Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair

Introduction and hypothesis  

This study is about evaluating safety and potential risk factors for complications following pelvic organ prolapse repair with the GYNECARE PROLIFT system.     

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy

Introduction and hypothesis  

The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy.     

Tension-free vaginal mesh repair for anterior vaginal wall prolapse

OBJECTIVES: We determined the efficacy of the use of a tension free prolene mesh to correct a grade III anterior vaginal wall prolapse recurrence. METHODS: Twelve women (mean age 65.6 years) with stress urinary incontinence (SUI) (4 type II and 1 type III) and bladder prolapse entered the study. After vaginal incision a pretailored polypropylene mesh was fixed to its four angles by absorbable sutures to the urethropelvic ligaments and pubocervical fascia anteriorly and to the cardinal ligaments and pubocervical fascia posteriorly. When present, a posterior descensus was corrected during the same procedure. SUI was treated with the tension-free vaginal tape procedure (TVT) through a separate vaginal incision over the mid-urethra. RESULTS: All patients were available for postoperative pelvic examination at 3-month intervals, for a mean follow-up of 20.5 months (range 15-32). Nine patients were considered cured (no cystocele recurrence) while in 3 patients a grade 1 asymptomatic cystocele was present postoperatively (asymptomatic). No significant postoperative pain was reported by the patients. CONCLUSIONS: This study confirms that in patients with moderate cystocele a tension-free mesh to support bladder base and neck effectively treats the cystocele. It is particularly recommended in the treatment of previous failure with traditional techniques and when the quality of suspending tissue is poor or defective. A long-term study on a large number of patients is still warranted to confirm and validate its clinical use.     

Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse

AIMS: To identify risk factors for mesh exposures after anterior pelvic organ prolapse repair using a standardized trocar guided polypropylene mesh kit. METHODS: A secondary risk analysis combining patients from two prospective multicenter studies. Main outcome was clinical host-vs-implant reactions one year after surgery using a macroscopic inflammatory scale. RESULTS: 353 patients were included in the study. Mean age at surgery was 65.3 (±9.6 SD) years and surgery was performed as a primary procedure in 224/353 (63.5%) patients. Mesh exposures, of which the majority were mild-moderate, occurred in a total of 30/349 patients (8.6%). Multivariate logistic regression showed increased odds for mesh exposures for women who smoked before surgery (OR 3.48, 95% CI 1.18-10.28), who had given birth to more than two children (OR 2.64, 95% CI 1.07-6.51) and those with somatic inflammatory disease (OR 5.11, 95% CI 1.17-22.23). Age, body mass index, and menopausal status showed no significant association with clinical mesh exposures. CONCLUSIONS: Smoking, multiple childbirth, and somatic inflammatory disease are possible risk factors for mesh exposure after trocar guided mesh kit surgery for anterior pelvic organ prolapse. Preoperative smoking cessation may decrease the risk for exposures. Neurourol. Urodynam. 31:1165-1169, 2012. ? 2012 Wiley Periodicals, Inc.     

Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse

Introduction and hypothesis

The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA).

Methods

Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m²) and the third utilized IntePro Lite (mesh density 25.2 g/m²). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered.

Results

Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0?years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0?% following IntePro compared to 5.0?% following IntePro Lite (p?=?0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7?% following IntePro compared to 7.1?% following IntePro Lite (p?=?0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1?% with IntePro versus 6.0?% with IntePro Lite with an estimated odds ratio of 1.93 (95?% confidence interval 0.84–4.44, p?=?0.12).

Conclusions

No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46?% reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.     

Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors

Prosthetic reinforcement in the surgical repair of pelvic prolapse by the vaginal approach is not devoid of tolerability-related problems such as vaginal erosion. The purposes of our study are to define the risk factors for exposure of the mesh material, to describe advances and to recommend a therapeutic strategy. Two hundred and seventy-seven patients undergoing surgery due to pelvic prolapse with transvaginal mesh technique were included in a continuous, retrospective study between January 2002 and December 2003. Thirty-four cases of mesh exposure were observed within the 2 months following surgery, which represents an incidence of 12.27%. All the patients were medically treated, nine of whom were found to have completely healed during the check-up performed at 2 months. In contrast, 25 patients required partial mesh exeresis. Risk factors of erosion were concomitant hysterectomy [OR=5.17 (p=10⁻³)] and inverted T colpotomy [OR=6.06 (p=10⁻²)]. Two technical guidelines can be defined from this study as regards the surgical procedure required in order to limit mesh exposure via the vaginal route. The uterus must be preserved, and the number and extent of colpotomies needed to insert the mesh must be limited.     

