Mesh Kits 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.

Specialty-Specific Trends in Surgery for Apical Pelvic Organ Prolapse Post Vaginal Mesh.

Since transvaginal mesh (VM) kits for apical pelvic organ prolapse (APOP) were labeled "high-risk" in 2016 and subsequently banned in 2019 by the U.S. Food and Drug Administration, the most common remaining surgical options include abdominal mesh-augmented sacrocolpopexy (AS) and transvaginal native tissue suspension (VN). The objective of this study was to determine temporal trends in APOP procedures for urologists and gynecologists. Between 2011 and 2020, the American College of Surgeons National Surgical Quality Improvement Program database was queried for AS, VM, and VN. There were 26,477 cases of APOP repair (32% AS, 6% VM, 62% VN) included, 9% by urologists. Urologists operated on older (65 vs 61 years) patients with more medical comorbidities. Urologists performed significantly higher proportion of AS (65% vs 29%) and VM (8% vs 6%) relative to VN (27% vs 65%) than gynecologists ( P < 0.0001). Transvaginal mesh utilization has decreased over time for both specialties ( P < 0.05); nonsignificant trends toward increasing AS ( P = 0.1646) in urologists and VN ( P = 0.0913) in gynecologists concurrently occurred. Significant independent predictors of the operating surgeon being a urologist were surgery being performed in the latter half of the cohort (2016-2020; odds ratio [OR], 1.22), non-White patient race (OR < 1 for all), a concomitant sling being placed (OR = 0.89), the surgery being VM (OR = 2.95) or AS (OR = 4.36), the patient being older (OR > 1 for each age range), and having a higher frailty index score (OR = 1.16). Significant differences in APOP repair choices exist between specialties. Urologists operate on older, more medically complex patients while demonstrating a strong preference for mesh-augmented compared with transvaginal native tissue repairs.

Restriction of Surgical Options for Pelvic Floor Disorders.

The purpose of this document is to update the 2013 AUGS Position Statement based on subsequent decisions made by the U.S. Food and Drug Administration, published clinical data, and relevant society and national guidelines related to the use of surgical mesh. Urogynecologists specialize in treating pelvic floor disorders, such as pelvic organ prolapse (POP) and urinary incontinence, and have been actively involved and engaged in the national and international discussions and research on the use of surgical mesh in the treatment of POP and stress urinary incontinence. In 2019, the U.S. Food and Drug Administration ordered manufacturers of transvaginally placed mesh kits for prolapse to stop selling and distributing their devices, stating that the data submitted did not provide a reasonable assurance of safety and effectiveness. Evidence supports the use of mesh in synthetic midurethral sling and abdominal sacrocolpopexy. The American Urogynecologic Society (AUGS) remains opposed to any restrictions that ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders. The AUGS supports the U.S. Food and Drug Administration's recommendations that surgeons thoroughly inform patients seeking treatment for POP about the risks and benefits of all potential treatment options, including nonsurgical options, native tissue vaginal repairs, or abdominally placed mesh. There are certain clinical situations where surgeons may assert that the use and potential benefit of transvaginal mesh for prolapse outweighs the risk of other routes/types of surgery or of not using mesh. The AUGS recommends that surgeons utilize a shared decision-making model in the decision-making process regarding surgical options, including use of transvaginally placed mesh.

Anterior-apical Transvaginal Mesh (Calistar-S) for Treatment of Advanced Urogenital Prolapse: Surgical and Functional Outcomes at 1 Year.

