Dynamic inguinal hernia repair with a 3d fixation-free and motion-compliant implant: a clinical study

Static solutions for highly motile structures such as the groin seem to represent a procedural incongruence. Another important issue in prosthetic hernia repair is related to the poor quality of tissue ingrowth within conventional flat meshes and plugs. These are all static, passive devices, and thus do not move in synchrony with the natural movements of the groin. In the literature there is a clear understanding of how conventional prostheses used for inguinal hernia repair are incorporated by rigid fibrotic tissue. The term "scar plate" well emphasizes this occurrence. The ingrowth of this kind of stiff fibrotic scar leads to mesh shrinkage and to the reduction of the mesh surface area. This is considered a significant cause of recurrence and discomfort. With this in mind, the need for a more physiologic procedure to further decrease complications and recurrences in inguinal hernia repair due to implant design seems obvious. This report shows how, by eliminating invasive fixation and improving the quality of tissue ingrowth within the implant, it is possible to reduce complications. To achieve these results, a new type of 3D dynamic (inherent recoil), self-retaining implant has been developed. This newly designed implant was previously implanted in the porcine model, showing excellent outcomes. Of note were the quality of tissue ingrowth and the near absence of shrinkage, even a long time after implantation. The present study describes the outcome of this device used in open inguinal hernia repair in 91 patients having direct and indirect inguinal hernia. In this patient cohort, evaluations were made for; operation length, intraoperative complications, late complications such as seroma, infection, chronic pain, and pain assessment through VAS score. Patient follow-up was made at 1 and 2 weeks, and 1, 3, 6, 12, and 36 months. Ultrasound scans were performed for the detection of any possible implant dislodgment, shrinkage, and implant incorporation. The results of this study demonstrate that by using a purposefully designed 30 geometric implant expulsion forces can be switched into gripping forces, avoiding the need for traumatic fixation. This eliminates the typical complications related to mesh fixation such as bleeding, hematoma, chronic pain, and tissue tearing, often resulting in mesh dislodgement and recurrence. This new 30 implant results in open hernia repair procedures being safer, faster, and easier.