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Keywords:

  • Efficacy;
  • mesh;
  • pelvic organ prolapse;
  • safety;
  • systematic review

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Background  The efficacy and safety of mesh/graft in surgery for anterior or posterior pelvic organ prolapse is uncertain.

Objectives  To systematically review the efficacy and safety of mesh/graft for anterior or posterior vaginal wall prolapse surgery.

Search strategy  Electronic databases and conference proceedings were searched, experts and manufacturers contacted, and reference lists of retrieved papers scanned.

Selection criteria  Randomised controlled trials (RCTs), nonrandomised comparative studies, registries, case series involving at least 50 women, and RCTs published as conference abstracts from 2005 onwards.

Data collection and analysis  One reviewer screened titles/abstracts, undertook data extraction, and assessed study quality. Data analysis was conducted for three subgroups: anterior, posterior, and anterior and/or posterior repair (not reported separately).

Results  Forty-nine studies involving 4569 women treated with mesh/graft were included. Study quality was generally high. Median follow up was 13 months (range 1–51 months). In anterior repair, there was short-term evidence that mesh/graft (any type) significantly reduced objective prolapse recurrence rates compared with no mesh/graft (relative risk 0.48, 95% CI 0.32–0.72). Nonabsorbable synthetic mesh had a significantly lower objective prolapse recurrence rate (8.8%, 48/548) than absorbable synthetic mesh (23.1%, 63/273) and biological graft (17.9%, 186/1041), but a higher erosion rate (10.2%, 68/666) than absorbable synthetic mesh (0.7%, 1/147) and biological graft (6.0%, 35/581). There was insufficient information to compare any of the other outcomes regardless of prolapse type.

Conclusions  Evidence for most outcomes was too sparse to provide meaningful conclusions. Rigorous long-term RCTs are required to determine the comparative efficacy of using mesh/graft.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Pelvic organ prolapse (POP)1 is common and is seen in 50% of parous women.2 POP affects a woman’s quality of life by its local physical effects (pressure, bulging, heaviness, or discomfort) or by its effect on urinary, bowel or sexual function. POP can be classified according to the compartment affected as anterior vaginal wall prolapse (urethrocele and cystocele), posterior vaginal wall prolapse (rectocele and enterocele), prolapse of the cervix or uterus, and prolapse of the vaginal vault (which can only occur after prior hysterectomy). A woman can present with prolapse of one or more of these sites. The present review focuses on anterior and posterior vaginal wall prolapse.

Current treatment options for anterior and posterior vaginal wall prolapse include pelvic floor muscle training, use of pessaries (mechanical devices such as rings or shelves), and surgery including anterior or posterior colporrhaphy and site-specific defect repair. Surgery can be augmented with implantation of mesh or graft materials that were first introduced in response to the high failure rate in both primary and secondary procedures: about 30% of women need an operation for recurrent prolapse.3

Mesh or graft repair is theoretically suitable for any degree of symptomatic anterior and/or posterior vaginal wall prolapse. In the UK, it has been most often used for women with recurrent prolapse.4 The technique for inserting mesh or graft varies widely between gynaecologists. It can be individually cut, positioned, and sutured using the surgeon’s preferred technique over the fascial (a ‘mesh inlay’) or the whole vagina can be surrounded by mesh/graft using introducers or commercial available kits (total mesh).

However, the efficacy and safety of mesh or graft to augment surgery for anterior or posterior POP is uncertain,5 especially the occurrence and impact of mesh/graft erosion. The current study reports a rigorous systematic review of the evidence for efficacy and safety issues arising from the use of mesh/graft materials.

There are numerous types of mesh and graft materials available, which vary according to type of material, structure, and physical properties such as absorbability and pore size. In the present review, the term ‘mesh’ was used for synthetic material and ‘graft’ was used for biological material; and mesh/graft were classified into four groups: absorbable synthetic mesh (e.g. polyglactin), biological graft (e.g. porcine dermis), combined absorbable/nonabsorbable mesh/graft (termed ‘combined’ hereafter, e.g. polypropylene mesh coated with absorbable porcine collagen), and nonabsorbable synthetic mesh (e.g. polypropylene).

