Transvaginal Synthetic Mesh Research Articles

Comparison Between Anterior-Apical Mesh (Surelift) and Anterior Mesh (Surelift-A) in Transvaginal Pelvic Organ Prolapse Surgery: Surgical and Functional Outcomes at 1-Year Follow-Up.

Surelift is a transvaginal synthetic mesh (TVM) kit that is intended to treat anterior and apical pelvic organ prolapse (POP). The kit can be configured to use an anterior-apical (Surelift) or anterior (Surelift A) approach. The aims of this study were to evaluate the short-term objective and subjective outcomes of the different approaches at the 1-year follow-up. From June 2018 to April 2021, a total of 280 patients with symptomatic advanced POP (stages III and IV) had surgery with the Surelift or Surelift A. The primary outcome was postoperative de novo stress urinary incontinence (SUI), as well as subjective evaluation based on the Urinary Distress Inventory 6 (question 3 score > 1) and Incontinence Impact Questionnaire 7, during the 1-year follow-up period. Secondary outcomes measured quality of life, the presence of lower urinary tract symptoms, and complications. In total, 265 patients were assessed. Among these, 137 had Surelift, whereas 128 underwentSurelift A with SSF. At 1-year postoperative follow-up, de novo urodynamic stress incontinence occurred more frequently in the Surelift group than in the Surelift-A group (28.8% vs 9.1% respectively, p = 0.012). Additionally, Surelift patients had a higher rate of de novo SUI than Surelift A (33.2 vs 11.4 respectively, p = 0.013). Both study groups experienced improvements in their quality of life indicators. The Surelift device is a safe and effective technique of treating advanced-stage POP. De novo urine incontinence appears to be more common in the Surelift group than in the Surelift-A group. We found good anatomical outcomes and subjective relief in both study groups, with a low complication rate.

Accreditation of an old surgical technique for stress urinary incontinence: long-term outcomes of modified autologous fascial pubovaginal sling.

To evaluate long-term outcomes of modified autologous fascial pubovaginal sling (AFPVS) in women with stress urinary incontinence (SUI). To evaluate long-term outcomes of modified AFPVS, we retrospectively reviewed the medical records of our patients from 2004 to 2015. From 2 decades ago, we have made modifications to classic surgical technique to make it simpler and faster. 199 patients were contacted with mean age of 52years. The mean follow-up period was 107months. According to Revised Urinary Incontinence Scale (RUIS) questionnaire, overall success rate was 83.9%. In patients with positive history for SUI surgery, success rate was 73% compared to 87% in those without it. Body mass index was negatively associated with cure rate. We did not encounter any major complications and most of the issues were managed conservatively. Recurrence of SUI occurred in 6 patients (3.5%) after initial improvement. Modified AFPVS is an effective surgical technique for treatment of SUI with high and durable success rate. At the present time with concerns regarding the use of transvaginal synthetic mesh, there is increasing interest and request for modified traditional procedures. It is likely that AFPVS may become more popular in upcoming years.

Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data.

The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.

Long-Term Observation on Postoperative Recurrence and Complications of Transvaginal Mesh Surgery for Pelvic Organ Prolapse

Objective: This study aims to evaluate the risk factors for subjective recurrence and complications of patients who underwent transvaginal synthetic mesh surgery. Design: This retrospective cohort study included patients who received transvaginal mesh (TVM) surgery between January 2005 and June 2019. Methods: The information of patients was collected, including basic characteristics, subjective recurrence, and mesh-related complications. The clinical characteristics of patients with and without subjective recurrence were compared. The sexual activities of patients before and after the operation were recorded. SPSS 20.0 was used for the statistical analysis. Results: A total of 257 patients were included. Among them, 62 (24.1%) patients were lost to follow-up. The median follow-up time was 80 months (12 months, 170 months). Finally, 195 patients were followed up, 11 (5.6%) patients had a subjective recurrence of pelvic organ prolapse, and 26 (13.3%) patients had mesh-related complications (11 patients with de novo pain and 15 patients with mesh exposure). We found significant differences in age (68.9 ± 5.1 vs. 63.4 ± 5.8 years old), years of postmenopause (17.5 ± 6.3 vs. 13.3 ± 6.9 years), previous hysterectomy (27.3% vs. 6.0%), and concomitant hysterectomy (45.5% vs. 81.0%) between patients with and without subjective recurrence (p < 0.05). The mesh exposure proportion of patients with total vaginal mesh (47.6%) was significantly higher than that with anterior vaginal mesh (2.9%) (p < 0.05). Furthermore, 6.7% of sexually active patients reported de novo dyspareunia. Limitation: The investigators could only record the subjective recurrence of patients, and thus there is a lack of objective recurrence data. Conclusion: Age, years of postmenopause, and previous hysterectomy are risk factors for subjective recurrence of TVM surgery; however, concomitant hysterectomy is a protective factor. Mesh exposure is the most common complication, especially for total vaginal mesh repair surgery.

