Trans‐Vaginal Mesh Revision: A Comprehensive Review on Etiologies and Management Strategies with Emphasis on Postoperative Pain Outcomes

The use of polypropylene mesh to augment surgery aimed to correct pelvic organ prolapse and stress urinary incontinence stems largely from the high recurrence rates of native tissue repairs. While objective outcomes were improved, mesh related complications began to emerge that included mesh exposures, extrusions, dyspareunia and other pain issues. However, the indication for and benefit of surgical intervention(s) to address these complications are lacking. We aim to review to current literature regarding postoperative pain outcomes following vaginal mesh revision. Evidence based literature indicates that mesh complications are not rare and surgery that aims to address them generally have an overall benefit. However, studies available are generally small case series of a retrospective nature with short follow up. Some themes are evident: there is a long lag period from mesh insertion to removal; there is a lack of a true denominator of total mesh insertions making it hard to gauge the real scope of the problem; mesh material found not along the expected trocar path or coursing close to neurovascular structures thus raises the possibility of technical errors during insertion. Transvaginal mesh revision(s) for mesh complications generally have a positive effect on pain outcomes, but better controlled studies are needed. Additionally, since technical issues may be a factor in the development of mesh complications, rigorous training and sufficient surgical case volume should be emphasized.     

Effect of procedure type and use of mesh on complications after surgery for pelvic organ prolapse: a retrospective cohort study

BackgroundConcerns have been raised about the safety of surgery for pelvic organ prolapse using synthetic mesh. We aimed to assess complication rates in similar procedures with and without mesh.MethodsWith routine hospital discharge data for Scotland, 1997–2014, we identified index pelvic organ prolapse procedures using previously validated coding. Multiple and repeat procedures were excluded. Mesh and non-mesh procedures were compared for anterior colporrhaphy, posterior colporrhaphy, and vaginal suspension using a vaginal approach. Primary outcomes were immediate postoperative complications during index hospital admission, admission within 5 years for later postoperative complications, and admission within 5 years for further surgery for pelvic organ prolapse or stress urinary incontinence. Poisson regression (for count data) was adjusted for age, deprivation, comorbidity, hospital type, and surgeon volume.Findings18 614 women (median age 61 years, IQR 53–69) underwent a first single pelvic organ prolapse procedure during 1997–2014 with 1648 (9%) of procedures using mesh. The dataset was complete apart from 148 patients (0·8%) with missing deprivation data. Analysis showed these to be similar to those without missing data and they were excluded from analyses. There were no statistically significant differences in rates of immediate complications between mesh procedures and their non-mesh comparators. Later postoperative complications were more common for both anterior and posterior colporrhaphies with mesh than with their non-mesh equivalent (adjusted incident rate ratio [IRR] 2·80 [95% CI 2·14–3·68] vs 3·23 [2·38–4·38], both p<0·0001). Further surgery for stress urinary incontinence or pelvic organ prolapse was more common for anterior and posterior colporrhaphies with mesh than with their non-mesh equivalent (adjusted IRR 1·89 [95% CI 1·51–2·37], p<0·0001 vs 1·35 [0·96–1·89], p=0·083). The risk of later complications or further surgery after vaginal suspension with mesh was similar to that after equivalent non-mesh surgery.InterpretationThere were substantially higher rates of complications among patients undergoing mesh compared with non-mesh surgery for pelvic organ prolapse. This is the first study to our knowledge to compare mesh complication rates for similar procedures. These findings add to a growing body of evidence that mesh use in surgery for pelvic organ prolapse needs to be carefully considered and patients adequately counselled about potential risks and benefits.FundingNone.     

Vaginal mesh infection due to Bacteroides melaninogenicus: a case report of another emerging foreign body related infection

We present a case of a 29-y-old woman with rectocele, cystocele, and uterine prolapse who developed a vaginal infection after the placement of a macroporous polypropylene vaginal mesh. Bacteroides melaninogenicus was isolated from the area of the infection. The exposed parts of the mesh were removed and she received treatment with metronidazole and doxycycline. No recurrence of the infection was noted during 12 months of follow-up. However, the patient continued to avoid intercourse due to severe dyspareunia. Vaginal mesh-related infections represent an emerging type of infection that may complicate reconstructive surgery in patients with pelvic organ prolapse.     

