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.

A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch: interim results of the PANACEA study.

PURPOSE: This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]). PATIENTS AND METHODS: A single-arm, multicenter prospective study of 126 patients undergoing open ventral hernia repair with the PCO-VP was performed. Patient outcomes were assessed at discharge and at 10 days, 1, 6, 12, and 24 months postoperative. RESULTS: All patients had hernioplasty for umbilical (n = 110, 87.3%) or epigastric hernia (n = 16, 12.7%). Mean hernia diameter was 1.8 ± 0.8 cm. Mean operative time was 36.2 ±15.6 minutes, with a mean mesh positioning time of 8.1 ± 3.4 minutes. Surgeons reported satisfaction with mesh ease of use in 95% of surgeries. The cumulative hernia recurrence rate at 1 year was 2.8% (3/106). Numeric Rating Scale (NRS) pain scores showed improvement from 2.1 ± 2.0 at preoperative baseline to 0.5 ± 0.7 at 1 month postoperative (P < 0.001), and this low pain level was maintained at 12 months postsurgery (P < 0.001). The mean global Carolina's Comfort Scale® (CCS) score improved postoperatively from 3.8 ± 6.2 at 1 month to 1.6 ± 3.5 at 6 months (P < 0.001). One patient was unsatisfied with the procedure. CONCLUSION: This 1-year interim analysis using PCO-VP for primary umbilical and epigastric defects shows promising results in terms of mesh ease of use, postoperative pain, and patient satisfaction. Recurrence rate is low, but, as laparoscopic evaluation shows a need for patch repositioning in some cases, an accurate surgical technique remains of utmost importance.

Clinical and Patient-Reported Outcomes after Absorbable Strap Fixation for Ventral Hernia Repair.

INTRODUCTION: Various mesh fixation methods are employed by surgeons during ventral hernia repair. These may include tacks, straps, sutures, glue, or a combination of methods. One of these choices is an absorbable fixation device, Securestrap® (Ethicon Inc., Somerville, New Jersey), consisting of an absorbable copolymer barbed U-shaped strap with a spring-loaded deployment system. MATERIALS AND METHODS: The International Hernia Mesh Registry is a prospective multi-center registry, designed to collect longitudinal data on hernia repair methods, products, and outcomes. Patients complete the Carolinas Comfort Scale™ (CCS) (The Charlotte-Mecklenburg Hospital Authority, Charlotte, North Carolina) pre-operatively, and at one month, six months, and 12 months post-operatively. Symptomatic patients defined as responding >1 to any CCS™ question. Statistical comparison of symptom frequency was made with the McNemar test and Kaplan Meier methods to determine the recurrence rate up to 365 days. RESULTS: Patients were enrolled at 16 centers. Data was available on 100 of the 203 patients at six months and on 119 patients at 12 months. Demographics: mean age of 52.7 (13.2 standard deviation[ SD]); mean body mass index (BMI) of 33.2 (7.5 SD) kg/m2; 64.3% having a BMI over 30kg/m2; male patients 47.4%; 16.7% for recurrent hernias. Mesh fixation with straps alone in 48.3% of cases or straps and sutures in 51.7% of cases. Percentage of patients with symptomatic pain decreased slightly from baseline to one month (70.0 vs. 60.6, p=0.0782) and significantly from one month to six months (60.6% symptomatic vs. 23.2%; p=0.0004). From six months to twelve months, the change in percentage of symptomatic patients was not significant (23.2% vs. 28.7%; p=0.8084). Similar results were observed with symptomatic CCS™ movement limitations. Overall recurrence rate at 12 months was 4.72% (2.39%-9.22%). CONCLUSION: Mesh fixation with straps with or without additional sutures is associated with significant improvements in patient-reported pain and movement limitation from baseline to six months post-operative.

Synthetic bioabsorbable hernia plug for plug and patch inguinal herniorrhaphy implantation technique.

New products have led the way in advancements of inguinal hernia repair. None is more impressive than the evolution of the plug patch. In 1968 Irving Lichtenstein introduced the first Marlex mesh plug repair when he rolled a piece of flat polypropylene into the shape of a cigarette to fill a femoral defect. He later expanded his use of the "cigarette plug" to repair recurrent hernias. Today, a wide array of mesh plugs, ranging from nonabsorbable to partially and fully absorbable biomaterials, are available from manufacturers. While some surgeons have used the plug alone for repair, most believe the overlay patch is of greater importance for the durability of the repair. With larger overlays, it is questionable whether a plug should be a permanent, nonabsorbable material. Heavyweight plugs have been reported to erode, migrate, or cause vocational-limiting inguinodynia. Using a fully absorbable plug in inguinal hernia repair minimizes the risk of these complications. This article focuses on the technical refinements associated with using the completely absorbable GORE BIO-A Hernia Plug (W.L. Gore & Associates, Inc, Elkton, MD) in combination with macroporous polypropylene or polyester. Additionally, this paper describes the use of GORE BIO-A Tissue Reinforcement as an alternative for repair following removal of prior polypropylene plug-patch herniorrhaphy that cause inguinodynia.