Transvaginal Mesh for Prolapse Repair: What is All the Controversy About?

The use of synthetic mesh for the management of pelvic organ prolapse has been embroiled in a contentious debate over the past decade, with only more partisanship among physicians strictly against its use versus those pelvic surgeons who believe it to be a useful tool in their armamentarium. At the heart of the controversy lies the concern, by its detractors, for complications related to mesh use outweighing the as yet not rigorously tested benefit of augmenting repairs with mesh. This article discusses, in detail, the current literature supporting the use of mesh in the management of pelvic organ prolapse repair. The rising concern for complications, both simple and complex, will be addressed. This review aims to narrow the divide between physicians and to address their discordant beliefs by objectively reporting the most up-to-date data on biologic and synthetic mesh use in pelvic organ prolapse repair.     

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.     

Female incontinence: a review of biomaterials and minimally invasive techniques

PURPOSE OF REVIEW: This article discusses the various grafts or biomaterials, minimally invasive techniques, and recent advances for the treatment of female stress urinary incontinence and pelvic organ prolapse. RECENT FINDINGS: The studies reviewed in this paper compared certain biologic grafts to synthetic grafts in clinical trials and histopathological studies. Data from long-term outcome studies for tension-free vaginal tape are evaluated. As tension-free vaginal tape is the foremost technique for stress urinary incontinence correction, many of the newer modalities such as transobturator tape and laparoscopy are compared with it. Immediate and long-term complications from mesh use in stress urinary incontinence and pelvic organ prolapse repair are examined. Correction of prolapse may eventually entail the use of specially designed 'kits' that allow total pelvic floor reconstruction with a single piece of mesh. SUMMARY: Although biological grafts are initially efficacious, the trend is to use synthetic grafts in repair of stress urinary incontinence and pelvic organ prolapse. Midurethral slings continue to be the front-line therapeutic modality for stress urinary incontinence. After analysis of long-term data, other surgical techniques may gain popularity. With increasing use of synthetic grafts, however, long-term complications such as de-novo urgency, erosion, and dyspareunia need to be assessed.     

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.     

Failures and complications in pelvic floor surgery

Objectives

To review current literature on the failures of different surgical approaches in pelvic floor surgery, in particular the use of alloplastic materials, and to analyze complications related to them.

Methods

A Medline search was performed to retrieve English language literature (from the year 1995 to 2011) on the success rates, failures, and complications profiles of pelvic floor surgery. Search terms used are “pelvic organ prolapse,” “stress urinary incontinence,” “complications,” “vaginal mesh,” “mid-urethral slings,” and “colposuspension.” The review includes surgical techniques for the correction of pelvic organ prolapse and stress urinary incontinence. Failure rates and complications in different studies are compiled and analyzed.

Results

Use of synthetic materials in pelvic organ prolapse surgery has reduced surgical failures but it is associated with an increased risk of complications compared to traditional surgical repairs. Synthetic mid-urethral slings for stress urinary incontinence seem to have good success rates over long term, but they have unique complication profile including denovo development of overactive bladder, voiding dysfunction, sling exposures, dyspareunia, and long-term pain. However, some of these complications seem to be related to wrong surgical indications and improper surgical techniques, although some complications may be directly related to the use of synthetic material itself.

Conclusion

Use of synthetic materials in pelvic floor surgery has definitely reduced surgical failures, but at the same time, it is associated with an increased risk of complications (some of which are unique to synthetic materials) compared to traditional surgical repairs.     

Rectal erosion of synthetic mesh used in posterior colporrhaphy requiring surgical removal

Treatment of pelvic organ prolapse with transvaginally placed synthetic mesh has recently increased. Several reports of complications have surfaced raising the overall question of safety regarding its use for vaginal prolapse repair. This case report describes a rectal erosion and dyspareunia that resulted from mesh placed into the posterior vaginal wall. A 47-year-old woman underwent a laparoscopic supracervical hysterectomy and a posterior repair with polypropylene mesh resulting in a rectal erosion. Despite removal of all of the mesh that could be excised rectally resulting in a healed rectal mucosa, the patient had persistent dyspareunia and pain requiring complete removal of the mesh using a vaginal approach. After surgery, the patient had resolution of all her symptoms. Further studies of transvaginally placed synthetic mesh need to be performed to determine its safety and efficacy.     

Autologous rectus fascia graft in the treatment of high-stage apical vaginal prolapse: preliminary results of a new surgical approach with native tissue

International Urology and Nephrology - Since vaginal meshes in pelvic organ prolapse have been associated with more complications in the last decades, native tissue vaginal repair is still the...     

