Mesh Sling Research Articles

Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence.

Although midurethral mesh slings are the criterion standard surgical treatment for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling procedure and to identify predictors of these outcomes. Using a population-based cohort of commercially insured individuals in the United States, we identified women aged 18 years or older who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models. We identified 334,601 mesh sling surgical procedures. For sling revision, the 10-year and 15-year risks were 6.9% (95% confidence interval [CI], 6.7-7.0) and 7.9% (95% CI, 7.5-8.3), with 48.7% of sling revisions associated with mesh exposure. The 10-year and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI, 17.3-18.6). Women aged 18-29 years had an elevated risk for both sling revision (hazard ratio, 1.20; 95% CI, 1.15-1.25) and repeat SUI surgery (hazard ratio, 1.30; 95% CI, 1.25-1.37) compared with women 70 years and older. In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and health care providers considering midurethral mesh slings.

Risk of reoperation 10 years after surgical treatment for stress urinary incontinence: a national population-based cohort study

There is a debate about the safety and effectiveness of surgical treatments for stress urinary incontinence. Controversy about the use of synthetic mesh sling insertion has led to an increased uptake of retropubic colposuspension and autologous sling procedures. Comparative evidence on the long-term outcomes from these procedures is needed. To compare the risk of reoperation at 10 years after operation between women treated for stress urinary incontinence with retropubic colposuspension, mesh sling insertion, and autologous sling procedures. The records of admissions to National Health Service hosptials were used to identify women who had first-time stress incontinence surgery between 2006 and 2013 in England. The first incidence of the following outcomes was assessed: further stress incontinence surgery, surgery for a complication (either mesh removal, prolapse repair, or incisional hernia repair), and any reoperation (either further stress incontinence surgery, mesh removal, prolapse repair, or incisional hernia repair). The cumulative incidence of each of these outcomes up to 10 years after surgery was calculated, considering death as a competing event. Multivariable modeling was then used to estimate the reoperation hazard ratios for the different initial surgery types with adjustments for patient characteristics and concurrent prolapse surgery or hysterectomy. The analysis included 2262 women treated with retropubic colposuspension, 92,524 treated with mesh sling insertion, and 1234 treated with autologous sling. The cumulative incidence of any first reoperation at 10 years was 21.3% (95% confidence interval, 19.5-23.0) after retropubic colposuspension, 10.9% (10.7-11.1) after mesh sling insertion, and 12.0% (10.2-13.9) after autologous sling procedures. The women who had a retropubic colposuspension were significantly more likely to have a reoperation than women who had an autologous sling (adjusted hazard ratio for any reoperation: 1.79 [1.47-2.17]; for further stress incontinence surgery: 1.64 [1.19-2.26]; for surgery for complications: 1.89 [1.49-2.40]), whereas the women who had mesh slings had a similar hazard (for any reoperation: 0.90 [0.76-1.07]; for further stress incontinence surgery: 0.75 [0.57-0.99]; for surgery for complications: 1.11 [0.89-1.36]). A sensitivity analysis excluding the women who had concurrent prolapse surgery or hysterectomy produced similar results. Retropubic colposuspension is associated with higher risk of reoperation at 10 years after surgery than mesh sling insertion or autologous sling procedures, with 1 in 5 women requiring reoperation.

Autologous fascial slings remain viable at long-term follow-up: a post cystectomy case report

