The Bilayer pericardium is an extracellular membrane (ECM) consisting of two distinct surfaces, one completely smooth and one fibrillar. Thanks to a fractional freeze-drying process that brings the membrane to a pressure of 0.020 mbar, it is possible to enhance the fibrillar state which will carry out a dual action, favor the healing process with
lower risk of fibrous tissue formation and prevent any movement of the prosthesis.
In recent years, more and more women have undergone breast surgery both of an aesthetic type (breast augmentation or breast lift with implants) and reconstructive (outcomes of breast tumors).
Even with the improvement of the materials, 10% of patients develop a capsular contracture linked to the prosthesis.
The prosthesis is normally recognized by our body as a foreign body and covered with a
fibrous tissue. In some cases there is an abnormal increase in this tissue which creates a contracture of the capsule around the implant.
Modern technology has improved dentures by placing non-smooth surfaces to reduce the risk while not erasing the risk.
Research is directed towards the creation of biomimetic surfaces that are able to reduce the incidence of fibrous tissue formation. 1 The University of Manchester has recently developed a new external surface for silicone breast implants that mimics the basal surface of the skin allowing a more physiological response of the body. 2 The Polytech company that manufactures breast implants has adopted different types of surface coatings such as Microthane® which is a micro-polyurethane foam breast implant coating that has an average roughness of 1500 microns.
Maggi srl proposes the covering of the prosthesis with the Exaflex membrane in its Bilayer variant
The double layer that makes the difference
The Exaflex membrane has been used since 2015 in numerous medical disciplines that deal with the regeneration and repair of injured tissues. The Exaflex pericardium is not a biomaterial but an ECM thanks to the particular conformation of the fibrillar layer.
it begins at the same time as contact with surfaces of organs or dermis
injured. The prosthesis coated with Bilayer pericardium will result
"invisible" to the immune system and will be accepted with minor
formation of fibrous tissue as in any tissue regeneration
performed with Exaflex.
In fact the coating of the prosthesis with Bilayer pericardium results
today the best possible biomimicry with an Active surface in
able to improve post-surgery healing processes.
The conformation of the ECM covering guarantees a coverage of the prosthesis equal to 99% of its surface in contact with the tissues which during the first days, especially after particularly bloody operations such as in the case of the removal of the gland following a tumor event intense involvement of the immune system which is not only of species (biocompatibility) but also of surface.
Bagged prosthesis with Exaflex membrane
Prosthesis coated with Bilayer Exaflex membrane
The double layer that makes the difference
The fractional freeze-drying process enhances the natural fibrillar layer of the bovine pericardium by generating an effect on the injured tissues similar to velcro. The total coating gives the prosthesis a high Grip that prevents any micro movement or rotation of the same. The phenomenon is further ensured by the rapid healing that occurs between the ECM and the patient's tissues. As observed in all cases of vulnology using ECM Exaflex, the membrane can no longer be separated from the patient's skin after 5 - 7 days of contact by means of an occlusive bandage.
The coating of the silicone prosthesis with ECM Bilayer is particularly indicated in all cases of explantation and reimplantation of prostheses following a fibrous capsule on patients who have therefore experienced this type of problem, on patients who have a previous tendency to develop keloids . It is also useful both as a preventive form in cosmetic breast surgery and for the removal of the gland in the presence of highly reactive tissues following massive breast reconstruction operations.
1 "Development and functional evaluation of biomimetic silicone surfaces with hierarchical micro / nano
topographical features demonstrates favorable in vitro foreign body response of breast-derived
fibroblasts "(/ warning / plastic-and-reconstructive-surgery /?
qurl = http% 3A% 2F% 2Fwww.sciencedirect.com% 2Fscience% 2Farticle% 2Fpii% 2FS0142961215001
Daniel JT Kyte, Antonios Oikonomou, Ernie Hill, Ardeshir Bayat
Biomaterials June 2015 Vol 52 - 88-102
(2) Pompei, Stefano, et al: Polyurethane Implants in 2-Stage Breast Reconstruction: 9-Year Clinical Experience. Aesthetic Surgery Journal, Volume 37, Issue 2, February 1, 2017, Pages 171-176, doi.org/10.1093/asj/sjw183