Transvaginal Mesh Placement Research Articles

Prediction of Pelvic Organ Prolapse Postsurgical Outcome Using Biomaterial-Induced Blood Cytokine Levels: Machine Learning Approach.

Pelvic organ prolapse (POP) refers to symptomatic descent of the vaginal wall. To reduce surgical failure rates, surgical correction can be augmented with the insertion of polypropylene mesh. This benefit is offset by the risk of mesh complication, predominantly mesh exposure through the vaginal wall. If mesh placement is under consideration as part of prolapse repair, patient selection and counseling would benefit from the prediction of mesh exposure; yet, no such reliable preoperative method currently exists. Past studies indicate that inflammation and associated cytokine release is correlated with mesh complication. While some degree of mesh-induced cytokine response accompanies implantation, excessive or persistent cytokine responses may elicit inflammation and implant rejection. Here, we explore the levels of biomaterial-induced blood cytokines from patients who have undergone POP repair surgery to (1) identify correlations among cytokine expression and (2) predict postsurgical mesh exposure through the vaginal wall. Blood samples from 20 female patients who previously underwent surgical intervention with transvaginal placement of polypropylene mesh to correct POP were collected for the study. These included 10 who experienced postsurgical mesh exposure through the vaginal wall and 10 who did not. Blood samples incubated with inflammatory agent lipopolysaccharide, with sterile polypropylene mesh, or alone were analyzed for plasma levels of 13 proinflammatory and anti-inflammatory cytokines using multiplex assay. Data were analyzed by principal component analysis (PCA) to uncover associations among cytokines and identify cytokine patterns that correlate with postsurgical mesh exposure through the vaginal wall. Supervised machine learning models were created to predict the presence or absence of mesh exposure and probe the number of cytokine measurements required for effective predictions. PCA revealed that proinflammatory cytokines interferon gamma, interleukin 12p70, and interleukin 2 are the largest contributors to the variance explained in PC 1, while anti-inflammatory cytokines interleukins 10, 4, and 6 are the largest contributors to the variance explained in PC 2. Additionally, PCA distinguished cytokine correlations that implicate prospective therapies to improve postsurgical outcomes. Among machine learning models trained with all 13 cytokines, the artificial neural network, the highest performing model, predicted POP surgical outcomes with 83% (15/18) accuracy; the same model predicted POP surgical outcomes with 78% (14/18) accuracy when trained with just 7 cytokines, demonstrating retention of predictive capability using a smaller cytokine group. This preliminary study, incorporating a sample size of just 20 participants, identified correlations among cytokines and demonstrated the potential of this novel approach to predict mesh exposure through the vaginal wall following transvaginal POP repair surgery. Further study with a larger sample size will be pursued to confirm these results. If corroborated, this method could provide a personalized medicine approach to assist surgeons in their recommendation of POP repair surgeries with minimal potential for adverse outcomes.

MP07-10 BEFORE AND AFTER THE BAN: NATIONAL INCIDENCES OF TRANSVAGINAL MESH PLACEMENT AND REMOVAL FOR PELVIC ORGAN PROLAPSE