BackgroundAutologous fascial slings (AFS) have been used for a very long time in the treatment of female stress urinary incontinence, but the introduction of synthetic mesh slings placed either retropubicallyor trans-obturator has decreased the need to harvest the autologous rectus muscle fascia, thus reducing invasiveness and operative time. However AFS are still indicated in complicated cases and re-interventions, and the FDA has underlined safety concerns over the use of surgical meshes for the transvaginal repair of prolapsed pelvic organs.Case presentationA 76-year-old woman with muscle-invasivebladder cancer underwent radical cystectomy 16 years after retropubic positioning of an autologous rectus muscle fascial sling for SUI, with complete symptom resolution. The sling was easily identified and removed en bloc with the bladder and urethra, providing an opportunity to histologicallyevaluate the autologous fascial graft after its long permanence in the new position. Histopathological examination demonstrated increased fibroblastic proliferation and formation of capillaries. A slight separation and an increased waviness of the connective fibers were both evident. An increased vascularity was also apparent, including transverse vessels, with clusters of vessels. A relative inflammatory reaction was present in over 300 cells/10 HPF. All these characteristics indicated viable connective tissue.ConclusionsAFS remain a valuable surgical option for both primary and recurrent SUI in women, showing high cure rates and low complications in the long-term. The present case, to the best of our knowledge, presents the longest follow-up period of an autologous rectus muscle fascia placed retropubically and its histological evaluation documents characteristics which support its mechanical strength and viability.

52 Management options for urethral erosion

Present options for the management of urethral erosion following transvaginal mesh sling placement. Urethral erosions following transvaginal mesh sling placement has been reported as a rare complication. We present the surgical options for the treatment of this complication from the minimally invasive option of holmium laser ablation at the time of cystourethroscopy to transvaginal excision of the mesh erosion with labial fat pad interposition. This video highlights the surgical options for the treatment of urethral mesh erosion following a transvaginal mesh sling placement.

Adverse Events Associated With Synthetic Male Slings: An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

PurposeWe sought to describe and analyze the adverse events associated with synthetic male slings reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.MethodsWe queried the MAUDE database for all entries including the terms “Male Sling,” “InVance,” “Virtue,” or “Advance” from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, and manufacturer. We reviewed and categorized the event description text for each medical device report (MDR).ResultsA total of 497 adverse events related to the male sling were identified. The adverse events were classified as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths described. The slings involved were the Advance or Advance XP sling (69.8%), InVance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). The 4 most common adverse events described were urinary incontinence (46.7%), sling erosion (9.1%), mechanical malfunction (8.2%), and pain/numbness (8.2%). There was no increase in the number of reports in the years following the FDA warnings for urogynecologic mesh.ConclusionsThere was an overall modest number of MDRs related to male slings and the majority of them were reported by the manufacturer. The reporting of adverse events for male slings does not seem to be affected by the controversy and scrutiny towards transvaginal mesh and midurethral slings. Further clinical studies and more objective and detailed databases are needed to investigate the safety of these synthetic slings.

O77: DOES MESH IMPROVE PATIENT SATISFACTION AND HEALTH-RELATED QUALITY OF LIFE AFTER IMPLANT-BASED BREAST RECONSTRUCTION? A MULTICENTRE PROSPECTIVE COHORT STUDY

Abstract Introduction Biological and synthetic meshes may improve outcomes of immediate IBBR by facilitating single-stage direct-to-implant procedures. However, high-quality supporting evidence is limited, particularly regarding PROs. Method 2108 consecutive women undergoing IBBR at 81 centres were prospectively recruited between 2014-2016. Demographic, operative, oncological and 3-month complication data were collected. An 18-month questionnaire assessed PROs using the validated BREAST-Q and a five-point Likert scale rating of overall reconstructive outcome. The impacts of different IBBR techniques on PROs were explored using mixed-effects regression models adjusted for clinically-relevant confounders and including a random effect to account for clustering by centre. The reference group was two- stage submuscular reconstruction without mesh. Result 1470 participants consented to receive the questionnaire and 891 completed it. 67 patients underwent two-stage submuscular reconstruction; 764 patients received subpectoral reconstructions with biological mesh (n=495) synthetic mesh (n=95) or dermal sling (n=174). 14 patients underwent prepectoral reconstructions (introduced late in the study). Compared with two-stage reconstructions, no differences in PROs were seen in biological or synthetic mesh-assisted or dermal sling procedures (p>0.05). However, prepectoral IBBR patients reported better satisfaction with breasts (difference=6.63, 95% confidence interval[1.65–11.61], p=0.009). Outcomes were similar to those in the NMBRA 2008/9 cohort, which included submuscular procedures only. Conclusion This study does not suggest that mesh improves PROs of IBBR. It provides early data supporting improved satisfaction with breasts following prepectoral reconstructions. Future trials are needed to robustly evaluate prepectoral techniques. Abbrev IBBR: implant-based breast reconstruction, PRO: patient-reported outcome, NMBRA: National Mastectomy and Breast Reconstruction Audit Take-home message Although mesh-assisted techniques have become widely adopted, this large, prospective, multicentre cohort study does not suggest that mesh improves patient-reported outcomes of implant-based breast reconstruction compared with standard submuscular techniques. However, it provides early data to support improved satisfaction with breasts in the prepectoral setting, which now requires robust evaluation.

