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Objective: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair., Design: Prospective cohort study using a registry., Setting: Nineteen French surgical centres., Population: A total of 2309 women participated between 2017 and 2019., Methods: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups., Main Outcome Measures: Serious complications and subsequent reoperations for POP recurrence., Results: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups., Conclusions: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making., Tweetable Abstract: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair., (© 2021 John Wiley & Sons Ltd.)

Objectives: 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., Methods: 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., Results: 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., Conclusions: 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., Competing Interests: R.dT. and B.F. are consultants for Boston Scientific. The other authors have declared that they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

Polypropylene (PP) mesh has been used as a primary or adjuvant material for vaginal reconstruction for both stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades. Whether polypropylene is the optimal material for such indications has been called into question by clinicians, regulatory agencies and the public in several countries around the world. This paper is a report of presentations and subsequent discussion at the annual International Consultation on Incontinence Research Society (ICI-RS) Meeting in June 2019 in Bristol, UK on the proposal "Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery?" in which several of the salient issues were presented and discussed., (© 2020 Wiley Periodicals, Inc.)

Introduction: The purpose of the study was to assess the frequency of late postoperative complications, surgical revisions and anatomical and functional outcomes > 1year after the insertion of an ultra-light vaginal mesh for the treatment of genital prolapse., Material and Methods: In our multicenter retrospective series, patients who had a previous ultra-light transobturator mesh (19g/m2) Restorelle®DirectFix™ mesh placed, either reviewed in post-operative consultation or interviewed by phone with a minimum of twelve months' follow-up were included., Results: 172 patients were included in the analysis. Among them, 8/141 (5.7%) had chronic pain, 7/141 (5.0%) recurrent urinary tract infections, 1/70 (1.4%) resolving granulomas, 2/70 (2.9%) painful retractions, 2/70 (2.9%) colpectomy for vaginal erosion, 1/141 (0.7%) ureteral reimplantation, 1/141 (0.7%) a reoperation for colonic occlusion on mesh and 1/141 (0.7%) self urinary catheterization, 9% of patients with at least one minor complication (without major complication) and 3% of patients with a major +/- minor complication. Nine patients out of 142 (6.3%) had a surgical revision for recurrence of prolapse and 2/70 (2.9%) for vaginal mesh exposure. The anatomical success rate of cystocele repair was 72%. 20% of patients had symptomatic recurrence. The rate of de novo dyspareunia was 13%. Functional success was noted in 82% of patients., Conclusion: The Restorelle® mesh has good safety and efficiency in the medium term. Long-term data and comparative studies are needed., (Copyright © 2019. Published by Elsevier Masson SAS.)

Objective: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse., Design: Prospective longitudinal cohort study using a surgical registry., Setting: Thirteen public hospitals in France., Population: A cohort of 1873 women undergoing surgery between February 2017 and August 2018., Methods: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems., Main Outcome Measures: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death., Results: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh., Conclusions: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors., Tweetable Abstract: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh., (© 2019 Royal College of Obstetricians and Gynaecologists.)

Aims: To identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh-associated complications., Methods: Patients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1-2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R., Results: We recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications., Conclusions: The presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh-related complications for targeted phenotyping of patients who could benefit from TVM surgery., (© 2019 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

Aims: To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12-month follow-up., Methods: Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168., Results: A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function., Conclusions: The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high-volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable., (© 2019 Wiley Periodicals, Inc.)

Background: Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP)., Objective: To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m 2 ): Restorelle ® Direct Fix™., Methods: A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle ® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification., Results: Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V., Conclusions: This multicentre case-series on the early experience of the use of anterior Restorelle ® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle ® Direct Fix™ mesh performances and to appraise patient satisfaction feedback., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Background: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes., Objective: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM., Design, Setting, and Participants: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery., Intervention: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM)., Outcome Measurements and Statistical Analysis: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results., Results and Limitations: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS)., Conclusions: LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS., Patient Summary: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Introduction: Prevalence of pelvic organ prolapse will increase with the aging of the population. Concerning the treatment of pelvic organ prolapse, transvaginal route is often preferred for elderly women. However few data are available concerning transvaginal mesh surgery in this population. The aim of this study was to compare efficiency and complications of transvaginal mesh surgery between women aged over 75 and younger women., Materials and Methods: A monocentric, retrospective study included all women who underwent anterior sacrospinous suspension with mesh for treatment of pelvic organ prolapse. The primary endpoint was anatomical success at the last follow-up, defined by a pelvic organ prolapse stage 0 or 1 of POP-Q classification. The secondary endpoints were rate of complications and urinary, colorectal and sexual functional results., Results: We included 329 patients, 69 were under 75 years old and 260 were aged over 75. The median of follow-up was 12 months (IQR: 6). The rate of anatomical success was significantly higher in patients aged over 75: 92% versus 85% in younger patients (P=0.02). However this difference was no more significant in multivariate analysis after inclusion of confusions factors (P=0.82). The rate of perioperative complications was low and similar in the 2 groups even in multivariate analysis., Conclusion: Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh seems to achieve at least similar results between women aged more than 75 years and younger women. There is no excess risk of complications in elderly women., Level of Evidence: 4., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Introduction: Perineal hernia is a protrusion of intra-abdominal viscera through a defect in the pelvic floor and is a rare but challenging complication after extensive abdominoperineal surgery. There have been small series published after colorectal exenteration, but no cases have been reported after radical cystectomy and urethrectomy., Case Presentation: A 68 years old woman developed an anterior perineal hernia, with no vaginal prolapse, after an anterior exenteration for bladder cancer. A perineal approach with the use of a synthetic polypropylene mesh was chosen to resolve the condition. After 6 months of follow-up, the patient has no symptoms or recurrence of the anterior perineal hernia., Conclusion: To our knowledge, this case is the first report of perineal hernia after radical urethrocystectomy. Although being a case report, this article describes a potential and challenging complication after extensive anterior pelvic surgery, that could increase its incidence in the future. Literature review shows that whether perineal, abdominal or combined approach is chosen, surgery must respect hernia repair principles., Competing Interests: Brigitte Fatton is consultant for Boston Scientific, Astellas and Allergan. Renaud de Tayrac is consultant for Boston Scientific and has research partnership with Aspide Medical and Coloplast. Other authors declare that they have no conflict of interest., (Copyright® by the International Brazilian Journal of Urology.)

