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.     

Evaluation of Current Synthetic Mesh Materials in Pelvic Organ Prolapse Repair

With increasing use of synthetic material in pelvic organ prolapse repair, the reporting and incidence of associated complications also have increased. The role of synthetic mesh in pelvic organ prolapse repair remains controversial and it is a therapeutic dilemma whether to continue its use in patients with poor native tissues, despite the recent public safety notification provided by the U.S. Food and Drug Administration. In this article, we review the biomaterials used in pelvic organ prolapse repair and discuss the outcomes and associated complications, paying emphasis to the benefits and the risks.     

Central Compartment and Apical Defect Repair Using Synthetic Mesh

Pelvic organ prolapse is an increasingly common condition for women that has been challenging to treat due to high recurrence rates after surgical repair. The introduction of mesh-augmented prolapse repairs as a means to achieve more robust repairs had great initial promise. As more data emerge on outcomes and novel mesh complications, the when and where of mesh augmentation has become much less clear. This article reviews the relevant literature on the use of mesh in central and apical repairs. This includes a detailed look at the available data for vaginal mesh kits and several recent trials comparing mesh kits to traditional repairs. The article ends with a discussion of the recent U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh in pelvic organ prolapse and the authors' views of how practice may change in this new environment.     

An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh

Currently, there is no consensus on the use of mesh in transvaginal surgical repairs for the treatment of pelvic organ prolapse. This review recapitulates and assesses the recent U. S. Food and Drug Administration (FDA) warnings about the use of surgical mesh in transvaginal pelvic organ prolapse repair and summarizes the responses of the national organizations that represent the health care providers most invested in treating patients with transvaginal surgical mesh. Mesh exposure or extrusion through the vaginal wall, true mesh erosion into viscera, and infection are the major complications that are currently used to define the safety of synthetic mesh use. Other potential adverse postsurgical outcomes that can affect quality of life, sexual function, and patient satisfaction include dyspareunia, "hispareunia" (ie, complaints of a sexual partner), prosthetic contraction or prominence, vaginal shortening, pelvic pain, urinary dysfunction, and failure of the repair. These outcomes are frequently attributed to mesh use, and can result in expense, frustration, and the need for further medical and surgical interventions for patients undergoing treatment for pelvic floor disorders. Information regarding the FDA's reports on the use of surgical mesh in pelvic organ prolapse repair should be made available to patients at the time of surgical planning and should be used as an adjunct in the process of obtaining informed consent.     

Laparoscopic sacrocolpopexy with deep attachment of anterior and posterior mesh

Introduction

Sacrocolpopexy is considered a gold standard to cure apical prolapse, and since the US Food and Drug Administration (FDA) warning about complications of vaginal mesh surgery, the technique is increasingly used. Surgeons perform sacrocolpopexy in different variations, some by attaching the mesh to the apical third of the vagina, and others by applying the mesh anteriorly to the level of the bladder neck and posteriorly to the inner part of the perineum. The different techniques are neither standardized nor evaluated by randomized controlled trials.

Methods

This video aims to provide insight into the technique of deep placement of anterior and posterior mesh.

Conclusions

The video shows that deep mesh placement is feasible and can be performed with standardized parameters. The technique is based on 12 years of experience with laparoscopic sacrocolpopexy; 1- and 5-year results, published in this journal, show it is safe and provides good long-term results.     

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996–2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.     