What a mesh! An Australian experience using national female continence surgery trends over 20years.

To review the evolution of female continence surgical practice in Australia over the last 20years and observe whether vaginal mesh controversies impacted these trends. From January 2000 to December 2019, medicare benefit schedule codes for female continence procedures were identified and extracted for: mesh sling, fascial sling, bulking agent, female urethral prosthesis, colposuspension, and removal of sling. Population-adjusted incidences per 100,000 persons were calculated using publicly available demographic data. Three discrete phases were defined over the study time frame for analysis: 2000-2006; 2006-2017, and 2017-2019. Interrupted time-series analyses were conducted to assess for impact on incidence at 2006 and 2017. There were 119,832 continence procedures performed in Australia from 2000 to 2019, with the mid-urethral sling (MUS) the most common (72%). The majority of mesh (n = 63,668, 73%) and fascial sling (n = 1864, 70%) procedures were in women aged < 65years. Rates of mesh-related procedures steeply declined after 2017 (initial change: -21 cases per 100,000; subsequent rate change: -12 per 100,000, p < 0.001). Non-mesh related/bulking agents increased from + 0.34 during 2006-2017 to + 2.1 per 100,000 after 2017 (p < 0.001). No significant change in mesh extraction was observed over 2006-2017 (+ 0.06 per 100,000, p = 0.192). There was a significant increase in mesh extraction procedures after 2017 (0.83 per 100,000, p < 0.001). Worldwide, controversy surrounding vaginal mesh had a significant impact on Australian continence surgery trends. The most standout trends were observed after the 2017 Australian class-action lawsuit and Senate Inquiry.

Prevalence of chronic pain following suburethral mesh sling implantation for post-prostatectomy incontinence.

To evaluate postoperative pain and complications following AdVance™/AdVance™ XP male sling implantation. A multi-center retrospective medical notes review of patients implanted for bothersome post-prostatectomy incontinence was conducted. All patients were telephoned to provide further information on pain or further complications related to their surgery. Statistical evaluation utilized logistical regression analysis. Additionally, a literature review was conducted reviewing pain outcomes following AdVance™/AdVance™ XP implantation. One-hundred and twenty-seven men were reviewed over an 8-year period. The mean age was 70 years, with mean follow up 52 months. Of those with mild stress urinary incontinence, 45 (79%) had a successful outcome compared to 42 (72%) in the moderate group. Twenty-nine (23%) men reported postoperative pain, with a mean maximal pain score of 6 (range: 0-10). The majority of pain resolved within 4 weeks (19/29 men). A further seven patients resolved by 3 months. Only three men (2.3%) had chronic pain greater than 3 months, which all resolved by 1 year. Men less than 65 years were more likely to suffer pain (p = 0.009). Acute urinary retention occurred in 23 (18%) men and correlated significantly with postoperative pain (p = 0.04). Overactive bladder symptoms, severity of incontinence or radiotherapy were not correlated with postoperative pain. In our cohort, there were no extrusions, divisions, or explantations. Approximately a quarter of men experience pain in the early postoperative period. However, the severity and rates of chronic pain (>3 months) are low (2.3%) but all settle within a year.