Introduction and Hypothesis: The use of mesh in pelvic organ prolapse (POP) surgery has become a widespread treatment option, but carries a risk of specific complications. The objective was to report the rate and type of reoperation for mesh-related complications after pelvic organ prolapse surgery in an urogynecological referral center over a period of 8 years., Methods: A retrospective study was carried out including all patients operated for a mesh complication after prolapse surgery between September 2006 and September 2014 in the urogynecology unit in Nîmes hospital., Results: Sixty-nine mesh complications were recorded among the 67 patients included. Surgical treatment of mesh-related complications accounted for 7% of all pelvic surgeries performed in our center. Thirty-two patients (47.8%) were referred from other centers and 35 patients (52.2%) were initially operated in our unit. The global rate of reintervention for mesh-related complications after prolapse repair performed in our unit was 2.8%. Of 69 mesh complications, 48 patients (71.6%) had transvaginal mesh (TVM) and 19 patients (28.4%) sacrocolpopexy (SCP). The indication for surgery was a symptomatic or large vaginal erosion (47.8%), symptomatic mesh contraction (20.3%), and infection (11.6%). The most frequent primary symptom was pelvic/perineal pain or dyspareunia (33.3% of cases). The mean time between initial mesh surgery and the reoperation for a complication was 33.4 months (95% CI, 24.5 to 42.2). Eleven patients (15.9%) required several interventions. In total, 77.9% of patients experienced complete recovery of symptoms after surgical management., Conclusion: In a referral center the global rate of reinterventions for mesh-related complications after POP repair is 2.8%. The surgical treatment of mesh complications appears to be a safe and effective procedure with cure of the symptoms in most cases.

Objectives: Synthetic mesh surgery for both abdominal and urogenital hernia repair is often unsatisfactory in the long-term due to postoperative complications. We hypothesized that a semi-degradable mesh hybrid may provide more appropriate biocompatibility with comparable mechanical properties. The aim was to compare its in vivo biocompatibility with a commercial polypropylene (PP) mesh., Methods: 72 rats were randomly allocated to either our new composite mesh (monofilament PP mesh knitted with polylactic-acid-fibers (PLA)) or to a commercially available PP mesh that was used as a control. 15, 90, and 180 days after implantation into the rat abdomen mesh tissue complexes were analysed for erosion, contraction, foreign body reaction, tissue integration and biomechanical properties., Results: No differences were seen in regard to clinical parameters including erosion, contraction or infection rates between the two groups. Biomechanical properties including breaking load, stiffness and deformation did not show any significant differences between the different materials at any timepoint. Macrophage staining did not reveal any significant differences between the two groups or between timepoints either. In regard to collagen I there was significantly less collagen I in the PP group compared to the PP/ PLA group at day 180. Collagen III did not show any significant differences at any timepoint between the two groups., Conclusion: A PP/PLA hybrid mesh, leaving a low amount of PP after PLA degradation seems to have comparable biomechanical properties like PP at 180 days due to enhanced collagen production without significant differences in erosion, contraction, herniation or infection rates.

Introduction and Hypothesis: Neovaginal prolapse (NP) is a rare event as few cases have been reported in the literature. Its management is complex and depends on the initial pathology, the vaginoplasty technique and the patient's history. We present a review the literature on this rare event., Methods: We describe the case of a 72-year-old woman who presented with NP 1 year after pelvic exenteration and radiotherapy for recurrent cervical carcinoma associated with vaginal reconstruction by shaped-tube omentoplasty. She had undergone two previous surgical procedures (posterior sacrospinous ligament suspension and partial colpocleisis), but NP recurred each time within a few months. We performed an anterior approach to the sacrospinous ligament and inserted a mesh under the anterior wall of the neovagina, with the two mesh arms driven through the sacrospinous ligament in a tension-free manner (Uphold Lite® system). The MEDLINE, Cochrane Library, ClinicalTrials and OpenGrey databases were systematically searched for literature on the management of NP following bowel vaginoplasty, mechanical dilatation, graciloplasty, omentoplasty, rectus abdominis myocutaneous flap and the Davydov procedure., Results: The postoperative course in the patient whose case is described was uneventful and after 1 year of follow-up, the anatomical results and patient satisfaction were good. The systematic search of the databases revealed several studies on the treatment of NP using abdominal and vaginal approaches, and these are reviewed., Conclusions: Overall, sacrocolpopexy would appear to be a good option for the treatment of prolapse after bowel vaginoplasty, but too few cases have been reported to establish this technique as the standard management of NP.

Introduction and Hypothesis: Pelvic organ prolapse is a major burden for the public health system, affecting up to 30 % of all women. One mesh kit has been introduced for pelvic organ prolapse surgery that can be inserted via a single anterior incision with the mesh arms driven through the sacrospinous ligament in a tension-free manner. The aim of this study was to describe the medium-term results of this vaginal mesh kit procedure for the combined treatment of the anterior vaginal wall and vault prolapse., Methods: This is a longitudinal case series of patients undergoing an anterior mesh operation between 2009 and 2013. All patients presenting with symptomatic stage II prolapse or higher were included when a minimum follow-up of 12 months was achieved. A structured interview and clinical examination were performed pre- and postoperatively., Results: One hundred and eighteen consecutive patients were operated with the Uphold® system during the study period. Three patients did not complete the 12-month follow-up and were excluded from the analysis, leaving 115 patients. Anatomical success at a mean follow-up of 23 months was 93 %, with a patient satisfaction rate of 95 %. Four patients (8 %) experienced de novo dyspareunia related to the mesh. The reoperation rate for mesh-related complications was 3.4 %; no patients were re-operated for POP recurrence., Conclusions: The subjective and objective cure rates were high and the mesh-related re-operation rate was 3 % in the medium term, suggesting that this surgical technique may be an option for women requiring anterior and apical prolapse repair.

Introduction and Hypothesis: The aim of this study was to assess the 36-month safety and efficacy of a lightweight polypropylene mesh used for the transvaginal repair of stage III-IV cystocele., Methods: A multicenter prospective cohort study was performed. Preoperative assessment included an interview and evaluation with the Pelvic Organ Prolapse Quantification (POP-Q) system. Inclusion criteria were stage III-IV cystocele and no contraindications for mesh use. A lightweight (28 g/m(2)) four-arm transobturator polypropylene mesh was used for the study. Pre- and postoperative symptoms and quality of life were assessed using the Urinary Symptoms Measurement (MHU), Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The main endpoint was mesh safety. Secondary endpoints were anatomic (Ba point ≤ -1) and functional success., Results: In all, 111 patients with a mean age of 67 ± 9 years (range 47-89) were included in the study, and 94 (84.7%) were included in the analysis. Two intraoperative complications occurred (one bladder and one rectal injury, 2.2%). Medium-term analysis of 79 patients (84%) after 36 months showed a satisfaction rate of 98.7% (78/79), a mesh contraction rate of 5.1% (4/78), only one case of vaginal mesh exposure (1.3%), no cases of chronic pelvic pain, and a postoperative dyspareunia rate of 2.8% (1/36). The anatomic success rate of cystocele repair was 75/79 (94.9%) and a highly significant improvement was noted for symptoms and on quality of life questionnaires. Overall, 7/79 patients (8.9%) were reoperated, including 1 for hemorrhage, 1 for vaginal mesh exposure, 3 for stress urinary incontinence, and 2 for cystocele recurrence (2.5%)., Conclusion: Transvaginal cystocele repair using a lightweight transobturator polypropylene mesh was safe and efficient in the medium term. Long-term data and comparative studies are needed.

