Rate Of Mesh-related Complications Research Articles

Medium-term clinical efficacy and safety of single incision and modified trans-obturator mid-urethral slings for female stress urinary incontinence

AimsTo evaluate the medium term efficacy and safety of Altis and Solyx single incision slings (SIS) compared with tension-free vaginal tape (TVT) Abbrevo trans-obturator sling. We hypothesize that both SIS show little difference in efficacy and safety and perform similarly to TVT Abbrevo. MethodsWe conducted an ambispective comparative cohort study of women with stress urinary incontinence who received a SIS in comparison to matched TVT Abbrevo subjects from a concurrent randomized controlled trial (RCT). Subjects were identified retrospectively, and prospectively invited for examination and questionnaires>12 months post-operatively. Exclusions included intrinsic sphincter deficiency, previous sling surgery, and others. Primary outcome was subjective cure [negative response to International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) question 6, leakage during coughing/activity]. Secondary outcomes include objective cure (negative cough stress test), functional outcomes, and adverse events. ResultsBetween 2012 and 2018, a total of 113 women received one of two SIS surgeries; Solyx (n ​= ​50) followed by the Altis (n ​= ​63); 104 were available for final efficacy analysis. Mean follow-up was 21.7 (Altis), 46.0 (Solyx), and 29.0 (Abbrevo) months. Baseline characteristics were comparable between the groups. There was no significant differences in the subjective or objective cure rates between the groups, and no differences in functional outcomes such as patient global impression of improvement, and post-operative ICIQ-UI SF score. There was a low rate of mesh related complications and no differences seen between the groups. ConclusionsDespite being an underpowered study, Altis and Solyx SIS have favourable efficacy and safety profiles which are comparable to an established trans-obturator mid-urethral slings (MUS).

Treatment of apical vaginal prolapse with minimal mesh repair (Uphold): patient‐reported long‐term outcomes and mesh‐related complications

To evaluate patient-reported outcomes and clinical findings after surgery for apical prolapse with the transvaginal Uphold mesh technique. Moreover, to evaluate the rate of mesh-related complications. A historical cohort study of patients who underwent surgery from January 1, 2012 to April 30, 2019, at Aarhus University Hospital, Denmark. Pelvic examination and patient completion of questionnaires were performed in 2018-2019. Information on adverse events and reoperations was obtained from medical records. A total of 240 patients were operated on using the Uphold mesh, 89% due to recurrent prolapse. Follow-up was attended by 192 patients (80%). Median follow-up time was 30months, interquartile range 19-52. During follow-up, 29 patients (15%) underwent reoperation due to prolapse and are considered failures. Among the remaining, patient satisfaction was high. Thus, average score for pelvic symptoms affecting daily life was 2, on a scale of 0-10, where 0 represents no symptoms. The Patient Global Impression of Improvement (PGI-I) had an average score of 6.4 (1: very much worse; 7 very much better). Preoperatively, 89.5% of the women had grade 2 or more apical prolapse, whereas at follow-up, this was only 6.1%. Perioperative heavy bleeding needing embolization was observed in one patient (0.5%). Two patients had serious constriction of the ureter and needed re-operation. Postoperative complications, primarily temporary voiding problems, were observed in 15 patients (8%). Complications during the follow-up period were registered in 23 patients (12%); eight of these were mesh erosions. Due to complications, 11 patients (6%) needed re-operation. The study confirms that the Uphold procedure in a centralized set-up is a procedure with high patient-reported satisfaction even in a population characterized by a high proportion of recurrent prolapse. Moreover, the procedure seems safe with acceptable complication rates.

Women with advanced pelvic organ prolapse and levator ani muscle avulsion would significantly benefit from mesh repair surgery.

