Mesh Exposure Research Articles

Second-Line Surgical Management After Midurethral Sling Failure.

Currently, the midurethral sling (MUS) is widely used as a standard treatment in patients with stress urinary incontinence (SUI). Several studies have reported the failure rate of MUS to be approximately 5%–20%. In general, sling failure can be defined as persistent SUI after surgery or a temporary improvement in incontinence followed by recurrence. Failure is also often considered to include cases requiring secondary surgery due to mesh exposure, postoperative voiding difficulty, de novo urgency/urge incontinence, and severe postoperative pain. Because of the lack of large-scale, high-quality research on this topic, no clear guidelines exist for second-line management. To date, transurethral bulking agent injections, tape shortening, repeat MUS, pubovaginal sling (PVS) using autologous fascia, and Burch colposuspension are available options for second-line surgery. Repeat MUS is the most widely used second-line surgical method at present. Bulking agent injections have lower durability and efficacy than other treatments. Tape shortening demonstrates a relatively low success rate, but comparable outcomes if the period from first treatment to relapse is short. In patients with intrinsic sphincter deficiency, PVS and retropubic (RP) MUS can be considered first as second-line management because of their higher success rate than other treatments. When revision or reoperation is required due to prior mesh-related complications, PVS or colposuspension, which is performed without a synthetic mesh, is appropriate for second-line surgery. For patients with detrusor underactivity, a readjustable sling can be a better option because of the high risk of postoperative voiding dysfunction in PVS or RP slings.

Glue mesh fixation in laparoscopic sacrocolpopexy: results at 3years' follow-up.

We assessed 3-year anatomic and functional results using synthetic glue to fix mesh in laparoscopic sacrocolpopexy. Prospective multicenter cohort study in three academic urogynecology departments. Seventy consecutive patients with stage ≥ 3 POP-Q (Pelvic Organ Prolapse Quantification) anterior and/or apical prolapse underwent laparoscopic sacrocolpopexy using synthetic surgical glue to fix anterior and posterior meshes to the vagina. Patients were followed up at 1, 2 and 3years. Primary outcome was anterior and apical anatomic success (POP-Q stage ≤ 1) at 3years. Secondary outcomes comprised functional results (international quality of life and sexuality scales), mesh-related morbidity and urinary incontinence at 3years. Mean age was 56.7 ± 1.2years. Mean follow-up was 43months. Anterior compartment anatomic success rate was 87% at 2years (Ba, -2.4cm; p < 0.0001) and 86.5% at 3years (Ba, -2.3cm; p < 0.0001); apical success was 96.3% at 2years (C, -6.8cm; p < 0.0001) and 97.3% at 3years (C, -6.5cm; p < 0.0001). All quality-of-life scores improved significantly and lastingly at 3years: PFDI-20, PFIQ-7 and PISQ-12, respectively, p < 0.0001, p < 0.0001 and p = 0.01. There was one case of vaginal mesh exposure at 3years (2.8%) and five of mesh shrinkage at 1year (7.8%), none at 2years and two at 3years (5.4%). Urinary incontinence rate was 29.7% at 1year, 14.8% at 2years and 11.1% at 3years. Vaginal mesh adhesive in laparoscopic sacrocolpopexy remained effective at 3years, with excellent tolerance and no specific complications. Anatomic and functional results were good and enduring in terms of both anterior and apical correction.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial

Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. Our objective was to compare the efficacy and adverse events of these 2 procedures. At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of-18% (95% confidence interval,-33% to-3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Titanium Meshes in Guided Bone Regeneration: A Systematic Review

The presence of satisfactory bone volume is fundamental for the achievement of osseointegration. This systematic review aims to analyse the use of titanium meshes in guided bone regeneration in terms of bone gain, survival and success rates of implants, and percentages of exposure. An electronic search was conducted Articles were selected from databases in MEDLINE (PubMed), SCOPUS, Scielo, and Cochrane Library databases to identify studies in which bone regeneration was performed through particulate bone and the use of titanium meshes. Twenty-one studies were included in the review. In total, 382 patients, 416 titanium meshes, and 709 implants were evaluated. The average bone gain was 4.3 mm in horizontal width and 4.11 mm in vertical height. The mesh exposure was highly prevalent (28%). The survival rate of 145 simultaneous implants was 99.5%; the survival rate of 507 delayed implants was 99%. The success rate of 105 simultaneous implants was 97%; the success rate of 285 delayed implants was 95.1%. The clinical studies currently available in the literature have shown the predictability of this technique. It has a high risk of soft tissue dehiscence and membrane exposure although the optimal management of membrane exposition permits obtaining a sufficient bone regeneration volume and prevents compromising the final treatment outcome.

Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model.

The aim of the study was to compare vaginal wound healing after exosome injection in a porcine mesh exposure model with (1) single versus multiple dose regimens and (2) acute versus subacute exposure. Six 80-kg Yorkshire-crossed swine each had 2 polypropylene meshes implanted to create the vaginal mesh exposure model. Animals were divided into 3 groups based on number and timing of exosome injection: (1) single purified exosome product (PEP) injection (acute-single), (2) weekly PEP injections (acute-weekly, 4 total injections), and (3) delayed single injection (subacute-single). Acute and subacute injections occurred 1 and 8 weeks after mesh implantation, respectively. EdU, a thymidine analog, was given twice weekly after the first injection to track tissue regeneration. Euthanasia and tissue analysis occurred 4 weeks after the first injection. ImageJ was used to quantify epithelial thickness, cellular proliferation, and capillary density. Statistical analysis was performed using analysis of variance and post hoc Tukey test. Acute-single PEP injection tissues mirrored pilot study results, validating replication of protocol. Within the acute groups, weekly dosing resulted in 1.5× higher epithelial thickness (nonsignificant), 1.8× higher epithelial proliferation (P < 0.05), and 1.5× higher regenerated capillary density (P < 0.05) compared with single injection. Regarding chronicity of the exposure, the subacute group showed 1.7× higher epithelial proliferation (nonsignificant) and similar capillary density and epithelial thickness as compared with the acute group. Exosome redosing resulted in significantly greater epithelial proliferation with significantly higher regenerated capillary density, leading to a trend toward thicker epithelium. Subacute exposure exhibited similar regeneration to acute exposure despite a delayed injection timeline. These results contribute to a growing body of preclinical research demonstrating utility of exosomes in pelvic floor disorders.

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.

Customized CAD/CAM titanium meshes for the guided bone regeneration of severe alveolar ridge defects: Preliminary results of a retrospective clinical study in humans

To present the results of guided bone regeneration (GBR) of atrophic edentulous ridges with customized CAD/CAM titanium meshes. Forty-one patients, presenting with 53 atrophic sites, were enrolled between 2018 and 2019. GBR was obtained with titanium meshes filled with autogenous bone chips and bovine bone mineral (BBM). After a mean of 7months (range: 5-12months), meshes were removed and 106 implants placed. After a mean of 3.5months (range: 2-5months), implants were uncovered and prosthetic restorations started. The outcomes were vertical and horizontal bone augmentation changes, biological complications and implant survival. Out of 53 sites, 11 underwent mesh exposure: eight of them were followed by uneventful integration of the graft, while three by partial bone loss. The mean vertical and horizontal bone gain after reconstruction was 4.78±1.88mm (range 1.00-8.90mm) and 6.35±2.10mm (range 2.14-11.48mm), respectively. At the time of implant placement, mean changes of initial bone gain were -0.39±0.64mm (range -3.1 to+0.80mm) and -0.49±0.83mm (range -3.7 to +0.4mm), in the vertical and horizontal dimensions, respectively. Reduction of bone volume was significantly higher (p<.001 for both dimensions) in the exposed sites. The mean follow-up of implants after loading was 10.6±6.5months (range: 2-26months). The survival rate of implants was 100%. Customized titanium meshes can represent a reliable tool for GBR of severely atrophic sites, with simplification of the surgical phases.

Transobturator four-arms mesh in the surgical management of cystocele: a long-term follow-up.

We studied the long-term efficacy and safety of cystocele operation by polypropylene mesh. A total of 198 women with stage ≥2 cystocele who had anterior vaginal wall repair with transobturator four-arm polypropylene mesh during 2003 to 2015 were evaluated. Outcomes including clinical characteristics and complications were reviewed by extracting patient data from electronic medical records. In addition, telephone interviews were conducted using a validated questionnaire along with physical examination. The follow-up period was 9.3±0.3 years. The cystocele stage in patients was significantly decreased post-operation compared to that preoperation. The anatomical cure rate for cystocele was 93.4%, and that for stress urinary incontinence was 95%. Comparing the three questionnaires indicated overall average score was improved significantly, except for Female Sexual Function Index Assessment. Early complications were either resolved spontaneously or controlled medically in four cases of hematoma or abscess, three cases of vaginal infection and urinary tract infection, and four cases of difficult micturition. In late complications, four cases of pain were managed, five cases of recurrence were observed and two cases of mesh exposure were treated with ointment and local excision. Transobturator four-arms mesh is an effective and safe method for cystocele repair with low rate of recurrence and complications. We suggest that the use of transobturator four-arm mesh is a still good choice for the old patients with cystocele who are not suitable for general anesthesia and reside in areas where laparoscopy and robots are not available.

Guideline No. 413: Surgical Management of Apical Pelvic Organ Prolapse in Women

To compare success and complication rates of apical suspension procedures for the surgical management of symptomatic uterine or vaginal vault prolapse. Women with symptomatic uterine or vaginal vault prolapse seeking surgical correction. Interventions included abdominal apical reconstructive repairs (sacrocolpopexy, sacrohysteropexy, or uterosacral hysteropexy) via open, laparoscopic, or robotic approaches; vaginal apical reconstructive repairs (vault suspensions or hysteropexy, sacrospinous, uterosacral, iliococcygeus, McCall's, or Manchester types); and vaginal obliterative procedures (with or without uterus in situ). Individual procedures or broad categories of procedures were compared: (1) vaginal versus abdominal routes for reconstruction, (2) abdominal procedures for reconstruction, (3) vaginal procedures for reconstruction, (4) hysterectomy and suspension versus hysteropexy for reconstruction, and (5) reconstructive versus obliterative options. The Urogynaecology Committee selected outcomes of interest: objective failure (obtained via validated pelvic organ prolapse [POP] quantification systems and defined as overall objective failure as well as failure rate by compartment); subjective failure (recurrence of bulge symptoms determined subjectively, with or without use of a validated questionnaire); reoperation for POP recurrence; complications of postoperative lower urinary tract symptoms (de novo or postoperative stress urinary incontinence; reoperation for persistent, recurrent, or de novo stress urinary incontinence; urge urinary incontinence; and voiding dysfunction); perioperatively recognized urinary tract injury (bladder or ureter); other complications (mesh exposure, defined as mesh being visible and exposed in the vagina, and non-sexual pelvic pain); and sexual function (de novo dyspareunia and sexual function score according to a validated questionnaire). This guideline will benefit patients seeking surgical correction of apical POP by improving counselling on surgical treatment options and possible outcomes. It will also benefit surgical providers by improving their knowledge of various surgical approaches. Data presented could be used to develop frameworks and tools for shared decision-making. We searched Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase from 2002 to 2019. The search included multiple terms for apical POP surgical procedures, approaches, and complications. We excluded POP repairs using transvaginal mesh and studies that compared procedures without apical suspension. We included randomized controlled trials and prospective or retrospective comparative studies. We limited language of publication to English and French and accessibility to full text. A systematic review and meta-analysis was performed. The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations). Gynaecologists, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with POP. All statements refer to correction of apical vaginal prolapse in the short and medium term (up to 5 years), except when otherwise specified.

The Technique of Scarless Latissimus Dorsi in Immediate Breast Reconstruction.