Objective: Fast-absorbing polyglactin 910 is commonly used to suture skin and vaginal incisions. In vitro studies have shown similar tensile strength properties between Velosorb™ Fast and Vicryl™ Rapide (Al-Qattan MM. J Hand Surg Br Eur. 2005;30(1):90-91). This randomized study compared Velosorb™ Fast (Covidien) with Vicryl™ Rapide (Ethicon) in a rabbit model of intradermic suture and episiotomy., Materials and Methods: This randomized prospective study was performed on 20 New Zealand rabbits, in which we realized a mediolateral perineo-vaginal incision and two vertical skin incisions of about 8 cm on the abdominal wall. The sutures were randomized between Velosorb™ Fast (Covidien) and Vicryl™ Rapide (Ethicon), and each rabbit was treated with the same suture on both vaginal incision and left abdominal incision, while the right abdominal incision was closed with an alternate suture. A macroscopic examination was performed on days 5 and 11. On day 11, animals were sacrificed for histological (Badylak quantitative score) and electron microscopic examinations. Differences were considered significant at p < .05., Results: All of the rabbits survived and were included in the final results. Fifty-one sutures were visible by histologic analysis (27 in the Velosorb™ Fast group and 24 in the Vicryl™ Rapide group). The power of the study was ≥80%. There was no significant difference between the two groups based on the total histologic Badylak score analysis or the Badylak sub-score analysis., Conclusions: Velosorb™ Fast seems to be as efficient as Vicryl™ Rapide for use in perineal and skin closure.

Background: Synthetic meshes are frequently used to reinforce soft tissues. The aim of this translational study is to evaluate tolerance and long-term MRI visibility of two recently developed Gadolinium-modified meshes in a rat animal model., Materials and Methods: Gadolinium-poly-ε-caprolactone (Gd-PCL) and Gadolinium-polymethylacrylate (Gd-PMA) modified meshes were implanted in Wistar rats and their tolerance was assessed daily. Inflammation and biocompatibility of the implants were assessed by histology and immunohistochemistry after 30 days post implantation. Implants were visualised by 7T and 3T MRI at day 30 and at day 90. Diffusion of Gadolinium in the tissues of the implanted animals was assessed by Inductively Coupled Plasma Mass Spectrometry., Results: Overall Gd-PMA coated implants were better tolerated as compared to those coated with Gd-PCL. In fact, Gd-PMA implants were characterised by a high ratio collagen I/III and good vascularisation of the integration tissues. High resolution images of the coated mesh were obtained in vivo with experimental 7T as well as 3T clinical MRI. Mass spectrometry analyses showed that levels of Gadolinium in animals implanted with coated mesh were similar to those of the control group., Conclusions: Meshes coated with Gd-PMA are better tolerated as compared to those coated with Gd-PCL as no signs of erosion or significant inflammation were detected at 30 days post implantation. Also, Gd-PMA coated meshes were clearly visualised with both 7T and 3T MRI devices. This new technique of mesh optimisation may represent a valuable tool in soft tissue repair and management.

Objective: To show place and usefulness of intra-uterine compression in management of post-partum haemorrhage (PPH)., Material and Methods: Retrospective cohort study, monocentric, including all consecutive cases of PPH during four years in an obstetric department of level IIa. The compression technique was the use of intra-uterine meshes, and efficacy was defined as a total and immediate bleeding interruption. Apart of meshes, patients received sulprostone then ocytocine and antibiotics., Results: The rate of PPH was 3.8% on 3913 deliveries. One hundred and fifty patients with PPH were managed following CNGOF guidelines. Ninety-nine patients were also treated with intra-uterine meshes during 24hours. The rate of mesh success was 91.9%. Sixty-two cases of subsequent pregnancies were also reported., Conclusion: In case of PPH, intra-uterine compression using meshes is simple, cheap and efficient. That technique could avoid the use of invasive surgical procedures and a safer post-natal transfer., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

We report a case of obturator neuropathy induced by trans-obturator vaginal mesh surgery for symptomatic cystocele. Initial electromyography excluded genito-femoral and pudendal nerve deficiency. Typical clinical arguments for severe obturator neuropathy at physical examination led to vaginal revision surgery with hemi-resection of the mesh to the ischio-pubic branch. This fully relieved obturator-induced pain and reversed adductor muscle motor deficiency.

Introduction: Vaginal prolapse surgery is at high risk of surgical site infections (SSI) because it's a "clean-contaminated surgery" and it's frequently associated with implantation of meshes., Objectives: To evaluate the rate of SSI and associated risk factors in vaginal prolapse surgery with mesh support., Methods: In a retrospective unicenter study, two groups of patients were operated by vaginal route for a pelvic floor reconstructive surgery with mesh support. Colporraphy was made by classic surgical sutures non-coated (Monosyn(®) 3/0, B-Braun) in the first group, and surgical sutures coated with triclosan in the second group. We collected risk factors of SSIs using the procedure of the CCLIN and analyzed the occurrence of SSIs with a statistical comparative univariate analysis., Results: Study included 78 patients in the first group and 72 in the second group. SSIs total rate was 2.6 % (4 of 150), as part of 3 in the group with surgical sutures non-coated and one in the group with surgical sutures coated with triclosan (P=0.62)., Conclusion: In our study, SSIs rate in vaginal prolapse surgery was twice higher than classic gynecologic surgery. As the interest of using a surgical suture coated with triclosan to reduce SSI has not been demonstrated statistically, we can't recommend it., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Introduction and Hypothesis: The aim was to review complications associated with pelvic organ prolapse surgery., Methods: Every 4 years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 (case reports). The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. Grade A recommendation usually depends on consistent level 1 evidence. Grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs. Grade C recommendation usually depends on level 4 studies or "majority evidence from level 2/3 studies or Delphi processed expert opinion. Grade D "no recommendation possible" would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi., Results and Conclusions: Transvaginal mesh has a higher re-operation rate than native tissue vaginal repairs (grade A). If a synthetic mesh is placed via the vaginal route, it is recommended that a macroporous polypropylene monofilament mesh should be used. At sacral colpopexy mesh should not be introduced or sutured via the vaginal route and silicone-coated polyester, porcine dermis, fascia lata and polytetrafluoroethylene meshes are not recommended as grafts. Hysterectomy should also be avoided (grade B). There is no evidence to recommend routine local or systemic oestrogen therapy before or after prolapse surgery using mesh. The first cases should be undertaken with the guidance of an experienced surgeon in the relevant technique (grade C). Expert opinion suggests that by whatever the surgical route pre-operative urinary tract infections are treated, smoking is ceased and antibiotic prophylaxis is undertaken. It is recommended that a non-absorbable synthetic mesh should not be inserted into the rectovaginal septum when a rectal injury occurs. The placement of a non-absorbable synthetic mesh into the vesicovaginal septum may be considered after a bladder injury has been repaired, if the repair is considered to be satisfactory. It is possible to perform a hysterectomy in association with the introduction of a non-absorbable synthetic mesh inserted vaginally, but this is not recommended routinely.