Mesh repair surgery for pelvic organ prolapse (POP) has been suspended in some countries owing to concerns about its associated complications. However, mesh repair has been shown to reduce the risk of prolapse recurrence after surgery. In view of this controversy, our aim was to assess the incidence of subjective and objective recurrence of POP following mesh repair surgery vs native-tissue repair in women with Stage-III or Stage-IV POP. This was a prospective observational study of women who presented with Stage-III or Stage-IV POP and received primary prolapse surgery between 2013 and 2018. Transperineal ultrasound was performed before the operation and volumes were analyzed offline to assess the presence of levator ani muscle (LAM) avulsion. All women were counseled on either mesh repair or native-tissue reconstruction. The mesh-repair group was followed up for up to 5 years and the native-tissue-repair group for up to 2 years after the operation. Prolapse symptoms and POP quantification (POP-Q) staging were assessed at follow-up. Subjective recurrence of POP was defined as symptoms of prolapse (vaginal bulge sensation or dragging sensation) reported by the patient. Objective recurrence was defined as POP-Q ≥ Stage II. The subjective and objective recurrences of prolapse were compared between women with and those without mesh use. Multivariate regression analysis was used to identify risk factors for the recurrence of POP. A total of 154 Chinese women with Stage-III or Stage-IV prolapse were recruited. Of these, 104 (67.5%) underwent mesh repair (transabdominal in 57 women and transvaginal in 47 women) and 50 (32.5%) had native-tissue repair surgery. Ninety-five (61.7%) women had LAM avulsion. Both the subjective POP recurrence rate (4.8% vs 20.0%; P = 0.003) and the objective recurrence rate (20.2% vs 46.0%; P = 0.001) were significantly lower in the mesh-repair group than in the native-tissue-repair group. On multivariate logistic regression analysis, mesh repair was associated significantly with a reduced risk of subjective recurrence (odds ratio (OR), 0.20 (95% CI, 0.07-0.63)) and of objective recurrence (OR, 0.16 (95% CI, 0.07-0.55)) of prolapse. On subgroup analysis of women with LAM avulsion, mesh repair significantly reduced the risk of subjective recurrence (OR, 0.24 (95% CI, 0.07-0.87)) and objective recurrence (OR, 0.23 (95% CI, 0.09-0.57)) of POP. The incidence of mesh-related complications was low, and mesh exposure could be treated conservatively or by minor surgery. Mesh repair surgery, compared with native-tissue repair, was associated with a 5-fold reduction in the risk of subjective recurrence and a 6-fold reduction in the risk of objective recurrence of prolapse in women with Stage-III or Stage-IV POP. In women with concomitant LAM avulsion, mesh repair surgery was associated with a 4-fold reduction in both objective and subjective recurrence of POP. The rate of mesh-related complications was low, and mesh exposure could be treated conservatively or by minor surgery. The benefit of mesh surgery for these high-risk women appears to outweigh the risks of mesh complications, and it could be a treatment option for this group of women. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Mesh-related complications in single-incision transvaginal mesh (TVM) and laparoscopic abdominal sacrocolpopexy (LASC)

ObjectiveFew studies have investigated the long-term impact of synthetic mesh reconstructive surgery for pelvic organ prolapse (POP) on patient outcomes. This study aimed to examine the incidence and risk factors of mesh exposure and the subsequent requirement for surgical interventions due to mesh-related complications. Materials and methodsThis retrospective study was conducted from November 2010 to April 2018. We recruited women with Pelvic Organ Prolapse Quantification (POP-Q) stage 3 or 4 who underwent mesh reconstructive surgery for POP, and enrolled 487 women who received transvaginal mesh (TVM) and 110 women who received laparoscopic abdominal sacrocolpopexy (LASC). Assessments included mesh exposure rate and mesh-related complications requiring surgical interventions in both groups. ResultsIn the LASC group, the overall mesh-related complication rate was 8.18% over a mean follow-up period of 18 months. Concomitant laparoscopic-assisted vaginal hysterectomy was associated with mesh exposure (OR = 9.240; 95% CI = 1.752–48.728). No patients in the concurrent supracervical hysterectomy group were exposed to mesh. In the single-incision TVM group, the overall rate of mesh-related complications was 3.29% over a mean follow-up period of 19 months. Concomitant total vaginal hysterectomy was also a risk factor for mesh exposure (OR = 4.799; 95% CI = 1.313–17.359). ConclusionPreserving the cervix or uterus decreased the rate of mesh exposure in those undergoing TVM and LASC surgery. The overall rate of mesh-related complications was low after up to 8 years of follow-up.

Long-term outcomes of robotic ventral mesh rectopexy for external rectal prolapse