Management of Mesh-Related Pelvic Inflammation

Purpose of Review

To review mesh used for transvaginal surgeries, specifically slings and prolapse repairs, as well as offer a review of management after mesh-induced inflammation occurs.

Recent Findings

There have been changes to FDA notifications regarding vaginal mesh, with continued high-profile press. The inflammatory changes and possible complications vary with different mesh characteristics. Risk for complications due to transvaginal mesh placed for prolapse is higher than that when placed for the treatment of stress urinary incontinence.

Summary

Transvaginal mesh aids in the effective treatment of female stress incontinence and pelvic organ prolapse but holds the possibility for complications. Placement of transvaginal mesh should continue in the hands of specially trained surgeons, who are knowledgeable regarding management of complications.

     

So the First Pelvic Organ Prolapse Repair Failed…Now What?

Purpose of Review

Surgical repair of pelvic organ prolapse (POP) is common and a significant number of women will experience POP recurrence. This paper provides a summary of management options for recurrent POP.

Recent Findings

Vaginal and abdominal approaches to recurrent POP utilizing native tissues, previously placed mesh, or a new mesh implant are all reasonable options for repair. Choice of surgical approach should be individualized to the patient.

Summary

Without evidence from randomized controlled studies to help clinicians delineate the appropriate repair for each patient, there is still no perfect answer as to the best surgical treatment for recurrent POP. Similar to primary repairs, vaginal and abdominal approaches to recurrent POP utilizing either native tissues or polypropylene mesh (new or previously placed) are all reasonable options for repair. In the hands of an experienced pelvic reconstructive surgeon, complication rates from mesh implantation are limited while potential benefits of additional strength and durability are offered. Debate continues over the appropriate use of polypropylene mesh for pelvic reconstruction in women with prolapse; in the setting of recurrent bothersome prolapse mesh may offer a durable option.

     

Pelvic organ prolapse: a review

Pelvic organ prolapse is a common medical problem in parous women. This condition usually refers to a combination of deficiencies of the pelvic organs as they relate to support mechanisms of the vaginal wall. Symptoms vary--an accurate diagnosis requires a careful and complete physical examination with attention directed toward the pelvis and perineum. Although many patients will not require surgical treatment for pelvic organ prolapse, a comprehensive approach to repair in which all of the anatomic defects affecting support are addressed is necessary for successful treatment. Patients presenting with pelvic organ prolapse often provide some of the most complex, challenging, and rewarding cases in reconstructive pelvic surgery. This article addresses the definitions and classifications, prevalence and risk factors, and anatomy and pathophysiology relevant to pelvic organ prolapse. Discussion also includes diagnosis and approaches to management (surgical and nonsurgical) of anterior vaginal wall prolapse, cystourethrocele, apical vaginal prolapse, uterine prolapse and enterocele, posterior vaginal wall prolapse, rectocele, and pelvic floor relaxation and perineal laxity, with indications for and approaches to surgery, along with possible complications.     

Treatment of Vaginal Cuff Prolapses with Posterior Intravaginal Sling and Evaluation of Efficiency with International Consultation on Incontinence Questionnaire—Vaginal Symptoms Method in the Long Term: Preliminary Results

Objectives: The aim of this study was to research the efficiency of posterior intravaginal sling (PIVS) procedure in vaginal cuff prolapse, together with possible complications, long‐term effects and effects of the method on vaginal and sexual function and quality of life of patients. This retrospective study comprised 21 patients with vaginal cuff prolapse. Methods: PIVS procedure was performed in 21 patients with vaginal cuff prolapse with quantification stages 2, 3, or 4 of pelvic organ prolapse. Patients were assessed according to the International Consultation on Incontinence Questionnaire—Vaginal Symptoms before and after operation. Results: The average follow‐up period was 24.6 months. The rate of surgical success was 100%, the rate of mesh erosion was 14.2% and the rate of dyspareunia was 33.3%. Vaginal symptom, sexual matter and quality of life scores were statistically significant in the postoperative period compared to the preoperative period (P = 0.001, P = 0.001, P = 0.001, respectively). Conclusion: PIVS is an effective and reliable method of treating vaginal cuff prolapse. However, its complication profile is not yet at an acceptable level. We believe that the rate of mesh erosion will regress to a more acceptable level with the improvement of mesh technology and postoperative method. The necessary incontinence surgery is easily performed together with PIVS procedure. PIVS restores the vaginal and sexual functions of patients and increases their quality of life significantly.     