Abstract OT-23-01: Examining and comparing the temporal changes and results of cosmetic, quality of life and patient satisfaction achieved with immediate and delayed-immediate implant-based breast reconstruction procedures and contralateral symmetrisation techniques after skin-sparing mastectomies with unilateral simple mastectomy and with bilateral skin-sparing mastectomies and immediate implant-based breast reconstructive surgeries. (ClinicalTrials.gov Identifier: NCT04356235)

Abstract IntroductionThe immediate (I-BR) or delayed-immediate (DI-BR) implant-based breast reconstruction (BR) of the affected breast following nipple, areola, skin-sparing mastectomy (NSM, ASM, SSM) techniques requires almost in all cases symmetrization of the contralateral breast. The long term results of implant-based BR (subpectoral or prepectoral) and symmetrization following advanced postmastectomy BR techniques significantly decrease over time and later result in a limited patient satisfaction rate. Beyond the satisfactory early results BRs, there are only limited long term data on cosmetics and patient satisfaction. In fact with time patient dissatisfaction necessitates repeated surgeries, with an extra load for both to the patient and the health system. The aim of the study is to gain high quality data about the deteriorating cosmetic outcomes of bilateral BRs on the long term. Trial design In this response-adaptive prospective randomized study patients are sub-grouped into 6 study groups after BR surgery with silicone implant (following uni- or bilateral NSM, ASM, SSM) with symmetrization in case of unilateral mastectomy (mastopexy and/or silicone implant and/or mesh sling technique to suspend the breast with or without reduction) or simple mastectomy without symmetrization. The planned number of patients is a minimum of 528 cases. The measurements of the breast, the ptosis, photo documentation using valid BCCT.core software, BREAST-Q questionnaire and Likert scale are performed preoperatively, 4 weeks after delayed BR with symmetrization, 3 months after, every 6 months for 5 years. Primary endpoint Using correlation analysis to measure objective changes over time in the quality of life (QoL) and patient satisfaction associated with the symmetry achieved by different surgical techniques up to five years of follow-up. To compare the QoL and the satisfaction rate in the control group with a simple mastectomy, bilateral SSM, ASM, NSM and BR. Secondary endpoint To determine the prognostic factors, patient subgroups, and surgical techniques associated with patients, surgery, and oncological therapies in an optimal way. Furthermore, the study should give relevant data about the oncoplastic concept of prophylactic SSM, ASM, or NSM on the contralateral side and BR, without the presence of hereditary breast and ovarian cancer syndrome, using the same surgical technique than on the affected side. The long term PRO results of postmastectomy BR should be necessarily part of the initial patient information in the future. Inclusion criteria- Under the age of 65 with uni- or bilateral primary breast cancer, needing advanced mastectomy independently of the axillary surgery, having I-BR os DI-BR on the ipsilateral side and symmetrization on the contralateral side - Control group: patients under 65 years with unilateral simplex mastectomy without BR. Exclusion criteria-Pregnancy-associated breast cancer-Prior breast surgery and/or radiotherapy -Severe non-surgical complication-Long-term steroid usage Present accrual and target accrual The trial was activated on 22 April 2020. As of 5 July, 23 patients have been randomized. Accrual is currently running according to protocol and is planned until 2025. Interim analysis performed after 2 years’ median follow-up period. The final analysis is performed 5 years after closing the patient inclusion period. Citation Format: Mihály Újhelyi, Ákos Sávolt, Orsolya Huszár, Orsolya Ping, Norbert Mészáros, Nóra Jani, Mátyás Újlaki, István Kenessey, Zsófia József, Zoltán Mátrai. Examining and comparing the temporal changes and results of cosmetic, quality of life and patient satisfaction achieved with immediate and delayed-immediate implant-based breast reconstruction procedures and contralateral symmetrisation techniques after skin-sparing mastectomies with unilateral simple mastectomy and with bilateral skin-sparing mastectomies and immediate implant-based breast reconstructive surgeries. (ClinicalTrials.gov Identifier: NCT04356235) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-23-01.

Comparison of Long-Term Outcomes of Transobturator Rectus Fascia Sling and Polypropylene Mesh in Obese Women?

Objective: This study compared the long-term outcomes of polypropylene mesh (PPM) and transobturator rectus fascia (RF) slings in transobturator tape (TOT) surgery in obese women. Materials and Met...

