Existing Clinical Problem
For a long time inguinal hernia repair has seen little invention, taking into account the root cause of inguinal hernias.
Recent studies(1-7) demonstrated the degenerative character of the disease, identifying the weakening of the inguinal floor caused by chronic compressive force, leading to groin degeneration.
The numerous postoperative complications associated with open inguinal hernia repair, most importantly the high incidence rate of acute and chronic post-operative pain caused by point fixation and onlay meshes, with recent studies reporting a 16.5% incidence of chronic pain 6 months after surgical repair(8), demand a new approach.
The Freedom ProFlor Solution
A SIGNIFICANT CONCEPT CHANGE
More than a decade of research has led to the invention of the ProFlor Dynamic Hernia Implant. Static mesh repair stands in direct contrast to repairing a muscular defect in the most mobile area of the human body.
ProFlor’s combination of the dynamic core and the posterior disk is designed to provide fixation-free placement and responsive movement with the surrounding muscles, allowing regrowth of healthy muscle tissue thereby restoring the inguinal barrier.
NO ONLAY COMPONENT, NO STITCHING
ProFlor anchors itself in the defect, obliterating the hernia defect and leaves the anterior space unaffected. This eliminates the risk of anterior nerve damage, shrinkage and therefore the most common factors contributing to chronic pain.
HEALTHY TISSUE IN-GROWTH
Proflor Implant Fully Occupied By Flesh Tissue
HUMAN HISTOLOGY RESULTS AT 8 MONTHS
healthy Muscle tissue
well-structured arteries
mature nerve structure
The Freedom ProFlor Group showed
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43% reduction in Operative Time*
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6x reduction in post-op analgesics*
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Significantly less pain at POD 7* (VAS)
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Significantly improved Quality of Life* (CCSTM)
TRIAL RESULTS: POST-OP PAIN AND QoL5
PAIN ASSESSMENT ON VISUAL ANALOG SCALE (VAS)
INDIRECT INGUINAL HERNIA REPAIR
DIRECT INGUINAL HERNIA REPAIR
Indirect Inguinal Hernia Repair
REFERENCES
- Amato G, Marasa L, Sciacchitano T, Bell SG, Romano G, Gioviale MC, Lo Monte AI, Romano M. (2009) Histological findings of the internal inguinal ring in patients having indirect inguinal hernia. Hernia 13;259-62
- Amato G, Ober E, Romano G, Salamone G, Agrusa A, Gulotta G, Bussani R. (2011) Nerve degeneration in inguinal hernia specimens. Hernia 15:53-58
- Amato G, Romano G, Salamone G, Agrusa A, Saladino VA, Silvestri F, Bussani R. (2012) Damage to the vascular structures in inguinal hernia specimens. Hernia 16:63–67
- Amato G., Agrusa A., Romano G. ,Salamone G., Gulotta G., Silvestri F., Bussani R. (2012) Muscle degeneration in inguinal hernia specimens. Hernia 16(3):327-31
- Amato G, Agrusa A, Romano G, Salamone G, Cocorullo G, Mularo SA, Marasa S, Gulotta G. (2013) Histological findings in direct inguinal hernia. Hernia 17(6):757-63
- Amato G., Agrusa A., Rodolico V., Puleio R., Di Buono G., Amodeo S., Gulotta E., Romano G. (2016) Combined inguinal hernia in the elderly. Portraying the progression of hernia disease Int J Surg. Suppl 1:S20-9
- Amato G, Calò P, Rodolico V, Puleio R, Agrusa A, Gulotta L, Gordini L, Romano G. (2018) The Septum Inguinalis: A Clue to Hernia Genesis? J Invest Surg. Oct 31:1-9.
- Reinpold WMJ, Nehls J, Eggert A. Nerve management and chronic pain after open inguinal hernia repair. Ann Surg. 2011; 254:163–168. [PubMed]
- Murphy JW, Porwal A (2016) Comparison of Lichtenstein and Proflor™ Open Inguinal Hernia Repair in Regards to Immediate Post-Op Pain: A Randomized Double Blinded Registered Clinical Study. J Surg Transplant Sci 4(5): 1040.