Case study: challenges of pessary management.

Genital prolapse is the relaxation of the supporting structures of the pelvic floor. Significant morbidity can be associated if left untreated. Patients can elect to have surgical repair of their prolapse or use a pessary. The more significant the pelvic organ prolapse the more difficult it is to manage with pessary support. The case study in this article describes such a patient and the challenges we faced with managing her advanced genital prolapse.     

Management of mesh complications and vaginal constriction: a urogynecology perspective

Once thought of as a long-term solution to pelvic organ prolapse, currently synthetic mesh augmentation is regarded as a dark area that is being critically assessed by surgeons, hospitals, industry, and most importantly the Food and Drug Administration. The development of midurethral sling kits has revolutionized the surgical treatment of stress incontinence. These systems, however, were not rigorously tested but instead marketed after being cleared by the Food and Drug Administration through a simple regulatory process using a previously approved predescent material. This article reviews the management of mesh complications of synthetic slings and mesh used to augment prolapse repair.     

Overt rectal prolapse following repair of stage IV vaginal vault prolapse

Pelvic organ prolapse is an increasingly common problem as women are living longer. With the growing numbers of surgeries performed to correct this problem, further research is needed to understand the long-term success as well as possible complications of these procedures. One potential complication that needs further study is de novo rectal prolapse after repair of pelvic organ prolapse, specifically after colpocleisis. Defacography may be an important part of the preoperative workup in the patient with pelvic organ prolapse. Currently, there is a controversy as to whether internal, or occult, rectal prolapse on defacography should be repaired at the time of other pelvic reconstructive surgery. We report on a case of overt rectal prolapse after repair of Stage IV vaginal vault prolapse with a colpocleisis, levator ani plication, and a minimally invasive midurethral sling. We discuss the issues surrounding preoperative management of these patients and propose a theory explaining why prolapse in other areas of the pelvis may occur after reconstructive surgery.     

Robotic Sacrocolpopexy: How Does It Compare with Other Prolapse Repair Techniques?

Abdominal sacrocolpopexy has been shown to have the highest, most durable success rates among techniques for apical pelvic organ prolapse repair. Recently, there has been increased application of minimally invasive techniques, such as laparoscopic and robotic approaches, to performing a sacrocolpopexy. We report an overview of the literature in order to compare between robotic sacrocolpopexy and other surgical techniques for the repair of apical pelvic organ prolapse. Our review will include a discussion of operative techniques, anatomic and subjective success rates, costs, and complications.     

Vesicovaginal fistula resulting from a well-cared-for pessary

An 84-year-old vaginally grand multiparous woman presented with a vesicovaginal fistula (VVF) after appropriate use of a Gehrung pessary for the past 12 years for stage III pelvic organ prolapse. The patient reported strict adherence to removing her pessary nightly and replacing it in the morning for the last 12 years. One morning, she awoke and noted a sudden gush of urine through the vagina followed by continuous leakage. Given the complex nature of VVF repair with concurrent stage III pelvic organ prolapse, the patient was referred to urogynecologic care. A Latzko fistula repair and LeFort colpocleisis were performed without complication. The patient recovered well with complete resolution of her pelvic organ prolapse and VVF based on negative cystogram findings at 3 weeks postoperatively. At 12 weeks postoperatively the patient denied any urine leakage or pelvic organ prolapse.     

Apical vault repair, the cornerstone or pelvic vault reconstruction

Pelvic organ prolapse remains a difficult problem for pelvic reconstructive surgery. Before new surgical procedures can be developed a good understanding of pelvic anatomy is necessary. It is widely held that the etiology of pelvic organ prolapse is secondary to stretch neuropathy following childbirth and chronic cough or constipation. Several transvaginal and transabdominal procedures have been developed over the years. With the increasing use of laparoscopy, a new variation on existing culdeplasty techniques has been developed. Following anatomical principles, the apical vault repair reestablishes the pericervical ring at the vaginal apex. The incorporation of pubocervical fascia, uterosacral-cardinal ligament and the rectovaginal fascia provides a strong anchor for the vaginal apex. In addition, the repair should help prevent future transverse cystocele, rectocele, enterocele and apical vault prolapse. Early outcome studies suggest that the apical vault repair should be used routinely with laparoscopic urethropexy, laparoscopic hysterectomy and the repair of pelvic organ prolapse. Good apical vault support is considered the cornerstone of pelvic reconstruction.     

Laparoscopic hysteropexy in a patient with spina bifida and ventriculoperitoneal shunt

Laparoscopic repair of pelvic organ prolapse in patients with ventriculoperitoneal shunts has not been previously described. The optimum management of patients with ventriculoperitoneal shunts undergoing laparoscopy is uncertain. We describe the case of a 21-year-old female patient with spina bifida and ventriculoperitoneal shunt who underwent laparoscopic hysteropexy for severe pelvic organ prolapse. The implications of performing laparoscopy on patients with ventriculoperitoneal shunts are reviewed along with strategies to reduce potential intraoperative complications.     

Do we need meshes in pelvic floor reconstruction?

Objectives

Transvaginally placed mesh in pelvic reconstructive surgery for women with pelvic organ prolapse has gained popularity because of excellent anatomical outcomes, but postoperative mesh-related complications have lead to a number of cautious reviews and warnings. This review focuses on functional outcomes after synthetic transvaginal mesh placement.

Methods

MEDLINE database was searched from 2010 to August 2011 for original articles on transvaginal mesh surgery for pelvic organ prolapse not included in recent reviews. The following search terms were used: pelvic organ prolapse, genital prolapse, cystocele, rectocele and mesh, synthetic graft, and repair. Studies were assessed and appropriate data extracted and tabularized. Studies were excluded if the follow-up time was less than 12?months and if studies did not contain original data or data on subjective outcome.

Results

Eleven studies irregularly reported functional outcomes. After trocar-guided transobturator vaginal mesh surgery, symptomatic recurrence of pelvic organ prolapse was reported between 7 and 33%. If analyzed cumulatively, 76 of 370 patients (21%) complained of prolapse symptoms postoperatively. De novo stress urinary incontinence occurred in 12–17% and persisted in up to 68% after trocar-guided mesh surgery. De novo dyspareunia was present between 2 and 15%, worsened or de novo dyspareunia between 25 and 44%. Deteriorating coital incontinence was described in 6 of 16 women after anterior Prolift in one trial.

Conclusions

When counseling women for pelvic reconstructive surgery, we should provide them with evidence-based information on functional outcomes and subsequently take the patient’s concerns and preferences into account. Pelvic floor symptoms were scarcely reported in reviewed trials, but demonstrated a worse scenario than anatomical outcomes.     

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.     

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.     

Controversies in the management of mesh-based complications: a urology perspective

Since the introduction of the synthetic midurethral sling, several transvaginal mesh delivery systems have been developed for treating stress incontinence and pelvic organ prolapse. Widespread use of these "kits" has introduced a new dilemma of mesh-specific complications that female pelvic surgeons must manage. Differing treatment techniques have been described and controversy exists as to which method is preferred for vaginal mesh extrusion, mesh perforations, pelvic pain, and dyspareunia. This article addresses the differing management strategies for mesh complications after reconstructive surgery and highlights the available literature on the success of each option.     

Synthetic biomaterials for pelvic floor reconstruction

Pelvic organ prolapse and stress urinary incontinence increase with age. The increasing proportion of the aging female population is likely to result in a demand for care of pelvic floor prolapse and incontinence. Experimental evidence of altered connective tissue metabolism may predispose to pelvic floor dysfunction, supporting the use of biomaterials, such as synthetic mesh, to correct pelvic fascial defects. Re-establishing pelvic support and continence calls for a biomaterial to be inert, flexible, and durable and to simultaneously minimize infection and erosion risk. Mesh as a biomaterial has evolved considerably throughout the past half century to the current line that combines ease of use, achieves good outcomes, and minimizes risk. This article explores the biochemical basis for pelvic floor attenuation and reviews various pelvic reconstructive mesh materials, their successes, failures, complications, and management.     

Surgery for Pelvic Organ Prolapse: A Historical Perspective

Surgical treatment of pelvic organ prolapse has evolved from the use of pomegranates as pessary devices to contemporary robot-assisted laparoscopic sacral colpopexy. Symptomatic pelvic organ prolapse requires correction of all the defects to achieve optimal outcomes. Factors to consider in selecting the appropriate repair include patient's age; stage of prolapse; vaginal length; hormonal status; desire for uterine preservation and coitus; symptoms of sexual, urinary, or bowel dysfunction; and any comorbidities that influence her eligibility for anesthesia or chronically increase intra-abdominal pressure. There is currently no consensus as to the best surgical approach for advanced pelvic organ prolapse. Reconstructive surgery for pelvic organ prolapse is currently performed by vaginal or abdominal (open, laparoscopic, and robotic approaches) approaches or a combination. It is important to maintain skills in proven procedures such as abdominal sacrocolpopexy and sacrospinous ligament suspension. This paper discusses the historical evolution of surgery for pelvic organ prolapse from antiquity to date.