Background: In dealing with the inferior pole coverage of an implant or a tissue expander in the partial submuscular technique, various surgical strategies have been introduced over the years. Among them, ADM and synthetic meshes were intensively studied and performed in order to obtain a good aesthetic result with satisfactory lower pole contouring, create a strong support of the implant and offer flexibility in adapting the volume of a tissue expander to the remaining mastectomy flaps (1,2). However, the viability of the skin from the mastectomy flaps is not always optimal. Vascular impairment and subsequent necrosis can occur at various extent in the mastectomy flaps (3). The necrosis of the mastectomy flaps is unpredictable and sometimes occurs with no obvious cause (4). Implant exposure and extrusion, ADM or mesh exposure are serious complications which can lead to the reconstructive failure. Methods: The scarless latissimus dorsi flap technique was introduced and observed in patients eligible for skin sparing and nipple sparing mastectomy with implant-based submuscular breast reconstruction. The keypoints of the surgical steps are described. Results: The main priorities of the outcome of the reconstructive process were stability and good definition of the lower pole of the reconstructed breast. The good vascularized underlying muscular tissue totally covering the implant increases chances in avoiding exposure or extrusion of the implant. In the advent of partial mastectomy flap necrosis, the healing by secondary intention provided good and stable results. Also, this technique decreases the morbidity and risks related with the change of the patient position during the procedure, improves the aesthetic results, by avoiding additional incisions for harvesting the flap. Conclusions: The scarless latissimus dorsi flap in implant based breast reconstruction is a valuable option for stable results and viable alternative to the use of ADM.

Clinical analysis of pain after transvaginal mesh surgery in patients with pelvic organ prolapse

BackgroundThe purpose of this study was to investigate the relevant factors of pain after transvaginal mesh (TVM) surgery for the treatment of pelvic organ prolapse and to analyse the management and relief of the pain.MethodsA multicentre retrospective study of a clinical database of patients who underwent TVM surgery was conducted, and pain related aspects were analysed.ResultsA total of 1855 patients were included in the study. We divided the patients into two groups: pain-free (1805 patients) and pain (50 patients) group. The incidence of pain after TVM surgery was 2.70%, with a median occurrence time of 7.5 months. Pain mainly involved the vagina, perineum, buttocks, groin, inner thighs, and lower abdomen. Excessive intraoperative blood loss (OR = 1.284, 95% CI 0.868–2.401) and postoperative anatomic failure (OR = 1.577, 95% CI 0.952–3.104) were analysed as risk factors with statistical significance. Mesh exposure rate in the pain group was 38%, showing a significant difference between the groups (P < 0.01). Forty patients underwent non-surgical treatment, with a relief rate of 40.0%, 33 patients received surgical treatment, 15 underwent partial mesh removal, and 18 underwent complete mesh removal, with a relief rate of 84.8%. The total relief rate was 88% within all 50 patients suffering from pain.ConclusionsExcessive intraoperative bleeding and unsatisfactory postoperative anatomic outcomes can increase the risk of postoperative pain; mesh exposure is also associated with the pain. Most patients can get pain relief with proper management, more than half of whom may need mesh removal with differing approach.

Short and Long Term Follow up and Efficacy of Trans Obturator Tape for Management of Stress Urinary Incontinence.

Stress urinary incontinence (SUI) is involuntary leakage of urine on raised intra- abdominal pressure which adversely affects quality of life usually requiring surgical treatment. This is a prospective study of efficacy, cure rates and complications of tension free transobturator tape (TOT) surgery on 85 women with SUI. Pre-operatively and 6months post-operatively International consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) scores were calculated for all patients to know the severity of incontinence and efficacy of tape. Mean age, parity, body mass index and mean duration of symptoms were 45.78years, 2.68, 26.38kg/m2 and 3.85years, respectively. SUI was demonstrated in all cases on cough stress test and Bonney's test. Mean operative time, blood loss, post-operative analgesic injections, post- operative stay and post- operative catheterisation were 23.28min, 45.50ml, 1.2 injections, 1.2days and 1.2days. Various complications noted were excessive bleeding (3.52%), urinary retention (7.05%), urinary urgency (8.23%), urinary tract infection (2.35%), surgical site infection (1.17%), groin pain (28.23%) and mesh exposure (3.52%). At 6 months follow-up, the complete cure rate was 83.52% , partial cure rate was 11.76% and failure rate was found to be 4.70% whereas it was 79.16%, 12.0% and 8.33% respectively at 3 years follow up. 2 patients (2.35%) required burch colposuspension and 12 patients (14.11%) required pelvic floor exercises and duloxetine therapy for their symptoms. Mean pre- operative ICIQ-SF score reduced post- operatively (17.8 ± 4.67 to 2.71 ± 1.42) (p value = 0.001). Study demonstrates short and long-term efficacy and safety of TOT for surgical management of SUI.

