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

Эффективность и безопасность фиксации сетчатого имплантата при лапароскопической пластике паховой грыжи с использованием н-бутилцианоакрилата: долгосрочная биосовместимость при более чем 1300 фиксациях сетчатого имплантата
Jan F. Kukleta, Christiane Freytag, Michelle Weber
2011-10-20

inguinal hernia repairlaparoscopic TAPP repairlong-term biocompatibilitymesh fixationn-butyl cyanoacrylate
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.
1
Clinical use enabled fast glue application, reduced postoperative pain, a 0.0% infection rate, continuously low recurrence rates, and shorter hospital stays.
2
Glubran-2 was used for mesh fixation in 1,336 laparoscopic TAPP repairs of primary and recurrent inguinal hernias.
3
Long-term rabbit histology showed mesh integration into the abdominal wall comparable to routine suture fixation.
4
No adverse effects or patient complaints were recorded, supporting a favorable cost-benefit profile for non-fibrin adhesive mesh fixation.
5
n-Butyl cyanoacrylate demonstrated safety and biocompatibility in sensitization, irritation, genotoxicity, and systemic toxicity tests, satisfying ISO 10993 requirements.

Prosthetic meshes fixed with n-butyl cyanoacrylate in laparoscopic TAPP repair of primary and recurrent inguinal hernias

Long-term biocompatibility, safety, clinical effectiveness, and cost-benefit of adhesive mesh fixation

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2011-10-20
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Jan F. Kukleta
Christiane Freytag
Michelle Weber
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