Stylage XXL 2x1ml

• Cross-linked hyaluronic acid (BDDE): 21 mg.
• Phosphate buffer and mannitol, pH 7.2, q.s. to 1 g of gel.
• Without anaesthetic: it does not contain lidocaine hydrochloride. The contraindications for hypersensitivity to amide-type anaesthetics or for porphyria therefore do not apply. Consider topical or nerve-block anaesthesia at the practitioner's discretion.
• 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 differentiating 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 improve control of the deposit.
• Sterile, non-pyrogenic 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.

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. to 1 g).

The concentration of XXL is lower than that of XL: the range is not a linear ascending scale. XL and XXL share a volumising indication and injection plane, and differ in the rheological behaviour of the gel — the manufacturer positions XXL as a high-viscosity volumiser.

Injectable hyaluronic acid gel indicated for the restoration or augmentation of facial volumes by injection into the deep dermis or by the subcutaneous route.

It shares its indication and injection plane with STYLAGE® XL. Its hyaluronic acid concentration is lower (21 versus 26 mg/g); the manufacturer positions it as a high-viscosity volumiser, and the pack with cannula directs its use towards providing volume in large areas.

Areas excluded by the manufacturer: areas of thin skin (forehead, periorbital region including eyelids, tear troughs and crow's feet), areas with an exposed vascular network (glabellar region) and the lips.

• Injection plane: deep dermis or subcutaneous plane. Avoid superficial injection.
• Needle or cannula: injections of STYLAGE® XXL are performed with a needle or a cannula according to the practitioner's habits. The pack includes 3 sterile needles and 1 sterile single-use cannula.
• Recommended techniques: retrograde linear injection, multi-puncture technique or a combination of both.
• 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.
• 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 exceed 2.0 ml per treated area and session, and not to inject more than 20 ml of cross-linked hyaluronic acid per person per year.
• Do not inject into vessels or into muscles.
• Sessions: depending on the characteristics of the area, of the patient and of the depth of injection, one or two sessions are required for 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.
• Advise the patient to avoid massaging or compressing the injected area during the first 3 days, and to avoid sauna, hammam and very intense sport during the first week after injection.

• 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 shown on the packaging and on the syringe. Do not use if the packaging is damaged.
• Single-use product. Do not reuse or resterilise, even if the implant has not been injected. Inject immediately after opening.
• The pack contains: 2 pre-filled syringes of 1.0 ml, 3 sterile needles and 1 sterile single-use cannula, instructions for use and labels with the batch number — one for the patient and one for the medical record.

Must not be used:

• in combination 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.)
• in areas of thin skin (forehead, periorbital region including eyelids, tear troughs and crow's feet), in areas with an exposed vascular network (glabellar region) or in the lips

Precautions for use: it is strongly recommended to obtain the patient's informed consent. In patients with a history of herpes, the punctures may trigger a new outbreak. In patients with declared autoimmune disease or a history thereof, the practitioner must decide on a case-by-case basis, 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 haemostatic disorder or anticoagulant therapy, the risk of haematoma is increased. The intake of aspirin, NSAIDs, antiplatelet agents, anticoagulants or vitamin C should be avoided in the week before injection.

Vascular risk: do not inject into blood vessels. 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 application. The binding contraindications are those set out in the official documentation accompanying the product.