The aims of the present systematic review were to compare (a) efficacy and safety between procedures using mesh/graft and no mesh/graft and (b) efficacy and safety between different types of mesh/graft. This report is based on a systematic review commissioned and funded by the National Institute for Health and Clinical Excellence (NICE) through its Interventional Procedures Programme.6

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Search strategy

Extensive highly sensitive electronic searches were conducted to identify reports (both full text papers and conference abstracts) of published and continuing studies on the safety and efficacy of mesh/graft used in the repair of POP. Searches were restricted to publications from 1980 onwards and to those published in the English language. Studies that reported only procedures without mesh/graft were not identified. Experts in the field were contacted, and bibliographies of retrieved papers were scrutinised for additional reports. Eleven manufacturers were identified and contacted for properties of mesh/graft produced and for any studies related to mesh/graft. Full details of the search strategies used are available from the authors.

The databases searched were Medline (1980–June week 3 2007), Medline In-Process (3 July 2007), Embase (1980–2007 week 26), Biosis (1985–5 July 2007), Science Citation Index (1980–2 July 2007), Cochrane Controlled Trials Register (The Cochrane Library, Issue 2 2007), ISI Conference Proceedings (1990–27 June 2007), as well as current research registers (National Research Register [Issue 2, 2007], Current Controlled Trials [April 2007] and Clinical Trials [April 2007]). Additional databases searched for systematic reviews and other background information included the Cochrane Database of Systematic Reviews (The Cochrane Library, Issue 2, 2007), Database of Abstracts of Reviews of Effectiveness (June 2007), and the HTA Database (June 2007). Conference proceedings of major urogynaecological organisations (including American Urogynecologic Society, American Urological Association, European Association of Urology, European Society of Gynecological Endoscopy, Incontinence Society, and International Urogynecological Association) for 2005 onwards were scrutinised for additional reports of randomised controlled trials (RCTs).

Inclusion and exclusion criteria

To try to ensure that all the relevant studies wound be included, two reviewers (X.J. and C.G.) screened the first 200 titles/abstracts independently. Any discrepancies between the screening results were discussed and consensus was reached. The main reviewer (X.J.) then screened the remaining titles/abstracts using the agreed criteria. In cases of doubt, consensus was reached by discussing with the second reviewer (C.G.). Full text copies of all reports deemed to be potentially relevant were obtained and assessed by the main reviewer for inclusion.

Full text RCTs, RCTs published as conference abstract from 2005 onwards, nonrandomised comparative studies, registry reports, and case series using mesh/graft with at least 50 women were sought. Case series/registries with a mean follow up of at least 1 year were included for both efficacy and safety. Case series/registries with a mean follow up of less than 1 year were included for safety outcomes only. One year was considered a minimum adequate period of time to assess the efficacy of prolapse repair.

The participants were women undergoing anterior and/or posterior vaginal wall prolapse surgery. Studies of women with prolapse caused by pelvic trauma, congenital disease, or prolapse after creation of a neovagina were excluded. Women undergoing other concomitant operations, such as hysterectomy or a continence procedure, were considered providing the main indication for surgery was anterior or posterior prolapse.

The interventions considered were anterior and/or posterior vaginal wall prolapse repair with mesh/graft. There were no restrictions on type of mesh/graft or technique used. For RCTs and nonrandomised comparative studies, the comparators were another operation technique using mesh/graft or a type of surgery that did not involve mesh/graft.

Primary outcomes for efficacy included persistent prolapse symptoms (subjective failure) and recurrent prolapse at original site (objective failure). For objective failure, outcomes measured by different systems, such as pelvic organ prolapse-quantification system and Baden–Walker system, were combined. Secondary outcomes for efficacy included new prolapse at other sites that were free of prolapse at baseline, need for further surgery for prolapse (both recurrent and new), persistent urinary symptoms, persistent bowel symptoms, and persistent dyspareunia. For persistent urinary symptoms, bowel symptoms, and dyspareunia, only women having these symptoms at baseline were considered.

Safety outcomes included blood loss, damage to surrounding organs during the operation, mesh/graft erosion, requirement for a further operation for mesh/graft erosion, new urinary incontinence, new bowel symptoms, new dyspareunia, infection, and other potentially serious adverse effects. For new urinary incontinence, bowel symptoms, and dyspareunia, only women who were free of these symptoms at baseline were considered for these outcomes.

Data extraction and quality assessment

Data extraction and methodological quality assessment for the RCTs was conducted by two reviewers independently. The main reviewer extracted data and assessed the quality for the remaining studies. Two separate quality assessment checklists were used according to study design (Appendices S1 and S2). Both checklists were developed by the Review Body for Interventional Procedures (Health Services Research Units at the University of Aberdeen and Sheffield), an independent review body that carries out systematic reviews for the Interventional Procedures Programme of the NICE. The checklists were adapted from several sources.7–9

Data analysis

Data analysis was conducted for three subgroups of women according to the type of prolapse being repaired: anterior vaginal wall prolapse, posterior vaginal wall prolapse, and anterior and/or posterior vaginal wall repair (where the data were not reported separately).

