Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study

Amato, Giuseppe; Agrusa, Antonino; Puleio, Roberto; Calò, Pietro Giorgio; Goetze, Thorsten Oliver

doi:10.1016/j.ijsu.2020.02.046

Cited by 13 publications

(15 citation statements)

References 23 publications

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“…The outcomes of the present study are fully in line with previous investigations on the subject. [19][20][21][22] Ultimately, the described histological evidence likely proves that the biological response to the synthetic material of hernia implants differs in relationship to its structural arrangement. Briefly, static and passive alloplastic flat meshes always generate a typical foreign body response, but if the same synthetic material is arranged in a 3D dynamic responsive design, the biologic response turns into a completely different final product.…”

Section: Discussionmentioning

confidence: 82%

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

et al. 2021

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Section: Discussionmentioning

confidence: 82%

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

et al. 2021

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“…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.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

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confidence: 99%

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

Amato

Agrusa

Calò

et al. 2022

Sci Rep

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Laparoscopic TAPP/TEP approaches are well-established options for the cure of inguinal hernias. As in the open approach, mesh fixation and poor-quality biologic response represent controversial questions and are a source of concerns. Furthermore, hernia defect patency represents another problem which seems not well acknowledged among surgeons. These problems are considered the cause of frequent intra and postoperative complications. To overcome these concerns, recently a different concept of cure has emerged. Based on a newly developed dynamic responsive 3D scaffold named ProFlor, a permanent hernia defect obliteration has been finalized. Following its inherent centrifugal expansion due to its dynamic responsivity, this hernia device is positioned fixation free within the defect and induces a probiotic biological response allowing for the re-establishment of the degenerated inguinal barrier. A laparoscopic approach with the 3D scaffold has been tested on 71 patients to demonstrate its effectiveness in reducing intra and postoperative complications. The operated patients presented with bilateral and/or recurrent inguinal hernia. Overall, 122 hernia defects were obliterated with 119 dynamic responsive scaffolds. The procedures were carried out from January 2018 to January 2022 with a defined protocol and detailed procedural steps. The laparoscopic technique with the 3D hernia scaffold allowed for fixation free placement, permanent defect obliteration and dynamically induced regenerative effects. The technique proved effective in reducing intra and postoperative complications. In particular, early postoperative pain and discomfort significantly decreased. No chronic pain and no recurrences were reported during follow up. The results achieved with the described laparoscopic technique seem to embody an innovative concept for inguinal hernia repair. Fixation free, dynamic responsive, permanent defect obliteration, histologically proven regenerative effects are the distinctive features of this 3D scaffold. It seems to embody a more physiological and pathogenetically coherent concept of cure, thus improving treatment results of this widespread disease.

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“…Its dynamic responsivity consents a fully different biological response, allowing the incorporation into the 3D device of well-hydrated connective tissue as well as new arteries, veins, nerves, and muscles, thus re-establishing the integrity of the herniated inguinal barrier [ 17 , 18 , 19 ]. Additional evidence of the dynamically induced regenerative features of ProFlor in patients has been confirmed by signal intensity assessment in MR imaging [ 20 ]. To further explain the regenerative features, a recent investigation has documented the involvement of vascular growth factors in modulating the probiotic response of these tissue components [ 21 ].…”

Section: Introductionmentioning

confidence: 92%

Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin

Amato

Rodolico

Puleio³

et al. 2022

JFB

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Background: Postoperative chronic pain caused by fixation and/or fibrotic incorporation of hernia meshes are the main concerns in inguinal herniorrhaphy. As inguinal hernia is a degenerative disease, logically the treatment should aim at stopping degeneration and activating regeneration. Unfortunately, in conventional prosthetic herniorrhaphy no relationship exists between pathogenesis and treatment. To overcome these incongruences, a 3D dynamic responsive multilamellar scaffold has been developed for fixation-free inguinal hernia repair. Made of polypropylene like conventional flat meshes, the dynamic behavior of the scaffold allows for the regeneration of all typical inguinal components: connective tissue, vessels, nerves, and myocytes. This investigation aims to demonstrate that, moving in tune with the groin, the 3D scaffold attracts myogenic growth factors activating the development of mature myocytes and, thus, re-establishing the herniated inguinal barrier. Methods: Biopsy samples excised from the 3D scaffold at different postoperative stages were stained with H&E and Azan–Mallory; immunohistochemistry for NGF and NGFR p75 was performed to verify the degree of involvement of muscular growth factors in the neomyogenesis. Results: Histological evidence of progressive muscle development and immunohistochemical proof of NFG and NFGRp75 contribution in neomyogenesis within the 3D scaffold was documented and statistically validated. Conclusion: The investigation appears to confirm that a 3D polypropylene scaffold designed to confer dynamic responsivity, unlike the fibrotic scar plate of static meshes, attracts myogenic growth factors turning the biological response into tissue regeneration. Newly developed muscles allow the scaffold to restore the integrity of the inguinal barrier.

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Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study

Cited by 13 publications

References 23 publications

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

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

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

Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin

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