Anterior Pelvic Organ Prolapse Repair Using Synthetic Mesh

Since the U.S. Food and Drug Administration (FDA) statement on mesh in July of 2011, there has been controversy regarding synthetic mesh repairs for vaginal prolapse. In this article, we review the biochemical basis for the use of synthetic mesh in prolapse repair as well as clinical results of anterior compartment prolapse repair with synthetic mesh. Finally, we discuss the FDA warning regarding mesh.     

Anterior vaginal compartment surgery

Aim

To review the safety and efficacy of anterior vaginal compartment pelvic organ prolapse surgery.

Methods

Every 4 years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and the Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 case reports. The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. A grade A recommendation usually depends on consistent level 1 evidence. A grade B recommendation usually depends on consistent level 2 and/or 3 studies, or “majority evidence” from RCTs. A grade C recommendation usually depends on level studies or “majority evidence” from level 2/3 studies or Delphi processed expert opinion. A grade D “no recommendation possible” would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi.

Results

Absorbable mesh augmentation of anterior compartment native tissue repair improves the anatomical outcome compared with native tissue repair alone with no increased complication rate in meta-analysis of 2 RCTS (grade B). Biological grafts in meta-analysis have improved anatomical outcomes with no change in subjective outcomes compared with native tissue repairs (grade B). There is conflicting level 1 evidence to support porcine dermis and a single RCT to support small intestine submucosa as graft agents in anterior compartment prolapse surgery (grade B). Consistent level 1 data support a superior anatomical outcome for polypropylene mesh compared with a biological graft in the anterior compartment. Mesh exposure rate was significantly higher in the polypropylene mesh group (grade A). Consistent level 1 evidence demonstrates superior subjective and objective outcomes following anterior transvaginal polypropylene mesh as compared to anterior colporrhaphy (grade A). These outcomes did not translate into improved functional results using validated questionnaires or a lower reoperation rate for prolapse. The mesh group was also associated with longer operating time, greater blood loss and apical or posterior compartment prolapse as compared with anterior repair. Anterior polypropylene mesh had a mesh extrusion rate of 10.4 % with 6.3 % requiring a surgical correction (grade B). Single level 3 evidence does not support the use of transvaginal polypropylene mesh for recurrent anterior vaginal wall prolapse (grade C).

Conclusion

Polypropylene anterior compartment mesh offers improved objective and subjective outcomes compared with native tissue repair; however, these benefits must be considered in the context of increased morbidity associated with anterior polypropylene transvaginal mesh.     

Evaluation of Current Biologic Meshes in Pelvic Organ Prolapse Repair

Pelvic organ prolapse (POP) is a common disorder estimated to affect 15%-30% of women over the age of 50 years. About 11% of women will require surgery by the age of 80 years and there is an estimated 30% rate of prolapse recurrence. In an attempt to improve surgical outcomes, biologic grafts and synthetic meshes have been implemented in the repair of POP. Biologic grafts have been used with the hope of avoiding complications associated with synthetic mesh. This presents the existing data surrounding the use of biologic grafts in the surgical repair of anterior compartment, vaginal vault, and posterior compartment prolapse.     

Anterior vaginal mesh sacrospinous hysteropexy and posterior fascial plication for anterior compartment dominated uterovaginal prolapse

Introduction and hypothesis  

The surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques. This study evaluates anterior vaginal mesh repair, sacrospinous hysteropexy and posterior fascial plication in women with anterior compartment dominated uterovaginal prolapse.     

Native tissue repair or transvaginal mesh for recurrent vaginal prolapse: what are the long-term outcomes?

Introduction and hypothesis

The objective of this study was to assess outcomes in native tissue (NT) and transvaginal mesh (TVM) repair in women with recurrent prolapse.

Methods

A retrospective two-group observational study of 237 women who underwent prolapse repair after failed NT repair in two tertiary hospitals. A primary outcome of “success” was defined using a composite outcome of no vaginal bulge symptoms, no anatomical recurrence in the same compartment beyond the hymen (0 cm on POPQ) and no surgical re-treatment for prolapse in the same compartment. Secondary outcomes assessed included re-operation for prolapse in the same compartment, dyspareunia and mesh-related complications.

