Use Of Vaginal Mesh Research Articles

MP07-09 TRENDS IN IMPLANTATION AND EXPLANTATION OF MESH FOR PELVIC ORGAN PROLAPSE AMONG FPMRS AND GENERAL UROLOGISTS

You have accessJournal of UrologyCME1 Apr 2023MP07-09 TRENDS IN IMPLANTATION AND EXPLANTATION OF MESH FOR PELVIC ORGAN PROLAPSE AMONG FPMRS AND GENERAL UROLOGISTS Mitchell G. Goldenberg, Unwanaobong Nseyo, Madeleine Burg, Evgeniy Kreydin, and David A. Ginsberg Mitchell G. GoldenbergMitchell G. Goldenberg More articles by this author , Unwanaobong NseyoUnwanaobong Nseyo More articles by this author , Madeleine BurgMadeleine Burg More articles by this author , Evgeniy KreydinEvgeniy Kreydin More articles by this author , and David A. GinsbergDavid A. Ginsberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003222.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The use of synthetic mesh in the treatment of pelvic floor conditions has long been scrutinized. Statements from multiple professional societies recommend that mesh for pelvic organ prolapse (POP) be performed only by those properly trained in both implantation and management of complications. We used case logs from the American Board of Urology (ABU) to understand temporal changes in the use of pelvic mesh among subspecialty trained and general urologists. METHODS: Case logs submitted to the ABU for certification and recertification in 2013 and in 2020 were reviewed. Demographic data including surgeon age, fellowship training, certification cycle, and practice type and location was analyzed. We analyzed trends in mesh insertion (both for POP and SUI) and mesh revision/removal based using common procedural terminology (CPT) codes among FPMRS and general urologists. Statistical analysis was performed using chi-squared test, binary regression, and Cronbach’s alpha. RESULTS: Over the two study years, 1877 surgeons contributed 253,326 unique procedures. A total of 1910 (1.8% of total cases) mesh implantation procedures were performed in 2013 compared to 2245 (1.5%) in 2020. Among FPMRS providers (n=154, 8.2%), the use of vaginal mesh for POP decreased from 4.6% to 1.5% (p<.001) of their total procedure volume, while transabdominal mesh for POP increased from 3.1% to 5.3%, (p<.001, see Figure 1). Similar changes were seen among generalists, among whom the rate tripled (0.1% to 0.4%, p<.001, see Figure 1b). Mesh revision/removal rates were stable (2.9%, p=.224) among FPMRS providers, but significantly decreased among general urologists in 2020 (0.2% to 0.1% p<.001). On multivariable analysis, generalists more likely to perform mesh revisions/removals were non-academic, female, and practiced in areas with a population density ≥1 million. Generalists implanting mesh were also more likely to perform revision/removal (Cronbach’s alpha=0.343, p=.015). CONCLUSIONS: Mesh-augmented POP repairs continue to be used among FPMRS and general urologists. However, these data indicate that general urologists may be referring mesh complications onto FPMRS providers, indicating that societal and FDA recommendations are perhaps not being adhered to. Source of Funding: The Catherine and Joseph Aresty Department of Urology © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e87 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mitchell G. Goldenberg More articles by this author Unwanaobong Nseyo More articles by this author Madeleine Burg More articles by this author Evgeniy Kreydin More articles by this author David A. Ginsberg More articles by this author Expand All Advertisement PDF downloadLoading ...

Hysterectomy Versus Uterine Preservation at the Time of Pelvic Reconstructive Surgery.