Calistar-S is a single-incision synthetic mesh kit that addresses apical and anterior compartment prolapse. The aims of this study were to evaluate the short-term objective and subjective outcomes at the 1-year follow-up. The secondary objectives were to evaluate quality of life and lower urinary tract symptoms (LUTS) outcomes, as well as surgical complications. Records of 108 patients with symptomatic advanced pelvic organ prolapse (stages III and IV) who underwent prolapse surgery using the Calistar-S system from June 2018 to August 2022 were reviewed. The primary outcome was the objective cure of anterior and apical prolapse < stage 1, and the subjective cure was the negative response to questions 2 and 3 of the Pelvic Organ Prolapse Distress Inventory-6. Secondary outcomes measured quality of life, the presence of lower urinary tract symptoms, and complications. A total of 101 patients were evaluated. The overall objective cure rate is 97% and the subjective cure rate is 92.1%. Good outcomes were seen in all three compartments. Secondary outcomes show significant improvement in all validated questionnaires. Persistence and de novo urinary incontinence were 15.2% and 18.2% post-operatively. There is one case of bladder injury and one case of vaginal mesh exposure. The Calistar-S System is a safe and efficient method for treating advanced-stage POP. We observed good anatomical results and subjective relief with a minimal complication rate. LUTS have also been positively affected, showing a high success rate. Additional studies are needed to establish the long-term efficacy of this system.

Anterior approach sacrospinous hysteropexy: native tissue compared with mesh-augmented repair for primary uterovaginal prolapse management.

Anterior sacrospinous hysteropexy (SSH) was popularized by transvaginal mesh kits. Following mesh-kit market withdrawal, we hypothesized similar efficacy through native-tissue reattachment of the pubocervical fascia with fixation of the anterior cervix to the sacrospinous ligament. Few analyses for anterior native-tissue versus mesh-augmented SSH exist. A retrospective analysis of women who underwent transvaginal anterior SSH between 01 January 2016 and 31 December 2022 was performed. Women who underwent a mesh-augmented (Uphold Lite Vaginal Support System™) versus native-tissue repair were compared. Composite success was defined as no bulge symptoms, no retreatment, and no recurrence beyond the hymen with apex nondescended > one third of the total vaginal length. Descriptive and bivariate statistics were obtained as indicated. Of 223 women screened, inclusion criteria were met by 124 (40 mesh-augmented; 84 native-tissue). There was no difference in pre-operative characteristics between groups. Composite success was demonstrated in 95.2% of women with a median follow-up of 224 days (range: 30-988). Two women in the mesh-augmented group reported bulge symptoms and underwent re-treatment with a pessary. Four women in the native-tissue group reported bulge symptoms; 3 underwent re-treatment (2 pessary, 1 surgery). There were no differences in composite success rates between groups (p=0.954). There were additionally no differences in intra-operative (p=0.752) or post-operative (p=0.292) complication rates between the groups. There were no mesh-related complications, including exposure or chronic pelvic pain. Ninety-five percent of women achieved surgical success and the use of mesh augmentation did not confer added benefit in terms of efficacy or complications when compared with native tissue. Further long-term data are needed to continue our assessment of native-tissue anterior SSH.

MP07-17 NATIVE TISSUE ANTERIOR SACROSPINOUS HYSTEROPEXY IS AN EFFECTIVE AND SAFE APPROACH FOR PRIMARY UTEROVAGINAL PROLAPSE COMPARED TO MESH AUGMENTED REPAIR

