ProFlor – A Dynamic Regenerative Scaffold for the Treatment of Inguinal Hernias

Prof. Giuseppe Amato

ProFlor is currently the only device for the treatment of inguinal hernias that effectively resolves the causes of hernia disease by blocking its effects.

Furthermore, it counteracts the degeneration of the inguinal structure caused by hernial protrusion with a probiotic biological response that quickly leads to the regeneration of the inguinal wall structures, promoting the growth of new muscular, vascular and nervous structures in its context.

Index
    Add a header to begin generating the table of contents

    SURGICAL DEVICES FOR INGUINAL HERNIAs

    ProFlor – The first dynamic regenerative scaffold

    ProFlor is the very first dynamic regenerative scaffold ever applied to abdominal wall surgery. Born from scientific evidence demonstrating the progressive degeneration of the muscular barrier in patients affected by inguinal hernia, ProFlor was designed by Prof. Amato to permanently
    obliterate the hernia defect without any type of fixation and to stimulate tissue regeneration thanks to its three-dimensional, dynamic structure capable of adapting to abdominal movements.

    Are you interested in a collaboration or investment?
    Get in touch with our team

    THE PATHOGENESIS OF INGUINAL HERNIA: TISSUE DEGENERATION CAUSED BY CHRONIC VISCERAL IMPACT

    In recent decades, the professional and scientific activity of Prof. Amato has focused on the study of the pathophysiology of the abdominal wall, ventral hernias, incisional hernias, and in particular inguinal hernias. Prof. Amato has concentrated his research on these topics, developing innovative concepts on the pathogenesis of inguinal hernias—concepts whose aspects were, until recently, completely unknown. In several articles published in the most prestigious scientific journals worldwide, Prof. Amato has demonstrated that inguinal hernia is caused by a specific degeneration of the inguinal structures resulting from the continuous orthostatic impact of the viscera on the inguinal wall and the resulting chronic compression. (1–18)

    The theory of chronic visceral impact as the cause of inguinal hernia has been scientifically highlighted in the recent book “Inguinal hernia: pathophysiology and genesis of the disease”,  published by Prof. Amato.

    The discovery of the causes of inguinal hernia documented in Prof. Amato’s book puts an end to centuries of ignorance regarding the genesis of this disease.

    This important discovery has opened the way to new therapeutic concepts and technologically advanced systems for the treatment of this extremely common pathological condition.

    A REVOLUTIONARY CONCEPT

    THE DYNAMIC REGENERATIVE SCAFFOLD PROFLOR TO TREAT THE DISEASE OF ONE OF THE MOST MOBILE AREAS OF THE HUMAN BODY: THE INGUINAL HERNIA

    Considering the aspects of pathophysiology and functional anatomy of the inguinal region, and following successful experimentation in an animal model, Prof. Amato developed the revolutionary dynamic regenerative scaffold ProFlor for the treatment of inguinal hernias. (19–22) To date, ProFlor is the only device that allows treatment of the hernia protrusion in a way that is entirely consistent with the physiology of the inguinal region and the pathogenesis of the disease. (19–26)

    THE DYNAMIC REGENERATIVE SCAFFOLD PROFLOR RESPECTS THE PHYSIOLOGY OF THE INGUINAL REGION

    This newly conceived multilamellar 3D device is compressible with memory and is inserted—without any fixation (sutures or otherwise)—into the hernia defect, completely and permanently obliterating it while moving in harmony
    with the musculature of the inguinal region.

    Furthermore, positioned deep within the inguinal musculature, it is not perceived by the patient, who can move without difficulty right from the start. All of this occurs in full respect of the dynamics of the inguinal region, which are not hindered but actually supported.

    This concept is absolutely the antithesis of that of conventional prostheses, essentially a thin mesh of synthetic material (polypropylene or similar), almost always fixed to the inguinal musculature with sutures or other fixation systems. Fixation of conventional prostheses to the musculature is in clear contrast with the dynamics of the inguinal region and is not always effective: sometimes, even with the first movements, the sutures tear the tissues, causing pain, bleeding, and hematomas. Without fixation, the prosthesis may migrate, facilitating the onset of recurrences.