Tension-free vaginal tape: analysis of risk factors for failures

To investigate whether there are any demographic, clinical, or urodynamic variables associated with an increased risk of failure in women undergoing surgery with tension-free vaginal tape (TVT). We retrospectively analysed 325 consecutive patients who had been operated with the TVT procedure. Patients were assessed with a complete history, physical examination, and urodynamic testing. The operation was done under local or epidural anesthesia and any further surgical procedure was added as indicated. The postoperative evaluation included collection of data on intra- and postoperative complications and analysis of outcomes. The outcome of surgical treatment was evaluated subjectively and objectively. The Statistical Package for Social Sciences (SPSS, Chicago, Illinois, USA) was used for data analysis; P<0.05 was considered significant. The overall complication rate was 14%, voiding dysfunction being the most common. Three hundred and one women were available for the analysis of surgical outcome and the mean follow-up was 34+12 months (median 32 months). Subjectively, 269 women (89%) were cured by the procedure and 13 (4.3%) reported marked improvement. An objective cure was achieved in 263 (87%); 38 patients still having leakage while coughing during postoperative cystometry. Among the numerous presumed risk factors for failed antiincontinence surgery only urethral hypomobility and recurrent stress urinary incontinence were significantly associated with failure of the TVT procedure in our study. However, even in these complicated situations, the cure rate was more than 70%.     

Incidence rate and risk factors for vaginal vault prolapse repair after hysterectomy

Our objective was to estimate the incidence and identify the risk factors for vaginal vault prolapse repair after hysterectomy. We conducted a case control study among 6,214 women who underwent hysterectomy from 1982 to 2002. Cases (n = 32) were women who required vaginal vault suspension following the hysterectomy through December 2005. Controls (n = 236) were women, randomly selected from the same cohort, who did not require pelvic organ prolapse surgery. The incidence of vaginal vault prolapse repair was 0.36 per 1,000 women-years. The cumulative incidence was 0.5%. Risk factors included preoperative prolapse (odds ratio (OR) 6.6; 95% confidence interval (CI) 1.5–28.4) and sexual activity (OR 1.3; 95% CI 1.0–1.5). Vaginal hysterectomy was not a risk factor when preoperative prolapse was taken into account (OR 0.9; 95% CI 0.5–1.8).Vaginal vault prolapse repair after hysterectomy is an infrequent event and is due to preexisting weakness of pelvic tissues.     

Tension-free vaginal mesh repair for recurrence of pelvic organ prolapse after vaginal mesh procedures: a case report

A 61-year-old woman presented with the chief complaint of a vaginal bulge for 2 years. She had undergone two operations for pelvic organ prolapse. The initial procedure was the Manchester procedure and posterior colporrhaphy, and the second was a vaginal repair with mesh for recurrent rectocele 3 years after the initial surgery. She noticed the vaginal bulge shortly after the second surgery. A gynecological examination revealed a stage III rectocele associated with a 2 cm, firm mass at the posterior vaginal wall. T2-weighted magnetic resonance imaging showed a 2 × 3 cm high-intensity mass located between the vaginal wall and rectum. The recurrent rectocele might have been caused by incomplete support from the mesh, which was not fixed in the vaginal wall, resulting in formation of a mass. The patient underwent complete mesh removal and tension-free vaginal mesh-posterior surgery for the rectocele. The excised mesh had shrunk from a 7 × 5 cm rectangle mesh preoperatively into a firm 2 × 2 × 3 cm mass. No recurrence has been seen for 18 months postoperatively.     

Marlex mesh prosthesis for massive vaginal vault prolapse

A case of repeatedly recurrent massive vaginal vault prolapse is presented. Representative articles on various ingenious modalities for the repair of this condition are reviewed. An additional safe and simple procedure is described. Criteria for the ideal prosthetic material are listed. Marlex mesh prosthesis, which appears to fulfil all the criteria required for use in vaginal surgery, is recommended not only as an onlay graft to support the soft tissues approximated, but also to cover wide gaps, as was presented in this case.     

Delivery-related risk factors for covert postpartum urinary retention after vaginal delivery

Introduction and hypothesis

Postpartum urinary retention (PUR) is a common consequence of bladder dysfunction after vaginal delivery. Patients with covert PUR are able to void spontaneously but have a postvoid residual bladder volume (PVRV) of ≥150 mL. Incomplete bladder emptying may predispose to bladder dysfunction at a later stage of life. The aim of this cross-sectional study was to identify independent delivery-related risk factors for covert PUR after vaginal delivery in order to identify women with an increased risk of covert PUR.

Methods

The PVRV of women who delivered vaginally was measured after the first spontaneous micturition with a portable bladder-scanning device. A PVRV of 150 mL or more was defined as covert PUR. Independent risk factors for covert PUR were identified in multivariate regression analysis.

Results

Of 745 included women, 347 (47 %) were diagnosed with covert PUR (PVRV ≥150 mL), of whom 197 (26 %) had a PVRV ≥250 mL (75th percentile) and 50 (7 %) a PVRV ≥500 mL (95th percentile). In multivariate regression analysis, episiotomy (OR 1.7, 95 % CI 1.02 – 2.71), epidural analgesia (OR 2.08, 95 % CI 1.36 – 3.19) and birth weight (OR 1.03, 95 % CI 1.01 – 1.06) were independent risk factors for covert PUR. Opioid analgesia during labour (OR 3.19, 95 % CI 1.46 – 6.98), epidural analgesia (OR 3.54, 95 % CI 1.64 – 7.64) and episiotomy (OR 3.72, 95 % CI 1.71 – 8.08) were risk factors for PVRV ≥500 mL.

