Evaluation of a self-gripping slowly resorbable mesh for ventral hernia repair: in vitro degradation and in vivo biocompatibility in a rabbit model.

Abstract

This study evaluates a new self-gripping, slowly resorbable mesh (SRM) for ventral hernia repair, focusing on its in vitro degradation and in vivo biocompatibility in a rabbit model. Traditional ventral hernia repair methods often use permanent synthetic meshes, which can have limitations. Slowly resorbable synthetic meshes, such as the SRM, offer a promising alternative by providing temporary support and gradually degrading to be replaced by the body's own tissue. The SRM, made from a poly(L-lactide) and trimethylene carbonate copolymer, was tested for its mechanical properties and degradation behavior. In vitro degradation was assessed according to ISO 13781:2017, while in vivo biocompatibility was evaluated following ISO 10993-6 guidelines. The study included native and pre-degraded samples implanted in New Zealand White rabbits, with assessments at 4, 10-, 26-, 52-, and 78-week post-implantation. Results showed that the SRM provided mechanical support for at least 20 weeks, with favorable integration and biocompatibility. The in vitro degradation profile indicated a steady decline in molecular weight, while in vivo studies revealed controlled degradation and minimal inflammatory response. Comparative analysis with the commercially available TIGr® Matrix Surgical Mesh demonstrated that the SRM had similar or better performance in terms of tissue response and degradation. The preclinical results of SRM, combined with the findings from this ISO 10993 Part 6 standard study, provide important data for market approval filings and the initiation of clinical evaluations.