Long-Term Safety and Clinical Outcomes of Filaprop™ Mesh Variants in Elective Hernia Repair: A Multicenter Study
摘要
Polypropylene mesh remains a fundamental material in hernia repair, with ongoing advancements in mesh design intended to enhance biocompatibility and long-term results. The Filaprop™ Mesh and Filaprop™ Mesh Soft are heavyweight and lightweight polypropylene meshes used for various hernia procedures. The existing real-world evidence about their long-term clinical performance remains scarce. The study aims to assess the safety profile and operational outcomes of Filaprop Mesh and Filaprop Mesh Soft during elective hernia surgery through a retrospective observational study conducted at various centres in India. The retrospective multicenter observational study analysed 651 patients who received hernia repair surgery with either Filaprop™ Mesh or Filaprop™ Mesh Soft. The study evaluated patient outcomes at four different time points after surgery: 1 year, 3 years, 5 years and 7 years. The primary study objectives focused on hernia recurrence rates, mesh-related adverse effects, and surgical site infections (SSI). A total of 651 patients were enrolled in the study, with a mean age of 47.83 ± 14.84 years, the majority being male (79.88%). Of these, 510 patients (78.34%) completed the 1-year follow-up. Among them, 15 patients (2.94%) experienced adverse events, including seroma in 9 patients (1.96%), surgical site infection (SSI) in 4 patients (0.78%), and combined pain with seroma in 1 patient (0.20%). Notably, no adverse events were reported in the Filaprop™ Mesh Soft group. Furthermore, no cases of hernia recurrence or chronic postoperative pain were observed beyond the first year of follow-up. The long-term safety and performance of Filaprop™ Mesh and Filaprop™ Mesh Soft were favourable, with low postoperative complications and no recurrence for seven years, supporting their ongoing use in elective hernia repair.