    By contrast, the ProFlor dynamic regenerative scaffold is inserted into the hernia defect and stabilizes itself thanks to the centrifugal force exerted by its lamellae. No sutures or additional fixation are needed.

    THE DYNAMIC REGENERATIVE SCAFFOLD PROFLOR TARGETS THE ROOT CAUSES OF HERNIA DISEASE

    The most striking property of the dynamic regenerative scaffold with 3D multilamellar structure is the biological response induced by its unique and specific ability to compress and release in harmony with the inguinal barrier. (27–33)

    By moving in unison with the inguinal region, ProFlor attracts growth factors into its structure, which, within just a few weeks, regenerate the tissues that had been dissolved by the degeneration caused by hernia disease. Specific muscular, neural, and vascular growth factors present in ProFlor at various post-implantation stages have been identified in the course of scientific research, the results of which have been published in major international scientific journals. (34–35)

    It has thus been demonstrated that these growth factors activate a tissue regeneration process that leads to the regrowth—within the scaffold—of the typical tissues of the inguinal region: muscle fibers, connective tissue, arteries, veins, and nerves.

    These newly formed components inside the dynamic scaffold are entirely similar to those normally found in the inguinal wall. In essence, there is true regeneration of the tissues that had been dissolved due to the degeneration caused by hernia disease.

    This regenerative effect is finally in line with what should be the real purpose of therapy: stopping the degeneration induced by the disease and activating the regrowth of degenerated tissues, restoring the inguinal barrier with all its typical components.

    Currently, no other device for the treatment of inguinal hernia has been shown to produce similar regenerative probiotic effects. For this reason, instead of being considered a common prosthesis, ProFlor can be regarded in every respect as a dynamic regenerative scaffold.

    BIOLOGICAL RESPONSE: COMPARISON BETWEEN PROFLOR AND CONVENTIONAL MESHES

    The difference between the biological response of the ProFlor dynamic regenerative scaffold and that of conventional meshes is remarkable, even though both are made of the same material—polypropylene. Conventional meshes, after just a few weeks, begin to produce a fibrotic scar callus that gradually hardens,
    becoming irregular and inelastic, wrinkling and shortening the prosthesis. (36–41)

    The scar plate—essentially a typical foreign-body granuloma—can rub against the inguinal floor, giving rise to the bothersome discomfort often reported by patients even years after the operation. The growth of this fibrotic scar, characteristic of conventional prostheses, is uncontrolled and is considered one of the causes of the infamous chronic pain, an event that can seriously disrupt patients’ lives. (42–43)

    To document the notable differences in tissue incorporated within the two types of devices—traditional static mesh and the ProFlor dynamic regenerative scaffold—Prof. Amato conducted a comparative scientific study of the biological response of the two devices, examined in the short, medium, and long term after implantation.  This research clearly highlighted the superiority of the biological response of ProFlor compared with conventional static prostheses.

    The comparative scientific research showed that, over time, the conventional flat mesh becomes a mixture of hard fibrotic scar and amorphous synthetic material, whereas the ProFlor dynamic regenerative scaffold is incorporated by well-vascularized, fleshy tissue, making it impossible to recognize the original prosthetic structure.

    In the image on the side, the difference between the two prostheses several months after implantation is evident.
    The photos show a biopsy of the ProFlor dynamic regenerative scaffold and a conventional static prosthesis explanted due to recurrence.

    The structure of the 3D dynamic scaffold is no longer recognizable because it is completely embedded in well-vascularized, fleshy tissue. The conventional static prosthesis, on the other hand, appears as a piece of wrinkled and hardened mesh, distorted by fibrotic scar tissue.