A meta-analysis of RCTs, using Cochrane Collaboration Review Manager (RevMan 4.2) software, was conducted to directly compare the efficacy and safety of mesh/graft versus no mesh/graft and between different types of mesh/graft.

Crude event rates (and 95% CI calculated using binominal distribution approximation) for each of the intervention categories were tabulated by summing across studies for all outcomes and also according to study design (RCT, nonrandomised comparative studies, and case series/registries; data by study design not shown) to facilitate qualitative assessment of potential heterogeneity of event rates across different study designs.

In addition, Bayesian meta-analysis models were used to model the objective failure rates for the different interventions for anterior repair. This was the only outcome with sufficient data to generate a model. RCTs and nonrandomised comparative studies were included in the model. Case series were not included to avoid bias from the strong assumption of the equivalence of studies implicit in the crude event rates.10 The specific type of model used was a (Bayesian) binomial random effects model. Differences between interventions, adjusted for study design, were assessed by the corresponding odds ratio and 95% credible interval (CrI). CrIs are the Bayesian equivalent of confidence intervals. ‘Head to head’ indirect comparisons of the different mesh/graft types, adjusted for study design, were also conducted and reported as odds ratios and 95% CrIs. WinBUGS software was used to produce the models.11

Prespecified subgroup analysis by different mesh types within nonabsorbable mesh, that is Amid classification type I to IV,12 was not conducted because most studies did not report the type of mesh, resulting in insufficient data for subgroup analysis. Prespecified subgroup analysis by ‘total mesh’ (use of introducers/commercial available kits) and ‘mesh inlay’ was not conducted due to the lack of data. Potential differences between primary repairs and recurrent prolapse repairs were not assessed because only one study reported exclusively on women having recurrent repairs, and the remainder did not report these subgroups separately.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Number, type, and quality of included studies

From the initial 1633 publications identified by the literature search, 49 studies (reported in 67 publications) were included, of which 6 were full text RCTs,13–18 11 were RCTs available as conference abstracts,19–29 7 were nonrandomised comparative studies,30–36 1 was a prospective registry,37 and 24 were case series with a minimum sample size of 50 women.38–61 Six manufacturers provided data on mesh/graft properties and related studies, all of which had already been identified by our searches. The screening process is summarised in Figure 1. For the 17 RCTs, 14 compared mesh/graft with no mesh/graft and 313,22,26 compared different types of mesh/graft. Appendix S3 shows details of study design, methods, participants, and interventions. Seven continuing RCTs62–67 (Brandao, pers. comm., A Griffin, Johnson & Johnson, August 2007) and one continuing registry68 were also identified.

image

Figure 1. Flow diagram for screening process.

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The included studies took place during the period 1996–2007 and in 12 countries. The median follow up was 13 months (range 1–51 months). In total, 4569 women were treated with mesh or graft. In studies providing this information, the mean age was 64 years (range 24–96 years). Seventy-two percent of repairs were primary procedures. The most common use of mesh or graft was for anterior repair (54%, 2472/4569). Overall, just over half of the studies used nonabsorbable synthetic mesh (51%, 2320/4569), but for anterior repair alone and for posterior repair alone, biological graft was the most common alternative (46% [1124/2472] and 29% [121/417], respectively). The surgical techniques for implanting mesh/graft varied considerably across studies. Fifty-six percent (1404/2497) of women had a concomitant procedure for urinary incontinence and 37% (953/2583) had a hysterectomy.

The methodological quality was assessed for only the full text studies. For the six RCTs, adequate approaches to sequence generation for randomisation were reported in all studies except one;13 concealment of treatment allocation was adequate in all RCTs except two;13,17 all follow-up periods were 1 year or more; all studies used intention-to-treat analysis in that women were analysed in the groups to which they were randomised. For the seven included nonrandomised comparative studies, mean follow up was less than 1 year in two studies.31,36 For the registry and case series, mean follow up was 1 year or more in 17 studies. The drop-out rates ranged from 0 to 30%.

Anterior vaginal wall prolapse repair

Thirty studies involving 2472 women provided data on the use of mesh/graft for anterior repair (5 full text RCTs,13–15,17,18 7 RCTs available as conference abstracts,19,20,22–25,29 4 nonrandomised comparative studies,30,33–35 1 registry,37 and 13 case series38,44,46,49–52,55–60). Four studies used absorbable synthetic mesh,13,17,18,59 14 studies used biological graft,13–15,22,24,25,30,33,35,50–52,57,60 1 study used combined mesh/graft,38 and 14 studies used nonabsorbable synthetic mesh.19,20,22,23,29,33,34,37,44,46,49,55,56,58 The median follow-up time was 14 months (range 1–38 months). Two RCTs13,22 and one nonrandomised comparative study33 compared different types of mesh/graft and the others compared mesh/graft with no mesh/graft.

