Abstract
IMPORTANCE: As more mesh products are approved for inguinal hernia repair, postmarket surveillance is needed to assess their real-world performance. OBJECTIVE: To apply the Data Extraction and Longitudinal Trend Analysis (DELTA) safety surveillance methodology to a large inguinal hernia mesh database in a retrospective manner for proof of concept and to assess its ability to identify safety alerts for reoperation for hernia recurrence. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included adults who underwent elective mesh-based inguinal hernia repair between January 2010 and June 2023 within Kaiser Permanente, a US-based integrated health care system. Patients were followed up until membership termination, death, or the study end date (June 30, 2023). Data analysis was completed from June 2023 to December 2024. EXPOSURES: A total of 14 open and 12 minimally invasive (MIS) mesh brands were identified. MAIN OUTCOMES AND MEASURES: The primary outcome measure was reoperation for recurrence, evaluated quarterly over time after the first point of implantation. Each mesh of interest was 1:1 propensity score matched to different meshes based on patient age, body mass index, sex, and American Society of Anesthesiologists (ASA) classification. A safety alert was triggered if the cumulative reoperation rate for the mesh of interest exceeded the 95% confidence interval upper limit of the comparison group for 3 or more consecutive quarters. RESULTS: The study sample included 124 458 repairs in 104 241 patients performed by 784 surgeons at 38 hospitals. Mean (SD) patient age was 58.9 (15.5) years, and 9234 patients (7.4%) were female. None of the 3 most-used open meshes triggered safety alerts: ProGrip (reoperation rate = 1.4%; relative risk [RR] = 1.01; 95% CI, 0.87-1.17), Parietex (reoperation rate = 1.6%; RR = 0.96; 95% CI, 0.79-1.16), and PerFix (reoperation rate = 1.8%; RR = 0.98; 95% CI, 0.80-1.21). Surgipro (reoperation rate = 1.7%; RR = 1.27; 95% CI, 1.00-1.62; 9 quarters after first use) and Kugel (reoperation rate = 2.5%; RR = 2.05; 95% CI, 1.19-3.54; 9 quarters) triggered alerts. Of the 3 highest-volume MIS meshes, Parietex triggered an alert (reoperation rate = 2.1%; RR = 1.59; 95% CI, 1.31-1.92; 27 quarters); ProGrip (reoperation rate = 0.9%; RR = 0.47; 95% CI, 0.37-0.60) and 3DMax (reoperation rate = 1.2%; RR = 0.48; 95% CI, 0.29-0.78) did not. Parietene (reoperation rate = 1.7%; RR = 2.27; 95% CI, 1.12-4.60; 14 quarters), Surgipro (reoperation rate = 5.0%; RR = 1.92; 95% CI, 1.00-3.72; 9 quarters), and ProLite (reoperation rate = 1.2%; RR = 3.00; 95% CI, 0.31-28.64; 26 quarters) also triggered alerts. CONCLUSIONS AND RELEVANCE: In this cohort study, the DELTA methodology, applied retrospectively, triggered safety alerts for several inguinal hernia repair meshes warranting further investigation. This surveillance system may offer the opportunity for automated monitoring of mesh implants in a postmarket setting.