One-Year Safety and Clinical Performance of MERINEUM™ MESH with PROFOUND™ in Hernia Repair: A Multicenter Real-World Study

Naresh Arora; Tushar Dixit; Bhavesh Patel; Ilesh Shah; Jitendra Chawla; Poojan Kiran Kambli; Jayvi Patel; Kiran Kumar  Shetty

Authors

Naresh Arora Department of General Surgery, Arora Surgical Hospital, Surat, Gujarat, India.
Tushar Dixit Department of Surgery, Dixit Hospital, Vapi, Gujarat, India.
Bhavesh Patel Department of General Surgery, Haria L.G. Rotary Hospital, Vapi, Gujarat, India.
Ilesh Shah Department of General Surgery, Jeevandeep Surgical Hospital, Vapi, Gujarat, India.
Jitendra Chawla Department of General Surgery, Saket Hospital, Jaipur, Rajasthan, India.
Poojan Kiran Kambli Department of Product Performance Engineering and Post Market Clinical Follow Up, Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India.
Jayvi Patel Department of Product Performance Engineering and Post Market Clinical Follow Up, Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India.
Kiran Kumar Shetty Department of Product Performance Engineering and Post Market Clinical Follow Up, Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India.

Keywords:

Hematoma, Hernia repair, Laparoscopic hernia repair, MERINEUM™ MESH, Mesh, Post-market clinical follow-up, Recurrence, Seroma, Surgical site infection, Ventral hernia

Abstract

Background: MERINEUM™ MESH is a sterile, partially absorbable, dual-layer surgical mesh intended for laparoscopic ventral hernia repair and other fascial surgical interventions. This real-world post-market clinical follow-up study evaluated its safety and clinical performance over 12 months. Methods: This retrospective, single-arm, multicenter observational study was conducted across five centers and included patients undergoing hernia repair with MERINEUM™ MESH. The primary endpoint was hernia recurrence at 12 months, defined as the development of a new or recurrent bulge that increased in size with straining. Secondary outcomes included post-operative complications, surgical site infection (SSI), adverse events (AEs), serious AEs (SAEs), and operative time. Patient and procedural data were retrospectively collected from medical records. Results: A total of 141 mesh devices were implanted in 130 patients. The mean age was 54.59 ± 13.53 years, and 71.54% of patients were male. Laparoscopic repair was performed in 92.31% of patients, and the mean operative time was 80.92 ± 24.86 min. No hernia recurrence was observed during the 12-month follow-up, resulting in a 0% recurrence rate. Four patients (3.08%) developed seroma and two (1.54%) developed hematoma; all were managed conservatively and resolved. No SSIs or SAEs were reported. Two perioperative AEs were observed: post-operative abdominal distension managed conservatively and inflammation requiring mesh removal, which subsequently resolved. No additional device-related adverse reactions were reported during follow-up. Conclusion: MERINEUM™ MESH demonstrated a favorable safety and clinical performance profile, characterized by no clinically evident recurrence or SSI and a low incidence of conservatively managed post-operative complications. These findings support its use in hernia repair in the studied population. Larger prospective studies with longer follow-up are warranted to further establish long-term durability and safety.