Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias

Abstract

IMPORTANCE Biologic mesh is widely used for reinforcing contaminated ventral hernia repairs; however, it is expensive and has been associated with high rates of long-term hernia recurrence. Synthetic mesh is a lower-cost alternative but its efficacy has not been rigorously studied in individuals with contaminated hernias. OBJECTIVE To determine whether synthetic mesh results in superior reduction in risk of hernia recurrence compared with biologic mesh during the single-stage repair of clean-contaminated and contaminated ventral hernias. DESIGN, SETTING, AND PARTICIPANTSThis multicenter, single-blinded randomized clinical trial was conducted from December 2012 to April 2019 with a follow-up duration of 2 years. The trial was completed at 5 academic medical centers in the US with specialized units for abdominal wall reconstruction. A total of 253 adult patients with clean-contaminated or contaminated ventral hernias were enrolled in this trial. Follow-up was completed in April 2021.INTERVENTIONS Retromuscular synthetic or biologic mesh at the time of fascial closure. MAIN OUTCOMES AND MEASURESThe primary outcome was the superiority of synthetic mesh vs biologic mesh at reducing risk of hernia recurrence at 2 years based on intent-to-treat analysis. Secondary outcomes included mesh safety, defined as the rate of surgical site occurrence requiring a procedural intervention, and 30-day hospital direct costs and prosthetic costs.RESULTS A total of 253 patients (median [IQR] age, 64 [55-70] years; 117 [46%] male) were randomized (126 to synthetic mesh and 127 to biologic mesh) and the follow-up rate was 92% at 2 years. Compared with biologic mesh, synthetic mesh significantly reduced the risk of hernia recurrence (hazard ratio, 0.31; 95% CI, 0.23-0.42; P < .001). The overall intent-to-treat hernia recurrence risk at 2 years was 13% (33 of 253 patients). Recurrence risk with biologic mesh was 20.5% (26 of 127 patients) and with synthetic mesh was 5.6% (7 of 126 patients), with an absolute risk reduction of 14.9% with the use of synthetic mesh (95% CI, −23.8% to −6.1%; P = .001). There was no significant difference in overall 2-year risk of surgical site occurrence requiring a procedural intervention between the groups (odds ratio, 1.22; 95% CI, 0.60-2.44; P = .58). Median (IQR) 30-day hospital direct costs were significantly greater in the biologic group vs the synthetic group

Outcomes of Biosynthetic and Synthetic Mesh in Ventral Hernia Repair

“…A randomized trial of 253 patients showed that synthetic mesh significantly reduced the risk of hernia recurrence compared with biologic mesh in patients undergoing repair of clean-contaminated and contaminated ventral hernias. 1 However, another study of 725 patients who underwent abdominal wall reconstruction with porcine-or bovine-derived biologic mesh showed durable long-term outcomes with low recurrence rates that were comparable to those observed using synthetic mesh. 17 Recently, hybrid mesh devices were developed with the aim of addressing the limitations of purely synthetic and biologic meshes.…”

“…11,12 The most commonly reported drawbacks of biologic meshes relate to their high cost and elevated risk of hernia recurrence. 1 Since both biologic and synthetic substrate materials have a unique set of advantages and drawbacks respectively, hybrid meshes were recently developed, such as biologic decellularized ovine rumen reinforced with synthetic interwoven propylene [reinforced biosynthetic ovine rumen (RBOR)]. This reinforced tissue matrix attempts to combine the benefits of biologic material and polymer reinforcement to provide a more physiologic hernia repair when compared with mesh products composed of just synthetic polymer materials.…”

Clinical outcomes of open abdominal wall reconstruction with the use of a polypropylene reinforced tissue matrix: a multicenter retrospective study

“…Their purchase costs are, however, extremely high and recurrence rates are disappointing [ 7 , 8 ]. This was confirmed by a recently published randomized controlled trial that compared use of bovine biologic mesh with synthetic mesh in retrorectus position in clean-contaminated and contaminated hernia repair, demonstrating a significantly higher hernia recurrence rate for bovine biologic mesh at 2 years after surgery [ 9 ]. Biosynthetic meshes are composed of different resorbable polymers.…”

24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix

“…Ventral hernias occur in 1.7% of the US population, and the prevalence increases to 4% in patients over 45 years of age [ 1 , 2 ]. Ventral hernia repair techniques aim to reduce complications and recurrence rates, which are reported between 5.6 and 40% [ [2] , [3] ] The first prosthetics to reinforce hernia repairs were synthetic polymer meshes which are still the most common prosthetic on the market today [ 4 ]. In addition to traditional permanent synthetic meshes, resorbable synthetic meshes, biologic-based matrices, and reinforced biologic matrices are now also available.…”

“…Mesh or matrix type may influence these complication rates. There is some evidence that permanent synthetic meshes are more prone to complications like infections, and alternatively that pure biologics may not provide enough long-term strength leading to recurrence [ 3 , [10] , [11] , [12] , [13] , [14] , [15] ]. Reinforced biologics offer an alternative, designed with a biologic base to facilitate tissue remodeling and a low synthetic polymer footprint for reinforcement.…”