Pelvic organ prolapse (POP) surgery: the evidence for the repairs

What is known on the subject? and What does the study add? Substantial experience of the outcomes has been gathered regarding the acute and sub‐acute experience with various types of corrective procedures for POP. These include long‐term POP correction as well as more recent recognition of improvement in functional disorders associated with POP such as UI, colorectal dysfunction, and sexual dysfunction. Long‐term follow‐up is available for some of the older types of interventions and current multicentre trials are being accrued with longer term follow‐up for new interventions including mesh‐type repairs. The study adds a condensed and summarized version of the current literature regarding the various interventions for POP and also provides an overview of the current controversies and areas where knowledge is incomplete and in need of further elaboration for definitive answers regarding optimization of surgical care for POP. ? Our aim is to summarise the available data on the transvaginal placement of synthetic mesh for pelvic organ prolapse (POP) repair, with a focus on the outcomes and complications of commercial POP‐repair kits. ? As the stability and durability of autologous tissues may be questionable, nonabsorbable, synthetic materials are an attractive alternative for providing additional support during POP surgery. These materials are not novel, and most have been used for many years in surgical applications, e.g. hernia repairs. ? While theoretically appealing, the implantation of synthetic mesh in the pelvis may be associated with inherent adverse consequences, such as erosion, extrusion, and infection. Additionally, the routine use of these materials may carry potential long‐term complications, such as dyspareunia, chronic pelvic pain, and vaginal distortion. ? The success and failure of mesh‐augmented POP repair is related not only to the synthetic material itself, but also to patient‐ and surgeon‐related factors. ? Recent warnings by the USA Food and Drug Administration and other groups regarding adverse events further complicate the decision to use synthetic mesh.     

Synthetic mesh in the surgical repair of pelvic organ prolapse: current status and future directions

In light of the recent Food and Drug Administration public health notification regarding complications associated with transvaginally placed mesh for pelvic organ prolapse (POP) repair, we review recent literature to evaluate current outcomes and complication data, analyze the clinical need for mesh on the basis of genetic and biochemical etiologies of POP, and investigate trends of mesh use via an American Urological Association member survey. Mesh-based techniques show better anatomic results than traditional repair of anterior POP, but subjective outcomes are equivalent. Further research and Level I evidence are required before mesh-based repair of POP can be standardized. Adequate surgical training and patient selection should decrease complication rates.     

Managing chronic pelvic pain following reconstructive pelvic surgery with transvaginal mesh

In 2001, the US Food and Drug Administration (FDA) approved the first transvaginal mesh kit to treat pelvic organ prolapse (POP). Since the introduction of vaginal mesh kits, some vaginal meshes have been associated with chronic pelvic pain after reconstructive pelvic floor surgery. Pelvic pain results in between 0 % and 30 % of patients following transvaginal mesh placement. Common causes of chronic pelvic pain include pelvic floor muscle spasm, pudendal neuralgia, and infection. Paucity of data exists on the effective management of chronic pelvic pain after pelvic reconstructive surgery with mesh. We outline the management of chronic pelvic pain after transvaginal mesh placement for reconstructive pelvic floor repair based on our clinical experience and adaptation of data used in other aspects of managing chronic pelvic pain conditions.     

Repair of Pelvic Organ Prolapse: What is the Goal?

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18–24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.     

Where to for pelvic organ prolapse treatment after the FDA pronouncements?

Introduction

With the publication of the updated US Food and Drug Administration (FDA) communication in 2011 on the use of transvaginal placement of mesh for pelvic organ prolapse (POP) it is appropriate to now review recent studies of good quality on POP to assess the safety and effectiveness of treatment options and determine their place in management.

Methods

A systematic search for studies on the conservative and surgical management of POP published in the English literature between January 2002 and October 2012 was performed. Studies included were review articles, randomized controlled trials, prospective and relevant retrospective studies as well as conference abstracts. Selected articles were appraised by the authors regarding clinical relevance.

