Credentialing for transvaginal mesh placement—a case for “added qualification” in competency

Introduction and hypothesis

A process of added qualification of transvaginal mesh (TVM) placement is desirable.

Methods

Through a physician-led partnership of specialty societies, centers of excellence, and industry, a core curriculum encompassing mesh/graft biology, technical skills, and safety can be coupled with current educational endeavors instructing surgeons in the use of TVM. A posttest process can verify a knowledge-based competency in mesh/graft safety. An auditing process after implementation would be optimal.

Results

We recommend implementation of a five-step process in order to accomplish these goals.

Conclusions

It is hoped through these efforts, the ultimate goal of patient safety may be reached.

     

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.

     

Management of complications arising from transvaginal mesh kit procedures: a tertiary referral center’s experience

This case series’ purpose is to review a referral center’s experience with complications from mesh kits. A chart review of 12 patients who presented with complications associated with transvaginal mesh kit procedures was performed. All patients underwent complete surgical removal of the mesh to treat mesh exposure, pain, or vaginal bleeding/discharge followed by an anterior or posterior repair. The mean follow-up time after surgery was 3.4 months. Eight of 12 patients had mesh that had formed a fibrotic band. Six of 12 patients had complete resolution of pain. Of the nine patients with mesh exposure, all required significant resection of the vaginal wall. No further mesh exposure occurred. The use of transvaginal mesh kits may cause previously undescribed complications such as pelvic/vaginal pain or large extrusions requiring complete removal. Removal of all mesh except the arms may cure or significantly improve these problems.     

Inguinal hernia: mesh or no mesh in open repair?

The operative repair of inguinal hernias is the most common surgical procedure in general surgery. This review gives a survey of the current data on the "mesh or no mesh" question in open inguinal hernia surgery. The Cochrane Database Systematic Review of 2002 has the highest level of evidence. Five randomised controlled trials were published after the Cochrane analysis and in a retrospective study, 1,513,008 patients were summarised accordingly. According to these data, the incidence of postoperative complications (haematoma, seroma, wound infection and serious complications like bowel/vessel injury and bleeding) does not depend on the operative technique used. The implantation of meshes significantly decreases the overall recurrence rate, the occurrence of chronic pain and the time of return to normal activity, as compared to non-mesh techniques. The published data shows significant advantages for mesh techniques.     

Ultrasound appearances after mesh implantation��evidence of mesh contraction or folding?

Introduction and hypothesis  

Polypropylene meshes are frequently used in abdominal and vaginal reconstructive surgery. Recently, several authors have claimed that mesh-associated complications may be linked to mesh shrinkage. We have performed a prospective study with postoperative follow-up by ultrasound examination at two time points after Prolift anterior implantation to assess changes in the ultrasound appearance of mesh implants over time.     

To mesh or not to mesh with polypropylene: does carcinogenesis in animals matter?

Polypropylene in sheets has been been found to be carcinogenic in some laboratory animals. Although no human carcinogenicity has been reported, long-term follow-up in humans implanted with polypropylene mesh will be important.     

Which mesh for hernia repair?

INTRODUCTION

The concept of using a mesh to repair hernias was introduced over 50 years ago. Mesh repair is now standard in most countries and widely accepted as superior to primary suture repair. As a result, there has been a rapid growth in the variety of meshes available and choosing the appropriate one can be difficult. This article outlines the general properties of meshes and factors to be considered when selecting one.

MATERIALS AND METHODS

We performed a search of the medical literature from 1950 to 1 May 2009, as indexed by Medline, using the PubMed search engine (<http://www.pubmed.gov>). To capture all potentially relevant articles with the highest degree of sensitivity, the search terms were intentionally broad. We used the following terms: ‘mesh, pore size, strength, recurrence, complications, lightweight, properties’. We also hand-searched the bibliographies of relevant articles and product literature to identify additional pertinent reports.

RESULTS AND CONCLUSIONS

The most important properties of meshes were found to be the type of filament, tensile strength and porosity. These determine the weight of the mesh and its biocompatibility. The tensile strength required is much less than originally presumed and light-weight meshes are thought to be superior due to their increased flexibility and reduction in discomfort. Large pores are also associated with a reduced risk of infection and shrinkage. For meshes placed in the peritoneal cavity, consideration should also be given to the risk of adhesion formation. A variety of composite meshes have been promoted to address this, but none appears superior to the others. Finally, biomaterials such as acellular dermis have a place for use in infected fields but have yet to prove their worth in routine hernia repair.     

Umbilical hernia, Mayo or mesh?

Summary Unlike inguinal herniorraphy, the results of surgery for umbilical hernia have been poorly audited. The extent to which the popular sutured repair of Mayo has given way to mesh-based repairs in recent years is also unknown. To investigate these deficiencies, a review was undertaken of 651 umbilical hernia repairs performed between April 1994 and March 1999 at a single institution by 10 general surgeons.Excluding children and umbilical hernias repaired at laparotomy, a total of 473 primary adult hernias and 18 recurrent hernias were repaired. The proportion repaired for recurrence was 3.8%. Follow up ranges between 12 and 60 months (mean 27 months, median 25 months).Of the 18 recurrences, there were 16 sutured repairs and 11 of the patients had predisposing factors for recurrence such as wound infection, obesity, chronic renal failure or ascites.Sutured repair of primary umbilical hernias in this large series was successful in 96% of cases; in the remainder underlying co-morbidity was an important predisposing factor for recurrence.This study does not support the routine use of mesh in primary adult umbilical hernia repair.     

