Assessment and initial management of mesh complications

Synthetic polypropylene mesh have been used in the surgical management of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) since 1990's. However, following patients'-led campaign with concerns regarding the complications associated with mesh, their use in surgical management of SUI and/or POP has been controversial. Complications associated with these mesh implants include chronic pain, vaginal mesh exposure, perforation into organs, infections and sinus tract formation. In April, 2019, the NICE guideline (NG123) provided an evidence review for management of mesh complications. Following Independent Medicine and Medical Devices Safety Review (IMMDS) publication in 2020, a network of specialized complex mesh centres across the UK have been set up. All patients with mesh-related complications should receive specialist multidisciplinary care in these centres. In this review, we outline the assessment and initial management of patients who present with mesh-related complications. Assessment and management options should be tailored per individual cases. Assessment includes clinical assessment and investigations including radiological imaging. All management options including no treatment, conservative, medical and surgical treatment, including minimally invasive treatment with the pros and cons of every option should be offered and patient should be actively involved in their decision making in a “shared-decision making” manner.     

Combined vaginal and laparoscopic surgical treatment of genito-urinary prolapse

BACKGROUND: A new combined technique for vaginal prolapse and cystocele using minimal access surgery is presented and evaluated. METHODS: Thirty-five patients (mean age 57.1) with genitourinary prolapse (II-IV degree Baden-Walker) without urinary incontinence underwent surgery between January 98 and December 99 with 4-24 months of follow-up (mean 14.6 months). The surgical stages include total vaginal hysterectomy with bilateral adnexectomy, wide opening of the vagina without excessive removal of the vaginal mucosa; the bladder is loosened and the polypropylene mesh (PPM) is lightly fixed to the bladder and stitched to the anterior and posterior vaginal wall. The PPM is introduced into the abdomen and laparoscopically fixed to the sacral promontory with titanium spirals having checked vaginally the right tension of the mesh. Accurately laparoscopic peritonization of the PPM ends the surgical procedure. RESULTS: The operation time was 90'-140' (mean 112') followed by 3-7 days of hospitalization (mean 4.3). Vaginal prolapse and cystocele were corrected in all cases. No surgical complications, de novo urinary incontinence, prolapse recurrence or inconvenience to sexual activity have been observed. There was one erosion of the vaginal wall by the PPM 45 days after the operation. CONCLUSIONS: Initial studies suggest that laparoscopic sacrocolpopexy and cystocele repair with PPM is an effective treatment for genitourinary prolapse. If subsequent studies will confirm these findings, the development of minimal access techniques for genitourinary prolapse will represent a significant surgical advance.     

Prolift网片联合尿道中段悬吊治疗POP或合并SUI患者的近期疗效

目的:探讨全阴道修复网片(total vaginal mesh,TVM)即Gynecare Prolift网片修复系统及联合经闭孔无张力阴道吊带(tensiongfree vaginal tape-obtutor,TVT-O)尿道中段悬吊手术治疗盆腔器官脱垂(pelvic organ prolapse,POP)或合并压力性尿失禁(stress urinary incontinence,SUI)的近期疗效。方法:选择Ⅱ度以上子宫和(或)阴道壁脱垂患者24例,其中本次手术前已切除子宫5例,术中同时切除子宫12例,保留子宫7例。16例用全盆底修复网片(total Prolift),8例用前盆修复网片(anterior Prolift);10例因合并压力性尿失禁同时行TVT-O尿道中段悬吊术。结果:24例患者术中均无严重并发症发生,3例(12.5%)出血量超过500ml;术后随访12～20个月,1例至术后10个月时发现阴道壁网片侵蚀(4.2%,1/24),经门诊4次修剪好转;24例患者均无复发。结论:用Prolift盆底修复网片系统进行盆底重建术,手术安全、易行、微创,近期疗效肯定;合并SUI者同时使用TVT-O不增加手术难度和并发症的发生率。     

Efficacy and outcome of anterior vaginal wall repair using polypropylene mesh (Gynemesh)