Results

Prospective comparative studies show that vaginal pessaries constitute an effective and safe treatment for POP and should be offered as first treatment of choice in women with symptomatic POP. However, a pessary will have to be used for the patient’s lifetime. Abdominal sacral colpopexy is effective in treating apical prolapse with an acceptable benefit-risk ratio. This procedure should be balanced against the low but non-negligible risk of serious complications. The results of native tissue vaginal POP repair are better than previously thought with high patient satisfaction and acceptable reoperation rates. The insertion of mesh at the time of anterior vaginal wall repair reduces the awareness of prolapse as well as the risk of recurrent anterior prolapse. There is no difference in anatomic and subjective outcome when native tissue vaginal repairs are compared with multicompartment vaginal mesh. Mesh exposure is still a significant problem requiring surgical excision in approximately ≥10 % of cases. The ideal mesh has not yet been found necessitating more basic research into mesh properties and host response. Several studies indicate that greater surgical experience is correlated with fewer mesh complications. In women with uterovaginal prolapse uterine preservation is a feasible option which women should be offered. Randomized studies with long-term follow-up are advisable to establish the place of uterine preservation in POP surgery.

Conclusion

Over the last decade treatment of POP has been dominated by the use of mesh. Conservative treatment is the first option in women with POP. Surgical repair with or without mesh generally results in good short-term objective and functional outcomes. However, basic research into mesh properties with host response and comparative studies with long-term follow-up are urgently needed.     

Review of synthetic mesh-related complications in pelvic floor reconstructive surgery

There is significant risk of re-operation after pelvic reconstructive surgery. In an attempt to improve outcome, synthetic materials are increasingly being used to augment pelvic organ prolapse repair despite lack of strong evidence to support their routine use. The use of synthetic mesh to correct apical, anterior and posterior vaginal wall prolapse is not without complications. This review aims to evaluate the long-term complications of synthetic mesh in pelvic reconstructive surgery.     

Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known

Many properties of polypropylene mesh that are causative in producing the complications that our patients are experiencing were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not sufficiently taken into account prior to the sale of these products for use in patients. This report indicates when this information was available to both mesh kit manufacturers and the Food and Drug Administration.     

New minimally invasive slings: TVT Secur

Single-incision slings are now approved by the US Food and Drug Administration. TVT Secur (Ethicon, Somerville, NJ), the first mini sling available for use, offers a minimally invasive approach to the surgical treatment of stress incontinence, with its greatest benefit being reduced patient discomfort in the immediate postoperative period. Although little data are available regarding the safety and efficacy of this new generation of slings, TVT Secur appears to be relatively safe. Long-term efficacy has not yet been determined, but short-term efficacy rates seem to compare with traditional midurethral mesh slings. Long-term follow-up is warranted and comparative studies are needed to determine its true efficacy.     

Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh

Introduction and hypothesis

In 2008 and 2011, the US Food and Drug Administration (FDA) released notifications regarding vaginal mesh. In describing prolapse surgery trends over time, we predicted vaginal mesh use would decrease and native tissue repairs would increase.

Methods

Operative reports were reviewed for all prolapse repairs performed from 2008 to 2011 at our large regional hospital system. The number of each type of prolapse repair was determined per quarter year and expressed as a percentage of all repairs. Surgical trends were examined focusing on changes with respect to the release of two FDA notifications. We used linear regression to analyze surgical trends and chi-square for demographic comparisons.

Results

One thousand two hundred and eleven women underwent 1,385 prolapse procedures. Mean age was 64?±?12, and 70 % had stage III prolapse. Vaginal mesh procedures declined over time (p?=?0.001), comprising 27 % of repairs in early 2008, 15 % at the first FDA notification, 5 % by the second FDA notification, and 2 % at the end of 2011. The percentage of native tissue anterior/posterior repairs (p?<?0.001) and apical suspensions (p?=?0.007) increased, whereas colpocleisis remained constant (p?=?0.475). Despite an overall decrease in open sacral colpopexies (p?<?0.001), an initial increase was seen around the first FDA notification. We adopted laparoscopic/robotic techniques around this time, and the percentage of minimally invasive sacral colpopexies steadily increased thereafter (p?<?0.001). All sacral colpopexies combined as a group declined over time (p?=?0.011).

Conclusions

Surgical treatment of prolapse continues to evolve. Over a 4-year period encompassing two FDA notifications regarding vaginal mesh and the introduction of laparoscopic/robotic techniques, we performed fewer vaginal mesh procedures and more native tissue repairs and minimally invasive sacral colpopexies.     

