HYAcorp MLF 2 1x10ml

1 ml of HYAcorp MLF2 contains:

• Hyaluronic acid: 2.0 mg
• Cross-linked hyaluronic acid: 20.0 mg
• Sodium chloride: 6.9 mg
• Water for injections q.s. to 1.0 ml

Biphasic gel: cross-linked hyaluronic acid particles of selected size (300–500 µm) suspended in non-cross-linked hyaluronic acid, which acts as the vehicle. The hyaluronic acid is of non-animal origin and is obtained by fermentation.

Sterile, pyrogen-free, viscoelastic, water-insoluble and biologically compatible gel implant (non-immunising, non-inflammatory, non-toxic). The product degrades completely over time.

Without anaesthetic: the formulation does not include lidocaine. The manufacturer envisages the use of a local anaesthetic to reduce discomfort during implantation.

MLF1 and MLF2 share the same concentration and differ in particle size: MLF2 allows a greater volumising effect. Both are body implants; their use in the face is contraindicated by the manufacturer.

Restoration of lost volume and contouring of body surfaces. The depth of injection varies according to the area treated, from subcutaneous to supraperiosteal application.

• Buttocks
• Calves
• Correction of concave deformities

A greater volumising effect can be achieved with HYAcorp MLF2 than with MLF1. The manufacturer also mentions shaping of the décolleté and use as an adjunct after aesthetic surgery procedures such as liposuction. On its product page, BioScience positions MLF2 for augmentation and lifting of the gluteal region and for correction of lateral hip depressions.

Contraindicated: use in the facial region, breast augmentation and genital augmentation.

• Implantation plane: subcutaneous and/or supraperiosteal tissue. Technique and depth are chosen according to the region treated.
• Qualification: the manufacturer restricts treatment to physicians with knowledge and experience in fat grafting or comparable procedures, with specific training in injection techniques.
• Preparation: mark the areas to be treated and prepare them under aseptic conditions. A local anaesthetic may be used and, at the physician's discretion, antibiotic prophylaxis.
• Assembly: remove the syringe from the blister, take off the cap and attach a suitable sterile needle to the Luer Lock connector. The pack does not include needles or cannulas.
• Correction: correct to a maximum of 100 % of the desired volumising effect. Do not overcorrect.
• Never inject into blood vessels or by the intramuscular route: risk of vascular occlusion and embolism.
• If a needle becomes blocked, replace it with a new one; do not increase pressure on the plunger.
• Syringe graduation: this is an indicative reference to the nominal volume of 10 ml, not a measuring function. Sufficient volume is assessed visually and by palpation.
• Aftercare: do not expose the area to intense heat (sun, solarium, laser, IPL) or extreme cold; avoid sporting exertion for a few days; do not massage or press the area over the following days.

Duration: the manufacturer states up to 18 months; the duration of the filling effect varies according to the depth and area of injection.

• Storage: at room temperature, between 2 °C and 25 °C. Do not freeze or expose to extreme heat.
• The pack includes: 1 syringe of 10 ml in a blister, instructions for use and labels with batch number and expiry date. One label is given to the patient to ensure traceability.
• Single-use product. Do not re-sterilise, do not mix with other injectable products and do not transfer to another container.
• Do not use if the packaging or blister is damaged, or after the expiry date.
• Used syringes and needles are considered contaminated and must be disposed of in accordance with the rules of medical practice.

Contraindications according to the manufacturer: tendency to hypertrophic scars and keloids; intolerance to Gram-positive bacteria; active inflammatory or infectious processes; acute or chronic skin diseases; anticoagulant therapy; known allergy to hyaluronic acid; autoimmune diseases.

There are no clinical data on use in pregnant women, breastfeeding women or patients under 18 years of age. Patients with multiple allergies must be excluded from treatment.

Specific contraindications for the body product: the use of HYAcorp MLF2 in the facial region is contraindicated, as are breast and genital augmentation.

Warnings: do not inject into blood vessels or by the intramuscular route. Do not inject into areas where a permanent implant has been placed or into areas already treated with another filler material. Thorough anatomical knowledge of the area is essential, as is particular caution in the vicinity of vulnerable structures such as nerves, vessels and viscera. Patients taking substances that affect coagulation (acetylsalicylic acid, NSAIDs) may show increased bleeding or bruising at the injection site.

Reported adverse events: pruritus, redness, tenderness and swelling at the puncture site, subcutaneous bleeding or haematomas, indurations and hypersensitivity reactions, usually resolving spontaneously within one or two weeks. Very rare late reactions: bacterial infections, biofilm formation, chronic inflammatory nodules, reactivation of herpes infections, migration of the material, skin necrosis, foreign body reactions and granulomas. The technique may give rise to overcorrection or bluish discolouration (Tyndall effect).

Always consult the instructions for use enclosed in the packaging before application.