh group had significantlyess vaginal bulge symptoms at 1 year compared with the col-orrhaphy group (75.4% vs 62.1%, P � .008). When comparingecondary outcomes between groups, however, there was noignificant difference in overall postoperative UDI or PISQ-12cores. In another study, Vollegregt et al32 found a 91% ana-

tomic cure rate at 1-year follow-up in 58 women undergoingtrocar-guided transvaginal mesh repair (Avaulta, Bard) com-pared with 41% cure rate in 56 women who had a traditionalprocedure for cystocele repair (P �.001). Both UDI and IIQquestionnaire scores were assessed as secondary outcomes, butthere was no significant difference in overall scores betweengroups. Overall, most trials report better anatomic success ratesin the mesh-based procedures but do not demonstrate anysignificant differences in functional or quality-of-life outcomes.

Several other trials have not found synthetic mesh to besuperior to traditional repair. Carey et al33 reported on their-year follow-up comparing 63 women undergoing transvaginalurgeon-tailored mesh repair (Gynemesh PS, Ethicon) for an-erior or posterior wall prolapse to 61 women who had tradi-ional colporrhaphy. Midurethral slings for SUI were concom-tantly placed in both groups. Although anatomic success,efined as prolapse �stage II POP-Q, was higher in the meshroup (81% vs 65.6%), it did not reach statistical significanceP � .07). For secondary outcomes, scores from several ques-ionnaires measuring quality of life (PSI-QOL, SUDI, SIIQ,CCS) were not different between groups. In a small RCT,opes et al34 randomized 30 women with apical prolapse toither sacrospinous ligament fixation (n � 16) or transvaginally

placed polypropylene mesh kit (n � 14; Nazca, Promedon).The recurrence rates at the anterior wall (57% for the meshgroup and 44% for the sacrospinous ligament fixation [SSLF]group) and the measures of quality of life were not significantlydifferent at 1-year follow-up between groups. In an RCT thatwas prematurely halted because of complications in the meshgroup, Iglesia et al35 randomized women with apical or anteriorprolapse to either Gynecare Prolift transvaginal mesh repair(n � 32; Gynecare Prolift, Ethicon) or vaginal colpopexy (n �3). Overall, recurrence of prolapse at 3 months was similaretween groups, as were subjective measures of vaginal bulge.inally, Maher et al36 randomized women with vaginal vault

prolapse to laparoscopic sacral colpopexy (LSC, n � 53) vstotal vaginal mesh (n � 55; Gynecare Prolift, Ethicon) andevaluated outcomes 2 years postoperatively. The LSC group hadbetter objective cure of prolapse, with 77% success rate vs 43%in the mesh group (P �.001). There were no differences be-tween groups in the improvement of functional or quality-of-

life questionnaire scores.

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Meta-analyses can effectively analyze data from multiple re-ports to generate higher-powered results, but their applicationextends only as far as the quality of the studies they review.Because trials evaluating efficacies of nonabsorbable syntheticmesh exhibit a high degree of variability, accurate meta-analysisis difficult. Jia et al37 carried out an international review onanterior or posterior wall prolapse, analyzing studies from 1980-2007, only revealing enough high-quality data to report resultsin anterior repair. Using a Bayesian meta-analysis model, anytype of adjuvant mesh resulted in lower objective failure ratescompared with standard techniques, with nonabsorbable syn-thetic mesh conferring a significantly lower objective failurerate when compared with absorbable synthetic mesh (OR 0.23,CI 0.12-0.44) or absorbable biological mesh (OR 0.37, CI0.23-0.59). Summarizing the 2011 Cochrane review, Maher etal38 also report that no definitive conclusions can be drawnabout mesh use for posterior or apical vaginal repair. Regardinganterior wall prolapse, however, anterior colporrhaphy hadhigher rates of objective failure in the same compartmentcompared with polypropylene mesh onlay (RR 2.14, CI 1.23-3.74) and surgeon-tailored or commercial transobturator meshkits (RR 3.55, CI 2.29-5.52). Although both meta-analysesdemonstrate higher objective/anatomic success of syntheticmesh use, neither can conclude that there are increased sub-jective success rates or improved quality of life parameterscompared with traditional repair techniques.