To evaluate national trends in apical prolapse surgery with and without uterine preservation using the National Surgical Quality Improvement Program (NSQIP) database. Based on the International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes, patients diagnosed with uterovaginal prolapse who underwent apical suspensions between 2013 and 2018 were identified, and procedures involving uterine preservation were differentiated from those with concomitant hysterectomy. Patient characteristics and postoperative complications were analyzed. A total of 16 427 patients met inclusion criteria, with 2235 (13.6%) undergoing uterine-preservation procedures and 14 192 (86.4%) undergoing hysterectomy. Between 2013 and 2018, the rates of uterine preservation ranged from 12.8% to 15.3%, with the last 2 years having significantly lower rates. Patients in the uterine-preservation group were older (62.8 vs. 60.5 y; P < 0.001), had higher BMI (28.4 vs. 28.1 kg/m2; P= 0.018), and were more likely to have diabetes (12.4% vs. 10.5%; P= 0.006) and hypertension (43.4% vs. 38.0%; P < 0.001). These patients also had higher frailty index than hysterectomy patients. Patients in the uterine-preservation group were more likely to have vaginal mesh. There were no differences between the 2 groups in length of stay or postoperative complications. On multivariate logistic regression, older age (adjusted odds ratio [aoR] 1.02; P < 0.001), higher BMI (aOR 1.01; P= 0.009), and use of vaginal mesh (aOR 2.75; P<0.001) were associated with higher odds of uterine preservation. Uterine preservation decreased operative time by about 30 minutes after controlling for confounders. Patients with more comorbidities were more likely to undergo uterine-preserving surgeries, which offered reduced operative time and no differences in postoperative complications.

303 Mapping the Landscape of Surgical Registries in the United Kingdom

Abstract Introduction Well-designed surgical registries are essential for high-quality patient-centred evaluation of implantable devices and surgical procedures. The importance of registries was highlighted in the recent Cumberlege report that detailed important innovation failures such as the use of vaginal mesh. Many surgical registries exist, but it is currently unclear how different registries are funded; designed; what data are collected; how databases are hosted and if the data can be linked to other datasets. There is therefore a need to understand the characteristics of and variation in existing surgical registries to make recommendations for how these could be improved. The aim of this work is to identify existing surgical registries in the UK and describe and summarise their key characteristics to inform recommendations for how surgical registries may be improved. Method Existing surgical registries will be identified using multiple different sources, including society websites; search engine review; a targeted search of Medline and Embase databases and expert knowledge. Details of each registry will be extracted using a standardised data extraction proforma developed by the study team. Characteristics of identified registries will be summarised into a narrative review. Results Identification of registries is ongoing. Preliminary data extraction has highlighted marked heterogeneity in the design, content, and structure of existing surgical registries. Data extraction is ongoing, but results will be available for presentation at the ASIT meeting. Conclusions There is considerable heterogeneity in existing surgical registries. Further work is needed to establish the extent of this variation and identify areas that can be improved.

Is pelvic organ prolapse correction with vaginal mesh suitable with a correct indication and protocolized follow-up?

The use of vaginal mesh in order to correct Pelvic Organ Prolapse (POP) has been banned by the FDA due to the complications associated with them. The objective is to determine efficacy and safety in the short and long term in a sample of women undergoing transvaginal mesh surgery performed by properly trained surgeons, in a referral center and with a protocolized follow-up. We present a longitudinal, descriptive study of a cohort of 53 patients with POP who underwent transvaginal mesh surgery between 2001 and 2015. The efficacy of the treatment is evaluated quantifying both clinical changes and life quality, as well as the rate for prolapse recurrence and the short-and long-term treatment-related complications. A total of 53 patients with average follow-up of 87 months were included. All of them had their surgery performed by three properly-trained surgeons. Indication for mesh placement was assessed in 49.1% of cases due to previous surgery recurrence. Treatment improved urinary incontinence rates, constipation, voiding difficulty, dyspareunia and quality of life. Long-term complication rate was 9.6% (5.7% exposure, 1.9% urinary obstruction and 1.9% pain). None of the patients presented recurrence in the mesh-treated compartment and 6 patients (11.3%) needed surgery after recurrence in a different compartment at the end of follow-up. Vaginal placement of synthetic mesh for POP treatment is safe in the short-, medium- and long-term when performed in referral centers. The correct indication and long-term follow-up are essential to diagnose and treat possible complications.

Mapping the Landscape of Surgical Registries in the United Kingdom: A Review According to the SWiM Methodology.