    The difference is remarkable: living tissue versus a wrinkled, hardened piece of fabric! (28)

    3D DYNAMIC REGENERATIVE SCAFFOLD PROFLOR

    SIGNIFICANT REDUCTION OF POSTOPERATIVE PAIN AND SURGICAL COMPLICATIONS IN OPEN INGUINAL HERNIA SURGERY

    Thanks to the dynamic regenerative scaffold ProFlor, it has been possible to drastically reduce postoperative pain and the typical complications associated with conventional inguinal hernioplasty using standard prosthetic meshes. Clinical studies have shown that a significant percentage of these complications are caused by the fixation of conventional prostheses using sutures or similar methods. (44–46)

    In contrast, the ProFlor dynamic regenerative scaffold is inserted in compressed form into the hernia defect, where it expands to permanently obliterate it. It is self-stabilizing and requires absolutely no fixation.  Therefore, all complications associated with fixation in conventional prostheses simply do not exist when using ProFlor. (47–51)

    Additionally, to further reduce postoperative pain, the skin is sutured using the complete intradermal technique with self-locking knots (with no external stitches), developed by Prof. Amato. (52)

    This approach to wound closure, in addition to reducing postoperative pain, has proven very useful in preventing postoperative infections by limiting wound dressings to a single one—since there are no external sutures, there is no need to remove stitches from the skin.

    For those wishing to learn more, we recommend reading the following scientific article published in the prestigious
    journal International Journal of Surgery Open: https://www.sciencedirect.com/science/article/pii/S2405857219300658

    LAPAROSCOPIC APPROACH FOR THE TREATMENT OF INGUINAL HERNIAS WITH THE DYNAMIC REGENERATIVE SCAFFOLD PROFLOR

    Prof. Amato has also developed the laparoscopic technique using the dynamic regenerative scaffold ProFlor, with truly exceptional results, especially in the treatment of bilateral inguinal hernias and recurrences after open hernioplasty. The positive outcomes of this laparoscopic procedure are even more evident because they combine the benefits of a “fixation-free” approach with the advantages of the minimally invasive laparoscopic technique.

    The results of this technique have been scientifically validated and published in high–impact factor scientific journals (53, 55).

    For those wishing to learn more, we recommend the following scientific publications in prestigious international journals:

     

    Are you interested in proflor?

    ProFlor represents a revolution in hernia surgery.

    Contact us for clinical, industrial collaborations or investment opportunities.

    Modulo info dispositivi chirurgici EN
    SUMMARY SHEET

    PROFLOR - KEY FEATURES AND SCIENTIFIC PUBLICATIONS

    Clinical Problem Addressed

    Traditional inguinal hernia repair techniques rely on static prosthetic meshes that reinforce the wall but do not restore its natural physiology. This may lead to chronic pain, stiffness, and recurrences over time.

    DEVISED SOLUTION

    ProFlor is the very first dynamic regenerative scaffold designed specifically for the treatment of inguinal hernias: a three-dimensional prosthesis capable not only of obliterating the hernia defect but also of stimulating the regeneration of tissues typical of the abdominal wall (muscles, collagen, blood vessels, and nerve fibers).

    Its elastic and compressible structure ensures stable and adaptable filling, while simultaneously guaranteeing freedom of movement and full physiological functionality of the abdominal wall.

     

    DIFFERENCES BETWEEN PROFLOR AND TRADITIONAL PROSTHESES IN HERNIA TREATMENT

    Unlike traditional prostheses, which remain static foreign bodies, ProFlor acts as a true regenerative substrate, promoting the growth of muscular, vascular, and nervous tissue within its architecture and effectively addressing the degeneration underlying hernia pathology.

    This characteristic makes it technologically advanced, unique in its class, and supported by robust scientific literature documenting its clinical results.

    Project Status

    ProFlor is already clinically validated, with numerous scientific publications in international journals confirming its efficacy and safety, and it is currently in use in surgical practice.

    Patent

    Internationally patented device.

    Key Benefits

    For patients

    • Faster and less painful recovery.
    • No traumatic fixation (fixation-free)
    • Restoration of abdominal wall physiology
    • Addresses the degeneration that caused the hernia disease
    • Stimulates regeneration of degenerated tissues
    • Lower risk of recurrence and long-term complications

    For surgeons

    • Procedure usually performed under local anesthesia
    • Simple, safe, and minimally invasive placement
    • No need for sutures or glues for fixation
    • Reduced operating time
    • Discharge within a few hours
    • Reproducible and long-lasting clinical results