Nowadays in Europe, laparoscopic ventral mesh rectopexy is the gold standard treatment of external rectal prolapse (ERP). The benefits of robot ventral mesh rectopexy (RVMR) are not clearly defined. The primary objective of the study was to evaluate the long-term results of RVMR. The secondary objective was to determine predictive factors of recurrence. Monocentric, retrospective study. Data, both pre-operative and peri-operative, were collected, and follow-up data were assessed prospectively by a telephone questionnaire. The study was performed in a tertiary referral center. Between August 2007 and August 2017, we evaluate all consecutive patients who underwent RVMR for ERP by three different surgeons. The primary outcome was the recurrence rate perceived by patients. Secondary outcome were functional results based on Knowles-Eccersley-Scott-Symptom score for constipation and Wexner score for incontinence, compared before and after surgery. During the study period 96 patients (86 women) underwent RVMR. The mean age was 62.3years (range 16-90). Twelve patients had a history of ERP repair. Sixty-nine patients were analyzed for long-term outcomes with a mean follow-up of 37months (range 2.3-92months). Recurrence rate was 12.5%. After surgery, constipation was significantly reduced: 44 patients were constipated before surgery versus 23 after surgery. Six patients described de novo constipation (6.25%). Fecal incontinence was significantly reduced: 59 patients were incontinent before surgery versus 14 after surgery. No predictive factor for recurrence was identified after multivariate analysis. No mesh related complications were related. In conclusion, RVMR presents good long-term functional result and a recurrence rate similar to LVMR as published in the literature. The rate of mesh related complications seems lower.

Long-term follow-up of patients treated by transvaginal mesh repair for anterior prolapse

ObjectiveThe aim of the study was to assess 5 years outcome of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). Study designThis was a prospective study including all patients from January 2009 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage ≥2, according to POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/ Incontinence Sexual Questionnaire (PISQ-12). Main outcome was subjective success (question 3 of PFDI-20 score = 0). Mesh-related complications, objective and functional outcomes were used as the secondary outcomes. Results270 patients were included in the study. Median follow-up was 5,7 years [4,5–8,2]. Subjective success rate was 86,6% at 5 years. Objective success rate was 53,1% at 5 years. At 5 years, composite failure (subjective + objective) occurred for 17 patients (12%), 7 patients with direct recurrence and 10 with indirect recurrence. Re-treatment was performed in six patients (2,8%; 3 hysterectomies for apical recurrence and 3 posterior repairs for posterior recurrence). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3,4%. At 5 years, de novo dyspareunia rate was 11,7%, 3,9% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. ConclusionFive-year results demonstrate that vaginal mesh surgery provides a durable and safe repair of anterior compartment prolapse with a low rate of mesh-related complications and reoperations. Between the 2- and 5-year follow-up, patient satisfaction and associated improvements in prolapse-specific symptoms were sustained and minimal new morbidity occurred.

Two years follow up of 270 patients treated by transvaginal mesh for anterior and/or apical prolapse

The aim of this study was to assess the 1 and 2 years outcomes of transvaginal single incision mesh surgery (SIMS) for anterior pelvic organ prolapse (POP). This was a prospective study including all patients from November 2008 to December 2012 who underwent SIMS for symptomatic anterior prolapse stage≥2, according to the POP Quantification (POP-Q). Symptoms and quality of life were assessed using validated questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact questionnaire (PFIQ-7), and Prolapse/Incontinence Sexual Questionnaire (PISQ-12). The main outcome was subjective success (question 3 of PFDI-20 score=0). Safety, anatomic and functional outcomes were used as the secondary outcomes. A total of 270 patients were included in the study. Subjective success rate was 95,4% and 92,2% at 1 and 2 years. Objective success rate was 65,9%and 60,5% at 1 and 2 years. At 1year, composite failure (subjective+objective) occurred for 11 patients (4,6%), 5 patients with direct recurrence and 6 with indirect recurrence. At 2 years, composite failure was reported for 14 patients (6,4%): 6 direct recurrences and 8 indirect recurrences. Re-treatment was performed in one case (0,4%). One case (0,4%) of asymptomatic mesh exposure occurred. The reoperation rate for mesh-related complications was 3%. We reported a de novo dyspareunia rate of 8,4%, 5,3% considered as mesh-related. A significant improvement was noted for symptoms and quality of life. POP repair using SIMS is a safe and efficient treatment of anterior compartment prolapse in the medium term with a low rate of mesh-related complications. Longer-term follow-up is ongoing.