Background:Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical procedures. The importance of registries was highlighted in the recent Cumberlege report that detailed important innovation failures such as the use of vaginal mesh. Many surgical registries exist, but it is currently unclear how different registries are funded, governed, designed, and how their databases are hosted and utilised. There is therefore a need to understand the variation and characteristics of existing surgical registries to identify limitations and make recommendations for improvement. This work aims to understand the characteristics and heterogeneity in the design, governance, and function of existing surgical registries in the United Kingdom (UK).Methods:Existing surgical registries will be identified using multiple data sources including surgical society websites; search engine review; a targeted search of the Medline and Embase databases and expert knowledge. The data identified were reviewed following the synthesis without meta-analysis (SWiM) methodology. This information will be gathered from sources in the public domain only to fully understand registry transparency for professionals and the public. Details of each registry including disease area/condition/device evaluated; types of outcomes collected; governance, consent, and oversight; linkage to other datasets and funding will be extracted using a standardised data extraction tool. Characteristics of identified registries will be summarised into a narrative review.Dissemination:Findings will be presented at national and international conferences and published in peer-reviewed journals. Results will be presented to key stakeholders including surgeons, methodologists, trialists, regulators, data managers and patients to provide an up-to-date description of the current state of surgical registries in the UK. This work will inform a consensus process to agree how the design of new and existing registries can be optimised to support high quality research to benefit patients and the NHS.Highlights:Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical proceduresPresently there is limited understanding on how these registries are designed, governed, what data they collect and how this data is utilised for research.This review aims to map the landscape of surgical registries in the UK, and understand how they are optimised for research.

Burch colposuspension using minimally invasive techniques

: The Burch urethropexy, a routinely performed stress incontinence operation, was displaced by the advent of the popular minimally invasive sling. However, with controversy surrounding the use of vaginal mesh in women’s pelvic reconstructive surgery, both patients and physicians have renewed interest in pursuing the Burch urethropexy as a viable alternative to treat stress incontinence. The Burch procedure stabilizes the bladder neck as a means to restore continence. Variations of Dr. Burch’s technique have been developed over time with Dr. Tanagho’s modification as the most widely accepted method for suture location placement. Current technique typically includes permanent sutures placed lateral to the urethra and bladder neck which are then secured to the iliopectineal line (also known as Cooper’s ligament). Originally developed as an open technique, both laparoscopic and robotic approaches have negated the need for an incision. Success rates of the operation have been published for both abdominal and minimally invasive techniques. The procedure has been found to have similar success to minimally invasive outpatient sling procedures in the absence of clinical evidence of intrinsic sphincter deficiency. Although it has a somewhat longer operative time, the Burch procedure is a comparable outpatient surgery with good patient satisfaction and a low complication rate. This article will discuss the history behind the procedure, the laparoscopic technique, and provide recommendations to optimize results for the correction of stress incontinence.

Long-term safety and efficacy of laparoscopically placed mesh for apical prolapse.

Concerns regarding the use of vaginal mesh for prolapse have led to questions about the safety and efficacy of abdominally placed mesh. Mesh procedures for treating apical prolapse have become popular, either a laparoscopic hysteropexy (LSH) for uterine prolapse or a sacrocolpopexy (LSC) for vaginal vault prolapse. Robust long-term safety and efficacy data for these procedures are essential. All patients who had LSH or LSC since 2010 were invited back for face-to-face review and examination. Case notes were reviewed for surgical morbidities and patients were questioned about short- and long-term complications. The Patient Global Impression of Improvement (PGI-I) scale was used to assess prolapse, bladder and bowel symptoms postoperatively. One hundred twelve patients were included in the review, 93 of whom were examined. The median time since surgery was 6years (range 1-9years); 2.7% cases had an intraoperative complication, two conversions to laparotomy and one bladder injury. Overall, 17.3% patients sought medical review postoperatively, with 10.7% having problems with their skin incisions. With regard to mesh safety, there was one case of bowel obstruction requiring resection following LSH and two vaginal mesh exposures following LSC; 97% had stage 1 or less apical prolapse at long-term follow-up and 79.6% reported symptoms of prolapse to be 'much better' or 'very much better' on the PGI-I scale. This study shows excellent long-term results from LSC and LSH with comprehensive follow-up, demonstrating a very low and acceptable level of intraoperative, short- and long-term complications.

Urogynecological surgical mesh implants: New trends in materials, manufacturing and therapeutic approaches.

Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are two prevalent disorders affecting 30-40% of women worldwide. Current strategies to repair or improve these medical conditions are non-surgical options such as physiotherapy, or surgical options such as the use of vaginal meshes. The synthetic material polypropylene (PP), which has long been used for manufacturing these vaginal meshes, is associated with severe complications such as chronic pain, infection or mesh erosion. As a result of a widespread reporting and unacceptably high rates of complications, these issues have become a public health concern. Regulatory bodies have recently deemed the transvaginal placement of PP mesh in the pelvic floor (PF) no longer a suitable treatment method for PF repair, leading to the need for a novel approach to the manufacture and selection of materials for urogynecological meshes. Medical devices, such as vaginal meshes can be manufactured using a variety of techniques including injection moulding, electrospinning, hot-melt extrusion (HME) or more recently 3D printing. Over the past decade, the use of 3D printing within the medical device industry has expanded and offers a promising approach to manufacture patient-specific surgical mesh when combined with imaging tools. This review will summarise the current strategies to treat POP and SUI, the issues and use of current meshes for the treatment of these pelvic floor disorders (PFDs), and the future directions for the manufacture of more suitable urogynecological meshes, as well as their potential materials.

Position of Ibero-American Society of Neurourology and UroGynecology (SINUG) on the use of vaginal meshes in pelvic organ prolapse.

Pelvic organ prolapse (POP) is a very prevalent condition with a great impact on women's quality of life. At present, there is great controversy regarding the use of mesh in POP surgery. To understand the current moment, it is advisable to make a brief summary of the historical evolution of mesh use for pelvic floor pathology. The aim of this paper is to establish the position of the Ibero-American Society of Neurourology and UroGynecology (SINUG for its acronym in Spanish) regarding vaginal mesh reconstructive surgery. A working committee from the SINUG's scientific board performed a literature search about the use of vaginal meshes for pelvic organ prolapse reconstructive surgery and about the position of different societies. We analyzed the evolution into three periods: before the Food and Drug Administration (FDA) statement, FDA statement, and after the statement. SINUG drew up a position statement regarding vaginal mesh reconstructive surgery, based on the available scientific evidence and the evolution of its use in different contexts. Before mesh appearance in the 1990s, native tissue repair was the surgical treatment of choice for POP. Vaginal mesh reconstructive surgery has been frequently accompanied by procedure underestimation by inexperienced surgeons, besides inadequate diagnoses and indications. This situation led to the presentation of serious complications including mesh extrusion, exposure, and contraction. Once reviewed the available evidence and the position of different societies, SINUG presents its vision in this communication, which is a summary of the document prepared by the society's scientific board.

Dr Jekyll and Mr Hyde.

On the 10 July 2018, the UK Independent Medicines and Medical Devices (IMMD) safety review led by Baroness Cumberlege implemented a hiatus in the use of vaginal meshes for incontinence and prolapse because of concerns about complications. The use of vaginal mesh for prolapse has seen a natural decline over the past decade (Jha Int Urogynecol J 2018;29:795–801) with robust evidence available to suggest outcomes for native tissue repair are not significantly inferior to mesh-reinforced repair (Glazener Lancet 2017;389:381–92). However, there was considerable concern in relation to incontinence that patients would be exposed to more complex procedures with a greater complication rate because they would no longer have access to synthetic slings. The two synthetic sling procedures performed for stress urinary incontinence (SUI) are the tension-free vaginal tape (TVT) retropubic and the TVT obturator. Recently, these two devices have been referred to in the press interchangeably. The devices are made from identical mesh and are the same in their composition, size and the amount that is embedded in the patient, with similar success rates. However, that is where the similarity ends. So how did the two types of synthetic tapes become the Jekyll and Hyde of continence surgery? The Scottish review of the use of transvaginal mesh implants found greater adverse effects with obturator synthetic tapes than with retropubic tapes (https://www.gov.scot/publications/scottish-independent-review-use-safety-efficacy-transvaginal-mesh-implants-treatment-9781786528711/). The review also identified a greater need for repeat SUI surgery following the transobturator approach beyond 12 months. In addition, the number of cases under review for litigious reasons was three times greater in the obturator group than in the retropubic group. In the 2006 National Institute of Health and Care Excellence (NICE) clinical guidance (CG 40) on the management of urinary incontinence, there was only a brief mention of obturator tapes and the advice was to make women aware of the ‘lack of long term data’. When this guidance was updated in 2013 (CG 171), this advice remained unchanged. In the recent NICE consultation document published in October 2018, the advice is more directive: ‘do not offer a transobturator approach unless there are specific clinical circumstances (for example, multiple previous abdominal procedures) in which the retropubic approach should be avoided’. Obturator tapes were developed to reduce the risk of bladder injury but have been associated with groin pain and obturator neuropathies. These present as pain and restricted mobility of the thigh and hip adduction, along with sensory loss and pain across the anterior thigh. Foot drop is another rare presentation. However, the greatest problem with obturator tapes is the difficulty of complete removal, which is hampered by their placement deep in the obturator foramen, requiring dissection of the groin (usually by a plastic surgeon). In the largest series of vaginal mesh removals for all indications, the commonest type of mesh removed was the obturator tape for incontinence (Miklos Surg Technol Int 2016;29:185–9) and the removal of these meshes also had the highest complication rates. Clinicians who traditionally undertook obturator tape placement should be aware that even if the temporary ban is lifted, they will have to change their practice, as this procedure has acquired the mantle of Mr Hyde and will be off limits in most future circumstances. None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Autologous rectus fascia sling for treatment of stress urinary incontinence in women: A review of the literature.