You have accessJournal of UrologyCME1 Apr 2023MP07-17 NATIVE TISSUE ANTERIOR SACROSPINOUS HYSTEROPEXY IS AN EFFECTIVE AND SAFE APPROACH FOR PRIMARY UTEROVAGINAL PROLAPSE COMPARED TO MESH AUGMENTED REPAIR Tyler Overholt, Liliya Velet, Mark Xu, Rahul Dutta, and Catherine Matthews Tyler OverholtTyler Overholt More articles by this author , Liliya VeletLiliya Velet More articles by this author , Mark XuMark Xu More articles by this author , Rahul DuttaRahul Dutta More articles by this author , and Catherine MatthewsCatherine Matthews More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003222.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Anterior sacrospinous hysteropexy (SSH) was popularized by transvaginal mesh kits. Following market withdrawal, we hypothesized similar efficacy could be achieved through native tissue reattachment of the pubocervical fascia to the cervix with fixation of the anterior cervix to the sacrospinous ligament. Few analyses exist for the efficacy of anterior SSH using native tissue versus mesh augmented repair. METHODS: A retrospective analysis of women who underwent transvaginal SSH at a tertiary center between 01/16-12/21 was performed. Women underwent mesh augmented repair using the Uphold Lite Vaginal Support System or a native tissue anterior SSH. Demographic, clinical, and operative data were reviewed. Composite success was defined as no bulge symptoms, no prolapse retreatment, and no recurrent prolapse beyond the hymen with apex non descended > 1/3 the total vaginal length. Descriptive and bivariate statistics were performed as indicated. RESULTS: We compared the data for 97 women (40 mesh augmented; 57 native tissue). There was no difference in age, BMI, or vaginal delivery history between groups (p > 0.05). Median pre operative POP Q was stage III. Those in the mesh augmented group were more likely to have undergone a prior prolapse (p=0.003) or intra abdominal (p=0.015) surgery. There was no difference in surgical time (p=0.211) between groups (Table 1). The median post procedure follow up time was 8.2 months. The composite success rate was 95% for all women (Table 1). Anatomic success was demonstrated in 100% of patients. Vaginal bulge symptoms were reported by 2 women in the mesh augmented group compared to 3 in the native tissue group (p=0.999). One woman in the mesh augmented group underwent retreatment (pessary) compared to 3 in the native tissue group (2 pessary, 1 surgery; p=0.639). There was no difference in intra operative (p=0.999) or 30 day post operative (p=0.775) complication rate between groups (Table 1). CONCLUSIONS: Ninety five percent of women who underwent an anterior SSH achieved surgical success. The use of mesh augmentation did not confer any added benefit in terms of efficacy or complications when compared to native tissue. Further long term data is needed to continue our assessment of native tissue anterior SSH. Source of Funding: NA © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e91 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tyler Overholt More articles by this author Liliya Velet More articles by this author Mark Xu More articles by this author Rahul Dutta More articles by this author Catherine Matthews More articles by this author Expand All Advertisement PDF downloadLoading ...

Subjective outcomes 12 years after transvaginal mesh versus native tissue repair in women with recurrent pelvic organ prolapse; a randomized controlled trial

Introduction and hypothesisThe present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study.MethodsOne hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome.ResultsAt 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03).ConclusionsThere was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.

Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse

Transvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear. To assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP. This multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020. Participants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh. The primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and/or interventional radiological procedures; and grade 4, life threatening). Among 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P = .006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P = .14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P = .23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P < .01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh. In this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income. ClinicalTrials.gov identifier: NCT03283124.

Ten-year surgical complications and mesh erosion of transvaginal Elevate™ mesh for management of pelvic organ prolapse

This study aims to review the surgical complications and mesh erosion with a cohort of patients who underwent Elevate™ mesh repair. This was a single-centre, retrospective study of women undergoing Elevate™ mesh reconstruction between 2006 and 2016. Women who presented with symptomatic prolapse of stage II or above were enrolled. The study outcomes were intra-operative and peri-operative complications (including mesh complications) at six weeks, one year and five years reporting with a standardised communicable method—the International Urogynecological Association (IUGA)/International Continence Society (ICS) scale and the Clavien and Dindo Classification. A total number of 350 women had Elevate™ mesh insertion. The mesh exposure rate was 1.1% and the surgical complication rate in our series was low and self-limiting (2% were Dindo grade 3). With the low morbidity and mesh-related complications, Elevate™ mesh should be at least kept as an alternative treatment of pelvic organ prolapse. Impact statement What is already known on this subject? Transvaginal mesh repair surgery was popular to treat advanced pelvic organ prolapse 10 years ago. However, after announcement of the Food and Drug Administration (FDA) public notification regarding mesh-related complications, particularly mesh exposure, use of transvaginal mesh and its safety have been scrutinised. Despite the increasing challenging and difficult medico-legal climate, several studies on second generation mesh kits, such as Elevate™ have shown favourable outcomes with low complication rates including our group. What do the results of this study add? In this paper, the surgical complications and mesh erosion of Transvaginal mesh was reported in a quantified communicable method—the International Urogynecological Association (IUGA)/International Continence Society (ICS) scale and the Clavien and Dindo Classification. This is significant because it is the largest case studies from a single centre with 350 patients. What are the implications of these findings for clinical practice and/or further research? This study well demonstrated using a standardised way to classify mesh exposure and peri-operative complications which is lacking in the past, while majority studies only focus to discuss on surgical outcome instead of complications. This may make a spark for future research analysis.

