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.