Stress urinary incontinence (SUI) is common in the adult females. Surgical treatment options include synthetic mid-urethral sling (MUS), autologous sling, bulking agents, and Burch colposuspension. The autologous pubovaginal sling (PVS) has re-emerged in response to complications of synthetic MUSs and FDA communications regarding the use of vaginal mesh. This resulted in patients' fear related to vaginal mesh and drop in number of patients seeking surgical treatment of SUI. PVS has re-emerged as an option for treatment of primary SUI. The aim of this review is to familiarize, disseminate information, and share tips for the practicing female pelvic surgeons related to the practice of the autologous fascia sling. We reviewed the literature related to the autologous sling. We used the following data bases and search engines: GoPubMed (Transinsight), Cochrane reviews (Wiley Interscience), google scholar (google), and Scopus (Elsevier). Because it is the most commonly investigated and utilized, we focused on the autologous rectus fascia sling. We also focused on the retropubic sling approach because the literature on transobturator rectus fascia sling is sparse. Out of 307 articles related to the subject found, 22 articles were included and the rest were excluded. ARFS is a valid primary method of treatment for female SUI. Also, it is used in particular indications such as patients with intrinsic sphincter deficiency (ISD), prior pelvic irradiation, failed and/or complicated synthetic MUS, and violated urethral lumen.

Changing surgical trends for female stress urinary incontinence in England.

Stress urinary incontinence (SUI) surgery has significantly evolved with the introduction of synthetic midurethral slings (MUS). However, following reports from the US Food and Drug Administration and European Commission, the use of vaginal meshes in urogynaecology has been largely scrutinised. We analysed trends in female SUI surgery in England from 2000 to 2017. The Hospital Episode Statistics database was retrieved from the Health and Social Care Information Centre website. Specific four-character codes of the evolving OPCS-4 coding system were used to quantify SUI operations. We analysed 180,773 admissions from 2000 to 2017. A steep rise in MUS use was noted until 2008-2009, followed by a consistent drop, with a nadir of 6383 procedures in 2016-2017. Removal of MUS has become increasingly popular, with a peak of 591 in 2012-2013. Numbers for traditional continence operations remained low. Colposuspensions markedly decreased to 189 in 2012-2013, with a slight positive trend only in the last few years, while autologous sling use costantly dropped from 262 to 124 throughout the study period. Admissions for urethral bulking agents increased from 650 to 1324 in the last 2years. MUS represents the most commonly performed procedure for SUI, despite an obvious reduction in the last 8years. Urethral bulking agents are becoming more popular, while the numbers of colposuspensions and autologous slings are still low. Training programmes should take into account current shifts in surgical practice.

The Effect of Medical Consultation on Patients' Concerns Regarding Vaginal Mesh Use in Pelvic Reconstructive Surgery.