Transvaginal subfascial synthetic mesh sling in female stress urinary incontinence: A Novel technique

The object of this paper is to assess the treatment outcome and overall efficacy of a novel technique of transvaginal subfascial synthetic mesh for female stress urinary incontinence. The study included 53 patients of female stress urinary incontinence managed at our institution between March 2005 and December 2015. Preoperative evaluation included a detailed history, base-line investigations and cystoscopic examination including stress test, uroflometry with residual urine was done in all cases. Lower urinary tract imaging and urodynamic evaluation was done in selected cases . patients with concomitant pelvic organ prolapse and severe BMI were excluded from the study. All patients underwent a transvaginal subfascial sling procedure under regional anesthesia. Urethral catheter was removed the day after procedure. Post procedure results were assessed in terms of improvement in stress urinary incontinence, procedure related complications, and overall satisfaction of the patient. Mean age of the patients was 43.5 years (25-63 years). All patients were multiparous. Complete resolution of symptoms in 49 patients (92.4%) while in 4 patients (7.5%) had some degree of SUI. Urinary retention in 3 (5.6%), increased frequency in 5 (9.4%) patients and urge incontinence in 2 (3.7%) One (1.8%) had mesh erosion at 3 months after the procedure. None of the patient had any sexual dysfunction on follow up. Overall success rate of the procedure was around 93%.However patients with preoperatively urge incontinence needs anticholinergics in post operative period for 1-2 months. Operative time was 30-45 minutes. Three patients (5.6%) who experience transient postoperative retention had no symptoms of SUI on follow up. Transvaginal subfascial sling is a modification of the original mid urethral sling procedure with an advantage of being less invasive, simpler to learn and achieve similar results compared to other sling procedures.

This Month in Adult Urology

This Month in Adult Urology

Long-Term Dynamic Changes in Cosmetic Outcomes and Patient Satisfaction after Implant-Based Postmastectomy Breast Reconstruction and Contralateral Mastopexy with or without an Ultrapro Mesh Sling Used for the Inner Bra Technique. A Retrospective Correlational Study.

Simple SummaryImmediate implant-based postmastectomy breast reconstruction (IPMBR) with contralateral symmetrization has mostly short-term limited evidence of cosmetic outcomes. Ageing after IPMBR and symmetrization may contribute to symmetry worsening. This non-interventional retrospective correlational study presents the clinical and aesthetic results of synthetic ULTRAPRO® mesh inner bra sling symmetrization mastopexy with standard mastopexies. A total of 59 patients were enrolled in the mesh group (MG), and 58 patients were enrolled in the non-mesh group (NMG). There were no significant differences in surgical complications (p = 0.521; chi-square. The median sternal notch-to-nipple distance difference was 1 cm in the MG and 3.5 cm in the NMG from the last follow-up, and the median nipple-to-inferior mammary fold distance differences were 0.5 cm and 0.75 cm. ULTRAPRO® mesh sling symmetrization can be successfully used to decrease pseudoptosis and nipple down-migration, offering a safe alternative for long-lasting symmetry and high patient satisfaction.Immediate implant-based postmastectomy breast reconstruction (IPMBR) with contralateral symmetrization has mostly short-term limited evidence of cosmetic outcomes. Because 84% of early-stage breast cancer patients have overall survival of more than 10 years, reconstructed breast symmetry should provide long-lasting results and acceptable patient satisfaction. Ageing, changes in body weight, and biomechanical changes after IPMBR and symmetrization may contribute to symmetry worsening. This non-interventional single-centre retrospective correlational study presents the clinical and aesthetic results of synthetic ULTRAPRO® mesh inner bra sling symmetrization mastopexy with standard mastopexies. According to the results, a total of 59 patients were enrolled in the mesh group (MG), and 58 patients were enrolled in the non-mesh group (NMG). There were no significant differences in surgical complications (p = 0.521; chi-square). The median sternal notch-to-nipple distance difference was 1 cm in the MG and 3.5 cm in the NMG from the last follow-up, and the median nipple-to-inferior mammary fold distance differences were 0.5 cm and 0.75 cm. The mesh did not hinder the follow-up investigation. In conclusion, ULTRAPRO® mesh sling symmetrization can be successfully used to decrease pseudoptosis and nipple down-migration, offering a safe alternative for long-lasting symmetry and high patient satisfaction.

