Two-year prospective single-arm multicenter study results of clinical safety and performance of synthetic ParieteneTM DS composite mesh in ventral hernia repair

Abstract Background In surgery, meshes are often used to provide additional support to weakened or damaged tissues. For ventral hernia procedures, synthetic meshes are the standard of care. This study aimed to assess the clinical safety and performance of synthetic Parietene™ DS Composite Mesh in primary and incisional ventral hernia repair. Methods This is a prospective, single-arm, multicenter, non-randomized study including subjects (≥ 18 years) undergoing intraperitoneal onlay mesh repair for ventral hernias using Parietene™ DS Composite Mesh . Patients were enrolled at 6 US sites and evaluated at discharge and 1-month, 3-months, 12-months, and 24-months postoperatively. Primary endpoint was to assess the incidence of hernia recurrence at 12 months; secondary endpoints included assessment of hernia recurrence at 1, 3 and 24 months, adverse device effects and patient quality of life (QoL). Surgeon satisfaction with mesh was also assessed. Results A total of 125 patients were included in this study: 70 were treated for primary hernias and 55 for incisional hernias; 68 patients underwent laparoscopy, 56 robotic and 1 open surgery. In 120 subjects completing the follow-up 4 (3.3%) hernia recurrences were reported, all within the 12-month follow-up (1 primary and 1 incisional after robotic surgery, 1 primary and 1 incisional after laparoscopy). At 24 months, no additional hernia recurrences occurred. No significant differences were found in hernia recurrence incidence between hernia type or surgery approach sub-groups. No adverse events related to mesh alone were reported. Patients experienced an overall significant improvement in QoL at 12- and 24-month post-surgery, as compared to baseline and 1 month. For > 95% of procedures, surgeons rated their experience handling the mesh, mesh deployment, and introduction into the working cavity as easy or very easy. Conclusions Parietene™ DS Composite Mesh use in ventral hernia repair assures a safe profile, low hernia recurrence rate and improvement in patient QoL. Trial Registration the study was registered in ClinicalTrials.gov under the code NCT03495154. Registered March 27, 2018.