Incidence of Extrusion Following Type I Polypropylene Mesh “Kit” Repairs in the Correction of Pelvic Organ Prolapse

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh “kit” repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning

Clinical Study Incidence of Extrusion Following Type I Polypropylene Mesh "Kit" Repairs in the Correction of Pelvic Organ Prolapse

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh "kit" repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning

Single-incision apical and posterior mesh repair: 1-year prospective outcomes

The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. This prospective multicenter study included 139 women with a parts per thousand yen stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage a parts per thousand currency sign I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considere

Elevate and Uterine Preservation: Two-Year Results

To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusio

Graft use in transvaginal pelvic organ prolapse repair: a systematic review

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0-3%), visceral injury (1-4%), urinary infection (0-19%), graft erosion (0-30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed