- Foreign body sensation
- Network migration
- Formation of granulomas
- Encapsulation and / or shrinkage of the network
- Post-operative pain
Alloplastic meshes have limitations in the treatment of potentially infected pathologies and most surgeons deem it unsuitable to use synthetic materials in these specific cases.
In recent years xenogenic materials (of bovine, equine and porcine origin) have aroused considerable interest in the scientific community as they are considered a valid alternative to the use of autotransplants and synthetic materials, expanding their fields of application to other surgical specialties such as gynecology , andrology, orthopedics, thoracic surgery, urology, plastic surgery, oral surgery, traumatology, implantology and periodontology.
BioRipar® is a non cross-linked collagen membrane obtained from bovine pericardium treated with an accurate multiphase processing system, designed and developed by ASSUT EUROPE SPA guaranteeing high quality and safety standards and complying with European directives. The manufacturing process ensures the inactivation of pathogens without altering the three-dimensional structure of collagen and its biomechanical properties. The membrane is available in various shapes and sizes:
- Hydrated and not hydrated
- Perforated and not perforated
The correct implantation of the BioRipar® membrane ensures that the network acts as a structural support, thus allowing the development of vessels and fibroblasts, with their deposition in the specific site. The biological tissue, through an incorporation process, will be gradually replaced by a new tissue formed in the site where the prosthesis is positioned, with the same anatomical and functional characteristics as the original one. The membrane is opaque white, but light yellow (for the non-hydrated membrane) or pink (for the hydrated membrane) streaks may occur.
The BioRipar® membrane is indicated for the repair of soft tissues, for the reinforcement of muscle flaps, for the reinforcement, increase and coverage of tendon structures, for the reinforcement and / or replacement of connective tissues, to prevent the formation of adhesions and to accelerate tissue recovery times in: abdominal, thoracic surgery, urology, gynecology, orthopedics, plastic surgery, andrology, oral surgery, traumatology, implantology and periodontology. The DM is not intended to come into contact with the central nervous system and the eye.
In particular, the perforated BioRipar® membrane (both hydrated and not) is used for the surgical repair of soft tissues, providing greater permeability to liquids and less chance of seroma formation.
How to use
Before application, it is necessary to immerse BioRipar® (both hydrated and non-hydrated), at room temperature, in 500 ml of sterile physiological solution (Na Cl 0.9%) for a recommended time of about 15 minutes. Secure the membrane by suturing it. It is advisable to choose membranes of suitable size for the application area. The membranes can be cut to fit the size of the defect, positioning them softly, free from tension in contact with the damaged tissue.
The bovine material used in the production comes from animals coming from farms where there have been no cases of Bovine Spongiform Encephalopathy (BSE), or from countries considered “with negligible risk of BSE”. In any case, to reduce any theoretical risk for bovine material, the following requirements are met:
- The fabric used comes from animals under the age of 24 months
- The pericardium is taken from animals recognized as healthy after ante and post mortem control according to the current Community provisions, in order to exclude any “cross-contamination” the tissues are processed with the “single donor” method (each bovine corresponds to a single batch) and there is never “mixing” of fabrics
- The animals selected by veterinarians, according to strict criteria, are all certified and used for food consumption
Stabilization and chemical dehydration
Wet form: after careful washing in purified water the fabrics are immersed in a solution of Propylene Glycol and Ethanol.
Dry form: the fabrics are subjected to baths in pure acetone; this process replaces the water contained in the fabrics which is replaced by acetone, which is then evaporated in negative pressure ovens.
Propylene Glycol and Ethanol
Propylene Glycol is an odorless and colorless synthetic chemical compound. Propylene Glycol does not cause sensitization and the absolute absence of carcinogenicity or genotoxicity was demonstrated.
According to the WHO, the concentration of non-harmful Propylene Glycol is 25 mg / l, or 1.25-2.0 g in the body of an adult.
The FDA (Food and Drug Administration) has classified Propylene Glycol as an additive whose safety is generally recognized in food use.
Some uses of Propylene Glycol include:
- Solvent in many pharmaceutical preparations , in formulations for use oral , injectable and for topical use
- Humectant in medicaments , cosmetics , food and products based on tobacco
- Food additive labeled with the initials E1520
Propylene Glycol is a low toxicity substance, safety class IV. The estimated residual content of Propylene Glycol in the BioRipar® membrane with the largest surface does not exceed 47 mg, consequently 25 times lower than the concentration considered not harmful to humans.
The endogenous content of ethanol in the blood is allowed from0.04 gr / l, ie in the body of an adult it is from 0.2 to0.5 gr. According to the WHO, the moderate daily dose of ethanol, which can be ingested for adult men is 25 ml while for women it is 12 ml. The concentration of ethanol, which can be considered not harmful, is 0.3 gr / l, i.e. 1.5 gr. in the body of an adult.
Ethanol belongs to the IV safety class for toxic substances. The estimated residual content of ethanol in the BioRipar® membrane with the largest surface does not exceed 79 mg, which is 19 times lower than the concentration considered not harmful to humans.
Once cut to size, BioRipar® membranes are packaged in a double multilayer aluminum bag, subjected to gamma-ray sterilization with a minimum dose of 17.0 kGy. Subsequently, the sterile product is placed inside cardboard boxes.