Evaluating the RCTs and Meta-AnalysesThe initial lack of high-quality data could not guide physiciansin the appropriate use of synthetic mesh-based procedures be-cause there was scant Level 1 evidence published in the yearsafter the FDA’s approval. Over the past few years, however,multiple RCTs and meta-analyses have helped provide higher-quality outcomes data regarding the use of synthetic mesh. TheRCTs reviewed are very well-designed, and all but one metstatistical power requirements. However, individual results mustbe interpreted with caution because most conclusions are weak-ened by their nonblinded outcomes assessment. Generalizationof these results is also significantly limited because surgicalmethodologies between trials are known to vary.

Specifically regarding efficacy, though, mesh-based proce-dures provide equal or greater short-term anatomic cure ratescompared with traditional repair, particularly for anterior vag-inal wall prolapse. Most RCTs only report short-term outcomes,however, and thus cannot be extrapolated to long-term results.Also, there is no consensus data to suggest mesh use for apicalor posterior compartment prolapse repair at this time. No in-vestigation has documented significantly improved patient re-ported outcomes when comparing the different repair methods.For these reasons, widespread use of mesh for POP cannot berecommended over traditional repair without a caution. Per-haps more important are the potential complications and safetyimplications associated with mesh-based repair, which shouldbe discussed with the patient when considering its use.

Complications of Mesh-Based RepairErosion through tissue planes is the principal obstacle in mesh-based repair. In these RCTs, rates of documented erosion rangefrom 4-35.7% (Table 1).26-36 Reporting of exact erosion loca-tion (incision site vs vaginal wall) and symptomatic occur-rences is low. Most erosions were treated under local anesthesia

by partial excision of the eroded mesh, and the rest needed only a

UROLOGY 80 (2), 2012

topical estrogen. Few cases required full removal. After coalesc-ing data from multiple studies, Maher et al38 calculated anoverall erosion rate of 10%, similar to the 10.2% rate reportedby Jia et al,37 who also found that only 6.6% of all cases requiredsurgical excision. In a recent systematic review, Abed et al39

report an erosion rate of 10.3% for all synthetic mesh proce-dures. In a review analyzing apical prolapse repair using vaginalmesh kits, Diwadkar et al40 report an overall erosion rate of5.8%. Although this study determined that the total complica-tion rate was higher for sacral colpopexy (17.1% vs 14.5% formesh kits), vaginal mesh kits induced more severe complica-tions requiring surgical correction.

Such reports, along with the increasing rate of complicationsreported to the FDA’s MAUDE database, prompted the FDA torelease its warning regarding mesh for POP repair. Unfortu-nately, there are several important issues that are often notincluded in these discussions. First is the lack of distinctionbetween complications caused by surgical technique as opposedto the mesh itself. Many technique-related factors increase therisk for mesh erosion, such as concurrent hysterectomy, incisiontype, and depth of tissue dissection. In fact, the high erosionrate reported in one of the RCTs (35.7%) was attributed to themesh placement in relation to the rectovaginal fascia.34 More-ver, Maher et al38 determined that there are no significantifferences in the incidence of other postoperative complica-ions, such as de novo SUI or dyspareunia, compared withraditional repair. Other complications, such as intraoperativenjuries, bleeding, and hematomas are caused primarily by meshnsertion techniques, not by the presence of mesh.

This leads to other critical issues that are often neglected,amely the role of surgeon education, as well as how market

orces affect practice standards. Increasing surgical experienceeads to improved outcomes in any field, and this has beenbserved in the arena of mesh-based repairs.41 The rapidlyncreasing availability of new devices may not only preventppropriate training, but also discourages the completion ofCTs as new products are marketed before a trial can beompleted.42,43 We performed a survey of all currently practic-ng AUA members who were e-mailed a 7-question surveyegarding their training and current use of synthetic mesh inaily practice (Table 2). On the basis of the responses, 75% ofrologists received training for mesh-based repair techniques

Table 2. AUA member survey results*

Current Use of mesh-based Procedures by PracticingUrologists†

Urologists who use mesh 86.8%Average mesh cases per month 5 (range 0–100)

For SUI 4.27 (range 0–100)For POP 1.34 (range 0–35)