Results

Of a total of 336 repairs, 196 were performed in the anterior compartment and 140 in the posterior compartment. Compared with the TVM groups, women undergoing repeat NT repair were more likely to experience anatomical recurrence (anterior 40.9 % vs 25 %, p?=?0.02, posterior 25.3 % vs 7.5 %, p?=?0.01), report vaginal bulge (anterior 34.1 % vs 12 %, p?<?0.01, posterior 24.1 % vs 7.5 %, p 0.02) and had a higher prolapse re-operation rate (anterior 23.9 % vs 7.4 %, p?<?0.01, posterior 19.5 % vs 7.5 %, p?=?0.08). Using composite outcomes, the success rate was higher with TVM repair in both compartments (anterior 34.2 % vs 13.6 %, p <0.01, posterior 56.6 % vs 23.0 %, p <0.01). Re-operations for mesh exposure were 9.3 % anteriorly and 15.1 % posteriorly. Although the number of women requiring a prolapse re-operation is lower in the TVM group, the overall re-operation rate was not significantly different when procedures to correct mesh complications were included.

Conclusions

Although the success rate is better with the use of TVM for recurrent prolapse, the total re-operation rates are similar when mesh complication-related surgeries are included.

     

The UK National Prolapse Survey: 10 years on

Introduction and hypothesis

To assess trends in the surgical management of pelvic organ prolapse (POP) amongst UK practitioners and changes in practice since a previous similar survey.

Methods

An online questionnaire survey (Typeform Pro) was emailed to British Society of Urogynaecology (BSUG) members. They included urogynaecologists working in tertiary centres, gynaecologists with a designated special interest in urogynaecology and general gynaecologists. The questionnaire included case scenarios encompassing contentious issues in the surgical management of POP and was a revised version of the questionnaire used in the previous surveys. The revised questionnaire included additional questions relating to the use of vaginal mesh and laparoscopic urogynaecology procedures.

Results

Of 516 BSUG members emailed, 212 provided completed responses.. For anterior vaginal wall prolapse the procedure of choice was anterior colporrhaphy (92% of respondents). For uterovaginal prolapse the procedure of choice was still vaginal hysterectomy and repair (75%). For posterior vaginal wall prolapse the procedure of choice was posterior colporrhaphy with midline fascial plication (97%). For vault prolapse the procedure of choice was sacrocolpopexy (54%) followed by vaginal wall repair and sacrospinous fixation (41%). The laparoscopic route was preferred for sacrocolpopexy (62% versus 38% for the open procedure). For primary prolapse, vaginal mesh was used by only 1% of respondents in the anterior compartment and by 3% in the posterior compartment.

Conclusion

Basic trends in the use of native tissue prolapse surgery remain unchanged. There has been a significant decrease in the use of vaginal mesh for both primary and recurrent prolapse, with increasing use of laparoscopic procedures for prolapse.

     

Anterior vaginal wall hammock with fascia lata for the correction of stage 2 or greater anterior vaginal compartment relaxation

PURPOSE: We determined the efficacy of the anterior vaginal wall hammock (AVWH) using fascia lata for the correction of anterior vaginal compartment relaxation. MATERIALS AND METHODS: A total of 58 patients with stage 2 or greater anterior vaginal compartment relaxation underwent an AVWH procedure with autologous or allograft fascia lata from June 1998 to March 2001. Patients were evaluated preoperatively with a history and pelvic organ prolapse quantitative examination. Postoperatively patients were evaluated at 6 weeks, 6 months and yearly thereafter with pelvic organ prolapse quantitative staging of the anterior, middle and posterior compartments. Objective cure was defined as stage 0 or 1 relaxation. Subjective cure was defined as no symptoms of pelvic pressure or a vaginal bulge. RESULTS: Of the 69 (89%) patients who underwent surgery 58 were available for followup. Median age of the population was 61.9 years and median followup was 24.7 months (range 12 to 57). There were 11 objective failures (19%) in the anterior compartment, of which 1 (2%) was symptomatic. Two patients (4%) had enteroceles that required surgical correction. Of the patients 16 (28%) had new onset or worsening stage 2 posterior relaxation at a median of 15.2 months postoperatively, including 7 (12%) who were symptomatic and underwent subsequent repair. CONCLUSION: The AVWH procedure with fascia lata is safe and effective for correcting stage 2 or greater anterior compartment relaxation. The whole pelvic floor must be evaluated and repaired to minimize the progression of prolapse of the middle and posterior compartments.     