This study sought to determine patients' background knowledge and attitudes towards the use of mesh in pelvic floor reconstructive surgery (PFRS) and the effect of medical consultation on their knowledge and attitudes about mesh use. New urogynecology patients seen for pelvic organ prolapse and/or stress urinary incontinence were asked to complete pre-consultation questionnaires involving 12 questions on demographics and knowledge, attitudes, and concerns about the use of vaginal mesh. If PFRS was discussed, a post-consultation questionnaire was administered. A total of 202 new patients were surveyed. Of these patients, 73.8% had heard of vaginal mesh, and most of this information came from a media source followed by their health care provider. A total of 102 of 202 patients completed both the pre- and post-consultation questionnaire. Before medical consultation, patients' "level of concern" on a Likert scale (1 = not at all concerned, 10 = very concerned) was 5.98 ± 3.04. After consultation, the level of concern decreased significantly to 4.25 ± 2.68 (P = 0.00005). Before consultation, 33.3% of patients stated that they would be willing to proceed with surgery using mesh; however, after receiving standardized information on vaginal mesh risks and complications on the basis of the most current information available, 62.8% stated that they would be willing to proceed with mesh if required (P = 0.00001). Almost 75% of patients presenting for urogynecologic consultation had heard of vaginal mesh use, and 55.7% cited the media as their source of information. Medical consultation significantly reduced the patients' level of concern regarding the use of mesh in PFRS and significantly increased the proportion of patients willing to have mesh placed if appropriate.

Sentiment Analysis of Web Sites Related to Vaginal Mesh Use in Pelvic Reconstructive Surgery.

The purpose of this study was to utilize sentiment analysis to describe online opinions toward vaginal mesh. We hypothesized that sentiment in legal Web sites would be more negative than that in medical and reference Web sites. We generated a list of relevant key words related to vaginal mesh and searched Web sites using the Google search engine. Each unique uniform resource locator (URL) was sorted into 1 of 6 categories: "medical", "legal", "news/media", "patient generated", "reference", or "unrelated". Sentiment of relevant Web sites, the primary outcome, was scored on a scale of -1 to +1, and mean sentiment was compared across all categories using 1-way analysis of variance. Tukey test evaluated differences between category pairs. Google searches of 464 unique key words resulted in 11,405 URLs. Sentiment analysis was performed on 8029 relevant URLs (3472 legal, 1625 "medical", 1774 "reference", 666 "news media", 492 "patient generated"). The mean sentiment for all relevant Web sites was +0.01 ± 0.16; analysis of variance revealed significant differences between categories (P < 0.001). Web sites categorized as "legal" and "news/media" had a slightly negative mean sentiment, whereas those categorized as "medical," "reference," and "patient generated" had slightly positive mean sentiments. Tukey test showed differences between all category pairs except the "medical" versus "reference" in comparison with the largest mean difference (-0.13) seen in the "legal" versus "reference" comparison. Web sites related to vaginal mesh have an overall mean neutral sentiment, and Web sites categorized as "medical," "reference," and "patient generated" have significantly higher sentiment scores than related Web sites in "legal" and "news/media" categories.

Additional treatments, satisfaction, symptoms and quality of life in women 1year after vaginal and abdominal pelvic organ prolapse repair.

To evaluate additional treatments, symptoms, satisfaction and quality of life 1year after vaginal and abdominal pelvic organ prolapse (POP) repair. Adult women enrolled in a prospective POP database were reviewed. Baseline and outcomes data 1year after surgery were collected including the Pelvic Floor Distress Inventory (PFDI) and mailed surveys. Data were analyzed with descriptive statistics, Fisher's exact tests and t tests. Of 222 women, 147 (66%) had vaginal and 75 (34%) had abdominal repair. Vaginal group patients were older (64.1 vs. 59.7years; p = 0.003), but other demographic characteristics did not differ. Vaginal group patients had lower baseline anterior and apical prolapse grades (anterior 2.7 vs. 3.1, p = 0.003; apical 2.1 vs. 3.1, p < 0.001). Baseline PFDI scores were similar. Scores improved significantly for both groups after 1year, but 1-year PFDI scores were significantly higher in the vaginal group (45.6 vs. 32.6, p = 0.032). Scores were not different when adjusted for age and prolapse grade (p = 0.24). At 1year, most patients in the vaginal and abdominal groups reported moderately/markedly improved overall symptoms (72/108 vs. 50/60, p = 0.030) and quality of life (89/101 vs. 54/59, p = 0.601). Most were satisfied with surgery (68/101 vs. 48/59, p = 0.067). Retreatment rates (pelvic floor physical therapy, medications, coping strategies, surgical procedures) were similar (34/109 vs. 15/62, p = 0.381). Vaginal mesh use did not affect additional treatments, patient satisfaction or symptoms. Although symptoms improve and most women are satisfied with surgery, about one in four women have additional therapy in the first year after POP repair.