Objective and subjective outcome 3 years after synthetic transobturator nonabsorbable anterior mesh use in symptomatic advanced pelvic organ prolapse surgery

Abstract Background The management of using a mesh graft in the anterior compartment is reported to lead to a higher rate of recurrent prolapse after anterior colporrhaphy than after mesh repair. Several randomized controlled trials (RCTs) have shown no significantly superior subjective cure rates or reoperation rates, despite better anatomical cure rates with synthetic mesh compared with traditional anterior colporrhaphy for anterior compartment defects, however, the follow-up period in most RTCs was only 1 year. Objective To evaluate the objective and subjective outcome in women with symptomatic advanced pelvic organ prolapse (POP) who underwent sacrospinous fixation (SSF) with anterior vaginal mesh (AVM). We postulated that in the hands of well-trained surgeons, AVM plus SSF yields better long-term success rates with a low rate of mesh-related complications. We studied the long-term postoperative outcomes of SSF with AVM. Study design This was a retrospective study of 114 patients who underwent surgery for POP between January 2006 and March 2010. Patient assessment at baseline and 3-year postoperative follow-up was analyzed. SSF plus AVM was performed for apical and anterior compartment repair. Primary outcome was objective cure (POP Quantification Stage ≤ 1) and subjective cure defined as a negative response to Questions 2 and 3 on the POP Distress Inventory 6. Secondary outcomes were complications, symptoms severity, and quality of life as measured using validated questionnaires. Results Postoperative data for 114 patients were analyzed. Median follow up was 59.6 months. All patients completed a minimum of 3 years follow up. The objective cure rate was 100% for anterior and apical compartments and 90.4% for posterior compartment. Regarding the individual compartment, the cure rate was significantly high ( p There were four cases (3.5%) of mesh exposure in which all patients were treated under local anesthetic with excision of the exposed mesh without additional suturing of vaginal tissue at the outpatient office. Topical estrogen therapy was prescribed to facilitate re-epithelialization of vaginal wounds. There were no cases of mesh erosion into the bladder or other organs, and no patient needed mesh removal due to chronic pain or infection. There was no recurrence in the anterior and apical compartment. Eleven patients (9.6%) had recurrence of the posterior compartment during postoperative follow up. There was a significant improvements in all questionnaires with p p = 0.001 for Prolapse/Urinary Incontinence Sexual Function Questionnaire. There was no significant difference for preoperative and 1-year postoperative urodynamic diagnosis. There were seven cases of occult urodynamic stress incontinence. Conclusion The Perigee System gave a favorable result in both anatomical and subjective success rates with a low rate of mesh-related morbidities. The strength of the study reported here is its long-term follow up of a relatively large number of patients and the use of validated questionnaires. Limitations are that it is not a RCT; hence, selection and indication bias is unavoidable. The favorable outcome and low morbidities resulting from mesh use is from a single surgeon's perspective and may not be generalized to others.

Tension-free polypropylene mesh-related surgical repair for pelvic organ prolapse has a good anatomic success rate but a high risk of complications.

Background:Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system.Methods:A prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ −1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data.Results:All patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients’ impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653).Conclusions:Tension-free polypropylene mesh (PROSIMA™)-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.

Management of Mesh Complications after SUI and POP Repair: Review and Analysis of the Current Literature.

Purpose. To evaluate the surgical treatment concepts for the complications related to the implantation of mesh material for urogynecological indications. Materials and Methods. A review of the current literature on PubMed was performed. Results. Only retrospective studies were detected. The rate of mesh-related complications is about 15–25% and mesh erosion is up to 10% for POP and SUI repair. Mesh explantation is necessary in about 1-2% of patients due to complications. The initial approach appears to be an early surgical treatment with partial or complete mesh resection. Vaginal and endoscopic access for mesh resection is favored. Prior to recurrent surgeries, a careful examination and planning for the operation strategy are crucial. Conclusions. The data on the management of mesh complication is scarce. Revisions should be performed by an experienced surgeon and a proper follow-up with prospective documentation is essential for a good outcome.

Long-term outcomes of synthetic transobturator nonabsorbable anterior mesh versus anterior colporrhaphy in symptomatic, advanced pelvic organ prolapse surgery

Anterior vaginal mesh (AVM) combined with sacrospinous ligament fixation (SSF) yields better long-term success rates over anterior colporrhaphy (AC) in advanced pelvic organ prolapse (POP) surgery, with a low rate of mesh-related complications. Medical records of 198 patients who underwent surgery for POP between January 2006 and March 2010 were reviewed retrospectively. Patients' assessment at baseline and third-year postoperative follow-up were analyzed. SSF plus AC or AVM was performed for apical and anterior compartment repair. Primary outcome was objective cure [Pelvic Organ Prolapse Quantification (POP-Q) stage ≤ 1)], and subjective cure defined as negative response to questions 2 and 3 on the POPDI-6. Secondary outcomes were complications, symptoms severity and quality of life as measured with validated questionnaires. Post-operative data were available for 186 patients, 72 in AC group and 114 in AVM group were analyzed. The mean age, parity and operating time in AVM group were significantly higher as compared to AC group. The overall objective and subjective cure rate in AVM group was significantly higher than AC group (90.3 % and 88.6 % versus 73.6 % and 70.8 %, with P value = 0.003 and 0.002 respectively). Mesh exposure rate was 3.5 %. Improvement in both POPDI-6 and PISQ-12 in AVM group was statistically significant compared to AC group. Transobturator synthetic nonabsorbable AVM combined with SSF yielded a favorable and sustainable result over 5 years as compared to traditional AC, both in anatomical and subjective success rate. Mesh related morbidities were low and acceptable.