Introduction and Hypothesis: To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse., Methods: Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity., Results: One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89%) than in the colporrhaphy group (64%) (p = 0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3% vs 52.2%, p = 0.007). Two patients (2.8%) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5% was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92% in the colporrhaphy group and 96% in the mesh group)., Conclusion: Trans-obturator Ugytex mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.

Introduction and Hypothesis: Our purpose was to verify whether extensive dissection toward the sacrospinous ligament (SSL) needed for mesh fixation during anterior compartment repair increases the risk of postoperative voiding difficulties., Methods: A total of 124 patients after anterior compartment mesh repair without simultaneous suburethral sling placement operated on in the period 2005-2012 were enrolled in this retrospective observational study. Patients with previous anti-incontinence surgery with normal urodynamics were not excluded; 30 patients with incomplete data, severe perioperative complications, and urinary retention before and after the surgery were excluded. Urinary retention was defined as post-void residual over 150 ml more than 48 h after permanent catheter removal. The rate of urinary retention after anterior compartment repair by mesh anchored to the SSL from an anterior approach (SSLS group) was compared to that following transobturator mesh repair often combined with SSL fixation from the posterior approach (TOT group)., Results: Of the 94 patients considered for statistical analysis, 62 were from the SLSS group and 32 from the TOT group. The groups were comparable in age (mean 65.5 vs 66.3), body mass index (24.8 vs 25.9), and parity (2.4 vs 2.9). Patients from the SSLS group had higher rates of prior vaginal reconstructive (27 vs 19 %) and anti-incontinence surgery (26 vs 19 %). Postoperative urinary retention was statistically significantly more frequent in the SSLS group compared to the TOT group [(17 (27 %) vs 2 (6.25 %), odds ratio 5.7, 95 % confidence interval 1.2-26.3, p = 0.027]. Hospital discharge with self-catheterization was statistically insignificantly more frequent in the SSLS group [8 % (5) vs 3 % (1)]., Conclusions: Extensive dissection needed for SSL suspension from an anterior approach may lead to more frequent postoperative voiding difficulties. This phenomenon could be explained by more considerable injury to pelvic splanchnic nerves during the dissection. A large prospective study is needed for validation of our results.

Objective: We sought to validate a sequence of ultrasonographic mesh measurements to determine the relevant time points in the postoperative monitoring of mesh size., Methods: Mesh was measured preoperatively ex vivo, prior to insertion, in 25 patients scheduled to undergo vaginal repair of cystocele involving insertion of a Ugytex™ transobturating polypropylene mesh. A 2D/3D perineal ultrasound scan was performed at the end of the surgical procedure (D0), then on third day after surgery (D3) and 6 weeks (W6) after the operation. Medio-sagittal view was used to measure mesh total length and the sagittal arc (length between the most distant points of the mesh)., Results: Time-course changes in sagittal arc were marked by a 8% increase on D3 (with respect to D0) and a 20% decrease at W6 (with respect to D3). Mesh total length at W6 on average corresponded to 74% (±20) of mesh total length measured on D3., Conclusion: This study showed the changes in the mesh ultrasonographic measurements following vaginal placement by vaginal route. The D3 ultrasound scan should appear to be suitable as a reference for subsequent ultrasonographic monitoring., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Background: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes., Method/design: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Objective: To assess safety and efficacy at short-term of a light-weight polypropylene mesh (28 g/m2) for stage 3-4 cystocele repair by the vaginal route., Material and Methods: A multicentric prospective cohort study, performed between 2010 and 2011 in seven centers. Pre-operative assessment included prolapse quantification using the POP-Q. Pre- and postoperative validated symptoms and quality of life questionnaires were used. Main objective was mesh safety. Secondary objectives were anatomical and functional success., Results: One hundred and eleven patients, with a mean age of 67±9 years, were included in the study, and 94 were included in the analysis (84.7%). In 14 cases (12.8%), it was a secondary surgery. Two intra-operative complications occurred (2.2%). Safety analysis on 86 patients followed up at 12 months (91.5%) has shown satisfaction rate of 98.8% (85/86), mesh contraction rate of 9.3% (8/86), one case of vaginal mesh exposure (1.2%), no cases of pelvic pain and rate of postoperative dyspareunia of 5.5% (3/55). Anatomic success rate on cystocele (Ba point < -1) at short-term was 82/86 (95.3%) and improvement of symptoms and quality of life was highly significant. Five patients (5.3%) were reoperated., Conclusion: Cystocele repair by the vaginal route using a light-weight transobturator polypropylene mesh was safe and efficient at short-term. Long-term data are needed., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Introduction and Hypothesis: Despite good anatomical outcomes of pelvic organ prolapse (POP) repair by the vaginal route using synthetic mesh, complications limit their use. Clinical data are needed to generalize prolapse mesh repair by the vaginal route. The current study aims to evaluate midterm rectoanal function and clinical outcomes after transischioanal rectocele repair using a medium weight polypropylene mesh., Methods: Between March 2003 and June 2004, 230 patients with stage II-IV anterior and/or posterior POP were included in a prospective multicenter study. The current study is based on the analysis of the 116 patients who underwent a rectocele repair via the infracoccygeal route through the sacrospinous ligament. Anatomical cure was defined when rectocele was at stage