    FURTHER RESOURCES

    Multimedia material

    Peer-reviewed scientific articles

    1. Sphincter-like motion following mechanical dilation of the internal ring during indirect inguinal hernia procedure. Hernia 2009;13:67-72
    2. Histological findings of the internal inguinal ring in patients having indirect inguinal hernia. Hernia 2009;13;259-62
    3. Nerve degeneration in inguinal hernia specimens. Hernia 2011;15:53-58
    4. Pathological anatomy of hernia disease. Hernia 2011;15:S46-4765-7
    5. Muscle degeneration in inguinal hernia specimens. Hernia 2012;16:327–331
    6. Physiopathology of hernia disease. Hernia 2012;17 (Suppl 1): S159-160Histological findings in direct inguinal hernia. Hernia 2013;17(6):757-63
    7. Histological findings in direct inguinal hernia. Hernia 2013;17(6):757-63
    8. Multiple ipsilateral inguinal hernias. If undetected source of complications and re-interventions. Hemia 2014; 18 (Suppl 2):26
    9. Addressing hernia genesis. It’s impact in the surgical management of inguinal protrusions. Hemia 2014; 18 (Suppl 2):87
    10. Combined inguinal hernia, a progressive protrusion disease. Hernia (2015) (Suppl 2):SI95-S340
    11. Combined inguinal hernia in the elderly. Portraying the progression of hernia disease. Int J Surg. 2016 Sep;33 Suppl 1:S20-9.
    12. External hernia of the supravesicalis fossa: a misidentified protrusion. More frequent than imagined, riskier than perceived. Hernia (2016) 20 (Suppl2):S198
    13. The septum inguinalis: a neglected feature of the inguinal backwall showing significant implications in hernia genesis. Hernia (2016) 20 (Suppl 2):S175
    14. External hernia of the supravesical fossa. A misidentified protrusion with high risk of incarceration. Hernia (2017) 21 (Suppl 2):S173
    15. Physiopathology of inguinal region & hernia genesis. Highlighting the visceral impact theory. Hernia (2017) 21 (Suppl 2):S208
    16. Lipoma of the fossa femoralis mimicking a femoral hernia. Report of 2 cases Int J Surg Case Rep. 2018; 49: 223–227
    17. The Septum Inguinalis: A Clue to Hernia Genesis? J Invest Surg. 2020 Mar;33(3):231-239
    18. Inguinal Hernia: The Destiny of the Inferior Epigastric Vessels and the Pathogenesis of the Disease. Surg Technol Int. 2020 Mar 18;36.
    19. Dynamic implant for inguinal hernia repair in porcine experimental model. A feasibility study. Hernia 2009;13:S1-332
    20. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181–E190
    21. Fixation-free inguinal hernia repair, using a dynamic self-retaining implant inducing enhanced biologic response. Results of a midterm follow up Hernia 2012 (Suppl 1):S85-S87
    22. Fixation-free inguinal hernia repair using a dynamic self-retaining implant. Surg Technol Int. 2012 Sep 30;XXII:22/17
    23. Defect obliteration vs. coverage: new concepts in the surgical treatment of inguinal hernia. Hernia 2013;17 (Suppl 2): S31-S70
    24. Modified fixation free plug technique using a new 3D multilamellar implant for inguinal hernia repair. Hernia 2014; 18(2):243-50
    25. Dynamic Inguinal Hernia Repair with a 3D Fixation-free and Motion-compliant Implant: A Clinical Study. Surg. Techol. Intl. 2014 Feb 14;XXIV
    26. Modified fixation free plug technique using a new 3D multilamellar implant for inguinal hernia repair. Hernia 2014; 18(2):243-50
    27. Enhanced biologic response using a fixation-free, dynamic implant for inguinal hernia repair. Results of a midterm follow up. Hernia 2013;17 (Suppl 2): S31-S70
    28. Biologic Response of Inguinal Hernia Prosthetics: A Comparative Study of Conventional Static Meshes Versus 3D Dynamic Implants Artificial Organs. 2015 Jan;39(1):E10-23
    29. Comparing the biological response of conventional static meshes and dynamic responsive implants Hernia (2015) (SuppI2):S3-SI94
    30. Neomyogenesis in 3D dynamic responsive prosthesis for inguinal hernia repair. Artif Organs. 2018 Dec;42(12):1216-1223