You have accessJournal of UrologyCME1 Apr 2023MP07-10 BEFORE AND AFTER THE BAN: NATIONAL INCIDENCES OF TRANSVAGINAL MESH PLACEMENT AND REMOVAL FOR PELVIC ORGAN PROLAPSE Elie Kaplan-Marans, Mariela Martinez, Arshia Sandozi, Jeffrey Lee, Dhaval Jivanji, Karis Buford, and Allison Polland Elie Kaplan-MaransElie Kaplan-Marans More articles by this author , Mariela MartinezMariela Martinez More articles by this author , Arshia SandoziArshia Sandozi More articles by this author , Jeffrey LeeJeffrey Lee More articles by this author , Dhaval JivanjiDhaval Jivanji More articles by this author , Karis BufordKaris Buford More articles by this author , and Allison PollandAllison Polland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003222.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In April 2019, the Food and Drug Administration (FDA) banned manufacturers from selling and distributing mesh for transvaginal repair of pelvic organ prolapse (POP). We assessed national incidences of transvaginal mesh placement and revision or removal for POP before and after the ban. METHODS: The Medicare Physician and Other Practitioners database was queried for all transvaginal mesh placements and revisions or removals for POP between 2013 and 2020 using CPT codes 57267 and 57295, respectively. Linear regression was performed with statistical significance set to 95% confidence intervals. RESULTS: A total of 51,234 mesh placements and 15,854 mesh revisions or removals were identified. As shown in the Figure 1, there was a significant and gradual downward trend in utilization of both procedures during the study period, without precipitous changes after the ban (mesh placement, R2=0.97, p<0.001; mesh revisions or removals, R2=0.97, p<0.001). From 2013 to 2020, mesh placement decreased from 10,397 to 2,813 cases (370%) and mesh revision or removal decreased from 2,975 to 1,091 cases (270%). Despite the FDA ban, transvaginal mesh placement for POP was still performed in 2020 (2,813 cases). CONCLUSIONS: There was not a precipitous decline in the use of transvaginal mesh for prolapse after the 2019 ban. Utilization has instead gradually decreased since the original FDA notification in 2011. Physicians may now be using the remaining stock of transvaginal mesh or other types of mesh that are off-label for prolapse repair. It is important to discuss the risks and benefits of using transvaginal mesh as well as the FDA notification and ban with patients prior to prolapse surgery. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e88 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Elie Kaplan-Marans More articles by this author Mariela Martinez More articles by this author Arshia Sandozi More articles by this author Jeffrey Lee More articles by this author Dhaval Jivanji More articles by this author Karis Buford More articles by this author Allison Polland More articles by this author Expand All Advertisement PDF downloadLoading ...

Early Experience of Transabdominal and Novel Transvaginal Robot-Assisted Laparoscopic Removal of Transvaginal Mesh.

Background: Mesh removal after transvaginal mesh placement has typically involved transvaginal, open pelvic, laparoscopic, or a combination of approaches. Robotic pelvic mesh removal has been described in a small number of cases only. This study aims at determining the feasibility and safety of using robot-assisted laparoscopic surgery in the removal of pelvic mesh via the transabdominal and novel transvaginal approach. Materials and Methods: This is a prospective case series study on women who underwent transabdominal or transvaginal robot-assisted removal of pelvic mesh. Women were offered participation in this study with pelvic mesh and a clinical indication for mesh removal if they were older than the age of 18. Alternative surgical options, including conventional open removal of mesh, were discussed and offered to patients. The primary outcome of this study is the rate of successful removal of mesh and the 30-day complication rates. Ethics approval was obtained for this study. Results: Thirty patients were included in this study. Median age was 62. Median operative and console time was 240 and 148 minutes, respectively. Concomitant reconstructive procedures were performed in 40% of patients. Complete or near-complete mesh removal was achieved in 83.3% of patients. For the remaining patients, partial removal of mesh was performed as planned preoperatively. Three Clavien-Dindo grade 3b complications resulted from mesh removal: concomitant ureteric and bladder injury, omental bleed, and groin wound infection. Conclusion: This study presents the early experience of robotic-assisted removal of transvaginal mesh with a transvaginal or transabdominal approach and demonstrates the feasibility of removal of both retropubic and transobturator mid-urethral synthetic sling as well as transvaginal prolapse meshes with transobturator and sacrospinous mesh arms. Further studies are required to expand understanding on the learning curve, operating times, complication rates, and functional outcome of this operation.

Long-term outcomes of transvaginal mesh surgery for pelvic organ prolapse: a retrospective cohort study

