OC-035 TEST METHODS FOR SURGICAL MESHES - AN INDUSTRY POINT OF VIEW

Abstract

Abstract Aim No standardized test methods currently exist for the characterization of the synthetic surgical meshes used in hernia repair and soft tissue reinforcement. While each mesh manufacturer developed their own test methods for comparative analysis, these were never harmonized across industry. A subgroup of the European Association of the Surgical Suture Industry (EASSI) was constituted, the Standardization of Surgical Meshes Working Group (SSM WG) with the objective to reach alignment of surgical meshes test methods. Materials & Methods The SSM WG agreed on the test methods that should be defined to provide a thorough in-vitro-characterization and comparison of surgical meshes. After several interlaboratory iterations, the group established common test protocols which may be performed by people with limited textile background. Extensive inter-laboratory test method verifications were then performed by conducting tests with different specimens by all manufacturers in a consistent manner. Results Common protocols were defined for the following test methods: Linear Tensile Test (Strength and elongation), Burst Test (Strength and displacement), Suture Pull-Out Test (Strength), Pore Size Measurement (Porosity and pore dimensions). 4 meshes were tested by each of the 4 involved manufacturers to assess the protocols validity. Despite methods harmonization, differences could be observed between laboratories. Conclusion The SSM WG recommends following the test protocols described and to maximize the sample size. Due to high sensitivity of specimen and difference in equipment used, only results of tests performed by a single testing center using identical testing features for all tested meshes should be compared.