    31. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. International Journal of Surgery Volume 76, April 2020, Pages 114-119
    32. Enhanced angiogenesis in the 3D dynamic responsive implant for inguinal hernia repair ProFlor Artificial Organs. 2021;45:933–942.
    33. A regenerative 3D scaffold for inguinal hernia repair. MR imaging and histological cross evidence. Qualitative study International Journal of Surgery 2021, 96, 106170
    34. Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin. J Funct Biomater. 2022 Nov 18;13(4):253
    35. Physiologic Cyclical Load on Inguinal Hernia Scaffold ProFlor Turns Biological Response into Tissue Regeneration Biology, 2023, 12(3), 434
    36. Functional and morphological evaluation of different polypropylene-mesh modifications for abdominal wall repair. Biomaterials 1998. 19:2235–2246
    37. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices 20052:103–117
    38. Long-Term Follow-Up of Lichtenstein Repair of Inguinal Hernia in the Morbid Patients With Self-Gripping Mesh (ProgripTM). Front Surg. 2021 Oct 15;8:748880.
    39. Meta-analysis of mesh-plug repair and Lichtenstein repair in the treatment of primary inguinal hernia. Updates Surg. 2021 Aug;73(4):1297-1306
    40. Inguinal hernia repair using the Lichtenstein technique under local anesthesia (with video). J Visc Surg. 2021 Jun;158(3):276-278
    41. Nationwide quality improvement of groin hernia repair from the Danish Hernia Database of 87,840 patients from 1998 to 2005. Hernia 2008;12:1–7
    42. Causes, prevention, and surgical treatment of postherniorrhaphy neuropathic inguinodynia: Triple neurectomy with proximal end implantation. Hernia2004 8: 343–349
    43. Randomized clinical trial assessing impact of a lightweight or heavyweight on chronic pain after inguinal hernia repair. Br J Surg 2005 92:166-70
    44. Bande D, Moltó L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.
    45. Zwaans WAR, Verhagen T, Wouters L, Loos MJA, Roumen RMA, Scheltinga MRM.Groin Pain Characteristics and Recurrence Rates: Three-year Results of a Randomized Controlled Trial Comparing Self-gripping Progrip Mesh and Sutured Polypropylene Mesh for Open Inguinal Hernia Repair. Ann Surg. 2018 Jun;267(6):1028-1033.
    46. Aasvang E, Kehlet H. (2005) Surgical management of chronic pain after inguinal hernia repair. Br J Surg 92: 795–801
    47. Defect obliteration vs. coverage: new concepts in the surgical treatment of inguinal hernia. Hernia 2013;17 (Suppl 2): S31-S70
    48. Modified fixation free plug technique using a new 3D multilamellar implant for inguinal hernia repair. Hernia 2014; 18(2):243-50
    49. Dynamic Inguinal Hernia Repair with a 3D Fixation-free and Motion-compliant Implant: A Clinical Study. Surg. Techol. Intl. 2014 Feb 14;XXIV
    50. Modified fixation free plug technique using a new 3D multilamellar implant for inguinal hernia repair. Hernia 2014; 18(2):243-50
    51. Fixation free inguinal hernia repair with the 3D dynamic responsive prosthesis ProFlor: Features, procedural steps and long-term results. International Journal of Surgery Open 2019; 21:34-4
    52. Total intradermal suture techniques. G Chir. 2010 Jan-Feb;31(1-2):48-54.
    53. First-in-man permanent laparoscopic fixation free obliteration of inguinal hernia defect with the 3D dynamic responsive implant ProFlor-E®. Case report. Int J Surg Case Rep. 2020;77S(Suppl):S2-S7
    54. Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor. Scientific Reports 2022, 12(1), 18971
    55. Progrip versus ProFlor: two fixation-free devices for laparoscopic inguinal hernia repair—the Pro/Pro study, a randomized clinical trial. Surg Endosc 39, 3113–3126 (2025) 

    Are you interested in proflor?

    ProFlor represents a revolution in hernia surgery.

    Contact us for clinical, industrial collaborations or investment opportunities.

    Get in touch with the team