A prospective randomized trial comparing Restorelle® Y mesh and flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy: 24-month outcomes.

To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh. A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse. Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic. At 24months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.

Retrospective Analysis of the Effect of Three-Dimensional Preformed Titanium Mesh on Peri-Implant Non-Contained Horizontal Defects in 100 Consecutive Cases

This study aimed to clinically and radiographically evaluate the results of guided bone regeneration (GBR) using three-dimensional preformed titanium mesh (3-D-PFTM) for non-contained horizontal defects in 100 consecutive cases. This study involved 100 patients (129 implants) with peri-implant non-contained horizontal defects. The patients were divided into three groups: 3-D-PFTM alone (Group 1), 3-D-PFTM plus cross-linked collagen membrane (Group 2), and 3-D-PFTM plus non-cross-linked collagen membrane (Group 3). Each implant was evaluated radiographically using CBCT at baseline and 6 months postoperatively. At the platform level, the mean horizontal hard tissue gain of all the sites was 3.1 ± 1.3 mm at 6 months postoperatively. The mean rate of mesh exposure was 11.8% in Group 1, 4.2% in Group 2, and 5.0% in Group 3. The mean hard tissue gain rate was 71.0 ± 23.0% in group 1, 84.2 ± 21.5% in group 2, and 84.0 ± 22.9% in group 3. Groups 2 and 3 showed significantly higher hard tissue gain rates than group 1. However, there was no significant difference between the rates in groups 2 and 3. Within the limitations of this study, 3-D-PFTM should be considered as a valuable option for GBR for peri-implant non-contained horizontal defects. The use of an additional resorbable collagen membrane provides additional advantages.

Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model.

The purpose of this study was to explore the utility of an injectable purified exosome product derived from human apheresis blood to (1) augment surgical closure of vaginal mesh exposures, and (2) serve as a stand-alone therapy for vaginal mesh exposure. Sixteen polypropylene meshes (1×1-3×3 cm) were implanted in the vaginas of 7 Yorkshire-crossed pigs by urogynecologic surgeons (day 0). On day 7, group 1 underwent surgical intervention via vaginal tissue suture reclosure with (n=2 pigs, n=4 meshes) or without (n=2 pigs, n=4 meshes) exosome injection; group 2 underwent medical intervention with an exosome injection (n=3, n=8 meshes). One animal in group 2 was given oral 2'-deoxy-5-ethynyluridine to track cellular regeneration. Euthansia occurred at 5 weeks. Mesh exposures treated with surgical closure alone experienced reexposure of the mesh. Exosome treatment with or without surgical closure resulted in partial to full mesh exposure resolution up to 3×3 cm. Exosome-treated tissues had significantly thicker regenerated epithelial tissue (208 μm exosomes-only and 217 μm surgery+exosomes, versus 80 μm for surgery-only; P < 0.05); evaluation of 2'-deoxy-5-ethynyluridine confirmed de novo regeneration throughout the epithelium and underlying tissues. Capillary density was significantly higher in the surgery+exosomes group (P = 0.03). Surgery-only tissues had a higher inflammatory and fibrosis response as compared with exosome-treated tissues. In this pilot study, exosome treatment augmented healing in the setting of vaginal mesh exposure, reducing the incidence of mesh reexposure after suture closure and decreasing the area of mesh exposure through de novo tissue regeneration after exosome injection only. Further study of varied local tissue conditions and mesh configurations is warranted.

Prospective International Multicenter Pelvic Floor Study: Short-Term Follow-Up and Clinical Findings for Combined Pectopexy and Native Tissue Repair.