Robotics for Pelvic Reconstruction

Robotic-assisted laparoscopy is increasingly used in female pelvic reconstructive surgery to combine the benefits of abdominally placed mesh for prolapse outcomes with the quicker recovery time associated with minimally invasive procedures. Level III data suggest that early outcomes of robotic sacrocolpopexy are similar to those of open sacrocolpopexy. A single randomized trial has provided level I evidence that robotic and laparoscopic approaches to sacrocolpopexy have similar short-term anatomic outcomes, although operating times, postoperative pain, and cost are increased with robotics. Patient satisfaction and long-term outcomes of both robotic and laparoscopic sacrocolpopexy are insufficiently studied despite their widespread use in the treatment of prolapse. Given the high reoperative rates for prolapse repairs, long-term follow-up is essential, and well-designed comparative effectiveness research is needed to evaluate pelvic floor surgery adequately.     

Lessons Learned from Mesh Litigation for Prolapse and Incontinence

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can cause significant impairment in quality of life and lead many women to seek surgical correction. These procedures are often performed using polypropylene mesh. The Food and Drug Administration (FDA) issued a Public Health Notification to inform patients of adverse events related to the use of mesh placed in these repairs. Since this time, there have been almost 50,000 legal proceedings related to complications of polypropylene mesh in the urogynecology setting. Currently, the FDA is conducting further studies to evaluate the safety and efficacy of polypropylene mesh, but it is still available for use in the repair of SUI and POP. Thus, patients should be carefully selected and counseled appropriately regarding conservative management options and alternative surgical therapies prior to mesh placement. As a result of the FDA recommendations, researchers are currently trying to develop a treatment alternative to mesh.     

Vaginal Prolapse Repair—Native Tissue Repair versus Mesh Augmentation: Newer Isn’t Always Better

The purpose of this article is to update the female urology and urogynecologic community on the controversy regarding approaches to vaginal surgery for pelvic organ prolapse. We will review the salient issues in traditional, vaginal native-tissue (NT) repair for pelvic organ prolapse. We intend to provide arguments advocating vaginal NT repair over that of vaginal mesh-augmented (MA) repair, and to show that newer is not always better.     

Surgical management of rectal prolapse

This article reviews the pathogenesis, clinical presentation and surgical management of rectal prolapse. Full-thickness prolapse of the rectum causes significant discomfort because of the sensation of the prolapse itself, the mucus that it secretes, and because it tends to stretch the anal sphincters and cause incontinence. Treatment of rectal prolapse is primarily surgical. Perineal surgical repairs are well tolerated, but are generally associated with higher recurrence rates. Abdominal repairs involve fixing the rectum to the sacrum by using either mesh or sutures, and tend to have the lowest recurrence rates. If significant preoperative constipation is present, a sigmoid resection can be performed at the time of rectopexy. For many patients, diarrhea and incontinence improve after surgery. Laparoscopic repair of rectal prolapse has similar morbidity and recurrence rates to open surgery, with attendant benefits of reduced length of hospital stay, postoperative pain and wound complications.     

Pelvic organ prolapse

Pelvic organ prolapse is downward descent of female pelvic organs, including the bladder, uterus or post-hysterectomy vaginal cuff, and the small or large bowel, resulting in protrusion of the vagina, uterus, or both. Prolapse development is multifactorial, with vaginal child birth, advancing age, and increasing body-mass index as the most consistent risk factors. Vaginal delivery, hysterectomy, chronic straining, normal ageing, and abnormalities of connective tissue or connective-tissue repair predispose some women to disruption, stretching, or dysfunction of the levator ani complex, connective-tissue attachments of the vagina, or both, resulting in prolapse. Patients generally present with several complaints, including bladder, bowel, and pelvic symptoms; however, with the exception of vaginal bulging, none is specific to prolapse. Women with symptoms suggestive of prolapse should undergo a pelvic examination and medical history check. Radiographic assessment is usually unnecessary. Many women with pelvic organ prolapse are asymptomatic and do not need treatment. When prolapse is symptomatic, options include observation, pessary use, and surgery. Surgical strategies for prolapse can be categorised broadly by reconstructive and obliterative techniques. Reconstructive procedures can be done by either an abdominal or vaginal approach. Although no effective prevention strategy for prolapse has been identified, considerations include weight loss, reduction of heavy lifting, treatment of constipation, modification or reduction of obstetric risk factors, and pelvic-floor physical therapy.     

