Purpose: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices.
Methods: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types.
Results: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results.
Conclusions: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.
Keywords: Food and drug administration; Hernia; Medical devices; Mesh; Real-world data; Real-world evidence; Registries; Surveillance.