International Journal of Recent Advances in Multidisciplinary Topics
Comprehensive Preclinical Biocompatibility Evaluation of an Implantable Hernia Mesh for Abdominal Wall Repair: In Vitro and In Vivo Assessment in Accordance with ISO 10993
By Minocha Pramod Kumar, Kothwala Deveshkumar, Kamna Rakesh Pandya and 5 others.
Abstract
Background
Hernia mesh is a type of medical equipment that can be permanently placed in a person to fix issues with the abdominal wall; therefore, ISO has established a framework for performing a comprehensive review of the device's safety to assure that it is safe to use and meets the requirements of the ISO 10993 standards.
Objective
The purpose of this study was to guarantee, using ISO 10993 testing, the safety of a sterile, non-absorbable polypropylene hernia mesh for long-term implantation.
Method
According to ISO 10993 standards, the hernia mesh was assessed for cytotoxicity (ISO 10993-5), heamolysis (ISO 10993-4), skin sensitization (ISO 10993-10), irritation (ISO 10993-23), acute systemic toxicity, sub-chronic toxicity, pyrogenicity (ISO 10993-11), and genotoxicity (ISO 10993-3). To conduct this testing, multiple test materials were prepared with different extraction conditions and solvents (polar and non-polar). Then, within both an in vitro and an in vivo environment, all material testing was performed according to Good Laboratory Practices (GLP).