BackgroundThe objective of this study was to evaluate the overall outcomes and complications of transvaginal mesh (TVM) placement for the management of pelvic organ prolapse (POP) with different meshes with a greater than 10-years of follow-up.MethodsWe performed a retrospective review of patients with POP who underwent prolapse repair surgery with placement of transvaginal mesh (Prolift kit or self-cut Gynemesh) between January 2005 and December 2010. Baseline of patient characteristics were collected from the patients’ medical records. During follow-up, the anatomical outcomes were evaluated using the POP Quantification system, and the Patient Global Impression of Improvement (PGI-I) was used to assess the response of a condition to therapy. Overall postoperative satisfaction was assessed by the following question: “What is your overall postoperative satisfaction, on a scale from 0 to 10?”. Relapse-free survival was analyzed using Kaplan–Meier curves.ResultsIn total, 134 patients were included. With a median 12-year (range 10–15) follow-up, 52 patients (38.8%) underwent TVM surgery with Prolift, and Gynemesh was used 82 (61.2%). 91% patients felt that POP symptom improved based on the PGI-I scores, and most satisfied after operation. The recurrence rates of anterior, apical and posterior compartment prolapse were 5.2%, 5.2%, and 2.2%, respectively. No significant differences in POP recurrence, mesh-associated complications and urinary incontinence were noted between TVM surgery with Prolift versus Gynemesh.ConclusionsTreatment of POP by TVM surgery exhibited long-term effectiveness with acceptable morbidity. The outcomes of the mesh kit were the same as those for self-cutmesh.

Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery.

Polypropylene (PPL) mesh is widely used in pelvic floor reconstructive surgery for prolapse and stress urinary incontinence. However, some women, particularly those treated using transvaginal PPL mesh placement for prolapse, experience intractable pain and mesh exposure or extrusion. Explanted tissue from patients with complications following transvaginal implantation of mesh is typified by a dense fibrous capsule with an immune cell-rich infiltrate, suggesting that the host immune response has a role in transvaginal PPL mesh complications through the separate contributions of the host (patient), the biological niche within which the material is implanted and biomaterial properties of the mesh. This immune response might be strongly influenced by both the baseline inflammatory status of the patient, surgical technique and experience, and the unique hormonal, immune and microbial tissue niche of the vagina. Mesh porosity, surface area and stiffness also might have an effect on the immune and tissue response to transvaginal mesh placement. Thus, a regulatory pathway is needed for mesh development that recognizes the roles of host and biological factors in driving the immune response to mesh, as well as mandatory mesh registries and the longitudinal surveillance of patients.

PD32-03 ROBOTIC SACROCOLPOPEXY WITH UTERUS PRESERVATION FOR WOMEN WITH COMPLETE VAGINAL VAULT EVERSION. SURGICAL TECHNIQUE WITH 10 YEAR EXPERIENCE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (PD32)1 Sep 2021PD32-03 ROBOTIC SACROCOLPOPEXY WITH UTERUS PRESERVATION FOR WOMEN WITH COMPLETE VAGINAL VAULT EVERSION. SURGICAL TECHNIQUE WITH 10 YEAR EXPERIENCE Cassandra Schuster, and Robert Carey Cassandra SchusterCassandra Schuster More articles by this author , and Robert CareyRobert Carey More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002033.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Robotic sacrocolpopexy with uterus preservation (RASCP-UP) is a transabdominal approach to repair of pelvic organ prolapse (POP) that avoids placement of transvaginal mesh and preserves female sexual organs. Although hysterectomy may be performed at the time of POP repair, many women choose to preserve their uterus for reasons of sexuality, female identity, religion, maintenance of maximal vaginal length, and resistance to removal of a normal organ. METHODS: Data is collected from an IRB approved prospectively maintained database of robotic POP repair in an 836 bed tertiary care hospital. The surgery is performed with a da Vinci Si or Xi system with 4 robotic ports and 1 assistant port. Commercially available 4 x 24 cm Y-shaped wide pore polypropylene mesh is modified to accommodate >10 cm anterior and posterior dissections of the vaginal walls. The anterior vaginal wall component is brought through the broad ligament and joined with the posteriorly placed component for attachment to the Anterior Longitudinal Ligament with GoreTex sutures. The mesh is then completely covered by peritoneum. All patients for RASCP-UP had Stage 4 prolapse with maximal anterior, posterior and apical descent with the cervix at the apex of the descent. All patients had normal PAP smears and pelvic ultrasounds. RESULTS: Between 2010 and 2021 a total of 351 patients underwent RASCP at the same institution. Of these, 54 presented with complete vaginal vault eversion requesting RASCP-UP. Mean age was 67.5 years and mean BMI 26.8. Cases were completed with robotic console time between 61 and 121 minutes and all patients discharged within 24-48 hours. At mean 60 month (12–124 month) follow-up, there were no mesh erosions, hernias, or reoperations for prolapse. There was one reoperation for hysterectomy at 6 year follow up for suspected endometrial carcinoma and one reoperation for small bowel obstruction in a patient with extensive lysis of adhesions. Mid-urethral slings were placed at the time of sacrocolpopexy to prevent de novo stress incontinence CONCLUSIONS: RASCP-UP is a reproducible, reliable procedure for patients with severe POP who desire uterus preservation. The surgery restores normal vaginal axis and length without placement of mesh material through vaginal mucosa. Long-term results show durable functional repair. Is the “unnecessary” removal of an otherwise normal uterus “necessary” for repair of POP? For a number of female patients, the answer appears to be no. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e545-e545 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Cassandra Schuster More articles by this author Robert Carey More articles by this author Expand All Advertisement Loading ...

