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Related Experiment Video

Updated: Jan 3, 2026

Laparoscopic Repair of Para-Esophageal Hernia Using Absorbable Biosynthetic Mesh

Laparoscopic Repair of Para-Esophageal Hernia Using Absorbable Biosynthetic Mesh

Published on: September 11, 2021

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.

Keywords:

Food and drug administration Hernia Medical devices Mesh Real-world data Real-world evidence Registries Surveillance

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Last Updated: Jan 3, 2026

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Use of a Rat Model to Study Ventral Abdominal Hernia Repair

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Published on: October 2, 2017

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.