Anterior Vaginal Wall Prolapse Repair and the Rise and Fall of Transvaginal Mesh. Did We Come Full Circle? A Historical Perspective

ObjectiveTo present a brief historical review of treatment options for pelvic organ prolapse with a focus on anterior vaginal wall defects and highlight changing practice patterns in the era of synthetic mesh controversy. MethodsA MEDLINE and PubMed search was performed using the keywords pelvic organ prolapse, anterior colporrhaphy, and cystocele followed by a manual search of bibliographies. ResultsAncient treatments included Hippocratic succession, local astringent, and use of pomegranates as crude pessaries. More sophisticated surgical techniques evolved in the 19th century with further refinement in the early 20th century. Numerous native tissue apposition techniques were popularized by Kelly, Kennedy, Burch, and Raz. Due to poor durability, surgeons sought alternate approaches including biologic and synthetic grafts. Synthetic transvaginal mesh (TVM) initially included use of Tantalum and Marlex to repair anterior wall defects. Both were eventually abandoned due to complications. TVM was re-designed, re-marketed, and re-introduced. Type 1 polypropylene monofilament TVM use became ubiquitous in female pelvic surgery peaking between 2004 and 2008. Initial promising outcomes were soon eclipsed by a surge of adverse events leading to multiple FDA warnings, reclassification to Class III, high-risk medical device, and ultimately a complete recall in 2019. ConclusionThe bidirectional pendulum swing on use of synthetic TVM has been occurring since its introduction 50 years ago. In the current era of mesh controversy, more practitioners are now revisiting previously described native tissue and biologic graft techniques. It appears that history has repeated itself.

Endoscopic management of transvaginal mesh kit bladder extrusion: A case report and literature review

Objective: A rare complication of transvaginal synthetic mesh kits is bladder mesh extrusion. Treatment options include abdominal or vaginal surgical mesh excision or endoscopic mesh vaporization. There are very few published studies detailing endoscopic management. This unique case describes how repeated endoscopic mesh vaporization may be required as mesh extrusion may progress. Methods: A 71-year old female with a history of pelvic organ prolapse managed with an anterior transvaginal mesh kit presented years later with persistent urgency incontinence and recurrent acute cystitis. Cystoscopy eventually revealed bladder calculi adherent to extruded mesh. The stones and extruded mesh were vaporized using the Holmium laser on three occasions over 3 years. Results: Our approach offered a minimally invasive technique with short recovery, no use of a catheter post-operatively and maintained original prolapse repair; however, these patients may be at risk of mesh extrusion recurrence. Conclusion: Bladder extrusion of transvaginal pelvic organ prolapse kit mesh is thankfully a rare complication. With no current consensus for treatment of bladder mesh extrusion, the decision to perform complete mesh excision versus endoscopic treatment should be based on the degree and location of the extrusion, the risk of major complications, mesh extrusion recurrence and the patient’s desired outcomes, including recovery time and risk for prolapse recurrence. Endoscopic vaporization of extruded pelvic organ prolapse mesh likely has a higher recurrence rate than vaginal or abdominal excision. The risks and benefits are important to discuss during counseling and informed consent in these difficult cases. Level of evidence: 4

13: Sexual function after pelvic organ prolapse surgery: A systematic review comparing different approaches to pelvic floor repair

