VERSIONE ITALIANA

P1010585a-300x254Instead  of the unphysiological “patches”, such as flat and motionless meshes or “plugs”, for the treatment of the degenerative damages caused by inguinal hernia disease, Prof. Amato developed a different strategy in line with the pathogenesis of the disease. It concerns the innovative prosthesis ProFlor: a 3D dynamic compliant regenerative scaffold intended for fixation free permanent obliteration of the hernia defect. Inguinal hernia repair with ProFlor represents a surgical solution in line with the physiology of the inguinal region. Thanks to its proprietary dynamic responsivity, ProFlor promotes the regeneration of the inguinal tissue wasted by hernia disease. The development of mature nerves, muscle bundles, arteries and veins represents the finalization of the regenerative response induced by ProFlor. The features of this innovative device and surgical method result decisive in improving postoperative results and patient’s comfort.

A regenerative scaffold for inguinal hernia repair

ProFlor inguinal hernia repair: features, procedural steps and clinical data.  https://youtu.be/YeP6gEolrt0

Background

Inguinal hernia is a protrusion of abdominal viscera through the muscular wall of the inguinal region. It’s a common disease which yearly afflicts millions of patients worldwide. The treatment is surgical, but to date no gold standard exists. The treatment concept of the most performed techniques is covering the herniated inguinal area, one of most mobile areas in the human body, with static flat meshes fixated with sutures or other fixation methods. Nevertheless, such treatment concept, intended to reinforce the herniated groin, doesn’t take into account nor the physiology of the inguinal area, neither the genesis of hernia disease.

At this regard, most scientific studies have focused on the effects of hernia protrusion, rather than its origins. As a result, years of surgical practice have been carried out without knowledge of the pathogenesis of the protrusion. Therefore, looks like the current hernia repair techniques are not evidence based but simply empirical treatments concepts. The frequent complications occurring after conventional prosthetic repair of inguinal hernias seem to clearly embody this incongruence.

Actually, being fixed to the inguinal musculature, these static meshes hinders the natural movements of the groin thus resulting unphysiological and causing pain. Furthermore, the biological response to such passive and motionless implants is a typical foreign body reaction characterized by uncontrolled fibrotic ingrowth producing a stiff scar plate and leading to mesh shrinkage. As a results discomfort is frequent and, in some cases, the fibrotic hardening enwraps the tiny inguinal nerves causing chronic pain. Another issue of mesh shrinkage is the decoverage of the hernia opening, prelude to recurrence.

Since end of past century, Professor Amato has carried out specific studies related to functional anatomy, physiology and histology of the inguinal region with the intent to definitely unveil the roots of hernia protrusions. As a result,  new concepts about the pathogenesis of inguinal hernia have been evidenced and scientifically validated through articles published in the most relevant scientific journal in the field. Taking into account these evidences, Prof. Amato developed a new, updated and more physiological concept for the repair of inguinal hernia by means of a dynamic responsive device engineered in 3 D fashion and experimented for years in large animal models. The outcomes of these experimental attempts have also been published. This prosthetic device, named ProFlor, owns a 3D multilamellar structure designed to move in accord with motile impulse received.

Differently of conventional motionless flat meshes, the 3D dynamic responsive prosthesis ProFlor is delivered fixation free to obliterate the inguinal defect and, in line with the physiology of the inguinal area, contracts and relaxes in harmony with the groin’s musculature. Thanks to its dynamic responsivity, ProFlor results coherent with the degenerative source of hernia disease since promotes the re-growth of the typical tissue components of the groin. Newly formed vessels, muscles and nerves developed into the implant’s fabric embody the regenerative behavior of ProFlor. Therefore, more than a hernia prosthesis ProFlor can be defined as a regenerative scaffold.

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The procedure

  • 100% “Tension free”: no fixation of the prosthesis with sutures, stitches, staples or similar.
  • Open approach is usually carried out in local anesthesia.
  • Laparoscopic approach in general anesthesia.
  • Patient is usually discharged same day of the surgical procedure.

Tissue regeneration following hernia repair procedure

The conventional static implants by the time shrink and form a regressive fibrotic scar plate which does not move in compliance with the groin structures but, hinders the kinetic of the inguinal region causing discomfort to the patients. Conversely, the dynamic implant contracts and relaxes in compliance with the muscular structures of the groin. Due to its continuous movements, ProFlor acts as a scaffold for new tissue regeneration, creating a thick barrier of dense, viable and well vascularized tissue. The dynamic implant does not shrink, does not cause discomfort and postoperative pain is sharply reduced allowing the return to normal activities within few days postop.

Biologic response: comparison between 3D dynamic implant and conventional meshes.

In terms of biologic response, the difference between the 3D dynamic implant and the conventional meshes is noteworthy. Conventional meshes after few weeks start to produce a fibrous, hard, irregular and inelastic scar that leads to shrinkage and surface reduction of the prosthesis.  This stiff scar plate, very similar to a foreign body reaction, rubbing on the inguinal floor can cause a frustrating discomfort, often complained by patients even  years after surgery. The hard scar plate, typical of conventional prostheses is also reputed to be one of the causes of chronic pain, an event that can upset life of patients.  To evaluate the differences in tissue incorporation between the two types of prosthesis, conventional static and 3D dynamic, Prof. Amato carried out a comparative scientific research on the biological response of the two implant types in the short, medium and long-term. This scientific experience showed a manifest superiority in biologic response of the 3D dynamic prosthesis compared to conventional static meshes. The comparative scientific research demonstrated that over time the conventional flat mesh becomes a mixture of stiff scar amalgamated with amorphous synthetic material. On the contrary, the 3D dynamic prosthesis is incorporated by a well-vascularized fleshy mass that fully overwhelm its fabric, which is no more recognizable.

Diapositiva3In the photo here on the side, the difference between the two prostheses few months postoperative is evident. The picture shows a biopsy of the 3D dynamic implant and a conventional static mesh explanted for recurrence. The structure of the 3D dynamic implant is no longer recognizable because incorporated by a well-vascularized fleshy tissue. The other picture shows an irregularly folded conventional static mesh turned into a hardened piece of scar plate. The difference is remarkable: viable fleshy structure against a piece of hard cloth!

For those wishing to deepen the subject, the scientific article related to this research was published in the renowned international scientific journal Artificial Organs: “Biologic response of inguinal hernia prosthetics. A comparative study: conventional static meshes vs. 3D dynamic implants. 

Quality of regenerated tissue within the 3D structure of ProFlor

  • After 3 months absence of inflammatory reaction
  • Newly formed mature muscle fibers
  • Plenty of nerves complete in all constituents
  • Well-structured veins and arteries
  • Soft and well hydrated connective

OTHER INNOVATIVE SOLUTIONS DEVELOPED BY PROF. AMATO FOR THE TREATMENT OF VENTRAL AND INCISIONAL HERNIAS

Prof. Amato also invented the tentacle shaped implant for the treatment of Diapositiva9abdominal wall hernias (incisional, umbilical, epigastric and Spigelian hernias). The related surgical technique allows a fixation free surgical procedure for the treatment of these widespread pathologies. Small skin incisions, minimized surgical trauma and sharply reduced postoperative complications are the highpoints of the surgical technique. This is possible thanks to the proprietary design of the prosthesis whose elongated straps at the edges of the implant, inserted through the abdominal wall musculature, allow a permanent fixation free positioning of the implant, using the principle of tissue friction.

The modern prosthetic devices and the innovative surgical techniques developed by Prof. Amato allowed for significant decrease of postoperative complications. These techniques have been scientifically validated by numerous articles published in the most important scientific journals.