Efficacy

There were too few data reported for most outcomes to draw reliable conclusions (Table 1).

Table 1.  Efficacy of anterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Absorbable synthetic mesh, n/N (%, 95% CI)Biological graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  • —, no studies reported this outcome.

  • *

    Surgery for prolapse (recurrent or de novo).

Subjective failure19/179 (10.6, 6.9–16.0)5/112 (4.5, 1.9–10.0)36/486 (7.4, 5.4–10.1)1/55 (1.8, 0–6.5)
Objective failure184/640 (28.8, 25.4–32.4)63/273 (23.1, 18.5–28.4)186/1041 (17.9, 15.7–20.3)48/548 (8.8, 6.7–11.4)
De novo prolapse8/58 (13.8, 7.2–24.9)8/45 (17.8, 9.3–31.3)
Further operation needed*2/85 (2.4, 0.6–8.2)16/174 (9.2, 5.7–14.4)9/280 (3.2, 1.7–6.0)3/234 (1.3, 0.4–3.7)
Persistent urinary symptoms9/10 (90.0, 59.6–98.2)5/49 (10.2, 4.4–21.8)13/14 (92.9, 68.5–98.7)17/44 (38.6, 25.8–53.4)
Persistent bowel symptoms
Persistent dyspareunia

However, in ten RCTs involving 1148 women, there was some evidence that mesh/graft (any type) was better than no mesh for preventing objectively determined recurrence of anterior prolapse (77/557 versus 179/591; relative risk 0.48, 95% CI 0.32–0.72; Figure 2). When evidence from other study types was also considered, there was a trend in the crude objective failure rates (Table 2) with procedures not using mesh/graft having the highest failure rate (184/640, 29%, 95% CI 25–32%), followed by procedures with absorbable synthetic mesh (63/273, 23%, 95% CI 19–28%), biological graft (186/1041, 18%, 95% CI 16–20%), and nonabsorbable synthetic mesh (48/548, 9%, 95% CI 7–11%). Compared with procedures not using mesh/graft, the numbers need to treat (NNT) were 17 for absorbable synthetic mesh, 9 for biological graft, and 5 for nonabsorbable synthetic mesh.

image

Figure 2. Anterior repair, efficacy, objective failure, mesh or graft versus procedures without mesh/graft: evidence from RCTs.

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Table 2.  Bayesian meta-analysis models (above)* and indirect comparison (below)*, anterior repair: objective failure (recurrent prolapse at original site)
CategoriesnNOR (adjusted for study design)95% CrI
No mesh/graft184640Reference technique
Absorbable synthetic mesh521610.820.50–1.32
Absorbable biological graft1205550.51**0.36–0.72
Nonabsorbable synthetic mesh413440.19**0.12–0.30
  • CrI, credible interval with 95% probability of containing the true odds ratio; n, cumulative number of women experiencing the event; N, cumulative number of women analysed by the studies.

  • *

    Based on RCTs and nonrandomised comparative studies only.

  • **

    Statistically significant.

ComparisonsOR95% CrI
Absorbable biological graft versus absorbable synthetic mesh0.640.36–1.06
Nonabsorbable synthetic mesh versus absorbable synthetic mesh0.23**0.12–0.44
Nonabsorbable synthetic mesh versus absorbable biological graft0.37**0.23–0.59

Bayesian meta-analysis based on the evidence from the ten RCTs and five nonrandomised comparative studies showed that procedures without mesh/graft had significantly higher objective failure rates than procedures with biological graft or nonabsorbable synthetic mesh. Comparisons between different types of mesh showed that nonabsorbable synthetic mesh had statistically significantly lower objective failure rates than absorbable synthetic mesh (41/344 versus 52/161; OR 0.23, 95% CrI 0.12–0.44) and biological graft (41/344 versus 120/555; OR 0.37, 95% CrI 0.23–0.59) (Table 2).

This trend appeared to be supported by the need for reoperation (for recurrent and new prolapse), which was highest in women treated with absorbable synthetic mesh (9% [16/174]) compared with 3% (9/280) for biological grafts and 1% (3/234) for nonabsorbable synthetic mesh (Table 1). However, counter-intuitively, the reoperation rate for women with no mesh was lower (2% [2/85]); this estimate is based on one small study with short follow up (1 year) and as such should be interpreted with caution.