OBJECTIVE Women consider preservation of sexual activity and improvement of sexual function as important goals following pelvic organ prolapse (POP) surgery. The aim of this systematic review is to compare sexual activity and function before and after prolapse surgery between specific approaches to POP surgery including native tissue (NT) repairs, transvaginal synthetic mesh (TVM), biologic grafts (BG), and sacrocolpopexy (SCP). DATA SOURCES MEDLINE, Embase, and clinicaltrials.gov databases from inception to March 2021. STUDY ELIGIBILITY CRITERIA Prospective comparative cohort and randomized studies of POP surgeries were included that reported specific sexual function outcomes: baseline and post-operative sexual activity, dyspareunia, and validated sexual function questionnaire scores. Four comparisons were made: TVM vs. NT, SCP vs. NT, TVM vs. SCP, and BG vs. NT. STUDY APPRAISAL AND SYNTHESIS METHODS Studies were double screened for inclusion and extracted for population characteristics, sexual function outcomes, and methodological quality. Evidence profiles were generated for each surgery comparison by grading quality of evidence for each outcome across studies using a modified GRADE system. RESULTS Screening of 3651 abstracts was performed and identified 77 original studies. The overall quality of evidence was moderate to high. There were 26 studies comparing TVM vs. NT, 5 comparing SCP vs. NT, 5 comparing TVM vs. SCP, and 7 comparing BG vs. NT. For TVM vs NT, no statistical differences were found in baseline or post-operative sexual activity, baseline or postoperative total dyspareunia, persistent dyspareunia, and de novo dyspareunia. PISQ-12 change scores were not different between TVM vs. NT (net difference -0.3; 95% CI -1.4 to 0.8). For SCP vs. NT, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, de novo dyspareunia, and PISQ-12 score differences were not different. For BG vs. NT, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, and PISQ-12 changes were also not different. For TVM vs. SCP, there was no difference in sexual activity and sexual function score change. Based on two studies, post-operative total dyspareunia was more common in TVM than SCP (27.5% vs. 12.2%, OR 2.72, 95% CI 1.33 to 5.58). Prevalence of post-operative dyspareunia was lower than pre-operative dyspareunia after all surgery types. CONCLUSIONS Sexual function comparisons are most robust between TVM and NT repairs and show similar prevalence of sexual activity, de novo dyspareunia, and sexual function scores. Total dyspareunia is higher after TVM compared to SCP. Although sexual function data are sparse in the other comparisons, no other differences in sexual activity, dyspareunia, and sexual function score change were found.

2957 Non-Mesh Sacrospinous Ligament Suspension for the Correction of Massive Vaginal Vault Prolapse and Ascites in A Patient With Stage IV Metastatic Colon Cancer

Video Objective The objective of this video is to demonstrate a non-mesh sacrospinous ligament (SSL) suspension for massive vaginal vault prolapse with ascites in a patient with stage IV metastatic colon cancer. Polyether-ether-ketone (PEEK) anchors and porcine bladder extracellular matrix for fixation and bio-scaffolding are utilized. The patient desired to undergo definitive surgical treatment of her symptomatic prolapse for the purposes of “personal dignity”. The patient also desired to maintain sexual options. Fixation utilizing PEEK anchors provides a vaginal repair that requires less dissection than traditional approaches to the SSL since anchoring is performed via palpation rather than tissue visualization. This is of great importance in patients with massive vault prolapse because of the obliteration of the operative field. The extracellular matrix provides bio-scaffolding which promotes constructive remodeling of the tissue rather than encapsulation of synthetic mesh. Risks and benefits were discussed at length including the direct spread of disease if the peritoneal cavity were entered. Synthetic polypropelene mesh continues to show diminishing acceptance with patients and continues to be a source of mass tort litigation. Internationally several jurisdictions have restricted the accessibility or banned the use of transvaginal mesh. Setting St. Agnes Hospital, Baltimore, Maryland Interventions The patient underwent transvaginal SSL suspension, anterior and posterior colporrhaphy, vaginal enterocele repair and perineoplasty utilizing PEEK anchors and porcine urinary bladder extracellular matrix. There were no intra-operative or post-operative complications. The follow up has been 8 months. The patient is currently sexually active. Conclusion Sacrospinous ligament suspension for the correction of massive vaginal vault prolapse utilizing PEEK anchors and porcine urinary bladder extracellular matrix is a reasonable alternative to transvaginal synthetic mesh repairs. Advantages to this vaginal approach include: 1) Avoidance of laparoscopic risks in a patient with massive ascites, 2) Avoidance of chronic pain, erosion and extrusion associated with synthetic mesh.

