Stylage S 2x0.8ml
Important Notice
Regulated medical device (EU MDR 2017/745). For sale exclusively to qualified healthcare professionals.
What this purchase includes
- Original productFrom the manufacturer or an official distributor, CE marked.
- Batch and expiry documentedRecorded per unit on the delivery note and the invoice.
- Controlled storageOur own Madrid warehouse, 12 to 18 °C under 24 h control.
- Dispatch in 24 to 48 hFrom Madrid, insured and with a tracking number.
- Reachable Monday to Friday9:00 to 17:00 by WhatsApp and email. People, not forms.
STYLAGE® S is the anaesthetic-free version of the lowest-concentration filler of the Laboratoires VIVACY range: 16 mg of hyaluronic acid cross-linked with BDDE per gram of gel, with mannitol as an antioxidant. It is injected into the superficial to mid dermis to fill skin depressions of the face and into the labial mucosa for lip contouring. Indicated when anaesthesia is preferably managed independently of the implant.
- Cross-linked HA 16 mg/g (BDDE)
- Anaesthetic Without lidocaine
- Contents 2 syringes × 0.8 ml
- Needles 4 sterile single-use
- Plane Superficial to mid dermis
Composition and technology
- Cross-linked hyaluronic acid (BDDE): 16 mg.
- Phosphate buffer and mannitol, pH 7.2, q.s. for 1 g of gel.
- Without anaesthetic: unlike STYLAGE® S Lidocaine, this reference does not contain lidocaine hydrochloride. It allows topical or nerve-block anaesthesia to be applied at the practitioner's discretion and avoids the contraindications specific to amide-type anaesthetics and to porphyria.
- Mannitol (antioxidant): incorporated into the formulation as an antioxidant agent. According to VIVACY's technical documentation, it protects the hyaluronic acid gel against the damage caused by the free radicals (oxidative stress) generated during the injection process, thereby slowing the degradation of the hyaluronic acid. It is the distinguishing element of the STYLAGE range compared with conventional HA fillers.
- IPN-Like technology (InterPenetrated Networks): VIVACY's patented cross-linking technology. It preserves the partial independence of the interpenetrated hyaluronic acid networks while increasing the density of chemical nodes. The manufacturer associates it with the optimisation of the gel's rheology —in particular the viscosity, to ensure injectability— and with the cohesivity and monophasic character of the gel.
- Cross-linker: BDDE. Hyaluronic acid of non-animal origin.
- Bi-SOFT® syringe: patented bi-material injection system (polycarbonate and thermoplastic elastomer with a soft-touch surface), with oversized plunger and finger flanges and an optimised centre of gravity. It is a property of the syringe, not of the gel: it aims to reduce the perceived injection force and to improve control of the deposit.
- Sterile, apyrogenic gel, of physiological pH and osmolarity, packaged in a pre-filled syringe and sterilised by autoclave (moist heat). The needles are sterilised by irradiation or ethylene oxide.
Differences between the variants of the STYLAGE® range
The range is graded by hyaluronic acid concentration and degree of cross-linking, which determines the consistency of the gel and, with it, the injection plane and the indication. The concentrations are taken from the manufacturer's instructions for use and are expressed per gram of gel (q.s. 1 g).
| S — 16 mg/g | Superficial to mid dermis. Skin depressions of the face; lip contouring by injection into the mucosa. 0.8 ml syringe |
|---|---|
| M — 20 mg/g | Mid to deep dermis. Skin depressions; lip contouring and/or volume augmentation; volume restoration of the dorsum of the hand by the subcutaneous route |
| L — 24 mg/g | Deep dermis. Skin depressions of the face. Not indicated for superficial wrinkles, thin skin, lips or areas with an exposed vascular network |
| XL — 26 mg/g | Deep dermis or subcutaneous plane. Restoration or augmentation of facial volumes. It is the highest concentration in the range |
| XXL — 21 mg/g | Deep dermis or subcutaneous plane. High-viscosity volumising; the only product in the range whose pack includes a cannula |
| Special Lips — 18.5 mg/g | Labial mucosa. Redefinition and/or augmentation of lip volume |
| HydroMax — 12.5 mg/g | Mid to deep dermis. Skin hydration and elasticity. The only product in the range formulated with sorbitol instead of mannitol |
The concentration of XXL is lower than that of XL: the range is not a linear ascending scale. XL and XXL share their volumising indication and injection plane, and differ in the rheological behaviour of the gel — the manufacturer positions XXL as a high-viscosity volumiser.
Indications and treatment areas
Injectable hyaluronic acid gel intended to fill skin depressions of the face by injection into the dermis. STYLAGE® S is equally indicated for lip contouring (ourlement) by injection into the labial mucosa.