Small bowel volvulus caused by migrating mesh plug

The choice of material and technique for repair of inguinal hernias is broad. The mesh plug technique has become one of these techniques. The local complications of this technique are well known and include entrapment and damage of nervous and reproductive structures causing pain and even infertility. Migration of the mesh recently has become evident. We found a few cases of migrating mesh plug in the literature. We report a 76-year-old male patient who presented during admission for a neurosurgical procedure. His hospital course was complicated by migrating mesh eroding into the small intestine presenting as a small bowel obstruction. During exploratory laparotomy, a small bowel volvulus was found and reduced along with resection of the bowel-mesh complex. We discuss and review this technique's complications, including a 9-year review of adverse events reported to the U.S. Food and Drug Administration.     

Synthetic ligaments. Current status

Many techniques for ligamentous reconstruction have been developed in recent years. In the United States, injuries of the knee have been increasingly treated with innovative methods of surgical reconstruction, most of which have used normal structures. There are obvious theoretic advantages in using synthetic materials that might simplify surgery, spare normal tissues, and possibly facilitate stronger repairs. To these ends, several synthetic substances have been used experimentally and clinically. This is a brief summary of eight of the materials that have been or are being investigated in the United States. Some are no longer in use, others are currently being used in clinical trials. As of this writing, only the Gortex ligament has received a general device release from the Food and Drug Administration (FDA).     

An algorithm for managing patients who have Composix® Kugel® ventral hernia mesh

Composix^® Kugel^® (CK) mesh is a prosthetic available since 2000 for ventral hernia repair. A recent voluntary, class I recall of CK has caused concern regarding implantable medical devices and has caused many patients to seek medical attention and advice related to their hernia repair. Surgeons are required to answer many patient inquiries and address their concerns. Although the Food and Drug Administration (FDA) warnings can help guide surgeons in dealing with events such as this recall, detailed information and algorithms are lacking. We present information regarding the composite mesh recall and propose an algorithm for the management of patients who have had this mesh implanted.     

Native tissue repair for central compartment prolapse: a narrative review

Central descent due to a level 1 defect is a main component in pelvic organ prolapse (POP) reconstructive surgery, whether for symptomatic apical prolapse or for the prolapse repair of other compartments. A recent growth in the rate of native tissue repair procedures for POP, following the US Food and Drug Administration (FDA) warnings regarding the safety and efficacy of synthetic meshes, requires a re-evaluation of these procedures. The safety, efficacy, and determination of the optimal surgical approach should be the center of attention. Functional outcome measures and patient-centered results have lately gained importance and received focus. A comprehensive literature review was performed to evaluate objective and subjective outcomes of apical prolapse native tissue repair, with a special focus on studies reporting impact on patients’ functional outcomes, quality of life, and satisfaction. We performed a MEDLINE search for articles in the English language by using the following key words: apical prolapse, sacrospinous ligament fixation, uterosacral ligament suspension, sacral colpopexy, McCall culdoplasty, iliococcygeus vaginal fixation, and functional outcomes. We reviewed references as well. Despite a prominent shortage of studies reporting standardized prospective outcomes for native tissue repair interventions, we noted a high rate of safety and efficacy, with a low complication rate for most procedures and low recurrence or re-treatment rates. The objective and subjective results of different procedures are reviewed. Functional outcomes of native tissue repair procedures have not been studied sufficiently, though existing data present those procedures as favorable and not categorically inferior to sacrocolpopexy. Apical compartment prolapse repair using native tissue is not a compromise. Functional outcomes of native tissue repair procedures are favorable, have a high rate of success, improve women’s quality of life (QoL), and result in high rates of patient satisfaction. This subject requires further long-term, standardized prospective studies following the International Continence Society/International Urogynecologists Association guidelines for surgical outcomes report, with the focus on patient-centered functional outcomes.     

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.