Vaginal mesh operations in the urogynecological practice after the FDA warnings. Use or not to use mesh?

The prevalence of pelvic organ prolapse (POP) with aging is escalating alarmingly, and now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh (TVM) has been employed with increasing popularity in the treatment of POP until the end of the last decade. After the U.S. Drug and Food Administration (FDA) warnings in the years 2008 and 2011, the number of vaginal mesh operations has decreased dramatically. The aim of the study was to evaluate and compare the anti-POP effectivity, the anti-stress incontinence (anti-SUI) efficacy, and the late (36 months) post-operative complications of the anterior vaginoplasty and the TVM operations. We analysed the clinical data from 120 patients with stage II-III anterior prolapse and concomitant SUI who had undergone surgery at a tertiary referral centre in Hungary between January 2013 and January 2014. Sixty patients underwent Kelly-Stoeckel vaginoplasty and the other 60 cases had TVM operation. The surgical complications were classified using the Clavien-Dindo (CD) classification system. The anti-POP (91.6% vs. 63.3%; p<0.001) and the anti-SUI efficacy (90% vs. 55%, p<0.001) were significantly higher in the TVM group than in the vaginoplasty group, while the overall extrusion rate was found 8.3% after a 3-year follow-up. The Clavien-Dindo score (CD) proved that the early post-operative complication profile was similar among the TVM patients as compared to the vaginoplasty group (p = 0.405). Vaginal mesh surgery represents an effective procedure for prolapse and concomitant SUI with a decreased risk of short- and long-term complications. Orv Hetil. 2018; 159(10): 397-404.

Efficacy of anchoring the four-arm transvaginal mesh to the mid-urethra vs original surgery as a surgical correction for stress urine incontinence in coexisting anterior vaginal prolapse grades II and III: study protocol for a randomized controlled trial

BackgroundThe prevalence of obesity with aging is escalating alarmingly; and pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh has been employed with increasing popularity in the treatment of POP and is usually highly effective in controlling the principal symptoms of prolapse. However, studies have reported that mesh operations provide fairly unfavorable SUI cure rates. Therefore, additional anti-incontinence surgical strategies are increasingly being scrutinized to achieve better postoperative continence without any significant side-effects for patients with both POP and SUI. We hypothesize that the modification with the fixing of the mesh to the mid-urethra is superior to the original transvaginal mesh operation (TVM) with regard to anti-incontinence.MethodsOne hundred and thirty patients diagnosed with POP–Q II–III and concomitant SUI requiring surgical treatment will be included in this prospective, randomized, double-blind, controlled clinical trial. Patients will be randomly allocated to receive either original TVM (TVM group, n = 65) or modified TVM surgery (mTVM group, n = 65). As the primary outcome parameter, we will evaluate the objective SUI and POP cure rates. Secondary endpoints include postoperative morbidity as assessed with the International Urogynaecological Association classification and subjective prolapse and incontinence cure rates reported by questionnaires.DiscussionRecognizing the importance of an additional surgical procedure for anti-incontinence management, we aim to investigate whether a stabilizing suturing of the mesh to the mid-urethra delivers superior SUI correction compared to the original prosthesis surgery.Trial registrationClinicalTrials.gov, NCT02935803. Registered on 20 May 2016.

300 - Laparoscopic Excision of Anterior Vaginal Wall Prolapse Mesh Kit

This video presents the technique of laparoscopic excision of an anterior vaginal wall prolapse mesh kit. A 67-year-old female underwent repair of anterior compartment defect using transvaginal synthetic mesh in 2009. She complained of persistent vaginal pain and dyspareunia. We removed the central portion of the mesh vaginally, followed by laparoscopic excision of remaining 4 arms of the mesh. This video will demonstrate the anatomical relations of the mesh and the key surgical principles followed during mesh dissection from the underlying tissue. Mesh was extracted successfully from both sides and resulted in resolution of patient's symptoms on the follow up.

