Preclinical Evaluation Of Acute And Chronic Systemic Toxicity Of A Novel Composite-Coated Mesh Implant For Minimally Invasive Hernioplasty

Background. Synthetic mesh implants are widely used in minimally invasive hernioplasty; however, their systemic safety remains a critical concern, particularly when modified with composite coatings. According to international standards, preclinical evaluation of acute and chronic toxicity is mandatory prior to clinical translation. Objective. To assess the acute and chronic systemic toxicity of a novel composite-coated mesh implant in accordance with ISO 10993-11. Methods. A preclinical in vivo study was performed on laboratory rats divided into acute (7 days) and chronic (1 and 3 months) observation groups (n = 30 per group). A 1 × 1 cm fragment of the composite-coated mesh was implanted onto the diaphragmatic surface of the liver. Clinical condition, body weight dynamics, relative organ mass coefficients, hematological indices, serum biochemical parameters, and histopathological changes were evaluated and compared with control groups. Results. No mortality or signs of systemic toxicity were observed throughout the study. Body weight gain remained within physiological ranges in all groups. Relative organ mass coefficients did not differ significantly from controls (p > 0.05), except for a transient increase in liver mass at day 7 without histopathological abnormalities. Hematological and biochemical parameters remained within reference limits at all time points (p > 0.05). Histological examination revealed no degenerative or necrotic changes in major organs. Conclusion. The composite-coated mesh implant did not induce acute or chronic systemic toxicity in rats and can be classified as a low-toxicity medical device. These findings support its preclinical safety and justify further experimental and clinical investigation.