Complications of anterior compartment vaginal surgery

Many complications can be associated with anterior compartment surgery of the vagina. With the integration of synthetic materials into the surgical armamentarium for the repair of stress urinary incontinence in the form of midurethral slings, and for the repair of vaginal prolapse as a primary procedure or to augment an existing repair, the spectrum of complications related to this type of surgery is evolving. Fortunately, these complications are mostly preventable, readily recognized, and/or reversible.     

Single-incision mesh repair versus traditional native tissue repair for pelvic organ prolapse: results of a cohort study

Introduction and hypothesis

To compare the efficacy and safety of the Elevate? anterior and posterior prolapse repair system and traditional vaginal native tissue repair in the treatment of stage 2 or higher pelvic organ prolapse.

Methods

A cohort study was conducted between January 2010 and July 2012. Patients who underwent transvaginal pelvic reconstruction surgery for prolapse were recruited. The primary outcome was anatomical success 1 year after surgery. The secondary outcome included changes in the quality of life and surgical complications. Recurrence of prolapse was defined as stage 2 or higher prolapse based upon the pelvic organ prolapse qQuantification system.

Results

Two hundred and one patients (100 in the Elevate? repair group and 101 in the traditional repair group) were recruited and analyzed. The anatomical success rate of the anterior compartment was significantly higher in the Elevate? repair group than in the traditional repair group (98 % vs 87 %, p?=?0.006), but not for the apical (99 % vs. 6 %, p?=?0.317) or posterior (100 % vs 97 %, p?=?0.367) compartments after a median 12 months of follow-up. Both groups showed significant improvements in the quality of life after surgery with no statistical difference. Mesh-related complications included extrusion (3 %) and the need for revision of the vaginal wound (1 %). Those in the mesh repair group had a longer hospital stay (p?=?0.04), operative time (p?<?0.001), and greater estimated blood loss (p?=?0.05). Other complications were comparable with no statistical difference.

Conclusions

The Elevate? prolapse repair system had a better 1-year anatomical cure rate of the anterior compartment than traditional repair, with slightly increased morbidity.     

Vaginal prolapse repair: suture repair versus mesh augmentation: a urology perspective

The ideal procedure for pelvic organ prolapse (POP) repair would be associated with a low chance of long-term anatomic recurrence in the corrected compartment and should not predispose the patient to de novo stress urinary incontinence (SUI) or POP in other compartments. The procedure should also improve the woman's quality of life and subjective symptoms of pelvic floor dysfunction, it should be safe, and not be associated with significant immediate and long-term morbidity. Each procedure for POP repair has strong advantages and potential detractors. This article discusses anterior and posterior compartment POP repairs.     

Total hysterectomy and anterior vaginal wall suspension for concurrent uterine and bladder prolapses: Long-term anatomical results of additional vault and/or posterior compartment prolapse repair

ObjectiveTo review the long-term results of an intraoperative decision to repair or not repair associated vault and posterior compartment defects after total hysterectomy (TH) and anterior vaginal wall suspension (AVWS) for uterine and bladder prolapses.MethodsAfter gaining Institutional Review Board approval, the operative records of women receiving TH and AVWS concurrently with a minimum follow-up period of 6 months were reviewed. Two groups were identified: Group 1 (G1) underwent TH + AVWS and intraoperative apical and/or posterior repairs, and Group 2 (G2) had TH + AVWS alone. The definition of prolapse recurrence was Pelvic Organ Prolapse—Quantification ≥ Stage 2 and/or any reoperation for prolapse.ResultsFrom 1998 to 2009, a total of 94 women were evaluated. At the mean 3 years follow-up, the rates of overall prolapse recurrence following initial surgeries between G1 and G2 were 30% and 24%, respectively. Additional operative repair for G1 and G2 was 18.5% and 16%, respectively. The progression rate for both groups was < 8%. The overall success for G1 and G2 was 70% and 76%, respectively.ConclusionAt long-term follow-up, nearly one in five apical recurrences in these two surgical groups was observed with stable results in the anterior compartment. The posterior compartment required the least surgical intervention.     

