HYAcorp Lips 1x1ml

1 ml of HYAcorp Lips contains:

• Hyaluronic acid: 2.0 mg
• Cross-linked hyaluronic acid: 16.0 mg
• Sodium chloride: 6.9 mg
• Water for injections q.s. to 1.0 ml

Biphasic gel: cross-linked hyaluronic acid particles 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). It 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, which is particularly relevant in the lip area.

Lips is the only reference in the range with 16 mg/ml of cross-linked hyaluronic acid and the only one whose indication is limited to the lips. The MLF products are body implants and are contraindicated in the face.

Restoration of lip volume and contour.

The duration of the filling effect varies and depends on the depth and area of injection. The achievable result depends on the skin type and on the change requested.

• Implantation plane: dermal layer; the manufacturer describes implantation in the mid dermal tissue. Technique and depth are chosen according to the region treated.
• Preparation: mark the area to be treated and prepare it carefully 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 one of the sterile needles supplied to the Luer Lock connector.
• Correction: correct to a maximum of 100 % of the desired volumising effect. Do not overcorrect.
• Never inject into blood vessels: 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 1 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.

The patient must be informed before treatment about the indications, warnings, intolerances, possible adverse effects and the expected result.

• Storage: at room temperature, between 2 °C and 25 °C. Do not freeze or expose to extreme heat.
• The pack includes: 1 syringe of 1 ml in a blister, 2 sterile needles, 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.

Warnings: do not inject into blood vessels. Do not inject into areas where a permanent implant has been placed or into areas already treated with another filler material. Particular caution is required in the vicinity of vulnerable structures such as nerves and vessels. 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.