Objective: To assess anatomical and functional preliminary results, and safety of a new surgical approach for a combined treatment of pelvic organ prolapse (POP) of anterior and medium compartments, using a mesh attached through the sacrospinous ligaments with the UpHold(®) system (Boston Scientific) and the Capio(®)., Material and Methods: A longitudinal case series of 59 consecutive patients operated between October 2009 and January 2012, by five senior surgeons in a single tertiary unit., Results: Mean age was 66.9 years. Ten patients (17%) had previous pelvic organ prolapse (POP) surgery. There was no intraoperative complication. Mean follow-up was 12 months. Anatomical success for both anterior and apical compartments, i.e. Ba and C/D point<1, was 93% (52/56). Anatomical results shown correction of cystocele with a mean Ba point from+0.79 cm (range -3 to +8) to -2.35 cm (range -3 to 0), correction of uterine/vaul prolapse with a mean C/D point from+0.14 cm (range -6 to+8) to -7.29 cm (range -9 to -1), and correction of rectocele with a mean Bp point from -0.68 cm (range -3 to 7) to -2.77 cm (range -3 to -1). Two patients required further surgery for mesh exposure (3.5%). One patient had a unilateral pudendal neuropathic pain postoperatively., Conclusion: In the current series, utero-vaginal suspension using a bilateral vaginal anterior sacrospinous fixation with mesh was associated with good anatomical success rates. Prospective, comparative and long-term data are needed., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Introduction and Hypothesis: The surgical treatment of a cystocele via the vaginal route may require the placement of a synthetic mesh below the bladder. However, the placement of a synthetic mesh via the vaginal route can be associated with specific complications, such as vaginal mesh exposure. There is a lack of data concerning the long-term follow-up of asymptomatic persistent vaginal polypropylene mesh exposure., Methods: This was a retrospective case series of nine patients presenting with persistent vaginal mesh exposure following the placement of a macroporous monofilament polypropylene mesh for cystocele treatment. Expectant management has been proposed since the patients were asymptomatic., Results: The median follow-up duration was 121 months [interquartile range (IQR) 119-132]. The median surface area of vaginal mesh exposure (1 cm(2); IQR 1-1) did not change significantly during the follow-up. No pelvic or perineal abscess occurred during the follow-up. Only one of them was sexually active; she complained of dyspareunia at the last follow-up, but refused renewed surgery since she had sexual intercourse on only a small number of occasions per year. Clinical examination using the International Continence Society Pelvic Organ Prolapse Quantification system: Ba -3 to -2 (n = 7; 88 %), Ba -1 (n = 1; 12 %), Ba 0 or greater (n = 0)., Conclusions: Persistent asymptomatic vaginal polypropylene mesh exposure is associated with few complications at long-term follow-up.

The clinical advantage of MRI visualization of prostheses in soft tissue prolapses is very appealing as over 1,000000 MRI-transparent synthetic meshes are implanted annually, and postoperative complications such as mesh shrinkage and migration are frequent. Here, the synthesis of a new material composed of a DTPA-Gd complex grafted onto a backbone of PMA via a covalent bond is described (DTPA-Gd-PMA). This new polymer is sprayed onto meshes and gives an MR signal for a long period without any significant release of Gd. In vitro cytocompatibility tests on fibroblasts show limited cytotoxicity. Microscopic investigations indicate that vital cells rapidly colonize the material. Finally, coated meshes implanted in rats are easily recognizable using an MR imaging system., (Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Introduction and Hypothesis: Different techniques of mesh placement for cystocele repair are known. Our goal was to compare anatomical and functional outcomes of three different techniques of mesh placement over a 3-year follow-up., Methods: Between March 2003 and June 2004, 230 patients (stage 2-4 pelvic organ prolapse (POP)) were included in a prospective study. For cystocele repair, mesh was implanted either with two arms into the retropubic space (RP) or with two to four arms into the obturator foramen (TO), or fixed to the arcus tendineous fascia pelvis (FG)., Results: Patients' distribution is as follows: 142 TO, 32 RP, and 31 FG. Anatomical success (cystocele < stage 2 in the POP staging system) was clearly poorer after the retropubic free technique, with success rates of 69% (RP), 90.1% (TO), and 96.6% (FG) (p = 0.004). POP distress inventory (p < 0.005) and POP impact questionnaire scores were both significantly poorer after RP., Conclusions: RP technique is less effective than TO and FG techniques.

The surgical repair of pelvic organ prolapse using synthetic mesh can fail because of slow or partial implant integration due to poor biocompatibility or infection. As systemic antibiotic prophylaxis has only limited success, we have developed a system that coats standard polypropylene mesh with clinically relevant antibiotics. Amoxicillin and ofloxacin are both released from the mesh in vitro at high levels over 3 days, preventing adhesion and biofilm formation by a clinical isolate of E. coli. In an in vivo incisional hernia repair model in rats, the antibiotic-coated mesh results in appropriate tissue integration with adequate vascularization and collagen formation. When implanted animals are infected with virulent E. coli, both antibiotic coatings provide full protection against infection (as assessed both clinically and microbiologically), thus demonstrating their bioavailability. This method is a specific approach for producing a therapeutic coating that could reduce postsurgical infections., (Copyright © 2011 Wiley Periodicals, Inc.)

Introduction and Hypothesis: Bacterial colonization following mesh-augmented pelvic floor reconstructive surgery for pelvic organ prolapse is probably an underestimated consideration., Methods: Although clinical infections are rare, subclinical contamination of the polypropylene mesh has been systematically demonstrated by bacteriological analyses during mesh implantation and on explanted meshes., Results: A model of subclinical mesh infection does exist and bacterial colonization and mesh shrinkage have recently been correlated experimentally., Conclusions: New meshes with surface modifications or an antibiotic or antiseptic coating should be explored.

Introduction and Hypothesis: The purpose of this study is to determine the effect of silver coating of polypropylene implants on infection in hernia surgery., Methods: Silver-coated and non-silver-coated large pore monofilament polypropylene mesh implants were compared with and without infection (four groups). The implants were inserted in the abdominal wall of female Wistar rats. An Escherichia coli strain was inoculated intraoperatively in the two infected groups. The implants were removed, and clinical, bacteriological, and histological analyses were performed at 2, 15, and 30 days postoperatively., Results: Eighty-four rats were studied. All inoculated rats (n = 21) in the non-silver-coated polypropylene group presented periprosthetic E. coli infection, compared with only five inoculated rats in the silver-coated polypropylene group (p < 0.0001). Erosion was significantly higher in the infected than in the non-infected silver-coated polypropylene groups (p < 0.01). There was no histological difference between the four groups., Conclusions: Silver-coated implants appear effective against bacterial infection in our rat model, with good histological tolerance but delayed healing.

