Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review

DOI: 10.1111/j.1471-0528.2008.02023.x www.blackwellpublishing.com/bjog Systematic review Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review B Feiner, a JE Jelovsek, b C Maher a a Division of Urogynaecology and Reconstructive Pelvic Surgery, Royal Women s, Mater and Wesley Hospitals, Brisbane, Queensland, Australia b Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH, USA Correspondence: Dr B Feiner, Wesley Urogynaecology Unit, The Wesley Hospital, Sandford Jackson Building, Suite 86/Level 4, 30 Chasely Street, Auchenflower, Qld 4066, Australia. Email feiner@tx.technion.ac.il Accepted 6 October 2008. Background Vaginal mesh kits are being used to surgically treat apical vaginal prolapse; however, their safety and efficacy are currently unknown. Objectives To summarise success and complication rates for commonly used vaginal mesh kits in the treatment of apical prolapse. Search strategy MEDLINE and other scientific databases were queried for primary research addressing the use of vaginal mesh kits for apical prolapse published between 1950 and 2007, including abstracts presented in major scientific meetings. Selection criteria Studies describing the use of mesh to support either the anterior or posterior compartment alone, for incontinence or fistula repair or not addressing the vaginal apex were excluded. Data collection and analysis Identified studies were grouped by the mesh kit and complications categorised using the Dindo classification system. Weighted averages and confidence intervals were calculated on objective success, follow-up length and complications. Main results Thirty studies totalling 2653 women met inclusion criteria. Objective success rates (95% CI) were ApogeeÔ (American Medical Systems Inc., Minnetonka, MN, USA) 95% (95 96), ProliftÔ (Ethicon Women s Health and Urology, Somerville, NJ, USA) 87% (86 87) and posterior intravaginal slingplasty 88% (87 89). Reoperations not requiring anaesthesia (Dindo IIIa) occurred in 0.4 2.3% and requiring anaesthesia (Dindo IIIb) in 1.5 6.0%, with a follow up between 26 and 78 weeks. Mesh erosion was the most commonly reported complication occurring in 4.6 10.7%. Author s conclusions Overall objective success using transvaginal mesh kits in restoring apical vaginal prolapse is high. However, an increasing number of women require surgical intervention for mesh-related complications based on limited data quality and short follow up. Further research addressing functional outcomes and the impact of these procedures on women s symptoms and quality of life is mandatory. Keywords Apical prolapse, Apogee, erosion, intravaginal slingplasty, Prolift, vaginal mesh. Please cite this paper as: Feiner B, Jelovsek J, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review. BJOG 2009;116:15 24. Introduction During the past decade, gynaecologists have seen widespread use of graft material placed in the vagina as an alternative or augmentation to traditional surgical repairs in order to correct pelvic organ prolapse. This can be largely credited to the suggestion that use of mesh improves the outcome of the surgical correction while reducing the recurrence rate 1 of pelvic organ prolapse and may, in part, be due to the popularity of mid-urethral slings for stress urinary incontinence. As a result, several mesh kits were introduced into the surgical market, promoting a minimally invasive alternative to the conventional armada of surgical techniques to repair vaginal and uterine prolapse. Although these procedures intuitively seem to make sense to surgeons by replacing or reinforcing damaged supportive vaginal tissue, there is a growing concern regarding a lack of information on safety and efficacy of these newly employed procedures. These mesh kits are being heavily marketed and surgeons are left to decide whether this new technology should replace traditional pelvic floor procedures despite a paucity of supportive evidence. ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology 15