Lessons Learned from the MAUDE Database on Transvaginal Synthetic Mesh and Sling Reports

IntroductionWe investigated the volume and sources of MDRs (medical device reports) on transvaginal mesh and sling complications in the FDA (Food and Drug Administration) MAUDE (Manufacturer and User Facility Device Experience) database. MethodsWe extracted and analyzed reports on transvaginal mesh and sling complications submitted to the MAUDE database from 2008 to 2014. We also examined reports for major mesh and sling brands as well as reporter occupation. ResultsThe number of reports on transvaginal mesh and sling implants increased slowly from 2008 to 2011, ending with 1,687 reports in 2011. In 2012 the volume increased nearly sevenfold, yielding 11,710 reports. The year 2013 witnessed an even greater surge, with a total of 43,680 complication reports. This trend quickly subsided in 2014 as the number of reports decreased to 5,467. Meanwhile, the number of attorney submitted reports greatly increased by a factor of 18.6 in 2012 and then by a smaller increment in 2013. Physician submitted reports increased threefold in 2012 and then by a factor of 5.6 in 2013. Unfortunately more than half of the 2013 reports list an unknown occupation for the reporter. ConclusionsThe marked growth of transvaginal mesh and sling reports in the MAUDE database, as well as attorney submitted reports, correlated with the timing of the 2011 FDA issued notification warning the public about the risk of complications associated with transvaginal mesh placement. Despite some shortcomings, the MAUDE database offers an appropriate tool to measure overall trends of device complications and serves as a vehicle for the FDA to alert the public regarding potential dangers.

Outcomes of Autologous Fascia Pubovaginal Sling for Patients with Transvaginal Mesh Related Complications Requiring Mesh Removal

We reviewed the outcomes of the autologous fascial pubovaginal sling as a salvage procedure for recurrent stress incontinence after intervention for polypropylene mesh erosion/exposure and/or bladder outlet obstruction in patients treated with prior transvaginal synthetic mesh for stress urinary incontinence. In a review of surgical databases at 2 institutions between January 2007 and June 2013 we identified 46 patients who underwent autologous fascial pubovaginal sling following removal of transvaginal synthetic mesh in simultaneous or staged fashion. This cohort of patients was evaluated for outcomes, including subjective and objective success, change in quality of life and complications between those who underwent staged vs concomitant synthetic mesh removal with autologous fascial pubovaginal sling placement. All 46 patients had received at least 1 prior mesh sling for incontinence and 8 (17%) had received prior transvaginal polypropylene mesh for pelvic organ prolapse repair. A total of 30 patients underwent concomitant mesh incision with or without partial excision and autologous sling placement while 16 underwent staged autologous sling placement. Mean followup was 16 months. Of the patients 22% required a mean of 1.8 subsequent interventions an average of 6.5months after autologous sling placement with no difference in median quality of life at final followup. At last followup 42 of 46 patients (91%) and 35 of 46 (76%) had achieved objective and subjective success, respectively. There was no difference in subjective success between patients treated with a staged vs a concomitant approach (69% vs 80%, p = 0.48). Autologous fascial pubovaginal sling placement after synthetic mesh removal can be performed successfully in patients with stress urinary incontinence as a single or staged procedure.

Two-years results of native tissue versus vaginal mesh repair in the treatment of anterior prolapse according to different success criteria: A randomized controlled trial.

To compare efficacy and safety of the traditional colporraphy and transvaginal polypropylene mesh for the treatment of advanced anterior vaginal prolapse according to different success criteria in two-year follow-up. In this randomized controlled trial, women with anterior prolapse stage II or greater, with Ba point ≥ +1 (POP-Q quantification), were randomly assigned to have either anterior colporraphy (n = 43) or transvaginal mesh repair (n = 43). The primary outcome was to compare objective success rate under two success definitions: prolapse stage I (Ba < -1) and stage II (Ba < 0). Secondary outcomes included complications and prolapse symptoms, satisfaction and quality of life (QoL). Intention to treat was used for the primary endpoint and per protocol analysis for the secondary outcomes. The groups presented similar preoperative data. Thirty three patients from the colporraphy and 37 from the mesh groups completed two-year follow-up. Under Ba < -1 definition, success rate was 39.53% for both groups (P = 1.00). Considering success as Ba < 0, analysis favored the mesh group by 23% (51.16% and 74.42%; 95% CI for difference: 3-43%; P = 0.022). Patients from the mesh group were more satisfied after two years (81.8% and 97.3% for colporraphy and mesh, respectively, 15.5% difference; 95% CI for difference 1-29%; P = 0.032). Both procedures similarly improved women's symptoms and QoL. Some complications were observed, one being a 13.5% mesh exposure rate. Transvaginal synthetic mesh repair for advanced anterior vaginal prolapse provided higher anatomical success and satisfaction rates compared with traditional colporraphy. Both procedures equally improved quality of life. Neurourol. Urodynam. 35:509-514, 2016. © 2015 Wiley Periodicals, Inc.