Short and middle‐term outcomes of vaginally assisted laparoscopic sacropolpopexy

AbstractObjectiveVaginally assisted laparoscopic sacrocolpopexy (VALS), which is a combined surgical approach where a vaginal hysterectomy is initially performed, followed by transvaginal placement of synthetic mesh and laparoscopic suspension, can be an alternative to overcome the dissection, suturing limitations of laparoscopic sacrocolpopexy. The aim of this study was to compare the operative times and middle‐term anatomic outcomes of women with uterovaginal prolapse undergoing VALS with those of women undergoing abdominal sacrocolpopexy.MethodsThis is a prospective cohort study that evaluates operation times, anesthesia times, estimated blood loss, middle‐term outcomes, perioperative and postoperative complications. We compared the results of 47 women who had the VALS to that of 32 abdominal sacrocolpopexy (AS).ResultsThe mean follow up was 22.4 months for AS group and 20.5 months for VALS group. The VALS group (median 1 day) had shorter hospitalization duration than the AS group (median 3 days). The mean operation time was significantly shorter in the VALS group (125.9 minutes) than the AS group (151.9 minutes) (P = .03). There was no significant difference in perioperative and postoperative complication rates. Objective failure rate (8.5% in VALS, 15.6% in AS), subjective failure rates (6.4% in VALS, 9.4% in AS), recurrence (2.1% in VALS, 9.4% in AS) and mesh exposition rates (2.1% in VALS, 9.4% in AS) were similar in both procedures.ConclusionsVALS with shorter operative time and hospitalization than conventional AS is a promising modification minimally invasive technique for sacrocolpopexy especially for those inexperienced in laparoscopic sacrocolpopexy.

Reoperation rate and outcomes following the placement of polypropylene mesh by the vaginal route for cystocele: very long-term follow-up.

The aim was to evaluate the reoperation rate and outcomes in women who underwent transvaginal non-absorbable monofilament polypropylene mesh placement for the treatment of cystocele. The retrospective cohort study included 63 patients who underwent transvaginal surgery using a synthetic polypropylene mesh (Gynemesh™) for cystocele. Patients were evaluated using a clinical examination (POP-Q) and validated questionnaires (PGI-I, PFDI-20, PFIQ-7) at 18years of follow-up (median 18years [IQR 16-19]). Cumulative death rate was 13 out of 63 (20%) and rate of total loss to follow-up was 21 out of 50 (42%). Finally, among the 63 women who underwent surgery, 29 completed maximum follow-up and 21 underwent a clinical examination. The cumulative reoperation rate was 35% (22 out of 63). Three patients were reoperated on because of recurrence of pelvic organ prolapse. Among the 63 patients initially operated, vaginal mesh exposure occurred in 16 (25%) during follow-up and 11 women (17%) needed a reintervention for vaginal mesh exposure. One patient was reoperated on for bladder mesh exposure. Among the 29 women who completed follow-up, the overall postoperative improvement rate was 93% after 18years (PGI-I: 1-3). Mean overall satisfaction rate was 80 out of 100. Functional success rate was 76% (22 out of 29) and anatomical success rate was 62% (13 out of 21). The median score of the POP-DI-6 was 4.1 (IQR: 0-11) and the median score of the PFDI-20 was 30.7 (IQR: 13-60) in the 29 women who completed maximum follow-up. At very long-term follow-up, the recurrence rate of cystocele following polypropylene mesh placement by the vaginal route remained low and the satisfaction rate was high. However, we found high cumulative reoperation and mesh exposure rates.