Efforts to use traditional native tissue strategies and reduce the use of meshes have been made in several countries. Combining native tissue repair with sufficient mesh applied apical repair might provide a means of effective treatment. The study group did perform and publish a randomized trial focusing on the combination of traditional native tissue repair with pectopexy or sacrocolpopexy and observed no severe or hitherto unknown risks for patients (Noé G.K. J Endourol 2015;29(2):210–215). The short-term follow-up of this international multicenter study carried out now is presented in this article. Material and Methods: Eleven clinics and 13 surgeons in four European counties participated in the trial. In order to ensure a standardized approach and obtain comparable data, all surgeons were obliged to follow a standardized approach for pectopexy, focusing on the area of fixation and the use of a prefabricated mesh (PVDF PRP 3 × 15 Dynamesh). The mesh was solely used for apical repair. All other clinically relevant defects were treated with native tissue repair. Colposuspension or TVT were used for the treatment of incontinence. Data were collected independently for 14 months on a secured server; 501 surgeries were registered and evaluated. Two hundred and sixty-four patients out of 479 (55.1%) returned for the physical examination and interview after 12–18 months. Main Outcome and Results: The mean duration of follow-up was 15 months. The overall success of apical repair was rated positively by 96.9%, and the satisfaction score was rated positively by 95.5%. A positive general recommendation was expressed by 95.1% of patients. Pelvic pressure was reduced in 95.2%, pain in 98.0%, and urgency in 86.0% of patients. No major complications, mesh exposure, or mesh complication occurred during the follow-up period. Conclusion: In clinical routine, pectopexy and concomitant surgery, mainly using native tissue approaches, resulted in high satisfaction rates and favorable clinical findings. The procedure may also be recommended for use by general urogynecological practitioners with experience in laparoscopy.

Anterior Bilateral Sacrospinous Fixation With Transvaginal Mesh: Is Hysterectomy a Risk Factor for Complications?

The aim of the study was to evaluate the effect of hysterectomy on the risk of complications from transvaginal pelvic organ prolapse surgery with mesh. We conducted a retrospective cohort study between October 2010 and December 2017. Transvaginal mesh surgery was performed in patients with symptomatic anterior and/or apical prolapse (Pelvic Organ Prolapse Quantification ≥ stage 2). The primary outcome was rate of severe surgical complications based on the Clavien-Dindo classification (defined as grade ≥3), and the secondary outcome was the anatomical success at the last postoperative follow-up visit. Three hundred and ninety-six patients were included, 289 of these patients underwent anterior sacrospinous fixation with uterine preservation, 50 had a previous hysterectomy and 57 underwent a concomitant hysterectomy. The median follow-up was 12 months (interquartile range, 7 months). The rate of severe complications was 2.1%, 6.0%, and 5.3% in the uterine preservation group, previous hysterectomy group, and concomitant hysterectomy group, respectively (P = 0.2). The operative time was significantly higher in the concomitant hysterectomy group, and the mesh exposure rate was significantly higher in the previous hysterectomy group. The overall recurrence rate was 7.6%, with no differences between the study groups. Concomitant and previous hysterectomy did not appear to increase the severe complication rate or anatomical failure after transvaginal mesh surgery. However, a history of hysterectomy appears to be a risk factor for vaginal mesh exposure. This must be considered in the choice between prosthetic and autologous management options for the treatment of posthysterectomy vault prolapse.

Comparative analyses of attitude, knowledge, and recollection of preoperative counseling regarding pelvic mesh among women with or without a mesh-related complication.

