Critical Under-Reporting of Hernia Mesh Properties and Development of a Novel Package Label

Abstract

Background: With an array of hernia meshes with varying properties, intraoperative decision making for the optimal mesh is critical. Although meshes are subjected to regulatory review through the Food and Drug Administration, it is unknown whether mesh properties are visually accessible. To facilitate greater knowledge for the surgeon on mesh choice, we aimed to comprehensively analyze hernia mesh packaging and regulations.

Study design: Labeling guidelines and 510(k) requirements across Food and Drug Administration-regulated products were analyzed and compared with mesh packaging. Packages and Instructions for Use were analyzed for commonly available hernia meshes. Literature review was conducted to understand recommended guidelines for mesh products. A novel hernia mesh packaging label was designed to rectify under-reporting.

Results: We found that food labels undergo critical scrutiny and detailed specifications, yet medical devices are not subjected to similar guidelines. The highest reported property on packages was the presence of a barrier (80%), and the lowest reported property was barrier composition (33%). For Instructions for Use, the lowest reported properties were mechanics (31%) and thickness (11%), both of which were not reported on packaging. Descriptive terms for pore size and mechanics were reported inconsistently. To overcome this under-reporting of properties, we propose a novel packaging label with properties chosen from regulatory guidelines, packaging analysis, and literature review.

Conclusions: Although standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines. There is extreme under-reporting and lack of consistency of clinically important mesh properties. Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.