HYAcorp Face 2x2ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
HYAcorp Face is the classic facial filler from BioScience GmbH: a resorbable cutaneous implant of non-animal hyaluronic acid at 22 mg/ml, formulated as a biphasic gel and supplied in 2 ml syringes with a Luer Lock connector. It is intended for the restoration of facial volume and contour by implantation in the mid dermis, with a specific indication in moderate to deep folds.
- HA 22 mg/ml (20 cross-linked + 2 free)
- Contents 2 syringes × 2.0 ml
- Plane mid dermis
- Needles sterile, included (EO)
- Without lidocaine
Composition and technology
1 ml of HYAcorp Face 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 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.
Differences between the HYAcorp references
| HYAcorp Fine — 1 ml | Non-cross-linked HA 14 mg/ml. Skin quality: hydration and elasticity. Mid dermis. |
|---|---|
| HYAcorp Lips — 1 ml | HA 18 mg/ml (16 cross-linked + 2 free). Lip volume and contour. |
| HYAcorp Face — 2 ml | HA 22 mg/ml (20 + 2). Moderate and deep folds, nasolabial folds, cheeks, glabella. Mid dermis. |
| HYAcorp MLF1 — 10 ml | HA 22 mg/ml, particle size 200–350 µm. Calves, concave deformities, hands. Subcutaneous / supraperiosteal. |
| HYAcorp MLF2 — 10 ml | HA 22 mg/ml, particle size 300–500 µm. Buttocks and larger volume augmentations. Subcutaneous / supraperiosteal. |
Face shares its concentration with MLF1 and MLF2 but differs in the implantation plane (mid dermis versus subcutaneous/supraperiosteal) and in syringe volume. The MLF products are contraindicated in the face.
Indications and treatment areas
Restoration of facial volume and contour: replacement of hyaluronic acid lost from the skin and volume replacement by filling folds.
- Moderate to deep folds
- Nasolabial folds
- Cheek area
- Glabellar lines
Do not inject HYAcorp Face into the periorbital region (eyelid, crow's feet, tear troughs).
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.
Technique and treatment protocol
- Implantation plane: mid dermal tissue. Technique and depth are chosen according to the region treated.
- Preparation: mark the areas to be treated and prepare them 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 2 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 physician's experience and specific training in injection techniques are decisive for the treatment result.
Technical data
| Manufacturer | BioScience GmbH — Walsmühler Straße 18, 19073 Dümmer, Germany |
|---|---|
| Active ingredient | Hyaluronic acid 22 mg/ml (20 mg cross-linked + 2 mg free) |
| Origin | Non-animal, obtained by fermentation |
| Excipients | Sodium chloride 6.9 mg/ml; water for injections |
| Presentation | 2 pre-filled syringes of 2.0 ml with integrated Luer Lock adapter, in a blister |
| Needles | Sterile needles included (ethylene oxide sterilised); the package insert states 2 needles per 2 ml syringe |
| Sterilisation | Syringe contents steam sterilised |
| Route | Implantation in the mid dermis |
| Classification | CE-marked medical device, single use |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: at room temperature, between 2 °C and 25 °C. Do not freeze or expose to extreme heat.
- The pack includes: 2 ml syringes in a blister, 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 and warnings
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.
The use of HYAcorp Face for breast and genital augmentation is contraindicated. Nor should it be injected into the periorbital region.
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.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official instructions for use of BioScience GmbH (HYAcorp Face package insert) and on the product documentation published by the manufacturer at bio-science.org. This data sheet does not replace the instructions for use accompanying the product.