Mesh Sling Arm Removal for Persistent Pain After an Initial Vaginal Suburethral Mesh Sling Removal Procedure.

Pain is a recognized complication of mid-urethral slings (MUS), which may lead to suburethral sling removal (SSR) alone, or to a more extensive removal approach. We report on the outcomes of women who required an SSR or an additional secondary MUS arm removal for pain only. After Institutional Review Board (IRB) approval, the charts of nonneurogenic women who underwent SSR for pain only were reviewed. Demographic information, MUS type, self-reported pain resolution, and preoperative and postoperative questionnaires, including Urogenital Distress Inventory-Short form question 6 (UDI-6 Q6) scores, were collected for the SSR (group 1) and secondary removal (group 2) groups. Of 52 women who underwent SSR for pain only between 2005 and 2018, 16 (31%) required a secondary procedure to remove the extension arms due to persistent pain after SSR. All women in group 2 experienced pain immediately after SSR (UDI-6 Q6 score of 2 to 3). Patients whose pain improved after SSR presented at a median 61 months after MUS whereas those in group 2 underwent SSR at median 34 months after MUS. Median duration of follow-up in group 2, after the secondary procedure, was 34 months. Over one half of those in group 2 (54%) noticed pain cure/improvement. Seven were left with persistent pain. In women who underwent SSR for pain only, 67% reported pain resolution. An additional procedure to remove the extension arms of the mesh was performed in one third of women for persistent pain after SSR.

Stress Urinary Incontinence Surgery Outcomes: A 6-Year Review

Study Objective A variety of surgical procedures exist to correct stress urinary incontinence (SUI). Mid-urethral slings are currently considered the gold standard. Recent FDA warnings regarding mesh use in pelvic organ prolapse surgeries may have caused negative perceptions towards mesh-based procedures. The objective of this study is to review the outcomes and complications associated with the different surgical procedures performed for SUI. Design A retrospective chart review of patients undergoing SUI surgery from 2013–2018 was performed and included: Mid-urethral sling (MUS), laparoscopic polypropylene mesh sling (Lap mesh sling), laparoscopic Burch (Burch) and autologous fascial sling (AFS). Setting Tertiary care academic center. Patients or Participants Patients were identified from our center's operating room database and verified with office charts from the involved 6 surgeons. Interventions N/A Measurements and Main Results Patient demographics, pre/intra/post-operative measures and surgical outcomes (up to 2 years post-surgery) were reviewed. Of 649 charts, 32% (209/649) had MUS, 31% (200/649) had lap mesh sling, 25% (161/649) had Burch and 12% (79/649) had AFS. 408/649 (62.9%) had concomitant procedures with the most common being posterior vaginal repair (274/408). Intra/post-surgical complication rates were: DVT/PE (0/649), transfusion (0/649), re-operation for hemorrhage (2/649), bladder injury (9/649), bowel injury (4/649), readmission (32/649). Post-op urinary retention rates (and mean duration of catheter use) were: MUS 22.5% (8.4 days), Lap mesh sling 52.0% (11.2 days), Burch 61.5% (5.7 days) and AFS 93.7% (15.9 days). Overall, 232/649 (35.7%) and 124/649 (19%) had information available for the 1- and 2-year follow-up visits. At 1-year post-operatively, SUI was cured in 89% (79/89) of MUS, 82% (63/77) of Lap mesh sling, 92.0% (23/25) of Burch and 58.5% (24/41) of AFS. Conclusion The 2 most common surgical procedures for SUI at our center involve the use of permanent mesh: MUS and laparoscopic mesh sling. Overall, there are low complication rates and good 1-year cure rates for all surgeries except AFS.