Transvaginal mesh,gender and the ethics of clinical innovation

On 10 October 2018, Australian Health Minister Greg Hunt issued a national apology to the Australian women who experienced ‘horrific outcomes’ following surgery using transvaginal mesh—acknowledging the ‘historic agony and pain that has come from mesh implantation’. This apology followed many decades of ‘innovative’ use of transvaginal mesh for the treatment of pelvic organ prolapse. We use the case of transvaginal mesh to explore how clinical innovation may not only harm patients, but also entrench vulnerability and exacerbate existing inequities—in this case, those relating to gender.     

Point-counterpoint: Transvaginal placement of synthetic grafts to repair pelvic organ prolapse

An ever-growing, aging population increases demand for effective, minimally invasive surgeries for pelvic organ prolapse (POP). The most recent urogynecologic debate relates to the use of mesh kits for the transvaginal placement of synthetic grafts to surgically repair POP. Recent publications demonstrate improved outcomes compared with traditional endogenous tissue suture repairs, yet many question the use of these kits due to complications and lack of long-term related research. Some believe that proper technique and training enable patients to achieve durable outcomes with low morbidity via a minimally invasive, cost-effective surgical approach. However, because these kits are often used by novice surgeons with little understanding of pelvic floor anatomy and traditional repairs, others urge caution before their routine use and implementation. Further, some believe that surgeons must not always wait for robust level I support, but others insist that the medical community should encourage restraint and promote well-designed prospective studies comparing these kits to traditional repairs before subjecting patients to potentially harmful, ineffective products. This article presents arguments in favor and against transvaginal placement of synthetic grafts to repair POP.     

Pessary placement and management

Female pelvic organ prolapse is a common and aggravating condition that few women openly discuss. Fortunately, nonsurgical and surgical treatment options exist for this condition. Nonsurgical treatments include pessaries, which are used to reduce prolapse. The type of pessary depends on the direction and extent or grade of the protruding organ. The use of vaginal pessaries for urinary stress continence is a relatively new treatment option. Proper fit that is determined by trial is essential for effectiveness. Nurses at all levels now need to be familiar with the use of the vaginal pessary for pelvic organ prolapse and urinary stress incontinence. Nurses' roles regarding pessary use need to be clearly defined. Continence nurses should be familiar with the indications for pessary use, the types available for incontinence, and patient education regarding pessary care. Home health and long-term care nurses are frequently asked to periodically remove and insert pessaries. Skills and tips for making removal and insertion as easy as possible need to be disseminated. Advance practice nurses need skills for assessment of prolapse, fitting, and current outpatient pessary care routines. Increasing nurses' understanding of and comfort with pessary use might make a significant difference in the treatment of pelvic organ prolapse and urinary stress incontinence.     

Augmented repairs and use of interposition grafts in pelvic reconstructive surgery: Part II

Part I of this review on graft interposition for pelvic organ prolapse focused on the properties of biologic and synthetic materials used in vaginal reconstructive surgery and on the widespread use of these materials in the treatment of anterior vaginal wall prolapse. Part II focuses on prosthetic reinforcement during reconstructive surgical procedures involving the middle compartment (vaginal vault and apex) and posterior compartment (rectocele). The new “minimally invasive” kits directed at total pelvic floor reconstruction are discussed in this context. We conclude with a review of the unique complications associated with graft interposition and their management, as well as a discussion of areas to direct future research with the intent of promoting a greater understanding of the role and use of prosthetic grafts during pelvic reconstructive surgical procedures.     