Safety

For anterior repair, there were too few data on safety outcomes to identify or rule out important adverse effects related to the use of mesh/graft either because the studies were not sufficiently large or because the adverse effects were rare (Table 3).

Table 3.  Safety of anterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Absorbable synthetic mesh, n/N (%, 95% CI)Biological graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  1. —, no studies reported this outcome.

Blood transfusion1/88 (1.1, 0.2–6.2)0/147 (0, 0–2.5)3/198 (1.5, 0.5–4.4)4/161 (2.5, 1.0–6.2)
Damage to surrounding organs0/19 (0, 0–16.8)0/112 (0, 0–3.3)0/94 (0, 0–3.9)6/251 (2.4, 1.1–5.1)
Mesh/graft erosionNot applicable1/147 (0.7, 0.1–3.8)35/581 (6.0, 4.4–8.3)68/666 (10.2, 8.1–12.7)
Operation for mesh/graft erosionNot applicable1/35 (2.9, 0–3.3)4/154 (2.6, 1.0–6.5)23/347 (6.6, 4.5–9.7)
De novo urinary symptoms0/63 (0, 0–5.7)3/42 (7.1, 2.5–19.0)3/44 (6.8, 2.3–18.2)
De novo bowel symptoms
De novo dyspareunia4/11 (36.4, 15.2–64.6)
Infection4/142 (2.8, 1.1–7.0)0/112 (0, 0–3.3)5/477 (1.0, 0.4–2.4)11/558 (2.0, 1.1–3.5)
Other serious adverse effects1/93 (1.1, 0.2–5.8)0/35 (0, 0–9.9)2/212 (0.9, 0.3–3.4)4/248 (1.6, 0.6–4.1)

There was some evidence to support the trends mentioned above (for objective failure rates and reoperation rates). Mesh/graft erosion increased from 0.7% (1/147, 95% CI 0.1–3.8) for absorbable synthetic mesh to 6.0% (35/581, 95% CI 4.4–8.3%) for biological graft and to 10.2% (68/666, 95% CI 8.1–12.7%) for nonabsorbable synthetic mesh. Women with a nonabsorbable synthetic mesh repair were also most likely to require an operation to remove it partially or completely because of mesh/graft erosion (23/347, 6.6%, 95% CI 4.5–9.7) than for either absorbable synthetic mesh (1/35, 2.9%, 95% CI 0–3.3) or biological graft 2.6% (4/154, 95% CI 1–6.5).

Posterior vaginal wall prolapse repair

Only nine studies involving 417 women treated with mesh/graft reported data on the use of mesh/graft in posterior repair (two full text RCTs,16,17 one RCT available as a conference abstract,26 two nonrandomised comparative studies,31,32 one registry report,37 and three case series53–55). Three studies used absorbable synthetic mesh,17,26,32 three used biological graft,16,31,53 two used combined mesh/graft,26,54 and two studies used nonabsorbable synthetic mesh.37,55 No RCTs or nonrandomised comparative studies compared different types of mesh/graft for posterior repair. The median follow up was 12 months (range 1–17 months).

There were too few data reported for any of the outcomes to draw reliable conclusions or to carry out further statistical analyses (Tables 4 and 5).

Table 4.  Efficacy of posterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Absorbable synthetic mesh, n/N (%, 95% CI)Biological graft, n/N (%, 95% CI)Combined mesh/graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  • —, no studies reported this outcome

  • *

    Surgery for prolapse (recurrent or de novo).

Subjective failure9/60 (15.0, 8.1–26.1)9/78 (11.5, 6.2–20.5)
Objective failure18/142 (12.7, 8.2–19.1)6/70 (8.6, 4.0–17.5)19/93 (20.4, 13.5–29.7)2/31 (6.5, 1.8–20.7)
De novo prolapse
Further operation needed*3/70 (4.3, 1.5–11.9)2/29 (6.9, 1.9–6.9)
Persistent urinary symptoms
Persistent bowel symptoms19/58 (32.8, 22.1–45.6)14/82 (17.1, 10.5–26.6)5/43 (11.6, 5.2–24.6)
Persistent dyspareunia5/14 (35.7, 16.3–61.2)
Table 5.  Safety of posterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Absorbable synthetic mesh, n/N (%, 95% CI)Biological graft, n/N (%, 95% CI)Combined mesh/graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  1. —, no studies reported this outcome.