Vaginal mesh hysteropexy: a review.

Pelvic organ prolapse surgery is performed via native tissue or graft augmented repair. Graft augmentation with synthetic mesh was introduced to improve long-term surgical outcomes compared with vaginal native tissue repairs. Vaginal hysteropexy has recently become increasingly popular due to patient preference and an improved morbidity profile over hysterectomy, while maintaining comparable efficacy. As long-term outcomes remain unanswered, mesh augmentation to vaginal hysteropexy has sought to improve efficacy while minimizing complications. Recent studies have demonstrated superiority of vaginal mesh hysteropexy to vaginal hysterectomy with native tissue vault suspension. Short-term follow-up of vaginal mesh hysteropexy has also demonstrated lower blood loss and operative time with improved vaginal length compared with hysterectomy. Mesh exposure rates across studies were low and comparable to those of abdominally placed prolapse mesh. Vaginal mesh hysteropexy is a comparably well tolerated and effective surgical treatment option for women with uterovaginal prolapse. Although vaginal mesh kits are not commercially available, this procedure may be a viable treatment option in select patients.

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.

How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial.

ObjectiveTo report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs.DesignSecondary analysis of the PROSPECT randomised controlled trial and cohort study.SettingThirty‐five UK hospitals.PopulationA total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair.MethodsEvent rates were calculated for all complications. Analysis was by treatment received.Main outcome measuresIUGA/ICS classification of complications and validated patient reported outcome measures.ResultsAt baseline, 8.4% of women had ‘generic’ pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re‐admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re‐admission were vaginal adhesions, urinary retention, infection and constipation.ConclusionsThis is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications.Tweetable abstractA prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.

Five-year outcomes of an anterior mesh kit for severe pelvic organ prolapse in women.

The Elevate™ Anterior mesh was designed to correct anterior vaginal wall defects by providing level 1 and 2 support via a single incision and transvaginal approach. This study aimed to examine the objective and subjective outcomes following prolapse repair using the Elevate™ Anterior mesh kit. A retrospective case series review of 270 patients with Baden-Walker Grades 3 or 4 anterior compartment prolapse who underwent the Elevate™ Anterior mesh kit was undertaken. Operative complications were recorded with follow-up intervals arranged at 1, 6, 12, 24, 36, 48 and 60 months. A standardized questionnaire directed at urinary, pain and recurrence symptoms was used at each follow-up visit. Pelvic examinations were performed at each follow-up visit to assess for objective cure and for detection of complications. The primary outcome was to assess the cure rate defined as anterior vaginal wall prolapse ≤ Grade 1. The follow-up rate was 28.9%. Subjective and objective cure rates at 60 months were 100% and 96.2%, respectively. Ten (3.7%) intraoperative complications were recorded. At 60 months, three (3.8%) patients complained of de novo stress/urge urinary incontinence. One patient had dyspareunia at 6 months postsurgery which resolved by the end of 1 year. Prolapse recurrences in the anterior compartment was 3.8% at the end of 5 years. Mesh exposure into the vagina occurred in three patients. In conclusion, our experience with the Elevate™ Anterior mesh kit had promising subjective and objective outcomes with high patient satisfaction rates.

