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

Abstract

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.

Robotic Ventral Transabdominal Preperitoneal Repair of Uncomplicated Spigelian Hernia

“…Appropriate mesh selection is an essential step of hernia repairs that can affect the rate of hernia recurrence and the rate of infections, hematomas, and seromas [15]. Therefore, surgeons must understand the advantages and disadvantages that different mesh materials may present.…”

“…They can include mesh infections, injuries to the abdominal viscera, seromas, hematomas, surgical site infections, and hernia reoccurrence [ 1 , 11 ]. Appropriate mesh selection is an essential step of hernia repairs that can affect the rate of hernia recurrence and the rate of infections, hematomas, and seromas [ 15 ]. Therefore, surgeons must understand the advantages and disadvantages that different mesh materials may present.…”

“…Then a synthetic absorbable preperitoneal mesh was used to close the left-sided Spigelian hernia. The GORE® SYNECOR hybrid composite mesh consists of a bioabsorbable 3D web scaffold layer, a PTFE layer, and a nonporous PGA:TMC film layer [ 15 ]. The bioabsorbable 3D web scaffold layer allows for tissue ingrowth while reducing the risk of infection in the PTFE layer.…”

“…The bioabsorbable 3D web scaffold layer allows for tissue ingrowth while reducing the risk of infection in the PTFE layer. The PTFE layer offers the benefit of high durability, and the nonporous PGA:TMC film layer reduces the risk of adhesions when a mesh is placed intraperitoneally [ 15 , 16 ]. These mesh features help ensure greater quality of life for a patient postoperatively.…”