Feiner et al. A recent systematic review on the use of mesh placed vaginally for the treatment of pelvic organ prolapse demonstrated that a limited number of randomised control trial data exist to support the use of graft material for anterior vaginal wall prolapse. However, the same review group failed to identify any studies satisfying rigorous criteria for use in treating apical prolapse (Systematic Review Group on Evidence Based Clinical Practice Guidelines for Vaginal Mesh Use, Panel Discussion, Society of Gynecologic Surgeons 34th Scientific Meeting 2008, Savannah, GA, USA). Due to the rapid pace of implementing these techniques in practice and increasing evidence on the importance of the vaginal apex in anterior wall support, 2 there is a need for timely and informed decisions regarding the use of these products for treating the vaginal apex. The aims of this study were to determine from currently available literature, whether the mesh should be placed using introducers during vaginal surgery for uterine or posthysterectomy vaginal vault prolapse, and, if so, what risks should be communicated to the woman when doing so? Our hypothesis was that the placement of graft material at the time of surgery for uterine or post-hysterectomy vaginal vault prolapse results in acceptable, objective, anatomic outcome, but also in high rates of complications compared with traditional surgical techniques. Methods This systematic review was implemented in accordance with recommendations from the Meta-Analysis of Observational Studies in Epidemiology group. 3 The search strategy was developed with the assistance of a research librarian specialising in medical sciences and included the following terms appearing in the title, abstract, or keywords: uterine prolapse, vault prolapse, uterovaginal prolapse, vaginal mesh, Prolift, Apogee, intravaginal slingplasty, infracoccygeal sacropexy and surgical mesh or mesh in combination with vaginal cuff or hysterectomy or prolapse that were crossreferenced with study or studies or trial or evaluation or prognosis or outcome or meta-analysis. We searched the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews and Effects, ACP Journal Club, MEDLINE Ò (1950 to December week 4 2007), Scopus and Web of Science using Ovid Technologies, Inc. (New York, NY, USA), Version: rel10.5.1. We also hand-searched for all conference presentations, including oral platform and oral poster presentations in their abstract form presented from the International Continence Society, International Urogynecological Association, American Urogynecologic Society and Society for Gynecologic Surgeons between January 2005 and December 2007. Studies were included in this review if women underwent vaginal surgery for uterine or post-hysterectomy vaginal vault prolapse and had graft material vaginally placed to surgically reinforce the apical portion of the repair. Posterior Prolift, Apogee, intravaginal slingplasty and infracoccygeal sacropexy are mesh kits placed through small perianal skin incisions posteriorly through the ischio-anal fossa and are designed to repair the vaginal apex. Studies were excluded if they described the use of mesh to support either the anterior or posterior vaginal compartment alone, used mesh for incontinence or fistula repair or did not address the upper vaginal compartment. If it could not be established whether mesh was used for apical vaginal support, then the study was excluded. When both posterior and total Prolift procedures were reported we attempted to distinguish between procedures where feasible. Thetypeofstudydesignsusedincluded cross-sectional, case series, case control, any design with historical controls, cohort or controlled trials. Case reports were excluded. Outcomes included both objective and subjective outcomes relating to prolapse, urinary, bowel, sexual function, pain, mesh erosion and perioperative surgical complications. Objective success was defined as any description of vaginal support symptomatic or asymptomatic prolapse less than stage 2 of the Pelvic Organ Prolapse Quantification (POP-Q) system or grade 2 of the Baden Walker Halfway System. Any combination of procedures for treating pelvic organ prolapse at the same time was acceptable. The type of exposure or intervention included the placement of any biological or synthetic mesh material during vaginal surgery for the treatment of uterine or post-hysterectomy vaginal vault prolapse. Variables selected included number of participants, length of follow up, objective and subjective success rates and a detailed list of complications, including the interventions for each complication. Complications were categorised using the previously validated Dindo system for classifying surgical complications (Table 1). 4 This validated classification system was chosen since severity of complications depends of the perspective of a multitude of individuals (e.g. surgeon, woman and payer) who often cannot agree. 5 The Dindo classification focuses on the medical perspective, with a major emphasis on the risk and invasiveness of the therapy used to treat the complication. For example, a complication is classified as Dindo grade III if it requires a surgical intervention without (IIIa) and with (IIIb) anaesthesia. In women with mesh erosion, when the management of the erosion was not specified, we conservatively assumed, based on clinical experience, that 50% of women received medical management (grade II) and 50% received surgical management requiring anaesthesia (grade IIIb). Identified manuscripts were grouped by the mesh kit presented in each, and the data were extracted into four tables: Apogee, Gynecare Prolift System and Posterior Intravaginal Slingplasty (PIVS)/Infracoccygeal Sacropexy (Tyco Healthcare, United States Surgical, Norwalk, CT, USA). Nonstandardised procedures that also use polypropylene mesh and are technically similar to the above-mentioned mesh kits 16 ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

A review on vaginal mesh kits for apical prolapse Table 1. Dindo classification of surgical complications Grade Grade I Grade II Grade III Grade IV Grade V Definition Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Includes wound infections opened at the bedside Includes drugs, such as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy Requiring pharmacological treatment with drugs other than such allowed for grade I complications; Blood transfusions and total parenteral nutrition are also included Requiring surgical, endoscopic or radiological intervention Grade IIIa intervention not under general anaesthesia Grade IIIb intervention under general anaesthesia Life-threatening complication requiring ICU management Grade IVa single organ dysfunction (includes dialysis) Grade IVb multi-organ dysfunction Death of a woman were combined into a single group. Given the paucity of published manuscript data and the large proportion presented in abstract form, we decided not to formally assess study quality. The extracted data was double checked by a second independent author. Weighted percentages, SDs and 95% CIs of objective success, total complication rate, Dindo grade, mesh erosion and dyspareunia rates were calculated using SPSS version 15 (SPSS, Chicago, IL, USA) for each of the four tables, based on the number of participants in each study. Results One hundred and twenty-four studies met the inclusion criteria, 94 of which were excluded, resulting in 30 studies totalling 2653 participants used for the analysis. There were 20 peerreviewed conference abstracts and 10 peer-reviewed articles. Overall, mean follow up was 36 weeks (range 26 78 weeks). Overall objective success, total complications, Dindo grade and mesh erosion and dyspareunia rates are summarised in Table 2. Apogee Eight studies reporting results obtained with the Apogee system for apical and posterior vaginal prolapse and are summarised in Table 3 and included two articles 6,7 and six conference abstracts 8 13 including one randomised controlled trial (RCT). 12 Apogee was performed alone 7,8,13 in three of the studies and in the remainder, a proportion of women underwent a concomitant Perigee (American Medical Systems Inc., Minnetonka, MN, USA) procedure. 6,9 12 Overall, 525 women had a mean follow up of 26 weeks (range 10 56 weeks). Mean objective success was 95% (range 81 100) and mean complications were 18% (11 47). The most common complications Table 2. Weighted averages analysis Apogee TM Prolift TM PIVS Polypropylene % SD 95% CI % SD 95% CI % SD 95% CI % SD 95% CI No. women (n) 525 1295 655 178 Mean follow up (weeks SD) 26 15 30 12 46 36 78 47 Objective success 95.4 3.6 95.1 95.7 86.8 7.3 86.4 87.3 88.2 11.3 87.2 89.1 91.6 4.6 90.9 92.3 Total complication rate 17.6 10.4 16.7 18.5 16.5 11.2 15.9 17.1 12.1 6.1 11.6 12.5 6.9 0.3 6.8 6.9 Dindo grade I 4.8 5.1 4.4 5.3 6.0 5.7 5.6 6.2 3.2 4.7 2.9 3.6 1.5 1.3 1.3 1.8 Dindo grade II 6.5 5.3 6.0 7.0 4.1 7.1 3.7 4.5 3.2 3.4 3.0 3.5 1.5 1.8 1.2 1.8 Dindo grade III 6.3 4.2 5.9 6.7 6.4 2.7 6.3 6.6 5.7 5.2 5.3 6.1 3.8 0.2 3.8 3.8 Dindo grade IIIa 0.4 1.2 0.3 0.5 0.5 0.8 0.4 0.5 0.6 1.2 0.5 0.7 2.3 1.2 2.1 2.5 Dindo grade IIIb 5.9 4.1 5.5 6.2 6.0 2.9 5.8 6.1 5.0 5.5 4.6 5.5 1.5 1.3 1.3 1.8 Dindo grade IV 0 0.1 0 0 Mesh erosion 10.7 6.9 10.1 11.3 5.7 4.8 5.5 6.0 7.8 7.1 7.2 8.3 4.6 2.3 4.2 5.0 Dyspareunia 2.7 3.6 2.4 3.0 2.1 2.1 2.0 2.2 1.7 2.8 1.5 1.9 5.5 4.7 4.7 6.3 ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology 17