AIM: The aim of the present study was to assess the safety and efficacy of anterior vaginal wall repair using polypropylene mesh for the correction of anterior vaginal wall prolapse. METHODS: From May 2001 to March 2005, 38 patients with cystoceles or uterine prolapse underwent transvaginal repair with implantation of polypropylene mesh. In all 38 patients anterior vaginal wall repair was done concurrently with other procedures: vaginal hysterectomy, n = 18 (47.4%) and tension-free vaginal tapes n = 22 (57.9%). RESULTS: Preoperatively 26 patients (68.4%) had stage III/IV prolapse on pelvic organ prolapse quantification examination. After mean follow up of 23.4 months, the objective cure rate at 12 and 18 months was 94.5% and 94.3%, respectively. As for complications associated with placement of the polypropylene mesh, no tissue erosion or infection was found. CONCLUSIONS: Transvaginal implantation of polypropylene mesh is an effective and safe technique for the correction of anterior vaginal wall prolapse.     

Severe mesh complications following intravaginal slingplasty

OBJECTIVE: Synthetic meshes are increasingly used in the management of stress urinary incontinence and pelvic organ prolapse. This report describes severe complications following anterior and/or posterior intravaginal slingplasties employing a multifilament polypropylene mesh. METHODS: We describe the symptoms, findings, subsequent management, and outcome of 19 consecutive women who have been referred with complications following anterior (n = 11) and/or posterior intravaginal slingplasty (n = 13) employing the multifilament polypropylene tape. RESULTS: The main indications for removal of the 11 anterior intravaginal slings were intractable mesh infection in 6 women, retropubic abscess with cutaneous sinus in one, and vesico-vaginal fistula in one, intravesical mesh and pain syndrome in one, and voiding difficulties and pain syndrome in two. The main indications for removal of the 13 posterior intravaginal slings were intractable mesh infection in three and pain syndrome and dyspareunia in 10 women. Removal of the slings was performed after a median time of 24 months post-slingplasty. At follow-up between 6 weeks and 6 months, in all women genital pain, chronic vaginal discharge and bleeding, voiding, and defecation difficulties had been markedly alleviated (5) or they had ceased (14). Twelve of 17 sexually active women (71%) resumed sexual intercourse without difficulties. Ten women required subsequent surgery for stress incontinence and pelvic organ prolapse. CONCLUSION: Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.     

经阴道植入TiLOOP网片的盆底重建术的临床疗效和安全性分析

目的:评价经阴道植入轻型钛化聚丙烯网片TiLOOP的盆底重建术的临床短期疗效和安全性。方法:回顾性分析南京医科大学附属无锡妇幼保健院2017年11月至2019年7月,以阴道前壁膨出Ⅲ~Ⅳ度为主的50例盆腔器官脱垂（POP）患者,对其实施经阴道植入TiLOOP网片的盆底重建术,其中自行裁剪TiLOOP网片的“协和式”盆底...     

Transvaginal repair of anterior and posterior compartment prolapse with Atrium polypropylene mesh

OBJECTIVE: To determine the efficacy and safety of a new technique using Atrium polypropylene mesh (Atrium, Hudson, New Hampshire, USA) as an overlay graft for repair of large or recurrent anterior and posterior compartment prolapse. DESIGN: A retrospective review of women who had vaginal prolapse surgery with Atrium mesh reinforcement. SETTING: Tertiary referral urogynaecology unit in Australia. POPULATION: Forty-seven women where mesh was placed under the bladder base with lateral extensions onto the pelvic sidewall, 33 women where a Y-shaped mesh was placed from the sacrospinous ligaments to the perineal body and 17 women who had mesh placement in both compartments. METHODS: Women were assessed by site-specific vaginal examination pre-operatively and post-operatively at six weeks, six months and two years. MAIN OUTCOME MEASURES: All complications. Rate of recurrent prolapse assessed by the Baden-Walker halfway classification system. RESULTS: Mean follow up was 29 months (range 6 to 52). Four of 64 women with anterior mesh placement (6%) developed a grade 2 asymptomatic cystocele. Five women (5%) required further surgery for recurrent prolapse at a non-mesh site. Erosion occurred in nine women (9%). Three healed after intravaginal oestrogen cream, five after excision of exposed mesh and vaginal closure and one woman also had surgical closure of a rectovaginal fistula. The risk of mesh erosion decreased over the study period. Urinary, coital and bowel symptoms were significantly improved following surgery. CONCLUSIONS: This technique shows promise in correcting pelvic organ prolapse. Vaginal mesh erosion is the most common complication and is related to surgical experience.     