Association between surgical volumes and real-world healthcare cost when using a mesh capturing device for pelvic organ prolapse: A 5-years comparison between single- versus multicenter use

Introduction and hypothesisThe aim of this study was to evaluate whether high surgical volume at a single center was associated with lower healthcare costs compared to lower surgical volume in a multicenter setting.MethodsAll patients had symptomatic and anatomical apical prolapse (POP-Q ≥ stage II) with or without cystocele and were operated on by a standard surgical procedure using the Uphold mesh. Data on time of resource use in terms of surgery time, hospital stay and re-interventions across 5 years were compared between the single center (97 patients) and multicenter (173 patients, at 24 clinics). Unit costs for surgical time, inpatient and outpatient visits were extracted from the single-center hospital’s operation analysis program and prime production cost. Total costs were estimated for primary surgery and during 5-year follow-up.ResultsCosts for primary surgery were comparable between the single and the multicenter ($13,561 ± 2688 and $13,867 ± 1177, P = 0.29). Follow-up costs 5 years after primary surgery were 2.8 times higher at the multicenter than single center ($3262 vs. $1149, P < 0.001). Mean cost per patient over 5 years was significantly lower at the single than multicenter [$14,710 (CI: 14,168–15,252) vs. $17,128 (CI: 16,952–17,305), P < 0.001)].ConclusionsUsing a mesh kit for apical pelvic organ prolapse in a high surgical volume center was associated with reduced healthcare costs compared with a lower volume multiple-site setting. The cost reduction at the high surgical volume center increased over time because of lower surgical and medical re-intervention rates for postoperative complications and recurrence.

Anatomical and functional outcomes of uterus preservation and pelvic organ prolapse repair with vaginal trocar-less mesh kit (Endofast): A retrospective study of 239 patients

ObjectiveThe aim of the study was to assess safety and long term efficacy as well as short and long term complications of vaginal prolapse mesh repair using single incision trocar-less system while preserving the uterus. Study DesignA single-center, retrospective cohort study including all patients who underwent vaginal prolapse mesh repaier surgery with EndoFast Reliant™ kit between October 2010 and January 2015. Outcomes included anatomical changes (POP-Q), overactive bladder symptoms (OAB) stress urinary incontinence (SUI), sexual function and constipation as well as the rate of surgical failure, immediate and long-term complications. Results239 women, with an average follow-up period of 1.7 years (range: 6 weeks to 7 years), were included. Uterus was preserved in 87 % of patients (184 out of 211 patients with intact uterus) and concurrent surgery for SUI was performed in 46 %. POP-Q significantly improved as well as OAB and SUI symptoms and remained without significant change during follow-up period. In 11 patients (4.6 %) a new/recurrent prolapse was observed during the follow up period.Immediate complications occurred in 4 patients. One case of bladder perforation, one case of mesh contamination, 2 cases of urinary retention, one of them permanent. Late complications included mesh erosion, de novo dyspareunia, cervical elongation and de-novo SUI, and were observed in 38 cases (16 %). Surgical intervention was required in 20 (8.4 %) cases; 10 cases of de-novo SUI, 2 cases of partial mesh removal because of dyspareunia, 1 case of mid urethral sling removal because of erosion and 7 cases of cervical amputation. ConclusionsRepair of prolapse with vaginal trocar-less mesh kit while preserving the uterus for the majoroty of women, is a relatively safe and effective surgery,with a low incidence of complications and re-operation rate which was mainly for de novo SUI or elongation of cervix. Randomiesed prospective long term studies are neaded to establish the results.

