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.

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.

Management of Synthetic Mesh Infection With Open Resection and Laparoscopic Ventral Hernia Repair Using Biosynthetic Prosthetic Material.

Ventral hernia repair (VHR) is a common surgical operation with the prevailing complication of hernia recurrence. The development of diverse mesh materials has led to a lower hernia recurrence rate but poses concern for mesh infection. Featured is the case study of a patient who underwent laparoscopic recurrent VHR with utilization of biosynthetic mesh and removal of prior permanent synthetic mesh. During the post-operative course, the patient developed a seroma, cellulitis, and wound dehiscence. Despite these complications, the biosynthetic mesh was salvaged using conservative measures. The patient has been followed over the course of three years without hernia recurrence or other complications to date.

A paradigm shift in the approach to families for organ donation: honoring patients' wishes versus request for permission in patients with Department of Motor Vehicles donor designations.

BACKGROUND: Recently, we reported a donation consent rate of only 80% for patients designated as donors with the Department of Motor Vehicles (DMV), which equaled missed opportunities for 17 potential transplant recipients during 3 months. We undertook the current study to increase our donation consent rate in patients with prior DMV donor designations. METHODS: In October 2006, we modified our approach for donor consent by asking to honor the patient's wishes rather than asking for permission. The consent rates from January through September 2006 (preinitiative) were compared with rates from October through April 2007 (postinitiative). RESULTS: During the preinitiative period, 66 approaches were made; 24 patients were registered as donors with the DMV (36%). In total, consent for donation was obtained from 43 families (65%). Only 20 of 24 (83%) families of patients with prior DMV designation donated, and 23 of 42 families of patients with no DMV designation donated (55%). One hundred forty-one organs were successfully transplanted (average 3.3 organs per procurement). Of 71 postinitiative approaches, 42 families donated (59%) and 125 organs were transplanted (average 3.0 organs per procurement). Consent for donation was obtained in 23 of 52 non-DMV-designated donors (44%). The families of all 19 DMV-designated donors consented for donation (100%). CONCLUSION: Modifying our approach to consent for organ donation to honor the patient's wishes based on DMV donor designation rather than ask for permission increased organ procurement in this population to 100%. However, further efforts are needed at the state and national levels regarding the recognition of first-person consent for organ donation.