Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study

Abstract

Objective: To assess the use of mesh in pelvic organ prolapse surgery, and compare short term outcomes between procedures using and not using mesh.

Design: All inclusive, population based cohort study.

Setting: Statewide surgical care captured in the New York Statewide Planning and Research Cooperative System.

Participants: Women who underwent prolapse repair procedures in New York state from 2008 to 2011.

Main outcomes measures: 90 day safety events and reinterventions within one year, after propensity score matching. Categorical, time to event, and subgroup analyses (<65 and ≥ 65 year age groups) were conducted.

Results: Of 27,991 patients in total, 7338 and 20, 653 underwent prolapse repair procedures with and without mesh, respectively. Mesh use increased by 44.7%, from 1461 procedures in 2008 to 2114 procedures in 2011. Most patients in the cohort were younger than 65 years (62.3% (n=17,424/27, 991)). However, more patients were aged 65 years and older in the mesh group than in the non-mesh group (44.3% (n=3249) v 35.4% (n=7318)). Complications after surgery were not common, irrespective of the use or non-use of mesh. After propensity score matching, patients who received the surgery with mesh had a higher chance of having a reintervention within one year (mesh 3.3% v no mesh 2.2%, hazard ratio 1.47 (95% confidence interval 1.21 to 1.79)) and were more likely to have urinary retention within 90 days (mesh 7.5% v no mesh 5.6%, risk ratio 1.33 (95% confidence interval 1.18 to 1.51)), compared with those who received surgery without mesh. In subgroup analyses based on age, mesh use was associated with an increased risk of reintervention within one year in patients under age 65 years, and increased risk of urinary retention in patients aged 65 years and over.

Conclusions: Despite multiple warnings released by the US Food and Drug Administration since 2008, use of mesh in pelvic organ prolapse surgery continues to grow. In this statewide comprehensive study, mesh procedures were associated with an increased risk of reinterventions within one year and urinary retention after surgery.