Surgical Management of Pelvic Organ Prolapse in Females: Functional Outcome of Mesh Sacrocolpopexy and Rectopexy as a Combined Procedure

Purpose Urogenital prolapse is relatively common compared with rectal prolapse and the combination of urogenital prolapse and rectal prolapse is still more infrequent. This study was designed to evaluate the functional outcome of a series of patients who have undergone open mesh sacrocolporectopexy surgery for combined vaginal and rectal prolapse. Methods Consecutive patients from June 2000 to June 2004 with confirmed vaginal and rectal prolapse subsequently underwent open mesh sacrocolporectopexy. The Cleveland Clinic Short Form-20 Pelvic Floor Distress Inventory questionnaire with Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory subscales was completed by all patients preoperatively and at six months postoperatively. Results There were 29 patients with a median age of 66 (interquartile range, 59–73) years. Median period of follow-up was 26 (interquartile range, 15–33) months. Median global pelvic floor distress inventory scores were lower postoperatively compared with preoperatively (96.4 (interquartile range, 50.8–149.7) vs. 182.3 (interquartile range, 140.6–208.6; P = 0.001). All three median subscales scores also were significantly lower postoperatively compared with preoperatively. Conclusions In patients with concurrent vaginal and rectal prolapse, open mesh sacrocolporectopexy confers good symptomatic improvement for urinary-, vaginal-, and rectal-related symptoms. Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Seattle, Washington, June 3 to 7, 2006.     

The posterior compartment: Evaluation and functional outcomes after surgical repair

Pelvic organ prolapse (POP) will continue to become more prevalent as the female population ages and life expectancy increases. POP repair poses a challenging dilemma that is difficult to manage. Current research on various techniques of posterior compartment repair favors a transvaginal approach. Randomized trials have demonstrated its superiority when compared to transanal repair. Fascial defect reconstruction is superior to levator ani plication, although outcomes are comparable. However, site-specific fascial repairs are inferior to midline fascial plication. No randomized trials compare the transabdominal to transvaginal repair, although the laparoscopic approach has proven superior to transanal repair. The use of graft in posterior compartment repair enhances functional and surgical outcomes; however, mesh erosion, infection, and rejection may influence its use.     

Total pelvic mesh repair

INTRODUCTION: This report describes our technique and experience in restoring the pelvic floor of females with pelvic organ prolapse. METHODS: Total pelvic mesh repair uses a strip of Marlex Mesh® secured between the perineal body and the sacrum. Two additional strips, attached to the first, are tunneled laterally to the pubis and support the vagina and bladder laterally. Candidates for the procedure have failed previous standard repair or manifest combined organ prolapse on physical and cystodefecography exams. RESULTS: From January 1990 to December 1999, 236 females had total pelvic mesh repair, and 205 (87 percent) were available for follow-up. Median age was 64 (range, 32–89) years, median parity 2 (range, 1–9); 63 percent had birth-related complications. Bladder protrusion, vaginal protrusion, or both were the predominant chief complaint (54 percent), followed by anorectal protrusion (48 percent). Findings on physical examination showed degrees of prolapse of rectum (74 percent) and vagina (57 percent), perineal descent (63 percent), enterocele (47 percent), and rectocele (44 percent). Mean procedure time and length of hospital stay were 3.2 (standard deviation 0.75) hours and 6 (standard deviation 2.2) days, respectively. Reoperation rate because of complications of the total pelvic mesh repair procedure was 10 percent. Marlex® erosion into rectum or vagina occurred in 5 percent of patients and constituted 46 percent of the complications requiring reoperation. Additional surgical procedures at various intervals subsequent to total pelvic mesh repair have been performed in 36 percent of patients to further improve bladder function and have been performed in 28 percent of patients to improve anorectal function. There has been no recurrence of rectal or vaginal prolapse to date. Reports of overall satisfaction for correction of primary symptoms for patients grouped into early (0.5–3 years), middle (>3–6 years) and late (>6 years) were 68 percent, 73 percent, and 74 percent respectively. CONCLUSION: Total pelvic mesh repair is a safe and effective operation for females with pelvic organ prolapse.Presented at the meeting of the American Society of Colon and Rectal Surgeons, Boston, Massachusetts, June 24 to 29, 2000.     

Rektovaginale Fistel durch Mesh-Migration nach Sakrokolpopexie

The use of synthetic mesh for pelvic organ prolapse repair is associated with the risk of mesh erosion into hollow viscera. We report about a patient who developed a rectovaginal fistula 9 years after mesh sacrocolpopexy. The cause of this complication was related to mesh migration into the rectum. Laparoscopic rectal resection was performed to remove the mesh.