Qualitative and quantitative analysis of women’s perceptions of transvaginal surgery

Background  

Prior surveys evaluating women’s perceptions of transvaginal surgery both support and refute the acceptability of transvaginal access. Most surveys employed mainly quantitative analysis, limiting the insight into the women’s perspective. In this mixed-methods study, we include qualitative and quantitative methodology to assess women’s perceptions of transvaginal procedures.     

Self-fixating mesh for the Lichtenstein procedure—a prestudy

Introduction

Secure fixation of the mesh in groin hernia repair is essential to avoid mesh dislocation. The fixation, however, is also thought to be a source of chronic postoperative pain. We tested the new self-fixating mesh Parietene progrip^© vs. traditional suture fixating Lichtenstein repair in a double-blinded randomized study evaluating postoperative pain and the use of analgesics.

Methods

Fifty patients were randomized into two groups: Patients of group A (24 patients) were operated with the new self-fixating Parietene progrip^© mesh without fixation sutures and patients of group B (26 patients) were operated with the traditional Lichtenstein repair. Postoperative course including pain and the use of analgesics were monitored. Patients were reinvestigated after 6 months regarding pain score and the amount of analgesics used during this interval. Primary end point was pain on the first operative day.

Results

The visual analog scale pain score showed at the first postoperative day a significantly lower level in group A than in group B (mean 17.9 vs. 32.3 mm, p?=?0.03). Additionally, the cumulative dose of postoperatively required analgesics was lower in group A than in group B. The operative time in group A was significantly shorter than in group B. Six months after the operation, a trend toward a lower pain score was observed in group A, but this did not reach statistical significance.

Conclusions

This is the first randomized study to show a beneficial effect of the new self-fixating mesh on pain score. According to our investigations, operative time is reduced, which is a considerable fact with regard to economic aspects as well as the beneficial aspects for the patients. A study with a larger cohort of patients should be conducted to confirm the promising results of this exploratory study.     

Is mesh fixation necessary in abdominal hernia repair?

Background: Abdominal hernia repair with implantation of synthetic meshes using the sublay technique has resulted in low recurrence rates and high patient satisfaction. Aim: The purpose of this experimental animal study was to investigate whether mesh fixation is necessary in abdominal hernia repair using a polypropylene mesh in the sublay technique. Methods: Forty-five rats were divided into three groups after creating an abdominal wall defect (CG control group, no mesh implantation; NoFixG mesh implantation without fixation group; SG mesh with suture fixation group) with 15 animals in each group. Endpoints were clinical herniation pressure, hydroxyproline (HP) concentration, mesh shape and number of fibroblasts/collagen fibres of the anchor zone 7, 14 and 90 days after implantation. Results: Herniation pressure, HP content and number of fibroblasts were similar between NoFixG and SG, although significantly higher in these groups than in the CG (P<0.05). Both mesh groups had significantly higher counts of fibroblasts and collagen fibres than the CG. Mesh shrinking occurred in both groups but was less in the SG. Conclusion: Mesh fixation was not mandatory in abdominal hernia repair using this animal model. Received: 18 May 1998; in revised form: 11 August 1998 Accepted: 5 October 1998     

Laparoscopic preperitoneal mesh repair or tension-free mesh plug technique? A prospective study of 471 patients with 543 inguinal hernias.

OBJECTIVE: To compare two modem mesh-based "tension free" hernioplasties, laparoscopic repair and mesh plug technique. DESIGN: Prospective, non-randomised study. SETTING: Two major medical centres, Greece. SUBJECTS: 471 patients with 543 inguinal hernias. INTERVENTION: Patients entering the study were treated in two major medical centres either by laparoscopic repair under general anaesthesia (n = 237) in hospital A, or by insertion of a mesh plug under monitored local, epidural, or spinal anaesthesia (n = 234) in hospital B. Patients with known bilateral inguinal hernias, femoral hernias, and those with both inguinal hernias and cholelithiasis were encouraged to undergo laparoscopic repair. MAIN OUTCOME MEASURES: Operative time, hospital mortality, morbidity and length of stay, costs, time to return to work, and recurrence rate. RESULTS: The median operative time for laparoscopic repair was significantly longer (57 compared with 33 minutes, p < 0.001). Laparoscopic repair was more costly (1,200 US dollars compared with 500), and technically more demanding than insertion of a mesh plug. The median postoperative hospital stay, consumption of narcotic analgesics, and return to full work and heavy activities were similar in the two groups, whereas light activities were started earlier after plug repair [5.4 (2.4) compared with 3.4 (1.5) hours, p < 0.0001]. There were 6 recurrences in the laparoscopic group and 1 in the plug group. CONCLUSIONS: Mesh plug insertion is faster, cheaper, technically easier, does not require general anaesthesia, and is suitable to be done by surgeons as part of their general practice without special instruments and by junior surgeons. Plug repair resulted in fewer short or long term complications and reduced the recurrence rate.