Laparoscopic and Robotic Mesh-Free Suture Hysteropexy Versus Mesh Sacral Hysteropexy: A Non-Randomised Comparison

Study Objective To compare the laparoscopic and robotic mesh-free suture hysteropexy (SutureH) with mesh sling sacral hysteropexy (MeshH) for uterine prolapse. Design A retrospective clinical audit of consecutive women who underwent SutureH or MeshH by laparoscopic or robotic route by a single surgeon. Subjects were assessed at baseline, 5-weeks and 1-year. Setting N/A Patients or Participants N/A Interventions SutureH uses sutures to re-support the uterus from each uterosacral ligament. During MeshH, the uterus is suspended form the sacral promontory using a mesh sling placed around the cervix. All women had a post-operative surgical support pessary placed for 5 weeks. Measurements and Main Results The primary outcome was success defined as a composite of: POP-Q C-point above the hymen, absence of vaginal bulge symptom, and no repeat prolapse surgery or pessary placement. Secondary outcomes included subjective improvement in prolapse symptoms using PGI-I, POP-Q C-point change, change in POP-Q scores and complications. 228 women underwent laparoscopic or robotic hysteropexy between Sept 2010 and Oct 2018. The 1-year data was available for 191 women (MeshH n=120; SutureH n=71). Success was not different between MeshH and SutureH (P=0.114). For MeshH v's SutureH, C-point at or above -1cm, absence of bulge and no repeat surgery was 99.2% v's 95.8%, 90.8% v's 90.1% and 81.7% v's 84.5% respectively (NS). MeshH (mean C point -7.14 cm) provided better apical support than SutureH (mean C point -5.9) (P Conclusion Laparoscopic and robotic sutureH and meshH provide women with minimally invasive durable options for uterine preservation during pelvic organ prolapse surgery. When controlling for age, MeshH provided better anatomic support than SutureH although SutureH gives women a mesh-free option.

Placement of mid-urethral mesh slings at the time of vaginal prolapse repair does not affect post-operative sexual function or orgasm

Because of the relationship between the clitoral neurovascular supply and the urethra, the dissection for placement of mid-urethral slings (MUS) may negatively impact orgasmic function. We aimed to analyze the role of MUS in orgasmic and overall sexual function in patients undergoing prolapse surgery. A single institution retrospective review was performed on 157 patients undergoing prolapse surgery with and without MUS from 2008 to 2014. Pelvic Organ Prolapse Incontinence Sexual Questionnaires (PISQ-12) scores at baseline, 6, and 12months post-operatively were compared. The difference in overall mean post-operative PISQ-12 scores at 6 and 12months in those undergoing POP with or without MUS placement was assessed using Wilcoxon rank tests. Of 157 women who underwent prolapse surgery, 81 (52%) had concomitant MUS. Mean baseline PISQ-12 scores were 32 in both groups (p = 0.98). Post-operative PISQ-12 scores between the two groups did not differ at 6 (p = 0.96) or 12months (p = 0.65). Within the MUS group, mean overall PISQ-12 scores improved at 6 (p = 0.05) and 12months (p < 0.01). Mean overall PISQ-12 scores did not improve in patients who did not have slings placed at 6 (p = 0.10) or 12months (p = 0.15). Orgasm frequency and intensity did not differ between the two groups at 6 (p = 0.39, p = 0.91, respectively) or 12months (p = 0.11, p = 0.44, respectively). MUS at the time of prolapse repair did not affect orgasmic or overall sexual function. PISQ-12 scores improved after prolapse surgery with concomitant MUS placement. Our findings may help counsel patients regarding the risk of MUS placement affecting sexual function.

Long-Term Safety with Sling Mesh Implants for Stress Incontinence.