From anatomy to patient experience in pelvic floor surgery: Mindlines, evidence, responsibility, and transvaginal mesh.

Beginning in the late 1990s, surgeons around the world widely adopted the transvaginal placement of permanent synthetic mesh for the treatment of several common pelvic floor disorders in women. By 2012 it had become the subject of extensive litigation, including one of the biggest mass-tort cases in U.S. history, with litigants reporting debilitating and unexpected complications. Based on qualitative research that includes interviews with surgeons, observations of medical conferences, and analysis of archival materials, we argue the adoption of transvaginal mesh cannot be fully explained without recognizing the role of mindlines, or collective moral-epistemological ways of knowing and acting responsibly. The adoption of mesh was anchored in a mindline focused on repairing anatomy. The harms that resulted from transvaginal mesh necessitated a shift to a focus on patient experience. We analyze the role of evidence-based medicine (EBM) in the re-organization of these surgeons' mindlines, showing that mindlines are not reducible to evidence as defined by EBM and that evidence thus defined facilitated the adoption of transvaginal mesh.

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.

"Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: " Retraction.

Female Pelvic Medicine & Reconstructive Surgery 26(5):p 349, May 2020. | DOI: 10.1097/SPV.0000000000000809

Transvaginal Mesh Placement and the Instructions for Use: A Survey of North American Urologists.

Since the issue of the FDA (Food and Drug Administration) Public Health Notification in 2008 regarding complications associated with the use of transvaginal surgical mesh for pelvic organ prolapse and stress urinary incontinence, multimillion dollar litigation has been brought against the companies that have manufactured these products. One component of the litigation has focused on risk information provided in the Instructions for Use document provided with each mesh kit. In this study we evaluated the types of urologists using transvaginal mesh kits and their use of the Instructions for Use provided with each mesh kit. A 14-question survey was e-mailed to all urologists registered with 7 of the 8 geographic sections of the American Urological Association in 2016. The survey inquired about the use of transvaginal mesh kits for prolapse and incontinence as well as how often, if ever, the urologist had read the Instructions for Use. Overall there were 314 respondents. The majority (79.3%) identified as general urologists and 12.7% identified as Female Pelvic Medicine and Reconstructive Surgery trained urologists. Of the respondents who reported having placed mid urethral slings and/or a mesh prolapse repair kit, 36.9% and 23.1%, respectively, had never read the Instructions for Use. Of those providers who had read the Instructions for Use the most common frequency was once before the first placement. The pertinent role of the Instructions for Use in mesh related litigation stands in contrast to our finding that many surgeons who use these kits read the Instructions for Use infrequently, if ever.

Management of Mesh-Related Pelvic Inflammation

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. 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. 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.

PD05-07 IMMUNOFLUORESCENCE LOCALIZATION OF BACTERIAL BIOFILMS ON EXPLANTED TRANSVAGINAL MESH SLINGS REMOVED FOR CHRONIC PAIN

