5 years ago

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

With an array of hernia meshes with varying properties, intraoperative decision making for the optimal mesh is critical. While meshes are subjected to regulatory review through the FDA, 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 FDA-regulated products were analyzed and compared to mesh packaging. Packages and Instructions for Use (IFUs) 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 underreporting. 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 IFUs, 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 inconsistently reported. To overcome this underreporting of properties, we propose a novel packaging label with properties chosen from regulatory guidelines, packaging analysis, and literature review. Conclusions While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines. There is an extreme underreporting 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.


Review of commercially available hernia mesh demonstrates a significant lack of consistency in reporting of product characteristics both in packaging and instructions for use. The adoption of a standardized label for packaging will provide surgeons with the knowledge to make more informed decisions in the operating room.

Publisher URL: www.sciencedirect.com/science

DOI: S1072751517320653

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