Conclusions

Episiotomy, epidural analgesia and birth weight are risk factors for covert PUR. We suggest that the current cut-off values for covert PUR should be reevaluated when data on the clinical consequences of abnormal PVRV become available.

     

Long-term follow-up of persistent vaginal polypropylene mesh exposure for transvaginally placed mesh procedures

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?cm²; 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.     

Incidence and risk factors for mesh erosion after laparoscopic repair of pelvic organ prolapse by lateral suspension with mesh

Introduction and hypothesis

The objective of our study was to estimate the incidence and identify the risk factors for mesh erosion after laparoscopic repair of pelvic organ prolapse (POP) by lateral suspension with mesh.

Methods

We conducted a nested case–control study among 480 women who underwent POP repair by laparoscopic lateral suspension with mesh from January 2004 to October 2012. Cases (n?=?18) were women who showed mesh erosion following the first intervention through December 2014. Controls (n?=?133) were women randomly selected from the same cohort who did not have any erosion.

Results

The risk of mesh erosion was 3.8 % with a mean follow-up of 82.3 months (range 28.2 – 130.6 months). The main risk factor was the use of a type 3 mesh (macroporous with either multifilamentous or microporous components) rather than a type 1 mesh (macroporous and monofilamentous; adjusted OR 13.0, 95 % CI 1.5 – 110.6; P?=?0.02). Risk factors included smoking (adjusted OR 10.4, 95 % CI 2.3 – 46.5; P?<?0.01) and posterior mesh placement (adjusted OR 5.1, 95 % CI 1.2 – 21.8 P?=?0.03).

Conclusions

The risk of mesh erosion is low and may be further reduced by using the appropriate mesh material, and by identifying specific patient characteristics such as tobacco use. As conventional vaginal surgery is effective for the treatment of the posterior compartment, the use of posterior mesh during laparoscopic pelvic floor repair needs to be questioned.

     

Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse

Introduction and hypothesis

To estimate the risk of repeat surgery for recurrent prolapse or mesh removal after vaginal mesh versus native tissue repair for anterior vaginal wall prolapse.

Methods

We utilized longitudinal, adjudicated, healthcare claims from 2005 to 2010 to identify women ≥18 years who underwent an anterior colporrhaphy (CPT 57420) with or without concurrent vaginal mesh (CPT 57267). The primary outcome was repeat surgery for anterior or apical prolapse or for mesh removal/revision; these outcomes were also analyzed separately. We utilized Kaplan–Meier curves to estimate the cumulative risk of each outcome after vaginal mesh versus native tissue repair. Cox proportional hazards models were used to estimate the hazard ratio (HR) for vaginal mesh versus native tissue repair, adjusted for age, concurrent hysterectomy, and concurrent or recent sling.

Results

We identified 27,809 anterior prolapse surgeries with 49,658 person-years of follow-up. Of those, 6,871 (24.7%) included vaginal mesh. The 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue (15.2 % vs 9.8 %, p?<0.0001) with a 5-year risk of mesh revision/removal of 5.9%. The 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4 % vs 9.3 %, p?=?0.70. The results of the adjusted Cox model were similar (HR 0.93, 95%CI: 0.83, 1.05).

Conclusions

The use of mesh for anterior prolapse was associated with an increased risk of any repeat surgery, which was driven by surgery for mesh removal. Native tissue and vaginal mesh surgery had similar 5-year risks for surgery for recurrent prolapse.     

Clinical pathway for tension-free vaginal mesh procedure: Evaluation in 300 patients with pelvic organ prolapse

Objectives:   To evaluate a clinical pathway of discharge on postoperative day 3 for the tension-free vaginal mesh (TVM) procedure in patients with pelvic organ prolapse (POP).
Methods:   Between May 2006 and December 2007, 305 consecutive women with POP quantification stage 3 or 4 were planned to undergo the TVM procedure in a single general hospital. Excluding five patients with concomitant hysterectomy, a pathway (removal of the indwelling urethral catheter on the next morning, discharge on postoperative day 3) was applied to the remaining 300 patients. The perioperative complications and postoperative hospitalization were prospectively evaluated in this case series.
Results:   Perioperative complications were: bladder injury (11 cases, 3.7%), vaginal wall hematoma (two cases, 0.7%), rectal injury (one case, 0.3%) and temporary hydronephrosis (one case, 0.3%). None needed blood transfusion. The indwelling urethral catheters were removed on the next morning as in the pathway in 287 cases (95.6%), and none required clean intermittent catheterization at home. Postoperative hospitalization was within 3 days in 280 cases (93.3%). The six cases (2.0%) with longer hospitalization were due to complications (two cases of bladder injury, one of rectal injury, one of blood loss over 200 mL, one of temporary urinary retention, and one of hydronephrosis). Two patients were re-hospitalized within one month due to vaginal bleeding or gluteal pain.
Conclusions:   Patients generally accepted the pathway of discharge on postoperative day 3 in spite of the Japanese culture preferring a longer hospital stay.