Chapter 4.2.1 74 complications, the development of anatomical failure and reintervention for graft-related complications or prolapse. There was no data imputation for missing data. Statistical methods and results are reported following the SAMPL (Statistical Analyses and Methods in the Published Literature) guidelines.157 This article follows the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for reporting observational studies.158 This audit was approved by the Ethics Committee on Clinical Research of the UZ Leuven, Leuven, Belgium (B322202042753). Written informed consent was obtained from all participants. Table 1. Mesh characteristics Period Number Weight Textile porosity (%) Heavier-weight meshes 101 Marlex 04/1997 – 07/1999 19/101 (18.8%) 95 g/m2 37 Prolene 08/1999 – 09/2003 42/101 (41.6%) 87 g/m2 56 Gynemesh 10/2003 – 12/2006 40/101 (39.6%) 44 g/m2 62 Light-weight meshes 238 Ultrapro 01/2007 – 07/2012 180/238 (75.6%) 28 g/m2* 67 Artisyn 08/2012 – 01/2016 58/238 (24.4%) 28 g/m2* 67 All mesh types in this audit are polypropylene meshes qualified as Amid type I (Macroporous >75 μm). *after resorption of poliglecaprone fibers. RESULTS Of 339 patients who underwent surgery, 279 (82.3%) agreed to participate in this audit; reasons for non-participation are displayed in Figure 1 (the flow diagrams for both cohorts are displayed in Appendix 2, available online at http://links.lww.com/AOG/C959). We report graft-related complications and functional outcomes in all 279 study participants. Recurrent apical prolapse is reported only in study participants who were clinically assessed (n= 191). Conversely, any reintervention for recurrent prolapse and graft-related complications are identified through the national health record for all 339 patients who underwent surgery. Table 2 displays the characteristics of both cohorts, categorized by mesh weight, indicating significant differences between heavier and lighter weight implanted patients for hormone therapy, prior hysterectomy and prior prolapse surgery. Table 3 displays the main findings of this study. At comparable median [interquartile range] follow-up (97 [16 months] for heavier-weight vs 92.5 [58 months] for lightweight), graft-related complications were more frequent in patients with heavierweight mesh (22.8%, 23/101) compared with patients with lightweight mesh (7.3%, 13/178) (hazard ratio [HR] 3.3; 95% CI 1.6-7.1). Graft-related complications were symptomatic in 16.8% (17/101) of patients with heavier-weight and 2.8% (5/178) of lightweight mesh (HR 6.0; 95% CI 2.5-14.3). We
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