Feiner et al. Table 3. Clinical information Apogee TM studies Complications Comments Percentage objective success First author No. women Mean follow up (weeks) Gauruder- 48 52 100 (48/48) No distinction from Perigee only 48/48 prior hysterectomy Burmester 7 Biller 9 104 29 96 (100/104) Proctotomy (1/104); haematoma (1/104); Porcine dermis graft: Uterine status (intact dyspareunia (9/104) vs hysterectomy) not given Davila 10 55 10 91 (50/55) Erosion (8/55); dyspareunia (2/55); haematoma (1/55) 55/55 vault prolapse Meschia 12 21 12 81 (17/21) Perineal pain (3/21); mesh exposure (1/21) RCT; 21/21 uterine prolapse undergoing uterine preservation with mesh Sarsotti 13 47 56 98 (46/47) Mesh erosion (5/47) Apogee performed with VH or hysteropexy. Proportion not given Davila 11 177 19 96 (170/177) Mesh exposure (24/177) Uterine status (intact vs hysterectomy) not given 97 (34/35) Mesh erosion (9/35) 35/35 vault prolapse Perineal pain (2/35) Balakrishnan 8 35 Not stated 6/38 concomitant VH; 1/38 concomitant Manchester repair; uterine status of remaining women not given Abdel-fattah 6 38 12 95 (36/38) Blood loss.400 ml (1/38), vaginal adhesions (1/38); UTI (1/38); Fever (6/38); Local infection (1/38); Buttock pain (1/38); Dyspareunia (2/38); Rectal injury (1/38); Vaginal erosion (4/38) VH, vaginal hysterectomy. were mesh erosion (11%) and dyspareunia (3%). Perineal, pelvic or buttock pain was reported in 1%. The only severe intraoperative complication was proctotomy, documented in two women (0.4%). Complications for Apogee using the Dindo classification system revealed that while 5% of the women had grade I complications (not requiring pharmacological or surgical intervention), 7% had grade II complications (treated pharmacologically) and 6% had grade III complication necessitating some form of surgical intervention. Prolift Eight studies used the Prolift system with a varying proportion of women undergoing anterior, posterior or total Prolift meshes (Table 4). Only data relating to posterior and total Prolift were quoted wherever such a distinction was feasible. Three of the eight studies were articles 6,14,15 and five were conference abstracts 16 20 with no randomised controlled trials. Overall posterior or total Prolift was performed in 1295 women with mean follow-up time of 30 weeks (range 12 52 weeks). Mean objective success rate was 87% (range 75 94) and mean complication rate was 16% (range 2 61). There existed some inconsistency for success and failure following prolapse surgery among authors partly due to the use of non-standardised grading systems for prolapse quantification. Fatton et al. 15 reported an objective success rate of 95% in a case series of 110 women undergoing pelvic reconstruction with Prolift, based on their definition of failure, being stages 3 and 4 of the Jacquetin classification system, which is different from both the POP-Q and the Baden Walker systems. While in the latter two, postoperative stage/ grade 2 prolapse would have been considered as a failure by most authors, in Jacquetin s classification stage 2 is defined when the leading edge descends to the mid-vagina and therefore should not be considered as a failure. The most common complications using Prolift were mesh erosion (7%) and dyspareunia (2%). Vaginal or buttock pain was reported in 2% and mesh contraction in 1.5%. While there was only a single woman with rectal injury, cystotomy occurred in 1% (16 women) with three women with fistula formation and 10 participants who received blood transfusion. Dindo complication grades included: grade I (6%), grade II (4%) and grade III (6%). There was a single woman with necrotising fasciitis reported by Abdel-Fattah et al., 6 considered as grade IVb (life threatening involving multi-organ failure) complication, which was treated by compete removal of the mesh, extensive perineal debridement, laparotomy and colostomy followed by prolonged stay in the intensive care unit. PIVS Four out of 10 studies in which PIVS was used for the treatment of vault/uterine prolapsed (Table 5) were published 18 ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

