A reliable and replicable test protocol for the mechanical evaluation of synthetic meshes.

ABSTRACT

Despite the worldwide spread of surgical meshes in abdominal and inguinal surgery repair, the lack of specific standards for mechanical characterization of synthetic meshes, used in hernia repair and urogynecologic surgery, makes performance comparison between prostheses undoubtedly difficult. This consequently leads to the absence of acknowledged specifications about the mechanical requirements that synthetic meshes should achieve in order to avoid patient discomfort or hernia recurrences. The aim of this study is to provide a rigorous test protocol for the mechanical comparison between surgical meshes having the same intended use. The test protocol is composed of three quasi-static test methods: (1) ball burst test, (2) uniaxial tensile test, and (3) suture retention test. For each test, post-processing procedures are proposed to compute relevant mechanical parameters from the raw data. Some of the computed parameters, indeed, could be more suitable for comparison with physiological conditions (e.g., membrane strain and anisotropy), while others (e.g., uniaxial tension at rupture and suture retention strength) are reported as they provide useful mechanical information and could be convenient for comparisons between devices. The proposed test protocol was applied on 14 polypropylene meshes, 3 composite meshes, and 6 urogynecologic devices to verify its universal applicability towards meshes of different types and produced by various manufacturers, and its repeatability in terms of coefficient of variation. The test protocol resulted easily applicable to all the tested surgical meshes with intra-subject variability characterized by coefficient of variations settled around 0.05. Its use within other laboratories could allow the determination of the inter-subject variability assessing its repeatability among users of alternative universal testing machines.