We examined long-term risks and predictors of mesh erosion and reoperation following mid urethral sling procedure for stress urinary incontinence. Women aged 18 years or older who received a mid urethral sling for stress urinary incontinence between 2008 and 2016 in outpatient surgical settings in New York State were included in our study. Those who underwent concomitant mesh pelvic organ prolapse repair were excluded. Primary outcomes were post-implantation time to erosion and reoperations. Kaplan-Meier analysis and Cox proportional hazard models were used to assess the risks of erosion diagnosis and reoperation. Our cohort included 36,195 women with a mean±SD age of 53.7±12.4 years. Estimated risks of erosions and reoperations at 7 years after sling procedures were 3.7% and 6.7%, respectively. Older age (≥65 vs <65: HR 0.83, 95% CI 0.70-0.99) and high volume facilities (high vs low: HR 0.79, 95% CI 0.68-0.92) were associated with a lower risk of erosion. History of hysterectomy was associated with a higher risk of erosion (HR 1.62, 95% CI 1.36-1.92). Predictors of reoperation included concurrent abdominal or native tissue transvaginal prolapse repair, previous hysterectomy and depression. One in 27 women had sling erosions and 1 in 15 had invasive reoperations at 7 years after sling procedures. The highest erosion cases were observed among younger White women treated at low volume facilities. Continued and vigilant surveillance of mesh in stress urinary incontinence repairs, the nature and burden of stress urinary incontinence recurrence, different types of re-treatment, patient reported outcomes and information about treating surgeons are crucial.

Vaginal calculus in a patient with a mid-urethral sling mesh exposure.

The present study reports a case of a patient with a mid‐urethral sling mesh exposure who developed a vaginal calculus on a portion of exposed mesh.

Comparison of 2 single incision slings on the vagina in an ovine model

Stress urinary incontinence carries a significant healthcare burden for women worldwide. Single incision slings are minimally invasive mesh devices designed to treat stress urinary incontinence. For prolapse repair, meshes with higher porosity and lower structural stiffness have been associated with improved outcomes. In this study, we compared the higher stiffness, lower porosity Altis sling with the lower stiffness, higher porosity Solyx sling in an ovine model. We hypothesized that SIS-B would have a negative impact on the host response. A total of Altis and Solyx single incision slings were implanted suburethrally into sheep according to the manufacturer's instructions on minimal tension. The mesh-urethral-vaginal complex and adjacent ungrafted vagina (no mesh control) were harvested en bloc at 3 months. Masson's trichrome and picrosirius red staining of 6 μm thin sections was performed to measure interfiber distance and tissue integration. Smooth muscle contractility to a 120 mM KCl stimulus was performed in an organ bath to measure myofiber-driven contractions. Standard biochemical assays were used to quantify glycosaminoglycan, total collagen, and elastin content, and collagen subtypes. Bending stiffness was performed in response to a uniaxial force to define susceptibility to folding/buckling. Statistical analysis was performed using Mann-Whitney, Gabriel's pairwise post hoc, Wilcoxon matched-pairs, and chi-square tests. The animals had similar ages (3-5 years), parity (multiparous), and weights (45-72 kg). Trichrome cross sections showed that the Altis sling buckled in a "C" or "S" shape in most samples (8 of 11), whereas buckling after Solyx sling implantation was observed in only a single sample (1 of 13; P=.004). Tissue integration, as measured by the presence of collagen or smooth muscle between the mesh fibers on trichrome 4× imaging, was increased in samples implanted with the Solyx sling compared with the Altis sling (P<.05). Total collagen content decreased significantly with both products when compared with the ungrafted vagina consistent with stress shielding. There was no difference in the 2 groups with regard to glycosaminoglycan or elastin content. The Altis sling mesh tissue complex demonstrated significantly higher amounts of both collagen types I and III than the Solyx sling-implanted tissue and the ungrafted control. Smooth muscle contractility in response to 120 mM KCl was decreased after implantation of both slings compared with the sham (P=.011 and P<.01), with no difference between mesh types (P=.099). Bending stiffness in the Altis sling was more than 4 times lower than in the Solyx, indicating an increased propensity to buckle (0.0186 vs 0.0883). The structurally stiffer Altis sling had decreased tissue integration and increased propensity to buckle after implantation. Increased collagen types I and III after the implantation of this device suggests that these changes may be associated with a fibrotic response. In contrast, the Solyx sling largely maintained a flat configuration and had improved tissue integration. The deformation of the Altis sling is not an intended effect and is likely caused by its lower bending stiffness. Both meshes induced a decrease in collagen content and smooth muscle contractility similar to previous findings for prolapse meshes and consistent with stress shielding. The long-term impact of buckling warrants further investigation.