A New Hernia Mesh Precisely Engineered to Prevent Hernia Recurrence
Mohamed M. Ibrahim, Richard R. Glisson, Ken Gall, Howard Levinson.
Duke University Medical Center, Durham, NC, USA.
Hernia repair recurrence-rate is 20% due to failure at the suture, mesh, tissue anchor-interface. We invented knitted polypropylene hernia-mesh with suture-like integrated mesh-extensions that are 15X the surface area of #0-suture and anchor the mesh akin-to-suture.
Polypropylene T-line mesh was fabricated with extensions 0.5-1cm-wide, 50cm-long, and spaced 2cm-apart (Table 1). Tongue-tear resistance, ball-burst, suture-retention, tensile-strength-strain, and extension-tensile-strength testing were compared to control-polypropylene-mesh. Physicomechanical-testing performed post-sterilization. Test and control-mesh were implanted in swine ventral-hernia-model and harvested 1-day post-operatively for mechanical-testing in the peri-operative period when most meshes are at greatest-risk of failure.
In-vitro mechanical performance demonstrated T-line mesh outperformed control mesh in all tested parameters (Table 2). Mechanical analysis of swine-specimens demonstrated mean-peak-load to failure for T-line mesh was 134.5N(SD +/- 54.5 N), compared to 49.0N for control-reference mesh(SD +/- 13.4 N). T-line mesh failure occurred by extensions tearing through-tissue. Control-mesh failed 60% of time by one suture tearing through-tissue and second suture tearing through-mesh, remaining 40% of failures was from both sutures tearing through-mesh. T-line mesh significantly outperformed control-mesh and averaged 275% stronger on peak-load-performance.
T-line mesh outperforms control-predicate mesh in all mechanical tests. It can be sterilized without undue effects. T-line mesh is 275%-stronger than control-mesh. Future-efforts are directed towards determining packaging-conformations, and completing tissue-toxicity testing per FDA-standards for 510(k)-clearance. T-line mesh has potential to dramatically reduce hernia-occurrence and recurrence.
Back to 2018 Program and Abstracts