Description
HYAcorp MLF1/MLF2 is a highly purified and resorbable dermal filler hydrogel. It is a single-use medical device, consisting of fermentative hyaluronic acid. HYAcorp MLF1/MLF2 is a sterile, non-pyrogenic, viscoelastic, and hydrodispersible (non-flammable, non-toxic) biomaterial composed of hyaluronic acid obtained through fermentation. Hyaluronic acid is a natural polysaccharide, a component of the dermal matrix of human skin. Hyaluronic acid is present with the same chemical, physical, and biological structure in the tissues of all higher organisms. HYAcorp MLF1/MLF2 is a clear, viscous gel, supplied in a 10ml syringe with a Luer-Lock fitting.
Composition
1ml of HYAcorp MLF1/MLF2 contains:
– Hyaluronic acid 2.0 mg
– Cross-linked hyaluronic acid 20.0 mg
– Sodium chloride 6.9 mg
– Water for injectable preparations q.s. 1.0 ml
Mechanism of Action
HYAcorp MLF1/MLF2 is implanted into the subcutaneous and/or supraperiosteal tissue as a supplement to the intercellular matrix and intermediate tissue, with the function of restoring anatomical structures. Its mechanism of action is based on the latest biotechnologies in the production of injectable hyaluronic acid. The product is completely degraded over time.
Indications and Method of Use
HYAcorp MLF1/MLF2 is used for volume restoration and contouring of body surfaces. The injection depth may vary depending on the subcutaneous or supraperiosteal application of the area to be treated.
· Buttocks
· Calves
· Correction of concave deformities
Body contouring with HYAcorp MLF1/MLF2 means that the buttocks and other body parts can be naturally restored. HYAcorp MLF1/MLF2 is used to reshape the décolletage, but it also has a complementary function following aesthetic surgical procedures, such as liposuction.
The gel is injected deep into the skin and lifts the tissue naturally. The duration of the filling effect may vary and depends on the depth and injection site. With HYAcorp MLF2, a stronger volume effect can be achieved. The result that can be obtained depends on the type of skin and the desired changes.
The treatment must be performed exclusively by physicians with knowledge and experience in the field of fat grafting procedures or similar treatments.
Contraindications
HYAcorp MLF1/MLF2 should not be used in case of:
· Previous history of hypertrophic scarring, keloids
· Susceptibility to infections, especially those caused by Gram+
· Ongoing inflammatory or infectious processes
· Acute or chronic skin pathologies
· Anticoagulant therapy
· Known sensitivity to hyaluronic acid
· Autoimmune diseases
To date, no clinical data is available regarding the use on pregnant or breastfeeding women and subjects under 18 years of age. Patients with allergies should be excluded from treatment. The use of HYAcorp MLF1/MLF2 is contraindicated in the facial area. HYAcorp MLF1/MLF2 is intended exclusively for subcutaneous and supraperiosteal injection. The use of HYAcorp MLF1/MLF2 is contraindicated for breast volume enhancement and genital organs.
Warnings
HYAcorp MLF1/MLF2 must not be injected into blood vessels or intramuscularly. Such an event could cause vascular occlusion or thromboembolic phenomena. HYAcorp MLF1/MLF2 must not be injected into an area where a permanent implant has been inserted. HYAcorp MLF1/MLF2 must not be used near or on anatomical areas with active skin alterations, inflammation, or associated conditions. It is recommended to avoid application in areas already treated with a filling solution.
The usual precautionary measures associated with intradermal injections must be strictly observed. HYAcorp MLF1/MLF2 is suitable for subcutaneous or supraperiosteal injections. Depending on the area treated, an appropriate injection technique and depth should be selected. The physician’s competence and specific training in injection techniques are crucial for the success of the treatment.
As with any similar procedure, the implantation of HYAcorp MLF1/MLF2 is associated with the inherent risk of infections. A thorough anatomical knowledge of the area to be treated is necessary, and particular attention should be paid when treating areas near vulnerable structures such as nerves, vessels, and viscera. The attending physician must be closely familiar with the patient’s medical history, and in case of pre-existing conditions, necessary precautions must be taken, and the patient must be properly informed. Patients taking substances that affect coagulation, such as aspirin, non-steroidal anti-inflammatory drugs, may experience increased bruising and bleeding at the injection site following any injection.
The treated area should not be exposed to excessively high (sun, lamps, lasers, and IPL) or low temperatures. Avoid muscle tension for a few days. The injected area should not be massaged in the days following the injection and should not be exposed to increased pressure. A clogged needle should be replaced with a new one. An increase in plunger pressure is expected. Used syringes and needles are considered contaminated and must be disposed of according to recognized medical practice rules.
Warnings
The markings on the syringe serve only as a visual aid for the operator regarding the injected volume. They do not serve as a measurement function but refer only to the volume injected relative to the 10ml volume contained in the syringe. The operator must visually or tactilely verify the sufficient amount of injected material.
Presentation
HYAcorp MLF1/MLF2 is supplied in sterile 10ml pre-filled syringes with an integrated Luer-Lock adapter in a single-use vial. The syringe contents are sterile (steam sterilized). The package also includes the instructions for use and labels bearing the batch number and expiration date. Do not use after the expiration date. The patient will receive a label to ensure product traceability.
Note
The product cannot be re-sterilized. It must not be mixed with other injectables or decanted. Do not use the product if the packaging or vial is damaged.
Storage
Do not freeze or expose to extreme heat. Store at room temperature (2°C – 25°C).
