Development and Implantation of 3D Anatomically Tailored Polypropylene Mesh for Laparoscopic Inguinal Hernia Repair Designed on the Basis of CT Images (the ILAM Study)

Abstract

Objective The aim of the ILAM (Individualized Laparoscopic Anatomical Mesh) study was to create and implant a fully individualized mesh based on CT scans, taking into account the published body of knowledge about the material and mechanical behavior of the implant for laparoscopic inguinal hernia repair. Summary Background Data The team creating and conducting this study consisted of surgeons and engineers. A specific project was made and divided into 4 phases. Methods The process of development and implantation was divided into 4 milestones: CT scans and modeling based on predefined subgroups, mesh manufacture, certification and clinical evaluation. Results The result of the study was the first individually designed hernia mesh to have been implanted in a human subject. After 12 months of follow-up, no recurrences or other complications were reported. Conclusions The new mesh provides a better anatomic fit to the patients’ inguinal region geometry. Mechanical stability is ensured by the multiple contact points between the implant and the tissues, which generate friction forces. Together with the possibility of shape design (proper overlap), the authors believe that there is no need for mesh fixation. If so, the use of such design meshes can change the guidelines in laparoendoscopic hernia repair in the future.