Sources of mesh-based proceduretraining‡

Self-instructed 31.9%Company course 25.9%Company hands-on course 48.8%Specialty Society hands-on course 5.7%Fellowship 9.7%Residency 22.3%

* A SurveyMonkey web-based survey was e-mailed to 8008 reg-istered AUA members who had validated e-mail addresses andpractice in the United States in September 2011.† Total response rate of 16.6% (1329 responses).‡ More than one answer could be selected.

t an industry-sponsored course, with only 49% receiving

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hands-on guidance. Although we are unsure of how many ofthese urologists initially had specialty training, one third of allresponders indicated they were self-instructed, whereas only10% reported training for mesh implantation techniques duringfellowship.

CONCLUSIONSThe ideal synthetic mesh likely has not yet been devel-oped.42 As current research endeavors provide a greaterunderstanding into the risk factors and etiologies of POP,the development of treatment modalities with greaterefficacies and lesser complications can be achieved. How-ever, it must be ensured that new technologies be ade-quately evaluated and tested and that surgeons undergoappropriate training before large-scale market competi-tion forces its disseminated use. Although intended pri-marily to warn patients of potential complicationsassociated with mesh-based repair, the FDA’s SafetyCommunication in July of 2011 has also served as a

Table 3. IUGA/ICS terminology classifications*

Terms Definition

Prosthesis A fabricated substitute to assista damaged body part or toaugment or stabilize ahypoplastic structure

Mesh A (prosthetic) network fabric/structure

Implant A surgically inserted/embeddedprosthesis

Tape (sling) A flat strip of synthetic materialGraft Any tissue or organ for

transplantation; this term willrefer to biological materialsinserted

Complication-specificterminology†

Erosion “does not necessarily suit theclinical scenarios. . . and itsuse is best avoided, to bereplaced by terms with greaterphysical specificity and cla-rity.”44

Exposure A condition of displaying,revealing, exhibiting, ormaking accessible, eg,vaginal mesh visualizedthrough separated vaginalepithelium.

Extrusion Passage gradually out of thebody structure or tissue

Perforation Abnormal opening into a holloworgan or viscus

* Adopted from Haylen et al. An International UrogynecologicalAssociation (IUGA)/International Continence Society (ICS) jointterminology and classification of the complications related di-rectly to the insertion of prostheses (meshes, implants, tapes) &grafts in female pelvic floor surgery. Int Urogynecol J. 2011;22:3-15.45

† The reviewed studies may not have followed these definitionswhen reporting complications, and thus the original language inthe articles are used for this review.

wake-up call for physicians and has encouraged medical

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organizations to take a bigger role in developing practicepolicies. The AUA, the American College of Obstetri-cians and Gynecologists, as well as the American Uro-gynecologic Society have made specific recommenda-tions that emphasize appropriate surgical education andcall for high-quality comparative trials in POP whilesupporting the mesh’s use as a midurethral sling forSUI.44 Development of use and outcome registries willprovide a better evaluation of rates of mesh-related com-plications. Standardization of complication reporting hasbeen initiated by the International Urogynecological As-sociation and International Continence Society (Table3),45 and this will we hope assist in delineating variousetiologies of complications. It is imperative that suchstandardization also be applied to better define the dis-ease state, as well as surgical outcome measures. Suchpolicies will assist in proper patient phenotyping andclinical decision making. Incorporating both objectiveand patient-reported subjective outcomes in defining dis-ease states, surgical success, or disease recurrence is ab-solutely essential.

For situations in which controversy abounds, there isan immense opportunity to advance knowledge and un-derstanding of the issue in dispute. Such is the case withusing synthetic mesh for the treatment of POP. Theapplication of mesh should not be ubiquitous to all pa-tients, nor should its availability be stricken from thesurgeon’s armamentarium. Further research into diseaseetiology along with improved physician training in sur-gical skill and patient assessment will help identifywomen who would or would not benefit from a mesh-based repair. Currently, however, it is the surgeon’s dutyto fully inform the patient and discuss the risks vs benefitsof such procedures. Just as important, the surgeon mustalso reflect on and judge their surgical competency, beingallowed to decide what is best for individual patients.46,47

References1. U.S. Food and Drug Administration. FDA Safety Communication:

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