经阴道后路悬吊带术治疗阴道穹窿膨出的中远期随访结局

目的:探讨经阴道后路悬吊带术(PIVS)治疗女性阴道穹隆膨出的中远期结局。方法:采用回顾性研究方法,对20名子宫切除术后阴道穹隆膨出的患者行PIVS治疗。对其术前、术后资料进行评估,并对术后3年以上随访结果进行总结。结果:平均手术时间53.95±16.88min,术中平均出血量57.50±24.682ml,平均住院天数3.82天,未发生直肠损伤、盆腔血肿等术中严重并发症。半年内所有患者均治愈,中远期随访2例(10.5%)患者因阴道穹隆脱垂复发行子宫托治疗;5例(26.3%)出现吊带侵蚀,剪除后加用雌激素局部治疗,4例好转,1例反复修剪侵蚀的吊带3次,仍有肉芽形成。结论:PIVS术是一种安全、有效、微创的治疗阴道穹隆膨出的手术方式,但术后中远期随访发现吊带侵蚀是一个不可忽视的问题,该术式所用多股编织吊带不宜作为重建材料。     

Combined anterior vaginal wall mesh with sacrospinous ligament fixation or with posterior intravaginal slingplasty for uterovaginal or vaginal vault prolapse

Objective

To evaluate outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) or with concomitant posterior intravaginal slingplasty (IVS) for uterovaginal or vaginal vault prolapse.

Study design

Women with symptomatic uterovaginal or vaginal vault prolapse were randomly allocated to SSLF or IVS. All underwent concomitant anterior repair augmented with self-tailored multifilament polypropylene and polyglactin composite mesh. Before and 2, 12, 24 and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of pelvic organ prolapse at stage II or beyond (−1 cm or greater) at any site of the vaginal wall. Secondary outcomes included perioperative and postoperative complications, symptom resolution, reoperation and mesh exposure.

Results

Twenty-two women were recruited from March 2003 to December 2005. At 3-year follow-up3 (2 posterior and 1 apical) out of 14 (21%) in the IVS group had anatomic recurrences of pelvic organ prolapse, and 1 anterior out of 8 (13%) in the SSLF group. Severe operative complications or reoperations did not occur. The proportions of symptomatic patients, including those with dyspareunia, did not differ between the groups. Erosion of the anterior multifilament mesh was found in 2 out of 22 cases (9%; 95% CI 3-28%).

Conclusion

At 3-year follow-up anterior repair reinforced with a composite mesh with concomitant sacrospinous ligament fixation or with concomitant posterior intravaginal slingplasty allowed feasible support in patients with severe pelvic organ prolapse.     

Abdominal sacrocolpopexy for vault prolapse without burial of mesh: a case series

OBJECTIVES: To audit the clinical outcome of abdominal vault suspension (sacrocolpopexy, hysteropexy or cervicopexy) using non-absorbable mesh, without burial by closure of the peritoneum. DESIGN: A case series. SETTING: Urogynaecology units of four hospitals. POPULATION: One hundred and twenty-eight women having open or laparoscopic sacrocolpopexy (121), hysteropexy (6) or cervicopexy (1) using non-absorbable mesh for vault prolapse. METHODS: Patients had suspension of the vault, uterus or cervix from the sacral promontory using a monofilament polypropylene mesh. The pelvic peritoneum was not closed over the mesh. Patients were followed up every six months. MAIN OUTCOME MEASURES: Incidence of bowel complications as a consequence of the mesh; cure rate of prolapse and incidence of other post-operative complications; rate of re-operation for prolapse or incontinence. RESULT: After a median follow up of 19 months (1.5-62), there were no bowel complications as a result of non-burial of mesh. Three patients had asymptomatic vaginal mesh erosion, which required minor surgical intervention. Ninety percent of patients had good resolution of their prolapse symptoms while 10% of patients required further surgery. CONCLUSION: Leaving the mesh uncovered by the pelvic peritoneum was not associated with complications. It appears safe to perform vault suspension without closing the peritoneum.     

Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial

Objective  To compare vaginal repair augmented by mesh with traditional colporrhaphy for the treatment of pelvic organ prolapse.
Design  Prospective randomised controlled trial.
Setting  Tertiary teaching hospital.
Population  One hundred and thirty-nine women with stage ≥2 prolapse according to the pelvic organ prolapse quantification (POP-Q) system requiring both anterior and posterior compartment repair.
Methods  Subjects were randomised to anterior and posterior vaginal repair with mesh augmentation (mesh group, n  = 69) or traditional anterior and posterior colporrhaphy (no mesh group, n  = 70).
Main outcome measures  The primary outcome was the absence of POP-Q stage ≥2 prolapse at 12 months. Secondary outcomes were symptoms, quality-of-life outcomes and satisfaction with surgery. Complications were also reported.
Results  For subjects attending the 12-month review, success in the mesh group was 81.0% (51 of 63 subjects) compared with 65.6% (40/61) in the no mesh group and was not significantly different ( P -value = 0.07). A high level of satisfaction with surgery and improvements in symptoms and quality-of-life data were observed at 12 months compared to baseline in both groups, but there was no significant difference in these outcomes between the two groups. Vaginal mesh exposure occurred in four women in the mesh group (5.6%). De novo dyspareunia was reported by five of 30 (16.7%) sexually active women in the mesh group and five of 33 (15.2%) in the no mesh group at 12 months.
Conclusion  In this study, vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy 12 months following surgery.     

采用聚丙烯网片的阴道前壁修补术治疗阴道前壁脱垂临床效果的荟萃分析

目的:比较聚丙烯网片和传统的前壁修补术对阴道前壁脱垂患者的临床效果及并发症。方法:通过Pubmed数据库、Cochrane图书馆数据库、荷兰医学文摘(EMBASE)、OVID数据库,收集国外已发表的1990年至2013年符合要求的英文随机对照实验,按纳入和排除标准进行筛选和质量评估,采用RevMan 5.2对手术失败率、术后新增压力性尿失禁、新增的性交困难、术后尿储留进行meta分析。结果:经筛选,共纳入10篇符合要求的随机对照文献,共1288例受试者。与传统的前壁修补术比较,使用聚丙烯网片能明显降低手术的失败率(P0.01,RR=0.37,95%CI为0.31~0.45),术后新增的压力性尿失禁和性交困难则无显著差异(P=0.10,RR=1.52,95%CI为0.93~2.48;P=0.16,RR=1.99,95%CI为0.97~4.08),术后尿储留网片发生率较高(P0.05,RR=2.31,95%CI为1.10~4.83)。结论:使用聚丙烯网片能显著降低手术的失败率和术后复发率,但在术后并发症上无特殊优势,并且术后尿储留的发生率略高。     

Transvaginal repair of genital prolapse with polypropylene mesh using a tension-free technique

Objectives

To assess the perioperative complications and short-term outcomes of prolapse repair using transvaginal polypropylene mesh.

Study design

Retrospective study. In the period from April 2007 to September 2009, 67 women underwent vaginal repair with implantation of a soft mesh manufactured by Gynecare.

Results

All the patients had a stage 3 or stage 4 prolapse. Total mesh was used in eight patients (11.9%), isolated anterior mesh in 36 patients (53.7%) and isolated posterior mesh in 23 patients (34.4%). We reported one intraoperative bladder injury and no other serious complications. At 3 months, all the 67 patients were available for follow-up. Vaginal erosion occurred in eight patients (11.9%), shrinkage of mesh in six patients (8.7%), granuloma without exposure in four patients (5.9%), de novo urinary incontinence in three patients (4.5%) and flatus incontinence in one patient (1.5%). Failure rate was 7.5% (recurrent prolapse stage 3 or 4, even asymptomatic).

Conclusion

Our study suggests that transvaginal polypropylene mesh applied with a tension-free technique is a safe and effective method with low intraoperative complications but with considerable potential postoperative morbidity.     

