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Use of real-world registry data: a hernia mesh example
T-H Lee1, A Choudhuri1, K Ulisney1
1Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA.
Hernia : the Journal of Hernias and Abdominal Wall Surgery
|November 29, 2019
Summary
Hernia mesh registries provide valuable real-world data (RWD) for understanding device performance. High-quality registry data are crucial for accurate interpretation of real-world evidence (RWE) in medical device surveillance.
Area of Science:
- Medical device surveillance
- Surgical outcomes research
- Health informatics
Background:
- Clinical performance of hernia mesh devices is not well understood.
- Limited clinical trial and real-world data (RWD) hinder accurate interpretation.
- Hernia mesh registries offer a solution for capturing longitudinal RWD.
Purpose of the Study:
- To highlight the need for high-quality data in hernia mesh registries.
- To emphasize the importance of data quality, completeness, and analysis methodology.
- To underscore the role of RWD in interpreting medical device performance.
Main Methods:
- Utilized hernia mesh registry data.
- Cross-tabulated 30-day infection rates across four mesh types.
- Incorporated additional registry RWD for contextual analysis.
Main Results:
- Initial review indicated lower infection rates for permanent mesh compared to absorbable mesh.
- Further analysis with additional RWD provided more context for interpreting infection rates.
- Demonstrated the potential for registries to yield meaningful RWE.
Conclusions:
- High-quality registries are essential for generating reliable real-world evidence (RWE).
- RWE from registries can support ongoing surveillance of medical devices.
- Registry data aids informed regulatory decision-making for hernia mesh devices.
