Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: Long-term biocompatibility in over 1, 300 mesh fixations

Abstract

Introduction In adult patients, most inguinal hernias are treated by implanting a prosthetic mesh. To prevent mesh dislocation and thus recurrence, different types of fixation have been proposed. In contrast to penetrating fixation known to cause acute chronic pain, adhesive fixation is becoming increasingly popular as it reduces markedly the risk of injury and chronic pain. Apart from the biological sealants (e.g., fibrin glue), surgical adhesives include a group of synthetic glues and genetically engineered protein glues. For example, cyanoacrylate is used in various medical and veterinary indications due to its fast action, excellent bonding strength and low price. Objective The main objective of this paper was to communicate positive results obtained using n-butyl-cyanoacrylate glue to fix prosthetic meshes in over 1, 300 TAPP repairs of primary and recurrent inguinal hernias. The secondary objective was to highlight the rationale (e.g., safety) for using non-fibrin based glue in this type of procedure. Method We present the in vitro and in vivo data necessary for the approval of n-butyl cyanoacrylate Histoacryl® glue. We use an equivalent glue, Glubran-2®, to fix prosthetic meshes in 1, 336 laparoscopic TAPP repairs. Results Standardized tests to detect sensitization, irritation, genotoxicity or systemic toxicity demonstrated the safety and biocompatibility of Histoacryl®, which met all requirements, including those of ISO 10993. Histological long-term studies in rabbits yielded results comparable to routine suture fixations, with full integration of the mesh into the abdominal wall. The clinical results showed the following advantages: fast application of the glue, reduced postoperative pain, 0.0% infection rate, continuously low recurrence rate and shorter hospital stay. No adverse effects and no complaints were recorded. Conclusion The experimental and clinical data demonstrate the safe use and the excellent cost-benefit ratio of n-butyl cyanoacrylate compared with other techniques of mesh fixation. © 2011 Springer-Verlag.