Vaginal mesh in prolapse surgery

Key content Mesh used in gynaecology can be permanent or absorbable. According to the Amid classification, there are four types of permanent synthetic mesh. In gynaecology, type 1 monofilament polypropylene mesh is used. Autologous, cadaveric (allograft) or porcine/bovine (xenograft) meshes are more correctly termed ‘grafts’. All are prepared so they are acellular, and free of antigens and viruses. Mesh usage has seen a rise and subsequent decline. When using mesh in practice, it is imperative to adhere to criteria recommended by the National Institute for Health and Care Excellence. Learning objectives To gain an overview of the types of mesh used in gynaecological surgery and their characteristics. To understand the origins of the use of meshes in practice, and their advantages and disadvantages. To understand the criteria that must be fulfilled before using mesh to avoid litigation. Ethical issues Informed consent through shared decision making is perhaps the most important ethical issue associated with the use of vaginal mesh in prolapse surgery. The characteristics of some patients might preclude them from accessing the best surgical approach for their problems, even if it involves the use of mesh. The use of mesh is associated with greater litigation than native tissue repair.

The UK National Prolapse Survey: 10\xa0years on

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

Short-term complications associated with the use of transvaginal mesh in pelvic floor reconstructive surgery: Results from a multi-institutional prospectively maintained dataset.

Vaginal reconstructive surgery can be performed with or without mesh. We sought to determine comparative rates of perioperative complications of native tissue versus vaginal mesh repairs for pelvic organ prolapse. Using the National Surgical Quality Improvement Program (NSQIP) database, we concatenated surgical data from vaginal procedures for prolapse repair, including anterior and posterior colporrhaphy, paravaginal defect repair, enterocele repair, and vaginal colpopexy using Current Procedural Terminology (CPT) coding. We stratified this data by the modifier associated with mesh usage at the time of the procedure. We then compared 30-day perioperative outcomes, postoperative complications (bleeding, infection, etc), and readmission rates between women with and without mesh-based repairs. We identified 10 657 vaginal reconstructive procedures without mesh and 959 mesh-based repairs from 2009 through 2013. Patients undergoing mesh repair were more likely to experience at least one complication than native tissue repair (9.28% vs 6.15%, P < 0.001), with the overall complication rate also being higher in the mesh group (11.37% vs 9.39%, P = 0.03). Procedures with mesh had a higher rate of perioperative bleeding requiring transfusion than native tissue repair (2.3% vs 0.49%, P < 0.001), and organ surgical site infection (SSI) (0.52% vs 0.17%, P = 0.02). There were no significant differences in rates of readmission, superficial, or deep SSIs, pneumonia, urinary tract infection, sepsis, or renal failure. The use of vaginal mesh for pelvic organ prolapse repair appears to result in a higher rate of perioperative complications than native tissue repair. Patients undergoing these procedures should be counselled preoperatively concerning these risks.

Patients’ Perspectives on Vaginal Mesh Use in Pelvic Reconstructive Surgery Prior to and After Initial Medical Consultation

To determine patients’ background knowledge and attitudes towards vaginal mesh use in pelvic reconstructive surgery before and immediately after medical consultation.

The mesh controversy

Pelvic organ prolapse and stress urinary incontinence are common conditions for which approximately 11% of women will undergo surgical intervention in their lifetime. The use of vaginal mesh for pelvic organ prolapse and stress urinary incontinence rose rapidly in the early 2000s as over 100 mesh products were introduced into the clinical armamentarium with little regulatory oversight for their use. US Food and Drug Administration Public Health Notifications in 2008 and 2011, as well as reclassification of transvaginal mesh for prolapse to class III in early 2016, were a response to debilitating complications associated with transvaginal mesh placement in many women. The midurethral sling has not been subject to the same reclassification and continues to be endorsed as the “gold standard” for surgical management of stress urinary incontinence by subspecialty societies. However, litigators have not differentiated between mesh for prolapse and mesh for incontinence. As such, all mesh, including that placed for stress urinary incontinence, faces continued controversy amidst an uncertain future. In this article, we review the background of the mesh controversy, recent developments, and the anticipated role of mesh in surgery for prolapse and stress urinary incontinence going forward.