Physiologic Cyclical Load on Inguinal Hernia Scaffold ProFlor Turns Biological Response into Tissue Regeneration

SIMPLE SUMMARY: A 3D scaffold developed for inguinal hernia repair has been designed to overcome the multiple incongruences of currently used flat meshes. Conventional hernia implants, positioned in a high-motile environment, are static, need fixation and, instead of healing the degenerative source of hernia disease, produce a granuloma of low-quality scar tissue. On the contrary, the new 3D scaffold, endowed with centrifugal expansion, avoids fixation, reacts dynamically to the motile impulses of the groin and attracts tissue growth factors, promoting the development of newly formed tissue structures. Despite being made of the same polypropylene material as conventional flat meshes, the dynamic behavior of the 3D scaffold that moves in tune with inguinal movements proves that modifying the design and kinetic attitude turns the biological response into tissue regeneration. ABSTRACT: Surgical repair of groin protrusions is one of the most frequently performed procedures. Currently, open or laparoscopic repair of inguinal hernias with flat meshes deployed over the hernial defect is considered the gold standard. However, fixation of the implant, poor quality biologic response to meshes and defective management of the defect represent sources of continuous debates. To overcome these issues, a different treatment concept has recently been proposed. It is based on a 3D scaffold named ProFlor, a flower shaped multilamellar device compressible on all planes. This 3D device is introduced into the hernial opening and, thanks to its inherent centrifugal expansion, permanently obliterates the defect in fixation-free fashion. While being made of the same polypropylene material as conventional hernia implants, the 3D design of ProFlor confers a proprietary dynamic responsivity, which unlike the foreign body reaction of flat/static meshes, promotes a true regenerative response. A long series of scientific evidence confirms that, moving in compliance with the physiologic cyclical load of the groin, ProFlor attracts tissue growth factors inducing the development of newly formed muscular, vascular and nervous structures, thus re-establishing the inguinal barrier formerly wasted by hernia disease. The development up to complete maturation of these highly specialized tissue elements was followed thanks to biopsies excised from ProFlor from the short-term up to years post implantation. Immunohistochemistry made it possible to document the concurrence of specific growth factors in the regenerative phenomena. The results achieved with ProFlor likely demonstrate that modifying the two-dimensional design of hernia meshes into a 3D outline and arranging the device to respond to kinetic stresses turns a conventional regressive foreign body response into advanced probiotic tissue regeneration.