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Effects of Ethylene oxide resterilisation and In- Vitro degradation on mechanical properties of partially absorbable composite hernia meshes
Abstract
Background: Prosthetic mesh repair for abdominal wall hernias is widely used because of its technical simplicity and low hernia recurrence rates. The most commonly used material is pure polypropylene mesh, however newer composite materials are recommended by some centers because of their advantages. However, these meshes are more expensive than pure polypropylene meshes. Resterilisation of a pure polypropylene mesh has been shown to be quite safe, and many centers prefer slicing a large mesh into smaller pieces that suitable for hernia type or defect size. Nevertheless there is no data about the safety after resterilisation of the composite meshes.
Objective: To search the effects of resterilisation and In vitro degradation in phosphate buffered saline solution on the physical structure and the mechanical properties of partially absorbable lightweigth meshes.
Design: Laboratory-based research.
Subjects: Two composite meshes were used in the study: One mesh is consisted of monofilament polypropylene and monofilament polyglecaprone -a copolymer of glycolide and epsilon (ε)-caprolactone- (Ultrapro®, 28 g/m2, Ethicon, Hamburg, Germany), and the other one consisted of multifilament polypropylene and multifilament polyglactine (Vypro II®, 30 g/m2, Ethicon, Hamburg, Germany). Two large meshes were cut into rectangular specimens sized 50x20 mm for mechanical testing and 20x20 mm for In vitro degradation experiments. Meshes were divided into control group with no resterilisation and gas resterilisation. Ethylene oxide gas sterilisation was performed at 55°C for 4.5 hours. In vitro degradation in 0.01 M phosphate buffered saline (PBS, pH 7.4) solution at 37 ± 1°C for 8 weeks was applied to one subgroup in each mesh group. Tensiometric measurements and scanning electron microscopyic evaluations were completed for control and resterilisation specimens.
Results: Regardless of resterilisation, when meshes were exposed to In vitro degradation, all mechanical parameters decreased significantly. Highest reduction in mechanical properties was observed for Ultrapro due to the degradation of absorbable polyglecaprone and polyglactin parts of these meshes. It was observed that resterilisation by ethylene oxide did not have significant difference on the degradation characteristics and almost similar physical structures were observed for resterilised and non-resterilised meshes. For Vypro II meshes, no significant mechanical difference was observed between resterilised and non-resterilised meshes after degradation while resterilised Ultrapro meshes exhibited stronger characteristics than non-resterilised counterparts, after degradation.
Objective: To search the effects of resterilisation and In vitro degradation in phosphate buffered saline solution on the physical structure and the mechanical properties of partially absorbable lightweigth meshes.
Design: Laboratory-based research.
Subjects: Two composite meshes were used in the study: One mesh is consisted of monofilament polypropylene and monofilament polyglecaprone -a copolymer of glycolide and epsilon (ε)-caprolactone- (Ultrapro®, 28 g/m2, Ethicon, Hamburg, Germany), and the other one consisted of multifilament polypropylene and multifilament polyglactine (Vypro II®, 30 g/m2, Ethicon, Hamburg, Germany). Two large meshes were cut into rectangular specimens sized 50x20 mm for mechanical testing and 20x20 mm for In vitro degradation experiments. Meshes were divided into control group with no resterilisation and gas resterilisation. Ethylene oxide gas sterilisation was performed at 55°C for 4.5 hours. In vitro degradation in 0.01 M phosphate buffered saline (PBS, pH 7.4) solution at 37 ± 1°C for 8 weeks was applied to one subgroup in each mesh group. Tensiometric measurements and scanning electron microscopyic evaluations were completed for control and resterilisation specimens.
Results: Regardless of resterilisation, when meshes were exposed to In vitro degradation, all mechanical parameters decreased significantly. Highest reduction in mechanical properties was observed for Ultrapro due to the degradation of absorbable polyglecaprone and polyglactin parts of these meshes. It was observed that resterilisation by ethylene oxide did not have significant difference on the degradation characteristics and almost similar physical structures were observed for resterilised and non-resterilised meshes. For Vypro II meshes, no significant mechanical difference was observed between resterilised and non-resterilised meshes after degradation while resterilised Ultrapro meshes exhibited stronger characteristics than non-resterilised counterparts, after degradation.