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I1 Apr 2018PD05-07 IMMUNOFLUORESCENCE LOCALIZATION OF BACTERIAL BIOFILMS ON EXPLANTED TRANSVAGINAL MESH SLINGS REMOVED FOR CHRONIC PAIN Victoria Scott, A. Lenore Ackerman, Guo Liu, Wenyuan Shi, and Shlomo Raz Victoria ScottVictoria Scott More articles by this author , A. Lenore AckermanA. Lenore Ackerman More articles by this author , Guo LiuGuo Liu More articles by this author , Wenyuan ShiWenyuan Shi More articles by this author , and Shlomo RazShlomo Raz More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.415AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The development of delayed, severe pelvic pain after the transvaginal placement of a mesh sling has been observed in patients who lack overt pathology at the surgical site (e.g. erosion or nerve entrapment). We previously demonstrated that proinflammatory bacteria can be seen in mesh explants from these patients. In this study, we sought to evaluate the localization of these bacteria and examine their relationship to host inflammatory processes. METHODS Mesh sling segments and the surrounding tissue removed from patients with delayed onset of pain and no evidence of vaginal mesh erosion were fixed in paraformaldehyde and analyzed using a combination of immunofluorescence and fluorescence in situ hybridization (FISH) with a bacteria-specific probe (EUB338) as well as by H&E microscopic histology. These were compared to mesh segments removed for isolated urinary retention and no pain or erosion, which served as negative controls. RESULTS By histology, 86% (129/150) of patients with chronic pain exhibited histologic evidence of moderate-severe, macrophage-predominant chronic inflammation, in contrast to the fibrosis seen in patients with retention. FISH staining allowed us to localize a high concentration of bacterial communities on the surface of mesh fibers in patients with chronic pain. Isolated bacteria were noted in vaginal tissue surrounding the mesh as well as accumulating in peri-mesh macrophages. The negative control did not show any bacteria on the mesh or in the surrounding tissue. CONCLUSIONS These findings confirm that that bacteria isolated from explanted mesh specimens using culture-independent methods originate from focal bacterial communities on the mesh fiber surface. In addition, the macrophage-predominant inflammatory infiltrate seen on classical histology appears to correlate with mesh-adjacent macrophages harboring intracellular bacteria. This proposes a novel mechanism for the development and maintenance of chronic pain after transvaginal mesh placement; bacteria inoculated onto the mesh at the time of implantation may survive at the mesh interface, interacting with the host immune system to promote a low-level, chronic inflammation manifesting as chronic pain. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e147 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Victoria Scott More articles by this author A. Lenore Ackerman More articles by this author Guo Liu More articles by this author Wenyuan Shi More articles by this author Shlomo Raz More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Risk factors for surgical site infection after transvaginal mesh placement in a nationwide Japanese cohort.

We conducted a nationwide survey on perioperative management and antimicrobial prophylaxis of transvaginal mesh surgeries for pelvic organ prolapse in Japan to understand the practice and risk factors for surgical site infection (SSI). Health records of women undergoing tension-free vaginal mesh (TVM) surgeries from 2010 to 2012 were obtained from 135 medical centers belonging to the Japanese Society of Pelvic Organ Prolapse Surgery. The questionnaire addressed hospital volume, perioperative management, and SSI. Risk factors for SSI were investigated by comparing cases with and without SSI. The hospital volume among institutions varied from 0 to 248 per year (median 16.7). Preoperative hair removal, bowel preparation, and urine culture were routinely performed at 74 (55%), 66 (49%), and 24 (18%) hospitals, respectively. Prophylactic antimicrobials used were mostly first-generation (43%) or second-generation (42%) cephalosporin. SSI was reported in 86 of 9323 patients (0.92%). A multivariate analysis indicated lower hospital volume (odds ratio [OR], 0.995 [by 1-point increase]; P < 0.001), preoperative bowel preparation (OR, 2.08; P = 0.013), non-routine urine culture (OR, 3.00; P = 0.0006), and the use of antibiotics other than first-generation cephalosporin (OR, 5.29; P = 0.0011) as significant risk factors for SSI. In contrast, the cut-off points of hospital volume for preventing SSI was 116.7 cases (area under curve: 0.61). The prevalence of SSI in TVM surgeries was 0.92% in Japan. Lower hospital volume, bowel preparation, non-routine preoperative urine culture, and prophylactic antibiotics other than first-generation cephalosporin significantly elevated the incidence of SSI.

Clinical predictors and risk factors for vaginal mesh extrusion.