Outside the indication: the instructions for use do not cover treatment of the tear trough or of the periorbital region, nor the restoration of facial volumes.
Technique and treatment protocol
- Injection plane: superficial to mid dermis of the face; labial mucosa for contouring.
- Recommended techniques: linear retrograde injection, multiple-puncture technique or a combination of both.
- Anaesthesia: as it does not incorporate lidocaine, consider topical anaesthesia or a prior block, especially in the labial mucosa.
- Only the needles supplied with the product should be used: the combination of both devices has been validated by the manufacturer. Screw the needle firmly onto the Luer-Lock cone.
- The use of sterile, CE-marked blunt-tipped cannulas is possible. In that case the practitioner must select the appropriate gauge and length and scrupulously observe aseptic conditions, in particular the pre-hole.
- Inject slowly to avoid overcorrection. If the injection is too deep the efficacy of the correction is reduced; if it is too superficial, skin discolouration, small indurations or an irregular correction may appear.
- It is recommended not to inject more than 20 ml of cross-linked hyaluronic acid per person per year (all ranges combined).
- Sessions: depending on the characteristics of the area, of the patient and of the injection depth, one or two sessions are required for an optimal treatment. Regular touch-up sessions allow the correction to be maintained.
- After injection: do not apply cold and massage the treated area thoroughly to optimise the uniformity of the correction.
Technical data
| Manufacturer | Laboratoires VIVACY, Archamps Technopole, 74160 Archamps (France) |
|---|---|
| Active substance | Cross-linked hyaluronic acid 16 mg/g |
| Anaesthetic | Not contained |
| Cross-linker | BDDE |
| Antioxidant | Mannitol |
| Technology | IPN-Like (cross-linking) · Bi-SOFT® syringe |
| pH | 7.2 (phosphate buffer) |
| Presentation | 2 pre-filled syringes of 0.8 ml |
| Needles | 4 sterile single-use needles (gauge not specified in the instructions for use) |
| Treatment plane | Superficial to mid dermis; labial mucosa |
| Sterilisation | Moist heat (syringe) / irradiation or ethylene oxide (needles) |
| Classification | CE-marked medical device in accordance with Directive 93/42/EEC; notified body 0344. According to the instructions for use, STYLAGE® S obtained the CE mark in 2008 |
| Traceability | VIVACY remote authentication system with RFID technology |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: in its original packaging between 2 °C and 25 °C, protected from freezing and from light. Failure to comply with the storage conditions may affect the performance of the product.
- If it has been kept in a refrigerator, allow the product to reach room temperature before injection.
- Do not use after the expiry date stated on the pack and on the syringe. Do not use if the packaging is damaged.
- Single-use product. Do not reuse or re-sterilise, even if the implant has not been injected. Inject immediately after opening.
- The pack contains: 2 pre-filled syringes of 0.8 ml, 4 sterile single-use needles, instructions for use and labels with the batch number — one for the patient and one for the medical record.
Contraindications and warnings
It must not be used:
- in association with a peel, a laser treatment or dermabrasion (the practitioner decides the waiting period required after these treatments)
- in patients with a tendency to develop hypertrophic scars
- in patients with known hypersensitivity to any of the components
- in pregnant or breastfeeding women, or in children
- in areas, or in the vicinity of areas, with inflammatory or infectious skin problems (acne, herpes, etc.)
Precautions for use: obtaining the patient's informed consent is strongly recommended. In patients with a history of herpes, the punctures may trigger a new outbreak. In patients with a declared or previous autoimmune disease, the practitioner must decide case by case, propose a prior double test and not inject if the disease is progressive. Patients with a history of streptococcal disease (recurrent tonsillitis, rheumatic fever) must undergo a prior double test; in the case of rheumatic fever with cardiac involvement, injection is not recommended. In the case of a haemostasis disorder or anticoagulant therapy the risk of haematomas is increased. The intake of aspirin, NSAIDs, antiplatelet agents, anticoagulants or vitamin C should be avoided in the week preceding the injection.
Vascular risk: do not inject into blood vessels. An accidental intravascular injection may cause vascular occlusion with rare but serious complications —visual disturbances, blindness, necrosis of the skin and/or of the underlying tissues— depending on the area injected. Do not inject into nerves: accidental nerve injury may cause transient paraesthesia.
Always consult the instructions for use included in the pack before treatment. The binding contraindications are those set out in the official documentation supplied with the product.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official instructions for use of Laboratoires VIVACY (OPDC340 v4) and on the manufacturer's technical documentation. This information sheet does not replace the instructions for use supplied with the product.