Blood transfusion3/79 (3.8, 1.3–10.6)0/5 (0, 0–43.4)1/31 (3.2, 0.6–16.2)0/90 (0, 0–4.1)1/71 (1.4, 0.2–7.6)
Damage to surrounding organs2/79 (2.5, 0.7–8.8)0/5 (0, 0–43.4)1/31 (3.2, 0.6–16.2)0/90 (0, 0–4.1)3/71 (4.2, 1.4–11.7)
Mesh/graft erosionNot applicable0/28 (0, 0–12.1)16/115 (13.9, 8.7–12.1)2/31 (6.5, 1.8–20.7)
Operation for mesh/graft erosionNot applicable11/90 (12.2, 7.0–20.6)
De novo urinary symptoms
De novo bowel symptoms2/45 (4.4, 1.2–14.8)1/29 (3.4, 0.6–17.2)
De novo dyspareunia4/25 (16.0, 6.4–34.7)2/36 (5.6, 1.5–18.1)
Infection13/94 (13.8, 8.3–22.2)0/5 (0, 0–43.4)7/48 (14.6, 7.2–27.2)4/106 (3.8, 1.5–9.3)
Other serious adverse effects

Anterior and/or posterior vaginal wall prolapse repair

Fourteen studies involving 1680 women treated with mesh/graft reported data on the use of mesh/graft in anterior and/or posterior repair (3 RCTs available as conference abstracts,21,27,28 1 nonrandomised comparative study,36 1 registry report,37 and 9 case series39–43,45,47,48,61). One study used absorbable synthetic mesh,21 none of the studies used biological graft, one study used a combined mesh/graft,45 ten studies used nonabsorbable synthetic mesh,27,28,37,40–43,47,48,61 and two studies used more than one of the above types of mesh/graft.36,39 None of the RCTs or nonrandomised comparative studies compared different types of mesh or grafts. The median follow up was 13 months (range 1–51 months).

For objective failure, there was a trend in the crude events rates (Table 6) with procedures not using mesh/graft having the highest failure rate (27/109, 25%, 95% CI 18–34%), followed by procedures with absorbable synthetic mesh (2/26, 8%, 95% CI 2–24%), combined mesh/graft (11/143, 8%, 95% CI 4–13%), and nonabsorbable synthetic mesh (41/645, 6%, 95% CI 5–9%). Compared with procedures not using mesh/graft, the NNT were six for absorbable synthetic mesh, six for biological graft, and five for nonabsorbable synthetic mesh. There were too few data (only three RCTs) to conduct Bayesian meta-analysis and too few data on any of the other outcomes to identify or rule out important adverse effects related to the use of mesh/graft (Tables 6 and 7).

Table 6.  Efficacy of anterior and/or posterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Absorbable synthetic mesh, n/N (%, 95% CI)Combined mesh/graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  • —, no studies reported this outcome.

  • *

    Surgery for prolapse (recurrent or de novo).

Subjective failure14/34 (41.2, 26.4–57.8)14/32 (43.8, 28.2–60.7)0/148 (0, 0–2.5)
Objective failure27/109 (24.8, 17.6–33.6)2/26 (7.7, 2.1–24.1)11/143 (7.7, 4.3–13.2)41/645 (6.4, 4.7–8.5)
De novo prolapse
Further operation needed*7/161 (4.3, 2.1–8.7)
Persistent urinary symptoms46/203 (22.7, 17.4–28.9)
Persistent bowel symptoms1/21 (4.8, 0.8–22.7)
Persistent dyspareunia1/10 (10.0, 1.8–40.4)
Table 7.  Safety of anterior and/or posterior repair, summary of crude event rates (95% CI, any study design) by type of mesh/graft
 No mesh, n/N (%, 95% CI)Combined mesh/graft, n/N (%, 95% CI)Nonabsorbable synthetic mesh, n/N (%, 95% CI)
  1. —, no studies reported this outcome.

Blood transfusion1/35 (2.9, 0.5–14.5)11/810 (1.4, 0.8–2.4)
Damage to surrounding organs4/143 (2.8, 1.1–7.0)12/541 (2.2, 1.3–3.8)
Mesh/graft erosionNot applicable9/143 (6.3, 3.3–11.5)62/1119 (5.5, 4.3–7.0)
Operation for mesh/graft erosionNot applicable6/143 (4.2, 1.9–8.9)45/1098 (4.1, 3.1–5.4)
De novo urinary symptoms34/355 (9.5, 6.9–13.1)
De novo bowel symptoms1/47 (2.1, 0.4–11.1)
De novo dyspareunia10/78 (12.8, 7.1–22.0)3/42 (7.1, 2.5–19.0)
Infection33/661 (5.0, 3.6–6.9)
Other serious adverse effects3/278 (1.1, 0.4–3.1)

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Summary of the evidence

In anterior vaginal wall prolapse repair, there was some short-term evidence suggesting that mesh/graft (any type) could reduce objective prolapse recurrence rates compared with no mesh/graft. In the comparison between different types of mesh/graft, nonabsorbable synthetic mesh had statistically significantly lower objective failure rates than absorbable synthetic mesh and biological graft. However, there was no information about efficacy in the longer term.

