Evaluation of Long-term Performance of the GORE SYNECOR Intraperitoneal Biomaterial in the Treatment of Inguinal Hernias.

BACKGROUND: The objective of this study was to analyze device safety and clinical outcomes of inguinal hernia repair with the GORE SYNECOR Intraperitoneal Biomaterial device, a hybrid composite mesh. METHODS: This retrospective case review analyzed device/procedure endpoints beyond 1 year in patients treated for inguinal hernia repair with the device. Three objectives were evaluated: procedural endpoint-incidence through 30 days of surgical site infection, surgical site occurrence (SSO), ileus, readmission, reoperation, and death; device endpoint-serious device incidence of mesh erosion, infection, excision/removal, exposure, migration, shrinkage, device-related bowel obstruction and fistula, and hernia recurrence through 12 months; and patient-reported outcomes of the bulge, physical symptoms, and pain. RESULTS: A total of 157 patients (mean age: 67±13 y) with 201 inguinal hernias (mean size: 5.1±5 cm 2 ) were included. Laparoscopic approach and bridging repair were performed in 99.4% of patients. All device location was preperitoneal. No procedure-related adverse events within 30 days were reported. No surgical site infection or SSO events or device-related hernia recurrence occurred through 12 months. Procedure-related serious adverse events occurred in 6 patients; 5 recurrent inguinal hernias (at 1 and 2 y) and 1 scrotal hematoma (at 6 mo). Through 24 months, no SSO events requiring procedural intervention occurred. Through 50 months, 6 (2.98%) patients had confirmed hernia recurrence and 4 (1.99%) patients had hernia reoperation. The patient-reported outcome for pain was reported by 7.9% (10/126) of patients who completed the questionnaire. CONCLUSIONS: In this study, inguinal hernia repair with the hybrid composite mesh was successful in most patients and the rate of recurrence was low, further supporting the long-term safety and device performance.

Evaluation of long-term performance of an intraperitoneal biomaterial in the treatment of ventral hernias.

BACKGROUND: One-year device safety and clinical outcomes of ventral hernia repair with the GORE® SYNECOR Intraperitoneal Biomaterial, a hybrid composite mesh was evaluated. METHODS: This retrospective, multicenter, case review analyzed device/procedure endpoints and patient-reported outcomes in patients treated for hernia repair ≥ 1 year from study enrollment. RESULTS: Included were 459 patients (with 469 ventral hernias) with a mean age of 58 ± 15 years; 77.1% met Ventral Hernia Working Group 2 (VHWG2) classification. Mean hernia size was 18.9 cm2 and 57.3% of hernias were incisional. Laparoscopic or robotic approach was utilized in 95.4% of patients. Mesh location was intraperitoneal for 75.6% and bridging repair was performed in 57.3%. Procedure-related adverse events within 30-days occurred in 5.0% of patients and included surgical site infection (SSI), surgical site occurrence (SSO), ileus, readmission, and re-operation. Procedure-related SSI or SSO events were 3.8% through 12 months. SSO events requiring procedural intervention (SSOPI) were 2.6% through 24 months. Four patients (0.9%) had confirmed hernia recurrence through the study (the mean follow-up was 32-months, range 14-53 months). Subgroup comparisons were conducted for all type recurrence; only diabetes was found to be statistically significant (p = .0506). CONCLUSION: In this analysis, ventral hernia repair with hybrid, composite mesh results in successful outcomes in most patients. This study represents a heterogeneous patient population undergoing repair using various approaches, mesh fixation, and mesh placement locations. These data appear to confirm long-term acceptable safety and device performance with a low rate of recurrence in a predominantly VHWG2 population.