Anterior compartment prolapse repair with a hybrid biosynthetic mesh implant technique

The aim of the present study is to assess the safety and feasibility of a new technique for cystocele repair using a hybrid biosynthetic graft fixed by the transobturator approach. This is a retrospective study of 13 women diagnosed with symptomatic anterior compartment prolapse that were in stages II and IV, using Pelvic Organ Prolapse Quantification score and treated between 2003 and 2006. The surgical procedure was carried out through a vaginal approach, exposing the arcus tendineus and the posterior surface of the obturator foramen from the ischial spine to the inferior pubic ramus bone. The patients were followed-up after 3, 6 and 12 months. The anatomical cure rate was 85% (stage 0), although two patients had a recurrence 8 months after surgery. All patients would repeat the procedure, if necessary. No de novo dyspareunia was observed in these small series. The results suggest that this technique is safe and feasible and is a comprehensive surgical approach for anterior compartment prolapse, without postoperative morbidity.     

Triangular resection of the anterior leaflet for repair of the mitral valve

Isolated anterior mitral leaflet prolapse, unlike posterior prolapse, is a difficult lesion to repair and may become a demanding surgical procedure. We report our experience with a technique of a triangular resection of the anterior leaflet to repair isolated segmental anterior leaflet prolapse in 18 patients. This technique simplifies the repair procedure and is a safe and rapid procedure which allows excellent results.     

In vivo assessment of anterior compartment compliance and its relation to prolapse

Introduction and hypothesis  

The objective of the study was to compare anterior compartment compliance between women with and without pelvic organ prolapse and to explore factors determining the extent of anterior compartment prolapse.     

The risk of urinary stress incontinence after anterior repair

Several reports have dealt with urinary stress incontinence in women who also have genitourinary prolapse. The problem of stress incontinence as a complication after anterior repair in previously continent women, has received little attention. This paper is a review of the problem of urinary stress incontinence after treatment for genitourinary prolapse. Most studies based on objective criteria for continence show an occurrence of approximately 20% of stress incontinence following an otherwise successful anterior repair. Various theories for the mechanism responsible have been suggested. Most authors agree, however, that the lack of elevation of the bladder neck and/or a too tight repositioning of the bladder is responsible for the development of incontinence following anterior repair. A preoperative barrier test seems useful in selecting patients who require an additional bladder neck suspension.     

Are Recurrence Rates for “Traditional” Transvaginal Prolapse Repairs Really that High? What Does the Evidence Show?

Pelvic organ prolapse (POP) is a common and bothersome condition. Multiple methods for surgical repair exist, and much attention has been given to improving the efficacy of repair by implementing mesh interposition. Standard (native tissue-based) repairs in the anterior compartment have long been thought to be associated with high anatomical recurrence rates and the currently available randomized controlled trials (RCTs) support this thinking. However, subjective improvement in pelvic pressure and bulging and quality of life indices are similarly improved in both standard and mesh-augmented repairs. No RCTs are available to compare standard and mesh-augmented repairs in the posterior compartment. Despite the presence of RCTs, the data is often inconsistent and questions remain regarding the optimal criteria to describe POP recurrence. While there is a role for both types of repair, the optimal patient scenario is not known.     

What is the Gold Standard for Posterior Vaginal Wall Prolapse Repair: Mesh or Native Tissue?

Reports in the literature of high recurrence rates after native tissue repair for pelvic organ prolapse led to the development of alternative techniques, such as those using synthetic mesh. Transvaginal mesh (TVM) delivery systems were implemented in search of better outcomes. Despite reported recurrence as low as 7.1 % after posterior colporrhaphy, mesh kits were developed to correct posterior compartment prolapse. There is a paucity of data to substantiate better results with TVM for rectocele repair. Three randomized controlled trials comparing native tissue repair to synthetic mesh reported posterior compartment outcomes and two of these failed to show a significant difference between groups. Complications of TVM placement are not insignificant and mesh extrusion was reported in up to 16.9 %. Based on currently available data, native tissue repairs have similar outcomes to synthetic mesh without the risks inherent in mesh use and remain the standard of care for the typical patient.