A review on vaginal mesh kits for apical prolapse Table 4. Clinical information Prolift TM studies First author No. women Mean follow up (weeks) Percentage objective success Complications Comments Miller 19 85 52 88 (75/85) Mesh erosion (6/85); dyspareunia (3/85); pain (1/85); fistula (2/85) Van Raalte 20 349 26 91 (318/349) Cystotomy (9/349); ureteral obstruction (1/349); haematoma (1/349); dyspareunia (15/349); vaginal pain (7/349); mesh erosion (4/349) Cosson 16 89 52 82 (73/89) Vaginal contraction (11/89); mesh erosion (9/89); dyspareunia (3/89); vesicovaginal fistula (1/89) Manchana 17 36 20 All 89 (32/36); total Prolift with Uterine preservation only 75 (6/8) Wound dehiscence (5/36); mesh erosion (3/36); blood transfusion (9/36); haematoma (3/36); laparotomy (2/36) Fatton 15 88 25 93 (82/88) haematoma (2/88); no distinction from anterior only for the remaining Belot 14 277 Not stated Not stated Mesh erosion (34/277) Abdel-fattah 6 143 12 94 (134/143) Bladder injury (1/143); rectal injury (1/143); blood loss.400 ml (3/143); blood transfusion (1/143); buttock pain (14/143); dyspareunia (7/143); mesh erosion vaginal (16/143); mesh erosion bladder (1/143); local infection (3/143); systemic infection (necrotising fasciitis) (1/143) Meschia 18 228 32 75 (170/228) Cystotomy (6/228); blood loss.300 ml (3/228); mesh erosion (11/228); mesh shrinkage (9/228); Urge incontinence (5/228) 17/85 concomitant hysterectomy; uterine status (intact vs hysterectomy) of remaining not given 7/349 concomitant hysterectomy; 2/349 concomitant uterosacral vault suspension; uterine status of remaining not given 18/90 prior VH; 72/90 concomitant VH 8/36 total Prolift with uterine preservation 79/110 (including anterior mesh group) no prior hysterectomy; 64/79 uterine preservation; 15/79 concomitant VH Uterine status not given 37/143 concomitant VH; 2/143 concomitant Manchester repair; uterine status of remaining not given 204/236 (total enrolled) no prior hysterectomy; 190/204 uterine preservation; 14/204 concomitant VH VH, vaginal hysterectomy. articles, 21 24 and six were conference abstracts, 25 30 of which two 25,27 (the de Tayrac paper is published now in Int Urogynecol J 2008) were randomised controlled trials. There were 655 women with mean follow up of 46 weeks (range 3 120 weeks). Mean objective success was 88% (range 37 99) and mean complications occurred in 12% (range 2 21). The two randomised controlled trials included 107 women randomised to either PIVS or sacrospinous fixation. Meschia et al. 27 reported 82% objective success rate with the PIVS compared with 88% with the sacrospinous fixation at 24 months follow up, while de Tayrac et al. 25 reported on 95% success with the PIVS at a mean follow up of 10.5 months compared with 100% success rate with the sacrospinous fixation at a mean follow up of 15.5 months. When combining data from all trials involving PIVS included in this review, the overall erosion rate was 8%, dyspareunia in 2% followed by haematoma in 1%. Other complications included four instances of prolonged pain, two women requiring blood transfusion, one proctotomy, one pararectal abscess and one fistula. Complications summarised using the Dindo classification yielded grade I (3%), grade II (3%) and grade III (6%) complications, the majority of which were of subclass IIIb, requiring surgical intervention under general anaesthesia. Polypropylene meshes Four studies used a self-styled polypropylene mesh for the treatment of anterior, apical or posterior compartment ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology 19

Feiner et al. Table 5. Clinical information PIVS studies First author No. women Mean follow up (weeks) Percentage objective success Complications Comments Biertho 21 34 12 91.2 (31/34) Tape erosion (1/34); haemorrhage (1/34) 21/34 no prior hysterectomy; 9/21 uterine prolapse; no concomitant hysterectomy performed Foote 22 52 20 82.7 (43/52) Tape erosion (11/52) 52/52 vault prolapse Luck 26 91 32 86 (78/91) Tape erosion (17/91) 91/91 vault prolapse Mattox 23 21 7 37 (7/19) Proctotomy (1/21); 21/21 vault prolapse haematoma (1/21) Vardy 29 54 52 85 (46/54) Tape extrusion (3/54) 54/54 vault prolapse Meschia 27 33 104 82 (27/33) Tape erosion (2/33); pararectal abscess (1/33) RCT; 33/33 vault prolapse Riva 28 172 52 87 (149/172) Haematoma (3/172); blood transfusion (2/172); skin fistula (1/172); prolonged pain (4/172); dyspareunia (11/172); tape erosion (6/172) 90/172 concomitant hysterectomy; 82/172 vault suspension Vardy 30 98 3 99 (97/98) Tape erosion (2/98) Uterine status (intact vs hysterectomy) not given Neuman 24 79 120 100 (44/44) VH; 97 (34/35) uterine preservation Tape extrusion (10/79) 44/79 concomitant VH; 35/79 uterine preservation; 6/35 cervical amputation De Tayrac 25 21 42 95 (20/21); 1 failed uterine suspension Haematoma (2/21) RCT; no. women undergoing uterine preservation vs vault suspension not given VH, vaginal hysterectomy. prolapse (Table 6). One of these papers was a peer-reviewed article, 31 while the remaining three were in the form of conference abstracts 32 34 and there were no RCTs. A total of 178 women with advanced prolapse were treated using self-styled polypropylene meshes with mean follow up of 78 weeks (range 12 123 weeks). Amrute et al. 31 used a single H-shaped polypropylene mesh to treat women having multicomponent prolapse. Two anterior arms were passed retropubically Table 6. Clinical information polypropylene mesh studies First author Method used No. women Mean follow up (weeks) Percentage objective success Complications Comments Amrute 31 Four-point polypropylene mesh (H-shaped) 76 123 95 (72/76) Mesh erosion (2/76); dyspareunia (2/21) 36/76 Concomitant hysterectomy; results do not distinct uterine preservation from vault suspension Farnsworth 32 Total vaginal mesh 25 78 92 (23/25) Not reported 19/25 prior hysterectomy Murphy 33 Yu 34 Total vaginal mesh (self-styled) Self-styled, 3 pieces polypropylene mesh 55 12 85 (47/55) Mesh exposure (4/55) Uterine status (intact vs hysterectomy) not given 22 87 95 (21/22) Not reported 22/22 Uterine preservation 20 ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

A review on vaginal mesh kits for apical prolapse towards the anterior abdominal wall and two posterior arms were secured to the sacrospinous ligaments. Uterine preservation using three separate polypropylene mesh grafts (anterior, posterior and apical) was described by Yu 34 on a group of 22 women. Mean objective success was 92% with only two studies reporting on complications. Mesh erosion was documented in 5% of the women and dyspareunia in 5.5%. Discussion This review suggests there is an overall high, short-term objective success rate (ranging from 87 to 95%) of the commonly used mesh kits in the treatment of apical vaginal prolapse. Although mean objective success rate was highest in the Apogee group, similar results were obtained by other, nonstandardised procedures also employing polypropylene mesh for apical support. These figures are in accordance with the reported long-term success rates of more established surgical procedures, such as sacral colpopexy and sacrospinous fixation that, unlike mesh kits have been evaluated in better controlled trials and have more evidence available on their safety and efficacy. The Cochrane review on the surgical management of pelvic organ prolapse by Maher et al. 35 analysed randomised controlled trials comparing abdominal sacral colpopexy to vaginal sacrospinous colpopexy. There was 96% (81/84) objective success using the abdominal route and 85% (72/85) in the vaginal route. Long-term (mean 57 months) success of 96% following sacrospinous colpopexy was reported by Hefni and El-Toukhy. 36 Although subjective success rates 9,18,24 were reported by few manuscripts and abstracts included in this review, the results were similar between all three mesh kits, ranging from 89% (202/228) for Prolift 18 to 92% (96/104) for Apogee. 9 The lack of subjective data may be due to the limited word counts that frequently apply to submitted abstracts or due to study design. Researchers should be encouraged, however, to use validated tools for the assessment of prolapse symptoms both at baseline and following surgical interventions. An example of such a tool is the pelvic organ prolapse symptom score, which was recently validated in terms of internal consistency, construct validity and sensitivity to change. 