Commercial classification of conventional polypropylene and polyester meshes for groin hernia repair: A descriptive study

Abstract

Abstract OBJECTIVE: Despite established definitions of weight classification available from the European Hernia Society and others, a discrepancy exists in the classification used by mesh companies. This descriptive study aimed to summarize available data from mesh companies regarding how meshes are classified according to weight. MATERIALS AND METHODS: We included Food and Drug Administration (FDA)-approved conventional non-coated flat meshes made of polypropylene or polyester. To access all medical companies that produce hernia repair meshes, we conducted a broad search on Access Global Unique Device Identification Database, which is a database created in collaboration between the National Library of Medicine and the FDA. RESULTS: Five companies with 14 meshes met the inclusion criteria. Meshes were classified by the companies as lightweight (seven meshes), heavyweight (one mesh), or lacking specific weight terms (six meshes). Lightweight meshes had a median density of 48 g/m2 (range 36–114 g/m2), while the heavyweight mesh had a density of 125 g/m2. Six meshes were neither defined as lightweight nor heavyweight, and they had a median density of 62 g/m2 (44–76 g/m2). Seven meshes were defined as macroporous, with a median pore size of 2.8 mm (range 1.5–3.5 mm). Six meshes had data on the pore size but did not specify microporous or macroporous characteristics. CONCLUSIONS: A discrepancy exists between companies’ and researchers’ definition of lightweight and heavyweight meshes. Further investigation into mesh classification is warranted to establish clear guidelines for companies, researchers, and clinicians.