While there might be some evidence of differences in objective efficacy related to the use of mesh, these must be considered alongside any safety concerns. There was some evidence to suggest that mesh/graft may cause problems with erosion and a subsequent need for operations to remove the foreign material. However, the numbers were too few to conduct statistical analyses to compare the erosion rates between different types of mesh or graft.

Methodology

In the present review, RCTs, nonrandomised comparative studies, and large case series (sample size ≥ 50) were included. The results were considered generalisable as the majority of studies recruited participants from routine practice without restriction on the severity of prolapse or other patient characteristics.

As this review focused on the efficacy and safety of treatments involving mesh/graft, studies reporting only procedures without mesh/graft were not systematically searched for. Data on no mesh/graft treatments came only from the control groups of RCTs and nonrandomised comparative studies only. Therefore, the results for ‘no mesh/graft’ were not derived from a comprehensive literature search and should be interpreted with caution. However, considering that there was insufficient evidence for most outcomes involving procedures with mesh/graft, including studies reporting only procedures without mesh/graft, would increase the accuracy of the estimates for the ‘no mesh/graft’ group but would not impact on the mesh/graft comparisons or change the conclusions of the review.

Categorising some of the reported outcomes was problematic. For instance, cutoff points used to determine objective failure rates varied between studies. All types of infections such as urinary tract infection, wound infection, and pelvic abscess were grouped together.

Apart from conducting meta-analysis of the RCTs in RevMan to compare the efficacy and safety between different types of mesh/graft, crude event rates from the RCTs and nonrandomised comparative studies were calculated by treating each arm in effect as a case series. The rate from each arm was then combined with those from other such ‘case series’ derived from comparative studies and from case series reporting mesh/graft. This was considered an alternative way to compare all the available mesh/graft types. The analyses were adjusted to account for bias from nonrandomised comparative studies and case series, which are more prone to systematic biases than RCTs.

It was impossible to determine whether safety and efficacy of mesh differs between primary repair and recurrent prolapse repair. Of the 49 included studies, 12 reported a case mix (72% primary and 28% secondary operations) in 1359 women, but no study reported the outcome data separately for the two groups. These data, however, suggest that many gynaecologists are already using mesh in women for primary repair. Only one31 of the included studies reported exclusively on women having recurrent repair (a small comparative study of only 12 women in each of two arms).

Efficacy

One year was considered a minimum adequate period of time to assess the efficacy of prolapse repair. However, even 1-year outcomes are too early to judge whether prolapse surgery is successful in the longer term. The mean time to first reoperation is reported in the literature as 12 years,3 and therefore, failure at 1 year should not be regarded as an adequate representation of efficacy. Prospective studies would require extended follow up to assess meaningful mesh/graft failure.

The conundrum in prolapse surgery is that objective prolapse recurrence is not necessarily related to continuation of prolapse symptoms (subjective failure). It is increasingly recognised that in prolapse surgery, subjective failure is a more appropriate outcome measure of efficacy than objective failure. It is also recognised that criteria for measuring such subjective prolapse outcomes are difficult to quantify and the most appropriate methods are still being evaluated. In the present review, only a few studies reported data on subjective prolapse symptoms and other genitourinary symptoms of importance to women (urinary, bowel and sexual function).

Safety

The clinical importance of mesh/graft erosion was difficult to assess. The diagnosis was both problematic as different authors used different definitions (mesh erosion, vaginal mesh extrusion, and minor mesh exposure) and its clinical impact controversial as some gynaecologists operated on erosions15,18,33,34,40–49,54,61, whereas others treated erosions with debridement, vaginal estrogens, antiseptics, or antibiotics.36,41,48,57,60

One of the anecdotally cited contraindications for the use of mesh is the likelihood of dyspareunia. This outcome is more problematic to measure because some women are not sexually active, but not all studies take this factor into account when reporting their sexual function data. Second, some women may be sexually inactive because of their prolapse surgery (especially when the outcome is measured within 6 months of operation). Third, many studies do not measure or report this outcome at all. Two outcomes were used in the present review to make the best estimates: persistent dyspareunia in women having dyspareunia at baseline (efficacy) and de novo dyspareunia in women without dyspareunia at baseline (safety). However, few studies reported such data.