Morbidity of a Single Incision Transvaginal Mesh to Correct Apical Prolapse

Study ObjectiveTo determine complications and related reintervention rates associated with use of the Uphold Vaginal Support System (Boston Scientific, Boston, MA) for symptomatic vaginal apical prolapse.DesignA multicenter retrospective study.SettingTwo teaching hospitals.PatientsFifty-nine women with symptomatic vaginal apical prolapse.InterventionVaginal apical prolapse surgery using the Uphold Mesh Kit system with or without other concomitant procedures.Measurements and Main ResultsA chart review was performed, including the following parameters: perioperative and postoperative complications, repeat surgery, and recurrence rate. A total of 59 patients met the criteria for inclusion in the study. Bladder perforation occurred perioperatively in 1 patient. Postoperative voiding difficulties were observed in 16 patients (27.1%), including 9 women (15.2%) who left the hospital with an indwelling catheter in place. There were 5 cases (8.5%) of transient groin pain, all of which resolved spontaneously. One patient developed a vaginal hematoma. Nine women (15%) required reoperation, including 4 (6.7%) because of recurrent prolapse and 1 (2%) for pelvic pain considered related to the mesh. Three patients (5%) required release of a midurethral sling (MUS) that had been placed concomitantly with the Uphold system. Two patients (3%) required a MUS for de novo stress incontinence.ConclusionUse of the Uphold Vaginal Support System for symptomatic vaginal apical prolapse was associated with a significant risk of obstructed micturition. In our study population, 15% required repeat surgery, mainly for recurrent pelvic organ prolapse and de novo stress urinary incontinence. No surgical-related complication resulted in long-term morbidity.     

Outcome after anterior vaginal prolapse repair: a randomized controlled trial

OBJECTIVES: To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy. METHODS: Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. RESULTS: Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group. CONCLUSION: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups.     

盆腔器官脱垂应用网片术后疗效观察

目的:评价盆腔器官脱垂应用网片术后的疗效。方法:回顾分析2007年4月～2009年4月收住入院的盆腔器官脱垂病例24例(包括2例子宫切除术后穹窿脱垂,4例合并压力性尿失禁),应用网片盆底重建,评价术后各项客观和主观疗效。以POP-Q评分为客观疗效评价指标,以盆底功能障碍问卷(PFDI-20)为主观评价指标。结果:手术均顺利完成,术后恢复良好,无1例血管损伤、尿道损伤膀胱及直肠损伤。术后随访,无感染,无复发,无性生活障碍,补片侵蚀发生率8.33%,经治疗后好转,子宫脱垂复发2例。尿失禁、肛门坠胀感各1例,经治疗后症状消失。结论:网片用于盆腔器官脱垂的治疗安全,有效,术后并发症少,值得推广,仍需长期随访。     

Transvaginal cystocele repair using tension-free polypropylene mesh at the time of sacrospinous colpopexy for advanced uterovaginal prolapse: a prospective randomised study

The management of an advanced multi-compartment prolapse requires a combination of techniques. The objective of this study was to report the anatomical outcomes of a prospective randomised trial comparing tension-free polypropylene mesh-reinforced anterior vaginal prolapse with anterior colporrhaphy at the time sacrospinous colpopexy and posterior fascial plication for the management of massive uterovaginal prolapse. A total of 116 patients with a stage III or IV (Pelvic Organ Prolapse Quantification System/International Continence Society) uterovaginal prolapse were randomised into two groups. The mesh group includes transvaginal cystocele repair using a tension-free polypropylene mesh, while the non-mesh group includes anterior colporrhaphy. All patients in the two groups underwent a sacrospinous colpopexy and posterior fascial plication. The primary outcome was objective success < stage 2 prolapse. The secondary outcomes were reoperation for recurrent prolapse, subjective success rates, patient satisfaction with the surgery and complications. The overall objective success rates (in all compartments) were 79 % (42/53) in the mesh group and 62 % (39/63) in the non-mesh group (p?=?0.043). The objective success rates in the anterior compartment were 85 % (45/53) in the mesh group and 62 % (39/63) in the non-mesh group (p?=?0.006). Three (6 %) patients in the mesh group and 12 (19 %) in the non-mesh group underwent repeat surgery for recurrent pelvic organ prolapse (p?=?0.03). The subjective success rates were 89 % (47/53) in the mesh group and 76 % (48/63) in the non-mesh group (p value?=?0.08). The mean patient satisfaction rates with the surgery were 84 % in the mesh group and 76 % in the non-mesh group (p?=?0.08). The development of a urinary tract infection, right-sided buttock pain (temporary sciatic neuralgia) and new-onset stress urinary incontinence were not significantly different between the two groups. The mesh exposure rate was 8 %. Transvaginal cystocele repair using tension-free polypropylene mesh at the time of sacrospinous colpopexy and posterior fascial plication offers lower anatomic recurrence and less need for further prolapse surgery to correct recurrent pelvic floor defects than anterior colporrhaphy, sacrospinous colpopexy and posterior fascial plication.     