Introduction and Hypothesis: the aim of this study was to evaluate a link between mesh infection and shrinkage., Methods: twenty-eight Wistar rats were implanted with synthetic meshes that were either non-absorbable (polypropylene (PP), n = 14) or absorbable (poly (D: ,L: -lactic acid) (PLA94), n = 14). A validated animal incisionnal abdominal hernia model of mesh infection was used. Fourteen meshes (n = 7 PLA94 and n = 7 PP meshes) were infected intraoperatively with 10e6 CFU Escherichia coli, and compared with 14 non-infected meshes (n = 7 PLA94 and n = 7 PP meshes) (control groups). Explantations were performed on day 30. Shrinkage was evaluated by a reproducible numerical analysis of mesh area. Infection and histological study were evaluated on day 30., Results: non-infected meshes were less shrunk than infected meshes for both non-absorbable (5.0 ± 1.7% versus 21.6 ± 6.1%, p < 0.05) and absorbable meshes (2.4 ± 0.9% versus 11.0 ± 2.5%, p < 0.05)., Conclusion: this study highlights a link between infection and shrinkage in the model used.

Objective: The aim of this study was to propose a classification of surgical techniques for treatment of prolapse by vaginal route using prosthetic reinforcements and to relate the evaluation of surgeons involved in the care of surgical patients., Methods: A literature review was conducted searching for all articles relating novel technique of surgical management of patients with use of prosthetic reinforcements vaginally. The classification was made from descriptions found and then assessed by questionnaires filled out by surgeons., Results: The classification takes account of all the techniques available today and can integrate new. Among the surgeons, 56.5% (13/23) found that the POP-ST is adapted to reflect the reality and variety of techniques and 60.8% (14/23) will be ready for daily use., Conclusion: A classification covering all the techniques put them at risk of a final tool too complex for routine use. The simplification would make it more usable but limited the comprehensiveness and evolutionary. Only 23 surgeons returned the questionnaire. A larger sample would be desirable. The POP-ST is the first classification of this type. We believe that it would assess the new techniques to better understand the complications., (Copyright © 2010 Elsevier Masson SAS. All rights reserved.)

Objectives: Prospective randomized controlled trials, with 2 years' follow-up, seem to lean in favour of anterior repair using synthetic mesh. The goal of this study was to report on long-term (>5 years) follow-up., Study Design: Polypropylene mesh was inserted in 63 women (in 1999-2001) from the retropubic space to under the bladder using a tension-free technique., Results: At 79 months' follow-up, 45 women were anatomically cured (76%). Four (7%) were lost to follow-up and 14 (24%) presented with stage 2 or 3 cystocele recurrences. None of them required surgery for cystocele recurrence. Vaginal extrusion was reported in 10 (16%) patients (in four cases after 4 years of follow-up) and all required partial surgical removal of the mesh (n=10, 16%)., Conclusion: Cystocele repair using tension-free polypropylene mesh is associated with a low long-term rate of repeat surgery for cystocele recurrence., (Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.)

The purpose of this study was to evaluate host response and soft-tissue regeneration after poly(lactic acid) (PLA) mesh implantation in a rat model, in comparison with light-weight polypropylene (PPL) and poly(glycolic acid) (PGA) meshes. Full-thickness abdominal wall defects were created in 45 Wistar rats and reconstructed with 15 PLA(94), 15 PPL and 15 PGA meshes. Animals were killed on days 7, 30 and 90 to evaluate the presence of adhesions and changes in tensile strength of the implants. Histopathology and immunohistochemistry were performed to evaluate the collagen deposition and the inflammatory response. Statistics were done using unpaired Student's t-test, Mann-Whitney rank sum test, Student-Newman-Keuls test and Bonferroni (Dunn) t-test. The inflammatory response induced by the PLA mesh implantation was significantly milder than after PPL mesh. In PLA, vascularity and collagen organization was significantly higher than in PPL and PGA at 30 and 90 days, and collagen composition score was significantly higher than in PPL at 7 and 30 days. In PLA, shrinkage was significantly lower than in PPL and PGA at 7 and 30 days. Elongation at break and tensile strength were comparable between PLA and PPL over the 90-day period. The PLA mesh induces a milder inflammatory response, more orderly collagen deposition than PPL, and preserved comparable tensile strength after 90 days.

Objectives: The purpose of this study was to develop an animal model of prosthetic infection and compare in vivo bacterial infectiosity of different biomaterials used in vaginal surgery., Materials and Methods: We implanted 36 prostheses of poly(lactic acid) with 94% L forms (PLA94), in a model of incisional abdominal hernia in Wistar rats. Bacterial inoculation was done just after implantation with three strains of Escherichia coli of variable virulence, two different concentrations and two different times of inoculation (during surgery or 48 hours after). All meshes were explanted and animals sacrificed on day 30 after intervention. Bacteriology and histology were then performed. In the same way, three materials used in vaginal surgery (knitted light-weight polypropylene [PP], thermoformed PP [Uratape] and polyurethane coated poly[ethylene terephtalate] [PTFE]) were tested and compared to the PLA94 using the same protocol., Results: All inoculated prostheses were still infected at day 30 after implantation with the same E. coli strain. There was a significant difference in bacterial infectiosity linked to virulence of the inoculated strain (p=.005) and the amount injected (P<0.001). Infectiosity was significantly lower for PLA94 when compared to the three other prostheses (P=0.008). The most important infectiosity was seen with PTFE and thermoformed PP. For histologists, PLA94 also gave the weakest inflammatory reaction., Discussion and Conclusion: An original animal model of prosthetic infection allowed us to compare in vivo bacterial infectiosity of different biomaterials used in vaginal surgery and to demonstrate that the PLA94 mesh induces a milder risk of infection than polypropylene.

The aims of this study were dual. First, to evaluate the feasibility of a sheep model as an animal model for vaginal surgery with meshes. Second, to compare host response to two low-weight polypropylene (PP) meshes, a noncoated (Soft Prolene, Gynecare, Ethicon) and a coated mesh with an absorbable hydrophilic film (Ugytex, Sofradim). Thirty-six 20 x 20 mm polypropylene meshes (18 coated and 18 noncoated) were surgically implanted by the vaginal route in 12 adult ewes. Meshes were implanted in the anterior (n=12) and the posterior vaginal compartments (n=24). Animals were killed 1 (n=6) and 12 (n=6) weeks after surgery. Postimplantation evaluation included macroscopical examination, histological and immunohistochemical analysis and histomorphometrical measures of the distance between the meshes and the vaginal epithelium. The experimental procedure was feasible in all cases. Vaginal erosions were observed twice as frequently with the noncoated-PP meshes (6/18, 33.3%) as with the coated-PP meshes (3/18, 16.7%), even if that difference was not significant (p=0.4). However, no differences were observed between the two meshes in terms of shrinkage, tissue ingrowth, inflammatory response, and position of the mesh in the vaginal wall. The mechanism involved in the reduction of vaginal erosion could be due to the lesser adhesion of the coated mesh on the vaginal wound during the early postoperative period.