37 The PIVS procedure achieved favourable anatomical outcome in the majority of studies included in this review. Exceptionally poor outcome (objective success rate of 37%) was reported by Mattox et al. 23 on a group of 21 elderly women (mean age 70). Apart from the higher age of participants, this could be partially explained by the stringent criteria of primary failure employed in this study, being POP-Q point C within 2 cm of the preoperative value, leading to the possibility that women with postoperative POP-Q stage 1 might still be considered as failures. A considerable number of articles in the last year have reported significant complications following IVS procedures, frequently blaming the type 3 multifilament mesh for their occurrence. Meschia et al. 38 randomly assigned stress incontinent women to either TVT (tension-free vaginal tape) or anterior IVS. Cure rates did not differ significantly between the groups, but 9% of women in the IVS group experienced tape erosion compared with none in the TVT group. Baessler et al. 39 described serious complications following anterior and/or posterior IVS, including vaginal pain and dyspareunia, painful defaecation, retropubic abscesses developing into cutaneous sinus or vesicocutaneous fistula, purulent vaginal discharge and tape erosion. Mikos et al. 40 reported on a gluteovaginal sinus formation 3 months after a PIVS procedure and Yee et al. 41 reported on a rectocutaneous fistula 2 months postoperatively. However, this review suggests that the mean complication rate of the PIVS procedure (12%) was even lower compared with Apogee and Prolift, presumably due to the smaller amount of mesh used, although some unique complications like pararectal abscess and skin fistula were reported sporadically. Overall, mean complication rates for the different procedures ranged from 7 to 18% and were highest in the Apogee group. Although mesh erosion and dyspareunia were the most frequently reported complications in all procedures, erosion ranged from 5 to 11%. This is in contrast to erosion rates up to 20% (Deffieux et al. 42 ) following application of synthetic mesh to the anterior vaginal wall. This disparity may be explained by the type and amount of mesh, the surgical technique and the properties of the overlaying tissue such as presence of atrophy or scar tissue at the apex from a previous hysterectomy. A significant limitation included management of mesh erosions. Several authors reported erosion rates, but failed to determine how these were managed. Management ranged from conservative treatment with local estrogen, through office trimming and oversewing of the eroded mesh, to complete excision of the mesh, requiring an operating theatre setting. Additionally, excision may have occurred in the same individual more than once and in different settings. In these instances, the most severe Dindo grade was collected. Wherever the management was not specified, a proportion of 50/50% between conservative and surgical management was assumed. Dyspareunia was reported between 1.5 and 3%. These data are relatively low compared with published data on other prolapse repair procedures. Weber et al. 43 reported 19% dyspareunia rate following surgery for prolapse or incontinence. Pauls et al., 44 in a survey aiming to assess sexual function after prolapse surgery, found that for 25% of participants, vaginal pain was the single most bothersome barrier to intercourse. Dyspareunia has often been associated with posterior colporrhaphy, with or without levator plication. 45 It is possible that the lower prevalence of dyspareunia following mesh kit procedures is attributed to the fact that fascial or levator plication ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology 21

Feiner et al. is not an essential component of the surgical technique and frequently not performed as part of the surgery. It may also be due to selection bias in our studies, as they were limited to studies involving the apex or that sexual function was assessed using non-validated questionnaires. Since all mesh kits reviewed used specially designated insertion needles, attention should be paid to the occurrence of complications that can be referred to as trocar-related rather than mesh-related. These include cystotomies, proctotomies and vascular injuries. Unlike mesh-related complications that can evolve at any stage during the postoperative course, trocar-related complications occur intraoperatively and can lead to extremely unfavourable consequences if not identified and treated meticulously at the time of occurrence. The strengths of this review are our attempts to gather as much of the currently available data