Outcomes of a prospective multi-center trial of a second-generation composite mesh for open ventral hernia repair

PURPOSE: Composite mesh prostheses incorporate properties of multiple materials for use in open ventral hernia repair (OVHR). This study examines clinical outcomes in patients who underwent OVHR with a polypropylene/expanded polytetrafluoroethylene (ePTFE) composite graft containing a novel polydioxanone (PDO) absorbable ring to facilitate placement and graft positioning. METHODS: Data were prospectively collected on consecutive patients undergoing OVHR using a synthetic composite mesh. Seven centers enrolled patients during the study period. All patients underwent a standardized surgical procedure consisting of OVHR with sublay intraperitoneal placement of mesh. Mesh fixation was accomplished with peripheral tacks and transfascial sutures. RESULTS: One hundred and nineteen patients underwent OVHR with the composite mesh. Average age was 55.8 years; there were 71 (59.7 %) females and 48 (40.3 %) males with mean BMI of 33.5 ± 7.1 kg/m(2). One hundred and two (85.7 %) patients presented with primary ventral hernias. Mean defect size was 13.6 cm(2), and mean mesh size was 113.6 cm(2). Most patients (67 %) were discharged the day of surgery. Twelve patients (10.1 %) experienced complications in the perioperative time period primarily consisting of seroma (4.2 %) and ileus (1.7 %). Two patients required reoperation and mesh removal in the early postoperative period for infection and herniorrhaphy site pain, respectively. There was a decline in pain and movement limitation scores between baseline and 1-year follow-up. Six-month (n = 109) and twelve-month (n = 99) follow-up revealed no hernia recurrences (95 % CI 0–3 %, and 0–4 %, respectively). CONCLUSIONS: The use of this second-generation composite mesh was associated with no hernia recurrences and a low complication rate after open ventral hernia repair.