Long-Term Follow-up of Treatment for Synthetic Mesh Complications

Transvaginal synthetic mesh products were introduced more than 10 years ago to improve success rates of traditional pelvic organ prolapse and stress urinary incontinence repair methods. However, limited data are available showing symptomatic benefits of transvaginal mesh use. Moreover, with increased use of vaginal mesh, there has been increasing incidence of mesh complications, including vaginal mesh exposure and contraction. Although several treatments of mesh complications have been investigated, it is unclear whether these treatments alleviate their symptoms, especially long-term. This retrospective study had 2 aims. The first was to describe the presenting symptoms, findings, and treatment of complications resulting from placement of synthetic vaginal mesh. The second was to describe the self-reported improvement and function at least 6 months after treatment of complications. Women presenting with mesh complications at a single urogynecology center between 2006 and 2011 were identified by diagnostic codes. Data were abstracted from a chart review of medical records; the women were asked to complete a follow-up questionnaire consisting of several validated survey instruments. One hundred eleven women met criteria for inclusion and were evaluated for complications associated with synthetic mesh. The mean interval from the placement of mesh to presentation for evaluation of symptoms was 2.4 years. Of the 111 women, 93 (84%) were referred from outside hospitals. Mesh complications occurred with the following index surgeries: vaginal mesh kits/vaginally placed mesh (47%), midurethral mesh slings (38%), abdominally placed vaginal mesh (11%), and vaginal mesh kit with concomitantly placed mesh sling (4.5%). The most common complications reported were mesh extrusion (65%), mesh contraction (17%), chronic pelvic pain (16%), and obstructive voiding (9%). Ninety-eight women (88%) underwent multidisciplinary treatment by urogynecologists, pelvic pain specialists, or physical therapists; 85 (87%) of these underwent mesh excision. Follow-up data were provided by 84 (76%) of the patients at a mean interval since management of the complication of 2.3 years. At follow-up, the mean (SD) Pelvic Floor Distress Inventory and EuroQol-5 Dimension questionnaire index scores were 98 (67) and 0.69 (0.23), respectively. Vaginal discharge was reported by 22% of the women; 15% had vaginal bleeding or spotting, and 45% sexually inactive women were abstinent because of mesh-related problems. At follow-up, 71% of the women reported being overall better than their status when presenting with the mesh complication, whereas 29% were the same or worse. These data show that, 2 years after multidisciplinary treatment of vaginal mesh complications, symptoms are still reported that negatively impact quality of life. Mesh complications are difficult to treat successfully. Most patients require surgical intervention.

