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Mesh fixation using novel bio-adhesive coating compared to tack fixation for IPOM hernia repair: in vivo evaluation in a porcine model

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Abstract

Background

Mesh fixation in hernia repair is currently based on penetrating sutures or anchors, with proven early and late complications such as pain, adhesions, erosions, and anchor migration. In an attempt to reduce these complications, a bio-adhesive-based self-fixation system was developed. The purpose of this study was to assess the performance and safety of this novel self-adhesive mesh (LifeMesh™) by comparing it with standard tack fixation.

Methods

A full-thickness abdominal wall defect was created bilaterally in 24 pigs. The defects were measured 14 days later, and laparoscopic intraperitoneal onlay mesh (IPOM) repairs were performed. In each animal, both LifeMesh and a titanium tack-fixed control, either uncoated polypropylene mesh (PP) or composite mesh (Symbotex™), were used. After 28 and 90 days, we performed macroscopic evaluation and analyzed the fixation strength, shrinkage, adhesion scores, and histopathology in all samples.

Results

Measurements at both time points revealed that LifeMesh had fully conformed to the abdominal wall, and that its fixation strength was superior to that of the tack-fixated Symbotex and comparable to that of the tack-fixated PP. Shrinkage in all groups was similar. Adhesion scores with LifeMesh were lower than with PP and comparable with Symbotex at both time points. Histology demonstrated similar tissue responses in LifeMesh and Symbotex. Lack of necrosis, mineralization, or exuberant inflammatory reaction in all three groups pointed to their good progressive integration of the mesh to the abdominal wall. By 28 days the bio-adhesive layer in LifeMesh was substantially degraded, allowing a gradual tissue ingrowth that became the main fixation mode of this mesh to the abdominal wall.

Conclusions

The excellent incorporation of LifeMesh to the abdominal wall and its superior fixation strength, together with its low adhesion score, suggest that LifeMesh may become a preferred alternative for abdominal wall repair.

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Acknowledgments

The study was funded by LifeBond Ltd., Caesarea, Israel.

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Correspondence to Amir Ben Yehuda.

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The study was funded by LifeBond LTD, Caesarea, Israel. Dr. Ben Yehuda Amir is a medical advisor to LifeBond and reports personal fees from LifeBond, during the conduct of the study. Dr. Szold Amir is a medical advisor to LifeBond and reports personal fees from LifeBond, during the conduct of the study. Dr. Nyska Abraham has no conflicts of interest or financial ties to disclose.

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Ben Yehuda, A., Nyska, A. & Szold, A. Mesh fixation using novel bio-adhesive coating compared to tack fixation for IPOM hernia repair: in vivo evaluation in a porcine model. Surg Endosc 33, 2364–2375 (2019). https://doi.org/10.1007/s00464-019-06806-x

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