on mesh kits in the treatment of apical vaginal prolapse as possible and the use of a valid method of classifying surgical complications. This is one of the first descriptions employing the valid Dindo system for classifying surgical complications 4 in the field of gynaecology. This useful tool enables one to compare complications using standard definitions between different surgical procedures in gynaecology and other surgical procedures. The highest rates of grade I and grade III complications were in the Prolift group, whereas grade II complications were commonest in the Apogee group. A significant limitation to our conclusions is the reliance on data from conference abstracts. These abstracts are limited in length and often lack relevant details, such as subjective data regarding women s symptoms and quality of life, making meaningful data extraction difficult. In the apical compartment, it is important to distinguish uterine prolapse from vaginal vault prolapse as well as hysterectomy with vault suspension from uterus-preserving procedures. Unfortunately, a large proportion of abstracts did not make these distinctions. We decided to include abstracts from recent major international meetings due to the long lag time between presented papers and publication in peerreviewed journals and to increase the sample size to better estimate success and complication rates. Although the quality of data cannot be ascertained as well from abstracts as from manuscripts, including abstracts helps to reduce the possible risk of publication bias against surgeons who use vaginal mesh kits. This may be illustrated in the two randomised trials using the PIVS procedure, 25,27 as reasons are unknown to the general surgical community as to why the de Tayrac trial has been published but the Meschia et al. trial has not. This review also likely underestimates the proportion of complications because of the space limitations placed on abstracts. However, data should be interpreted with caution, as quality is limited. Additionally, since there were major methodological differences between the trials included in this review, statistical comparison of outcomes between the various procedures is not valid. Conclusions Based on limited peer-reviewed data, transvaginal mesh kits appear to be effective in restoring apical vaginal prolapse but data on functional outcomes and long-term follow up are unknown. Surgeons should counsel women that devicerelated complications that may occur when using these procedures are not rare; most are related to the use of mesh and their management might necessitate surgical intervention under an anaesthetic. Future research should be directed towards well-conducted and adequately powered RCTs with longer follow up, comparing vaginal mesh procedures with traditional surgeries for apical prolapse and on how surgeons should manage device- and mesh-related complications. Functional outcomes following these procedures and their impact on prolapse symptoms and quality of life should also be thoroughly studied, as these techniques will likely be a part of gynaecologist s future. Disclosure of interest No potential conflict of interest exists for any of the authors. Contribution to authorship B Feiner participated in the design, implementation and writing of the manuscript. JE Jelovsek participated in the design, implementation and writing of the manuscript. C Maher participated in the design, implementation and writing of the manuscript. All authors have seen and approved the final version. Details of ethics approval As this systematic review only included studies previously published in peer-reviewed journals or presented in major scientific meetings, ethics approval was not sought. Funding No funding was accepted or involved in this systematic review project. Acknowledgements Dr K Baessler from Charité University Hospital Berlin, Campus Benjamin Franklin, Department of Gynaecology, Berlin, Germany, contributed to the literature search conducted for this systematic review. j References 1 Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 2007;110:455 62. 2 Chen L, Ashton-Miller JA, Hsu Y, DeLancey JO. Interaction among apical support, levator ani impairment, and anterior vaginal wall prolapse. Obstet Gynecol 2006;108:324 32. 3 Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. 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