The aim of this study was to evaluate the anatomical and functional results of a low-weight polypropylene mesh coated with an absorbable film in prolapse surgery by vaginal route. We have conducted a prospective multicentre study in 13 gynaecological and urological units. There were 230 patients requiring repair for anterior or posterior vaginal prolapse included. The present report is based on the analysis of the first 143 patients evaluated after at least 10 months follow-up. All patients were operated by the vaginal route using a specially designed mesh (Ugytex, Sofradim, France). Prolapse severity were evaluated using the Pelvic Organ Prolapse staging system. Symptoms and quality of life were evaluated preoperatively and during follow-up using the validated Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) self-questionnaires. Mean age was 63 years (37-91). Anterior, posterior and anterior-posterior repair with the mesh were performed in 67 (46.9%), 11 (7.7%) and 65 (45.4%) patients, respectively. With a mean follow-up of 13 months (10-19), 132 patients were considered anatomically cured (92.3%) with a recurrence rate of 9 of 132 for cystocele (6.8%) and 2 of 76 for rectocele (2.6%). Nine vaginal erosions occurred (6.3%), six of them necessitated another procedure by simple excision. The rate of de novo dyspareunia was 12.8%. At follow-up, improvement of PFDI and PFIQ scores were highly significant (p<0.0001). The use of low-weight polypropylene mesh coated with a hydrophilic absorbable film for vaginal repair of genital prolapse seems to decrease local morbidity while maintaining low recurrence rates.

The objective of this study was to compare mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft mesh. We retrospectively analyzed 138 consecutive cases of transvaginal repair of cystocele using synthetic mesh. The study endpoint was the pathological evidence of vaginal erosion. Multiple logistic regression was used to determine independent predictors of vaginal erosion. One hundred and thirty eight women (ages 30-83 years) with cystocele between October 1999 and October 2004, from a French University Hospital, participated in this study. Cystocele repair was performed in all patients according to the technique of tension-free polypropylene mesh. The median follow-up was 32.1 months (range 7.5-59.9) in the Gynemesh group and 7.1 months (range 1-21.9) in the Gynemesh-Soft group. Vaginal erosion was reported in 27 (20%) of the patients. Anatomically, the success rate was 95% (131/138). There was no statistically significant difference between the Gynemesh and the Gynemesh-Soft meshes [the rate of vaginal erosion of the mesh was 16% (15/89) vs 24% (12/49), respectively, p=0.39]. Univariate analysis only identified age class as factor significantly associated with the probability of vaginal erosion. Multivariate analysis revealed that age class is an independent predictive factor of vaginal erosion (age > 70 years, odds ratio (OR) 3.6, 95% confidence interval (CI) 1.3-9.7, p=0.010). Furthermore cystocele stage > 2 (Baden and Walker classification) is a protective factor against vaginal erosion (OR 0.3, 95% CI 0.1-0.8, p=0.016). Thirteen symptomatic patients (13/27, 48%) necessitated a partial excision of the mesh, associated with a vaginal mucosal closure. Two patients (2/27, 7%) underwent a complete excision of the mesh. The incidence of de novo dyspareunia was 9% in patients with vaginal erosion and 11% in patient without mesh erosion (p=0.85). There was no occurrence of bladder or urethral erosion and no vaginal or pelvic infection. Isolated vaginal erosion of the mesh did not prove to be problematic. Gynemesh-Soft mesh does not decrease the incidence of vaginal erosion. Age > 70 years is an independent predictive factor of vaginal erosion. We recommend that mesh placement by vaginal route should be avoided by women with moderate cystocele. Where possible, total hysterectomy and vertical incision should also be avoided. Management of vaginal erosion is simple and is associated with a low rate of morbidity. However, patients should be informed that vaginal erosion of the mesh can occur. A multivariate analysis reveals that the incidence of vaginal erosion is not significantly different between Gynemesh and Gynemesh-Soft meshes. Other factors of erosion are analyzed.

Objective: To describe management of vaginal mesh erosion following transvaginal repair of acystocele by placement of a polypropylene mesh., Materials and Method: Retrospective analysis of 34 consecutive cases of vaginal mesh erosion following transvaginal repair of cystocele using synthetic mesh (Gynemesh or Gynemesh-Soft). We have analyzed the results of both medical and surgical management of this complication. Furthermore, we also assessed sexual and urinary morbidity in women with mesh erosion (n = 34) and in women who had undergone the same procedure but without mesh erosion (n = 111)., Results: Among the 34 patients with vaginal mesh erosion, 23 (68%) have undergone local therapy using Colposeptine (Chlorquinaldol + Promestriène). In 12 (52%) cases no modification of the surface of the erosion was observed. In 6 (26%) cases, a decrease of the surface of the mesh erosion was observed. In 5 (22%) cases the mesh erosion had completely disappeared, with a follow-up of 2 to 9 months. Nineteen symptomatic patients (19/32, 59%) required partial (n = 18) or complete (n = 1) excision of the mesh, associated with vaginal mucosal closure, under general anaesthesia. Duration of operation ranged from 15 to 40 minutes for partial excision of the mesh. This procedure was successful in 14 cases (77%). Four women required repeated resection of the mesh because of recurrence. The incidence of de novo dyspareunia was 12% in patients with vaginal mesh erosion, and 11% in patients without mesh erosion (p = 0.81). The incidence of urge urinary symptoms and voiding dysfunction symptoms was respectively 8% versus 9% (p = 0.95), and 8% versus 10% (p = 0.81) in the 2 groups., Conclusion: Management of vaginal mesh erosion is simple and is associated with a low rate of morbidity. However, patients should be informed that vaginal erosion of the mesh can occur.