Our objective was to compare the recollection of preoperative counseling regarding mesh for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) among women with or without a mesh-related complication (MRC). We hypothesized that the patients who had MRC would better recollect counseling regarding complications associated with mesh. We conducted a retrospective cohort study among women who had prior implantation of synthetic, non-absorbable mesh for POP and/or SUI at least 3months prior who presented with or without a MRC. The primary outcome was the proportion of women who recalled being counseled preoperatively about the risk of mesh exposure. Ninety-six women were included in the final analysis (50 MRC; 46 no MRC). MRC women presented further in time from the index surgery [median 69months [IQR 26-115] vs 12months (IQR 6-64), p < 0.01]. After adjustment for time since surgery and age, MRC women were significantly less likely to recall being counseled about the possibility of any MRC [19/50 (38%) vs 32/44 (73%), aOR 0.29, 95% CI 0.11-0.79, p = 0.01]. They were also less likely to report they would undergo the same surgery again 5-point Likert scale [median 3 (IQR 1-4) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01], less satisfied with their mesh surgery [median 1 (IQR 1-3) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01] and recommended improved preoperative counseling [27/50 (54%) vs 6/46 (13%), p < 0.01]. Women who experienced MRC were less likely to recall being counseled about the possibility of MRC and report more unmet needs regarding perioperative counseling than women without MRC.

Advantages of robotic surgery in the treatment of complex pelvic organs prolapse.

Robot-assisted surgery is safe and effective to treat the complex pelvic organs prolapse (C-POP). The present study analyzes all the robotic procedures and their advantages in the treatment of C-POP performed in a Proctologic and Pelvic Floor Clinical Centre. All the patients affected by C-POP who had robot-assisted surgery were retrospective analyzed. The anatomical and functional outcomes were respectively evaluated through POP-Q grading system and Wexner score about constipation and incontinence. The satisfaction rate was investigated using a five-point scale. From September 2014 to December 2018, 229 women underwent robotic surgery. The follow-up was 12months. There were no robot-related complications. One hematoma (4.5%) of the recto-vaginal space occurred after Robotic Ventral Rectopexy with Folded Mesh (R-VRP-FM). In the robotic assisted lateral suspension (R-ALS) group there was one case of anterior vaginal wall mesh exposure (0.9%). After the robotic ventral rectopexy (R-VRP) the recurrence rate of external rectal prolapse, internal rectal prolapse, rectocele and enterocele was respectively 6.6, 9.5, 7.4 and 9.5%. After R-VRP-FM only one cystocele (14%) and one partial rectal prolapse (25%) recurred. Vaginal bulge symptoms resolution rate was 95.4%. The mean Wexner constipation score significantly decreased after R-VRP and R-VRP-FM. Vaginal bulge symptoms improved in 98.3% of cases with any apical prolapse recurrence after robotic abdominal colposacropexy. Success rate after R-ALS was 99.1% and 96.4% for apical and anterior prolapse respectively. Robotic assistance makes some surgical steps easier and more precise and this may result in less morbidity and better results.

Short-Term Outcomes of Vaginal Hysterectomy at the Time of Robotic Sacrocolpopexy.

With the introduction of robotic sacrocolpopexy (RSC) at our institution in 2008, we noted a reduction in residents' vaginal hysterectomy (VH) experience. In 2012, we made a transition to perform VH on all robotic sacrocolpopexies. Our objective was to report our short-term outcomes and adverse events. In this case series, we evaluated women who underwent VH with concomitant RSC for stages II to IV pelvic organ prolapse between 2012 and 2017. In these cases, the vesicovaginal and rectovaginal spaces were developed transvaginally. Descriptive analysis including demographics, short-term outcomes, and adverse events are reported. In this group of 209 women, median (interquartile interval) duration of follow-up was 49 (26-60) weeks. The majority of the women were white (84.7%) and postmenopausal (80.9%), with a mean (SD) age of 59 (9) years. At a median follow-up time of 49 weeks, pelvic organ prolapse quantification revealed 20 patients (12.4%) with Ba or Bp greater or equal to 0 and 1.4% of patients required repeat prolapse surgery. Among 9 women (4.3%) with postoperative fever, 4 (1.9%) were treated for pelvic collection/abscess. Of 5 women (2.4%) who had venous thromboembolism, 3 (1.4%) were diagnosed with pulmonary embolism. There were 18 patients (8.6%) treated for urinary tract infection within 6 postoperative weeks. Mesh exposure was noted in 16 (7.7%) of the patients, and 11 (6.2%) required reoperation. Vaginal hysterectomy at the time of RSC may increase the risk of infection and mesh exposure compared with procedures without concomitant hysterectomy.