Efficacy of Self-Cut Titanium-Coated Polypropylene Mesh Versus Mesh-Kit for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Non-Inferiority Trial

Background: Transvaginal mesh can increase the durability of surgery for pelvic organ prolapse. However, commercial mesh kits can be expensive. We assessed the efficacy of a much cheaper self-cut titanium-coated polypropylene mesh with a mesh-kit for treating symptomatic pelvic organ prolapse. Methods: We conducted a multicenter, randomized, non-inferiority trial. Patients were randomized to either self-cut mesh or commercial mesh-kit. Patients with symptomatic stage III-IV pelvic organ prolapse were enrolled at 11 centers between January 2018 and November 2019. The primary outcome measure was composite success at one year defined by absence of vaginal bulge symptoms, and no additional re-treatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality of life measures, complications and costs. Findings: A total of 336 participants were randomized. In the intention-to-treat analysis, 95∙9% (162/169) met the definition of surgical success in the self-cut group, which was noninferior to the 87∙4% (146/167) surgical success in the mesh-kit group (risk difference, 8∙5 [95%CI 2∙2 to 14∙3]). The frequency of Clavien-Dindo grade I-III complications were not significant between groups (12 [7∙2%] vs 20 [12∙4%], P=0∙14). Vaginal mesh exposure rates in women examined within 1 year [self-cut group 4/169 (2∙4%) vs mesh-kit group 8/167 (4∙8%)] were similar (P=0∙23). Interpretation: This trial demonstrated that composite surgical success of a self-cut mesh procedure was non-inferior to a commercial mesh-kit procedure using the same mesh. The use of self-cut mesh was effective and safe, while reducing the hospitalization expense by approximately 40%. Clinical Trial Registration Details: Clinicaltrials.gov, NCT03283124. Funding Information: Chinese Academy of Medical Science Initiative for Innovative Medicine(CAMS-2017-12M-1-002). Medstron Medical(shanghai) Co. Ltd, the agent of Tiloop® products in China, provided monetary support for this research including interim meeting and third party (LinkDoc Beijing company) EDC system. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The study was approved by the Institutional Review Board of Peking Union Medical College Hospital (JS-1278).

It's not that mesh, is it? What providers should know about the transvaginal mesh controversy.

The U.S. Food and Drug Administration recent ban on surgical mesh intended for the transvaginal repair of pelvic organ prolapse has called into question the safety of surgical mesh implants in general. As the media firestorm around vaginal mesh kits has continued to grow, important details about the specific type of mesh involved have been lost in the public discourse surrounding the controversy. This has left healthcare providers across the nation in the difficult position of addressing patient anxieties about the use of mesh in gynecologic surgery. This review seeks to educate women's health providers on the historical background and various uses of the different types of mesh in gynecologic surgery.

Outcomes of Single Incision Anchored Anterior Vaginal Mesh Repair for Recurrent Vaginal Prolapse

Objective: To report the safety and efficacy of single incision anchored anterior vaginal mesh repair for women with recurrent anterior vaginal prolapse.Methods: Retrospective study of women with recurrent anterior vaginal prolapse, Stage 2 or beyond, who underwent single incision anchored vaginal mesh repair with Anterior Elevate (American Medical Systems, Minnetonka, USA) between June 2012 and October 2016. Pre-operatively, the Prolapse Quality-of-Life questionnaire (P-QOL) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) were completed. Post-operatively, women completed the P-QOL, PISQ-12 and the global impression of improvement questionnaire (PGI-I). Preoperative POP-Q and post operative POP-Q examination at up to 24 months follow up were recorded. At average follow up of 36 months, participants were interviewed via telephone using questions from the P-QOL, PISQ and PGI-I.Results: 45 women had single incision anterior vaginal mesh kit repair for recurrent prolapse. Postoperatively, 85% of women reported cure of their prolapse symptoms. At 24 months, 80.0% had POP-Q stage 0 or 1 in the anterior compartment, and 93.8% achieved anatomical cure of apical prolapse (point C above 0). During structured telephone interview at mean follow up of 36 months, on PGI-I, 70% reported feeling ‘much better’ or ‘very much better’.Conclusion: Vaginal surgery using single incision lightweight mesh kits can be an effective approach for women with recurrent anterior vaginal prolapse, resulting in subjective and objective cure rates of over 80% with reasonable safety profile up to 60 months postoperatively.

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

Re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)

Re: Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)