Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair

Abstract

Despite undisputed improvements, prosthetics hernia repair continues to be affected by unacceptable rates of complications. Postoperative adverse events such as discomfort and chronic pain represent a subject of increasing concern among the surgical community. Poor quality biologic response, stiff scar plates, and mesh shrinkage, a typical effect of conventional static meshes and plugs, are all indicated as the main reasons for many of the complications related to inguinal hernia repair. Even the conventional concept of treatment based upon a supposed reinforcement of the groin consequent to the fibrotic incorporation of meshes, would appear to be inadequate in the light of the latest scientific evidence concerning the degenerative genesis of inguinal hernia. Following these recent studies, a newly conceived 3D dynamically responsive implant has been developed. It concerns a multilamellar shaped prosthesis, intended to be placed fixation‐free to obliterate the hernia defect. This 3D structure has already demonstrated to induce a probiotic biological response with development of viable tissue, instead of the fibrotic plaque typical of conventional meshes. Newly formed elastic fibers, neo‐angiogenesis, and neo‐nerve genesis in a surrounding of well perfused connective tissue are the typical elements of the biologic response in the newly conceived implant. In addition to these elements, muscle fibers have also been detected in the implant structure. The aim of this research was to determine the ingrowth of muscle fibers in the implant by assessing the quantity and quality of muscle development in the short, medium, and long term post‐implantation. Histological examination of biopsy samples excised from patients who underwent dynamic hernia repair with the 3D dynamic implant showed the presence of muscular elements that in the short term could be described as multiple spots of myocytes in the early stage of development. Over the mid‐ to long‐term, muscle fibers increased in number and level of maturation, assuming the typical aspect of standard muscle bundles in the final phase. Effectively, long term, myocytes histologically evidenced the distinctive arrangement of the muscle structure, with nuclei and striated elements being similar to normal muscle elements. The development of this highly specialized connective tissue in the 3D dynamic responsive implant seems to document the finalization of an enhanced biologic response leading to the ingrowth of typical tissue components of the groin. Reverting degenerative pathogenesis into effective regeneration recognized in the newly conceived 3D prosthesis would appear to represent a significant concept change in the repair of inguinal hernias.

Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor

“…Made of the same polypropylene material as conventional meshes and owing an intrinsic centrifugal expansion, this inguinal hernia device, named ProFlor, is intended to be inserted fixation free into the defect thus achieving permanent obliteration. Recent literature has demonstrated that the dynamic compliance of this 3D hernia scaffold allows for a totally different biological response achieving development of newly formed connective tissue, vessels, nerves and muscle bundles, to full maturation [20][21][22][23] . The pathogenetically and physiologically coherent therapy model embodied by this 3D hernia device is diametrically opposed to the concept of reinforcing the groin with fibrotic mesh incorporation, which has been widespread for more than half a century.…”

“…These adverse phenomena do not occur in ProFlor that, positioned fixation free to permanently obliterate the defect, moves in tune with the inguinal backwall. Lastly, ProFlor does not shrink because its intrinsic dynamic responsivity induces a unique biologic response with development of newly formed vessels, nerves and muscle fibers characterizing this 3D device as a regenerative scaffold [20][21][22][23][24] . These proprietary features of ProFlor embody a substantial difference to patch and plug technique.…”

“…This 3D hernia device is made of polypropylene material like conventional hernia prosthetics but owns inherent springiness, is positioned fixation free and, moving together with the groin, induces a probiotic biologic response. Modulated by specific growth factors, the development of newly formed connective tissue, vessels, nerves and muscles within the 3D scaffold has been documented in a series of scientific studies [19][20][21][22][23][24] . These proprietary regenerative effects, likely result of its intrinsic dynamic responsivity, allow the categorization of this new inguinal hernia device not as a conventional implant but rather a regenerative scaffold.…”

Artificial Organs 2018: A Year in Review

“…Giuseppe Amato et al of the University of Cagliari, Cagliari, Italy, reported on a 3D dynamically responsive implant for inguinal hernia repair. It is a multilamellar shaped prosthesis, intended to be placed fixation‐free.…”

Enhanced angiogenesis in the 3D dynamic responsive implant for inguinal hernia repair ProFlor

“…20 The ingrowth of viable connective tissue, newly formed muscles, and mature nerves in the 3D device has already been histologically demonstrated in humans. 21,22 However, to support and maintain the function of these newly ingrown and highly specialized tissue components the presence of specific growth factors promoting a contextual development until full maturation of a suitable vascular network is crucial. The scope of the present study is to demonstrate this specific feature of the 3D hernia device.…”