Analysis of mesh related complications after trans-vaginal mesh-augmented pelvic floor reconstruction surgery

To evaluate the complications after trans-vaginal mesh-augmented pelvic floor reconstruction in treatment of pelvic organ prolapse (POP). From February 2007 to October 2009, vaginal mesh procedures were performed on 91 women with POP stage III-IV in Peking University Third Hospital. The operative complications were studied. Ninety patients underwent successful surgery among 91 patients. Follow-up rate was 94% (85/90) at a median follow-up of 28.4 (15 - 44) months. One patient underwent intraoperative organ injuries, and 10 patients had postoperation mesh-related complications. The rate of mesh-related complications was 2% (2/85), 2% (2/85), 4% (3/85), 4% (3/85) on 6, 6 - 12, 12 - 24 and more than 24 months following up, respectively. Seven patients underwent conservative treatment and the symptoms were improved. Three patients underwent the second surgery, and the symptoms were cured or relieved. The incidence of mesh-related complications was low, and interventions were effective in vaginal mesh procedure.

Risk of Mesh Extrusion and Other Mesh-Related Complications After Laparoscopic Sacral Colpopexy with or without Concurrent Laparoscopic-Assisted Vaginal Hysterectomy: Experience of 402 Patients

Study Objective To estimate the incidence of mesh-related complications including mesh erosion/extrusion rates in patients undergoing laparoscopic sacral colpopexy, with or without concurrent hysterectomy, using macroporous soft polypropylene mesh. Design Historical cohort study (Canadian Task Force classification II-2). Setting Private urogynecology clinic. Patients A total of 446 consecutive patients with uterovaginal or vaginal vault prolapse underwent laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh from January 2003 through January 2007. In all, 402 consecutive patients met enrollment criteria. Two groups of patients were identified: (1) those receiving concurrent hysterectomy (n = 130); and (2) those with a history of hysterectomy (n = 272). Interventions Patients were treated with laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh in conjunction with other laparoscopic and/or vaginal procedures. Measurements and Main Results Data were collected in the form of chart reviews and patient questionnaires. Comparisons were made between groups 1 and 2. Patient demographics, history, mesh erosion/extrusion rates, and mesh-related complications were analyzed. Length of follow-up was 1 to 54 months with a median follow-up time of 12 months. No statistically significant differences existed between 2 groups in rates of mesh erosion/extrusion or other mesh-related complications. Overall vaginal mesh erosion/extrusion rate was 1.2% (95% CI 0.5%–2.7%) with an associated mesh revision rate of 1.2% (95% CI 0.5%–2.7%). Patients with concurrent hysterectomy had an erosion/extrusion rate of 2.3% (3/130) as compared with 0.7% (2/272) in patients with a history of hysterectomy, p = .18. No cases of mesh erosion through organs and tissues other than vaginal mucosa were observed. Cuff abscess occurred in 1 patient with concurrent hysterectomy, with an overall infection rate of 0.3% (95% CI 0.01%–1.2%). One more patient developed an inflammatory reaction to the mesh. Excision of exposed mesh was performed in all 5 patients with mesh extrusion. Vaginal approach to excision was uniformly used. Laparoscopic removal of the entire mesh took place in 4 patients with persistent pelvic pain, in 1 patient with cuff abscess, and in one patient with a questionable mesh reaction. An estimated 975 to 17 000 patients were required in each group to achieve power to detect a statistically significant difference in rate of mesh-related complications in this study. Conclusion Risk of mesh extrusion or other mesh-related complications after laparoscopic sacral colpopexy using soft macroporous Y-shaped polypropylene mesh is about 1% in our study. No significant increase in risk of mesh-related complications was observed in patients receiving concurrent hysterectomy when compared with patients who had a previous hysterectomy. The sample size of almost 2000 patients was needed to detect a statistically significant difference in rate of mesh-extrusion in this study.