The management of mesh complications

Polypropylene mesh has been widely used in Urogynaecology for the management of prolapse and stress urinary incontinence. Growing recognition of long-term complications has led to the pause on all vaginally inserted mesh within the UK and other countries. These complications include vaginal mesh exposure, visceral perforation and chronic pain. It is important for all gynaecologists to be aware of these complications, signs, assessment and possible management options. Ultimately, a regional mesh centre should be involved in the care of these women as management if often complex. This article discusses different types of mesh, possible clinical presentations and the investigations which may be offered. Management options are outlined, however, involvement of the multidisciplinary team to provide adequate management options is essential.     

The midurethral polypropylene sling for stress incontinence: 22-month results of 81 patients

Objective The objective was to review a cost-effective procedure called the midurethral polypropylene sling (MPS) in the treatment of urodynamic stress incontinence (USI).Study design A self-fashioned sling (7.5×1 cm) was created from a polypropylene mesh with two lengthening polypropylene sutures at the ends. The sutures are carried through the rectus fascia by a special needle carrier. The sling is placed around the urethra and its sutures are tied on the fascia. The procedure was performed on 81 patients. Of these patients, 73 had USI. The remaining 8 patients with uterine prolapse, who did not have USI, underwent the MPS prophylactically. Of 81 patients, 35 underwent the MPS alone, 46 underwent the MPS and abdominal or vaginal procedures.Results Three patients had bleeding in excess of 300 ml necessitating a vaginal tamponade. One had hematoma and the other underwent a laparotomy. Urinary retention for more than 3 days was observed in 6 of the patients who had the MPS alone, in 7 of the patients who had both MPS and abdominal procedures, and in 13 of the patients who had MPS with vaginal procedures. The sling was cut in 3 patients due to persistent urinary retention. Of 73 patients with USI, 70 were completely cured (95.9%) at a mean of 22 months follow-up.Conclusion The cure rates and complications of the MPS were comparable to those of the tension-free vaginal tap (TVT) procedure for the treatment of USI. The procedure costs about US$ 9. We conclude that the MPS can be considered as an alternative to the TVT procedure.     

Factors that affect early recurrence after prolapse repair by a nonanchored vaginal mesh procedure

ObjectiveProsima (Ethicon, Somerville, NJ, USA) is a novel procedure for treating pelvic organ prolapse (POP) that uses nonanchored vaginal mesh. However, nonfixation of the mesh may limit effectiveness. The aim of this study was to evaluate the safety, efficacy, and limitations of this procedure.Materials and methodsFrom January 2011 through to December 2011, 52 patients with symptomatic POP ≥ Stage 2 undergoing the Prosima procedure at a tertiary hospital were enrolled consecutively in this prospective study. A Data and Safety Monitoring Plan (DSMP) was developed to assess the results.ResultsFifty of the 52 patients (96%) attended the 3–6-month postoperative assessment. Symptom and quality-of-life scores were found to have improved significantly after surgery (p < 0.05). Forty-two patients (84%) underwent successful treatment for POP (Stage 0-1). The other eight patients (16%) were found to have recurrent Stage 2 anterior vaginal wall prolapse, although most of them (5/8) were asymptomatic. The highest morbidity, namely vaginal mesh exposure, occurred in four patients (8%) and was managed as a minor issue. Statistical analysis showed that anatomic recurrence was significantly (p < 0.05) associated with a “preoperative Ba ≥ +4 cm” (odds ratio = 20.57), “conservation of the prolapsed uterus” (odds ratio = 10.56) and “use of a concomitant midurethral sling” (odds ratio = 0.076).ConclusionProsima seems to have limitations when used to manage severe anterior vaginal wall prolapse and concomitant surgery may further affect its effectiveness. The information obtained from this study's DSMP will contribute to developing a strategy to improve the use of nonanchored vaginal mesh for POP repair.