MP75-17 PRESENTATION AND MANAGEMENT OF PATIENTS WITH MESH COMPLICATIONS: EXPERIENCE AT A SINGLE INSTITUION

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology II1 Apr 2014MP75-17 PRESENTATION AND MANAGEMENT OF PATIENTS WITH MESH COMPLICATIONS: EXPERIENCE AT A SINGLE INSTITUION Leah Nakamura, Judy Choi, Diana Kang, Erin Mellano, Tamara Hartshorn, Z. Chad Baxter, Ja Hong Kim, Larissa Rodriguez, and Shlomo Raz Leah NakamuraLeah Nakamura More articles by this author , Judy ChoiJudy Choi More articles by this author , Diana KangDiana Kang More articles by this author , Erin MellanoErin Mellano More articles by this author , Tamara HartshornTamara Hartshorn More articles by this author , Z. Chad BaxterZ. Chad Baxter More articles by this author , Ja Hong KimJa Hong Kim More articles by this author , Larissa RodriguezLarissa Rodriguez More articles by this author , and Shlomo RazShlomo Raz More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2390AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Transvaginal mesh has been utilized for the treatment of pelvic organ prolapse (POP) and urinary incontinence for many years. Recently there has been an increase in the number of mesh complications seen, especially at tertiary referral centers. This study aimed to evaluate the trends in patients presenting with mesh complications and how management has changed over time at a single institution. METHODS A retrospective review was performed on women who presented to our institution with complications related to the placement of transvaginal mesh between June 2009 and February 2013. Patients were identified through CPT codes for revision of a prosthetic vaginal graft or sling and/or if they had an evaluation including a translabial US for mesh. Only patients who had synthetic transvaginal mesh for pelvic organ prolapse or urinary incontinence were included in the analysis. The FDA warning update on transvaginal mesh was reported in 2011, therefore overall trends were divided into the time periods before and after June 2011. Demographics and variables were obtained from medical records. Statistical analysis was performed using t-tests and chi square analysis. RESULTS There were 468 patients who presented with transvaginal mesh complications. Out of these patients, 420 went on to have surgery. The tables below display the results broken down before and after June 2011 CONCLUSIONS After the FDA update in 2011, there has been an increasing number of referred cases of mesh complications. Operative time is slightly longer likely secondary to more cases of complete mesh removal. More patients are presenting with pain, dyspaureunia, complications of sacrocolpopexy and systemic complaints. There are less patients presenting with incontinence and mesh exposure. Demographics of patients with mesh complications Before June 2011 (n=205) After June 2011 (n=263) P value Mean Age (years) 58.7 57.9 0.54 Mean BMI (kg/m2) 26.5 28.1 0.003 Mean operative time (minutes) 74 104.5 <0.001 Mean mesh removed (cm) 9.8 8.4 0.79 Mean number of operations 2.6 1.5 <0.001 Sling only (percentage of patients) 52% 57% Prolapse mesh +/- sling (percentage of patients) 46% 36% Sacrocolpopexy +/- sling (percentage of patients) 2% 7% Outside referrals (percentage of patients) 69.8% 89.3% Complete mesh removal (percentage of patients) 9% 37% Presenting complaints of patients with mesh complications Presenting complaint Before June 2011 After June 2011 Urinary tract infections 35.5% 43.8% Pain 59.2% 73.2% Dyspareunia 45.6% 60.5% Obstruction/retention 45% 46.9% Mesh exposure 60.2% 42% Incontinence 62.7% 47% Bowel complaints 15.4% 14.1% Systemic complaints 3% 15.5% © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e880 Peer Review Report Advertisement Copyright & Permissions© 2014MetricsAuthor Information Leah Nakamura More articles by this author Judy Choi More articles by this author Diana Kang More articles by this author Erin Mellano More articles by this author Tamara Hartshorn More articles by this author Z. Chad Baxter More articles by this author Ja Hong Kim More articles by this author Larissa Rodriguez More articles by this author Shlomo Raz More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Translabial Ultrasonography for Evaluation of Synthetic Mesh in the Vagina

To compare the clinical and surgical findings using translabial ultrasonography (US) in the evaluation of symptoms after transvaginal synthetic mesh placement. From 2009 through 2010, a retrospective observational study was conducted to evaluate patients presenting with complaints after transvaginal mesh implantation for the treatment of stress urinary incontinence or pelvic organ prolapse repair. The clinical and translabial US findings were compared with the intraoperative findings, with a focus on mesh location, erosion, and extrusion. A total of 51 consecutive patients (mean age 59 years) were evaluated by history and physical examination, translabial US, and intraoperative findings. Using intraoperative findings as the reference standard, translabial US was able to predict the location of the sling in relationship to the urethra (6 distal, 25 mid-urethral, and 20 at the bladder neck), to differentiate between transobturator (n= 21) and retropubic (n= 30) slings, and to detect all anterior (n= 21) and posterior (n= 15) placed mesh. Translabial US was superior to physical examination in identifying mesh erosion into the periurethral fascia or sphincteric unit. US was inferior to physical examination in diagnosing vaginal extrusion but was superior for locating the mesh. Translabial US can identify the mesh material used to treat stress urinary incontinence and pelvic organ prolapse. It provides additional information on sling type, mesh location, and morphology compared with the clinical findings and could help in surgical planning and counseling. Prospective clinical studies evaluating the reliability of this technique in larger patient populations are warranted.

Indications, Contraindications, and Complications of Mesh in Surgical Treatment of Pelvic Organ Prolapse

Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use.

The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial

Introduction and hypothesisThe aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.MethodsThis is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80 % with 5 % cutoff point (p < 0.05) for statistical significance.ResultsThe groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5 % (95 % confidence interval 0.068–0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5 % of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).ConclusionsTrocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.