Our study aims to enhance the accuracy of the clinical diagnosis in patients with vaginal mesh extrusion following transvaginal mesh placement for pelvic organ prolapse using significant clinical parameters and risk factors. All patients who underwent vaginal mesh removal were retrospectively reviewed from January 2000 to May 2014. Eligible patients were divided into two groups according to the presence of vaginal mesh extrusion. A total of 862 patients, 798 were included. 357 (44.7%) had evidence of vaginal mesh extrusion, and 441 (55.3%) had no evidence of vaginal mesh extrusion. The mean age of the vaginal mesh extrusion group was slightly higher than in the group without vaginal mesh extrusion (58.7±11.2 vs. 56.4±11.5, respectively; p=0.002). From multivariate analysis, the significant clinical correlations for vaginal mesh extrusion were vaginal bleeding [60 (16.9) vs. 14 (3.2%), p<0.001], hispareunia [48 (13.5) vs. 15 (3.4%), OR=4.163, p<0.001], and vaginal discharge [45 (12.6) vs. 18 (4.1%), p=0.001]. The risk factors were multiple mesh implantations [218 (67.06) vs. 175 (39.68%), p<0.001] and menopause [314 (88) vs. 364 (82.7%), p=0.145]. Demographic data, including BMI, sexual activity, vaginal atrophy, both local and systemic hormonal use, smoking status, and hysterectomy status, were not significantly different, as well as the clinical symptoms including dyspareunia, vaginal infection, and symptomatic vaginal bulge. Vaginal bleeding, hispareunia, and vaginal discharge were the most significant clinical predictors for raising suspicion of vaginal mesh extrusion. Multiple mesh implantations were a significant risk factor for extrusion.

Effects of Surgical Anatomical Correction of Pelvic Anterior Compartment Defect on Lower Urinary Tract Symptoms.

To evaluate the effects of surgical anatomical correction on lower urinary tract symptoms (LUTS) in patients with a pelvic anterior compartment defect (PACD). This prospective study was carried out on 30 women who had stage II-IV PACD. The women were questioned regarding LUTS symptoms such as urgency, urge incontinence, frequency, hesitancy, abnormal emptying, nocturia and dysuria pre and postoperatively. After a 7-month follow up, the comparison of LUTS symptoms with respect to their healing, existence or de novo appearance was performed using the McNemar and Bowner and Wilcoxon signed-rank tests. For the repair of ACD, 15, 8 and 7 women were operated on using site-specific surgery, transvaginal mesh placement and anterior colporrhaphy, respectively. Surgery has significantly improved the LUTS: urgency (100 vs 26.7%, urge incontinence (70 vs 16.7%), frequency (76.7 vs 13.3%), abnormal emptying (56.7 vs 10%), hesitancy (30 vs 6.7%), nocturia (83.3 vs 60%) and dysuria (30 vs 6.7%). The differences were statistically significant (P < 0.05). The correctional surgery on anterior compartment defects not only maintains the anatomy but also significantly heals the LUTS.

Blood-supply reservation technique in transvaginal mesh for pelvic organ prolapsed

Objective To evaluate the efficacy and safety of transvaginal placement of mesh(TVM) with Blood-supply reservation technique(BRT) for treating pelvic organ prolapse(POP). Methods We retrospectively studied 201 POP patients undergoing BRT in our hospital from July 2007 to May 2013 and followed their recurrences and occurrences of mesh exposure. The 201 patients had average age of (65±11.3) years old, average BMI of (23.2±2.6) kg/m2 average parturition of (2.8±1.4) times and disease course median of (8.2±11.4) years. Results 201 POP patients underwent TVM. The average operation time was (60.6±16)min, the estimated blood loss was (62.6±43.5)ml, and the average postoperative hospital day was (9.2±4.9)d. 199 of 201 patients completed follow-up and mean follow-up time was 23.2 months. During the follow-up time, 2(1.0%) patients suffered recurrences, and 50(25.1%) patients developed related complications. The occurrence rate of mesh exposure was 1.0% (2/199). Conclusions Our technique of BRT for correction of POP is feasible in TVM procedures, which might gain favorable subjective and objective outcomes with lowest rates of mesh exposure in published data. Key words: Urogynecology; Pelvic organ prolapse; Pelvic reconstruction; Surgical complication

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.

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.