We report a case series of 63 women with cystocele who underwent the same trans-vaginal procedure between October 1999 and October 2002. The polypropylene mesh (GyneMesh, Gynecare, Ethicon, France) was placed from the retropubic space to the inferior part of the bladder in a tension-free fashion. Patients were followed up for 24 to 60 months, with a mean follow-up of 37 months. Fifty-five patients returned for follow-up (87.3%). At follow-up, 49 women were anatomically cured (89.1%), five women had stage 2 anterior vaginal wall prolapse (9.1%), and one had a recurrent stage 3 (1.8%). Functional results and sexual function were also investigated. Fifty-three women had significant improvement in their quality of life (96.4%). There were a total of three cases of local pain around a mesh shrinkage (5.5%) and five vaginal erosions of the mesh (9.1%). Four out of 24 patients had dyspareunia (16.7%). In conclusion, the vaginal repair of anterior vaginal wall prolapse reinforced with a polypropylene mesh was efficient at 2 to 5 years follow-up. However, the first generation of polypropylene mesh we used was responsible for high rates of local complications and dyspareunia. Therefore, the polypropylene mesh has to be improved (lower weight) and the technique has to be documented by a randomized controlled trial before we could recommend its use in clinical practice.

Objectives: We evaluated the results of surgical insertion of a polypropylene mesh via the vaginal route in young women presenting genital prolapse., Material and Methods: Retrospective study concerning 20 women under age 50 who underwent between July 2000 and December 2003 surgical insertion of an anterior (n=14), posterior (n=3) or double (anterior and posterior) (n=3) polypropylene mesh via the vaginal route. A minimum follow-up of 6 months was required for inclusion in the study. Anatomical results were assessed using the Pelvic Organ Prolapse Quantification (POP-Q) according to ICS (International Continence Society) recommendations. To document the functional results, the patients answered 3 validated self-assessment questionnaires related to pelvic symptoms, sexual behaviors and quality of life., Results: Mean follow-up was 21 months (6 to 52 months). A vaginal erosion of the mesh occurred in 2 women (10%). Cystocele recurred in one woman among the 17 patients who had an anterior polypropylene mesh (Gynemesh, Gynecare, Ethicon). Seventeen women were sexually active before the surgical procedure and 19 post-operatively. Among these women, 5 (26%) reported alteration of sexual activity after surgery (with dyspareunia in 4 cases (21%)), and 14 women (74%) reported no changes or improvement in sexual activity., Conclusion: Surgical management of genital prolapse using a polypropylene mesh inserted via the vaginal route has proven its anatomical efficacy in young women. The potential adverse consequences on sexual life would require clinical research concerning the surgical approach (abdominal or vaginal route) and synthetic materials used in prolapse surgery for young women.

Objective: To study the ongoing results of the repair of anterior vaginal wall prolapse reinforced with tension-free polypropylene mesh (GyneMesh, Gynecare, Ethicon, Issy-Les-Moulineaux, France)., Study Design: A case series of 87 consecutive women with anterior vaginal wall prolapse who underwent a transvaginal procedure using polypropylene mesh between October 1999 and August 2002. The mean age (+/-SD) was 62.4+/-13.4 years. Before the operation, patients underwent physical examination staging of the prolapse with the International Pelvic Organ Prolapse staging system. Thirteen women had stage 2 anterior vaginal wall prolapse (14.9%), 59 had stage 3 (67.9%), and 15 had stage 4 (17.3%). The polypropylene mesh was placed from the retropubic space to the inferior part of the bladder in a tension-freefashion. Patients were followed for 9-43 months, with a median follow-up (+/-SD) of 24+/-9.6 months. We defined "cure" as satisfactory (stage 1) or optimal (stage 0) outcome for point Ba in the staging system., Results: Eighty-four patients returned for follow-up (96.6%). At follow-up, 77 women were cured (91.6%), 5 women had asymptomatic stage 2 anterior vaginal wall prolapse, and 2 had a recurrent stage 3 (2.4%). There were no postoperative infections. There were a total of 7 vaginal erosions of the mesh (8.3%); 4 necessitated a second procedure for partial excision of the mesh., Conclusion: Vaginal repair of anterior vaginal wall prolapse reinforced with tension-free polypropylene mesh is effective and relatively safe. Vaginal erosion occurred in 8.3% of the study population but was easily manageable, with no sequelae.

Background: To evaluate the tension-free vaginal tape (TVT) in both stress urinary incontinence (SUI) and occult SUI as an associated procedure at the time of tension-free polypropylene mesh repair for the treatment of genitourinary prolapse., Methods: Forty-eight consecutive women undergoing surgery for genital prolapse and concurrent SUI from November 1999 to September 2002. Preoperatively, SUI was symptomatic in 29 women and occult in 19, with a positive stress test during repositioning of the prolapse. All patients had urethral hypermobility and none had intrinsic sphincter deficiency. The cystocele repair was performed in all patients according to the technique of tension-free polypropylene mesh. Twenty-six women had an associated TVT and 22 had no associated procedure for SUI (control group). The main outcome measures were postoperative SUI, voiding dysfunction, and recurrence of prolapse., Results: The median follow-up was 20 +/- 10.1 months (range 7-41). Patient characteristics and preoperative urodynamic evaluation were similar in the two groups. In patients with preoperative SUI, postoperative SUI occurred in 1/15 of the TVT group (6.7%) vs. 5/14 (35.7%) in the control group (p < 0.05), and voiding dysfunction occurred in 2/15 patients of the TVT group (13.3%) vs. 0/14 in the control group (p > 0.05). In patients with preoperative occult SUI, postoperative SUI occurred in 0/11 of the TVT group vs. 1/8 (12.5%) in the control group (p > 0.05), and voiding dysfunction occurred in 3/11 patients of the TVT group (27.3%) vs. 0/8 in the control group (p < 0.05). Anatomic success on prolapse was 88.5% (23/26) and 86.4% (19/22) in the TVT and the control group, respectively (p > 0.05)., Conclusion: In patients with preoperative SUI, TVT is more efficient than prosthetic cystocele repair alone to prevent postoperative SUI, without differences in voiding dysfunction. In patients with preoperative occult SUI, prosthetic cystocele repair is as efficient as TVT, with a decreased risk of voiding dysfunction.

Objective: To describe a new vaginal approach for the repair of cystoceles, reinforced with a tension-free polypropylene mesh., Methods: The vaginal procedure consisted of a complete dissection of the cystocele and a thorough entry from the vesicovaginal space under the inferior pubic ramus into the retropubic space. The polypropylene mesh (GyneMesh(TM), Gynecare, Ethicon France) was placed from the retropubic space to the inferior part of the bladder in a tension-free fashion., Results: Forty-eight consecutive women with grade 3-4 cystoceles underwent this procedure between October 1999 and September 2001. Mean age was 63.9 years (41-85). Mean follow-up is 18 months (8-32). The success rate was 97.9%. There were a total of four vaginal erosions of the mesh (8.3%). There were no postoperative infections of the mesh., Conclusion: The vaginal repair of severe cystocele reinforced with a tension-free polypropylene mesh is a simple and reproducible technique, with high success rate and low morbidity.