Stylage Lips Lidocaine 1x1ml

• Cross-linked hyaluronic acid (BDDE): 18.5 mg — a concentration intermediate between STYLAGE® S and M, adjusted to the mechanical behaviour of the labial mucosa.
• Lidocaine hydrochloride: 3 mg, intended to reduce the pain associated with injection.
• Phosphate buffer and mannitol, pH 7.2, q.s. for 1 g of gel.
• 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.

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).

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.

Injectable hyaluronic acid gel specifically indicated for the redefinition and/or augmentation of lip volume. The lidocaine hydrochloride is intended to reduce the pain associated with injection.

Unlike STYLAGE® S and M —which list the lip as a secondary indication alongside the filling of skin depressions of the face—, this reference has an exclusively labial indication.

Route limitation: the instructions for use expressly exclude injections other than intradermal, subcutaneous or into the labial mucosa.

• Injection plane: into and/or around the labial mucosa.
• Recommended techniques: linear retrograde injection, multiple-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 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.
• The practitioner must be thoroughly familiar with the labial anatomy and the injection planes, and must take into account the presence of lidocaine hydrochloride.

• 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: 1 pre-filled syringe of 1.0 ml, 2 sterile single-use needles, instructions for use and labels with the batch number — one for the patient and one for the medical record.

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.)
• for injections other than intradermal, subcutaneous or into the labial mucosa

In addition, because of its lidocaine content, it must not be used in patients with known hypersensitivity to amide-type local anaesthetics or in patients with porphyria. Association with certain medicines that reduce or inhibit hepatic metabolism is not advised. Lidocaine hydrochloride may induce a positive reaction in anti-doping tests.

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.