Some adverse effects occurred infrequently: in consequence their estimated event rates may be prone to random error. Some of the safety outcomes, such as blood loss, may not be due only to the repair of vaginal wall prolapse but also to concomitant procedures such as those for urinary incontinence or hysterectomy.

Although the numbers were not sufficient to perform meaningful subgroup analyses by ‘total mesh’ (use of introducers/commercial available kits) and ‘mesh inlay’, the use of blind introducers has given rise to some concern. These have only been used to date with nonabsorbable synthetic mesh. In total, there were 6/476 (1.3%) events of damage to surrounding organs for anterior repair, 6/276 (2.2%) for posterior repair and 16/684 (2.3%) for anterior and/or posterior repair, giving a total of 28/1436 (1.9%). Of the 28 events, half were associated with an introducer kit.

Conclusions and implications

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

In general, the evidence for most efficacy and safety outcomes was too sparse to provide meaningful conclusions about the use of mesh/graft in anterior and/or posterior vaginal wall prolapse surgery.

Rigorous RCTs are required to determine the comparative efficacy of using mesh/graft and its optimal place in clinical practice. The RCTs should primarily compare the subjective failure rate in procedures using mesh/graft versus those without mesh/graft and between different types of mesh/graft; use validated patient-reported outcome measures; have sufficient power to detect clinically meaningful differences in both efficacy and safety; and have the capacity to assess outcomes in the long term (at least 5 years), including cost-effectiveness.

In addition, prospective data collection should be considered in which the operative and clinical details of women undergoing prolapse surgery with mesh/graft can be recorded so that sufficient efficacy and safety data can be gathered to guide the use of mesh or grafts in the future.

Funding

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

This manuscript is based on a systematic review commissioned and funded by the NICE through its Interventional Procedures Programme. The Health Services Research Unit receives a core grant from the Chief Scientist Office of the Scottish Government Health Directorates. The views expressed are those of the authors and not necessarily those of the funding bodies.

Contribution to authorship

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

X.J. screened the search results, contacted manufactures, assessed studies for inclusion, undertook data abstraction and quality assessment, conducted meta-analysis, and drafted the review. C.G. drafted the scope, determined outcome categories, provided advice on assessing studies for inclusion, conducting meta-analysis, and on drafting of the review, drafted the discussion, and commented on drafts of the review. G.M. commented on the scope of the review, drafted letters for contacting mesh/graft manufacturers for additional information, supervised the conduct of the review, and commented on drafts of the review. G.M.L. conducted the statistical analysis, drafted the data analysis section of the review, and commented on drafts of the review. C.F. developed and ran the literature search strategies, obtained papers, formatted the references, and drafted sections concerning search strategies and search results. C.B. provided specialist advice on classification of prolapse and mesh/graft types, and commented on drafts of the review. J.B. supervised the conduct of the review and commented on drafts of the review.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

The authors thank Adrian Grant (Health Services Research Unit, University of Aberdeen) for commenting on the study design; James Browning (Mpathy Medical Devices Ltd.), Christine Clarke (Bard Ltd.), Hazel Edwards (American Medical Systems [UK], Ltd.), Adrian Griffin (Johnson & Johnson Medical Ltd.), William Hynes (WL Gore & Associations [UK] Ltd.), and Coloplast Ltd. for providing properties of mesh/graft produced by the manufacturers and published studies relating to mesh/graft; and Paul Moran for providing additional information for a study identified from the National Research Register database.

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  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information
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Supporting Information

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusions and implications
  8. Conflict of interest
  9. Funding
  10. Contribution to authorship
  11. Acknowledgements
  12. References
  13. Supporting Information

Additional Supporting Information may be found in the online version of this article:

Appendix S1. Details of the included studies.

Appendix S2. Checklist of quality assessment of randomised controlled trials.

Appendix S3. Checklist of quality assessment of nonrandomised studies.

Please note: Blackwell Publishing is not responsible for the content or functionality of any supporting materials supplied by the authors. Any queries (other than missing material) should be directed to the corresponding author for the article.

FilenameFormatSizeDescription
BJO_1845_sm_AppendixS1.doc201KSupporting info item
BJO_1845_sm_AppendixS2.doc82KSupporting info item
BJO_1845_sm_AppendixS3.doc4983KSupporting info item

Please note: Wiley Blackwell is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.