STYLAGE® XL BI-FLEX® with Lidocaine

Product specifications

• Active Ingredients: Cross-linked hyaluronic acid 26mg/g; lidocaine 3mg/mL
• Strength: 26mg/g HA | 3mg/mL lidocaine
• Dosage Form: Injectable gel
• Format: 2 × 1mL prefilled syringes (BI-FLEX® syringe system) + 2 × 23G needles + 2 × 27G needles
• Packaging: Teal and white box — updated visual identity under the BI-FLEX® rebrand
• Manufacturer: Laboratories VIVACY
• Brand: STYLAGE®
• Country of Origin: France
• Device Class: Class III Injectable Medical Device (Cross-linked hyaluronic acid dermal filler with lidocaine)
• FDA Approval Date: Not confirmed; verify current US FDA status before use
• Regulatory Status: CE-marked for EU use; verify current FDA and local jurisdiction status before use
• Route of Administration: Deep dermal, subcutaneous, or supraperiosteal injection, depending on treatment area and correction objective
• Storage Requirements: Store below 25°C; do not freeze; protect from direct sunlight
• Intended Use: Licensed aesthetic medicine professionals only

What is STYLAGE® XL BI-FLEX® with Lidocaine? Position in the STYLAGE® range

At 26mg/g HA, STYLAGE® XL BI-FLEX® with Lidocaine features the highest concentration in the STYLAGE range. Manufactured by Laboratories VIVACY in France, this CE-marked medical device treats severe facial volume deficits and provides deep structural contouring when lighter formulations (such as STYLAGE S, M, or L) are insufficient. It utilizes IPN-Like Technology™ (Interpenetrating Network) to ensure high elasticity, cohesivity, and resistance to mechanical deformation under sustained deep-tissue loads. The BI-FLEX® designation represents an optimized, rebranded syringe system (formerly Bi-SOFT®) designed to improve injection ergonomics and safety. For procurement, it features a distinctive teal-and-white box. While widely utilized under its European CE mark, practitioners investigating its US status should note that STYLAGE formulations are not FDA-approved; regulatory authorization remains product- and market-specific. Clinical selection should rely on an assessment of volume deficit, target anatomy, and injection plane.

Mechanism of Action & the Role of Lidocaine

Cross-linked HA (26mg/g) integrates into deep dermal and subcutaneous tissues, binding water for immediate, sustained volumization. At the deep subcutaneous and supraperiosteal planes, IPN-Like Technology™ optimizes gel cohesivity, elasticity, and resistance to mechanical deformation under sustained tissue loads. Like all hyaluronic acid gels, it degrades gradually via endogenous hyaluronidase and can be reversed with exogenous hyaluronidase injection if clinically indicated. Because deep-plane volumization inherently involves greater procedural discomfort, the co-formulated lidocaine (3mg/mL) acts as an amide-type local anesthetic to attenuate nociceptive signaling. This eliminates the need for a separate anesthetic step or a secondary needle pass, reducing procedural time and improving patient tolerance. Product longevity at these deep planes is affected by variables such as tissue quality, movement, and patient lifestyle; the expected duration should be verified against the product instructions for use (IFU).

What Are the Indications & Clinical Use of STYLAGE® XL BI-FLEX® with Lidocaine?

STYLAGE® XL BI-FLEX® with Lidocaine is appropriate when the degree of volume loss or the structural correction required exceeds what moderate-concentration STYLAGE® formulations can address. Product selection should be based on the volume deficit, condition of the patient's skin, tissue quality, injection plane, and local labeling.

• Severe volume loss: Significant facial volume deficit in areas such as cheeks, temples, midface, and jawline where maximum HA concentration is required.
• Deep facial volumization: Structural contouring of cheekbones, chin, and jawline at the supraperiosteal or deep subcutaneous injection plane.
• Nasolabial folds and marionette lines: Deep correction layer for folds with a significant volume-loss component, particularly in multi-plane protocols.
• Multi-plane correction: May be combined with lighter STYLAGE® formulations when both deep support and superficial refinement are required.
• Professional aesthetic procedures: For licensed aesthetic professionals with deep-plane injection experience, familiar with facial anatomy, vascular risk, and complication management.

Administration, Side Effects & Safety of STYLAGE® XL BI-FLEX® with Lidocaine

STYLAGE® XL BI-FLEX® with Lidocaine injection is placed at the deep dermal, subcutaneous, or supraperiosteal plane depending on the treatment area and correction objective. The provided 23G and 27G needles support deep-plane delivery. Technique options include bolus, linear threading, fanning, or other deep-plane approaches based on practitioner assessment and local labeling; volume per session is at the practitioner's discretion, with overcorrection avoided.

• Pre-treatment assessment: Evaluate medical history, allergies, prior filler use, active infection, pregnancy/lactation status, anticoagulant use, autoimmune history, and vascular risk factors.
• Aseptic technique: Use sterile technique and select the appropriate injection plane.
• Lidocaine: Co-formulated at 3mg/mL; supplemental topical or block anesthesia may be used at the practitioner's discretion. Screen for hypersensitivity to amide-type local anesthetics.
• Post-treatment care: Advise patients to avoid sun exposure, UV light, extreme heat, alcohol, and strenuous activity until redness or swelling resolves.
• Expected local reactions: Bruising at the injection site, redness, swelling, and tenderness may occur and typically resolve within a few days. Swelling may be more pronounced or longer-lasting than with superficial formulations at deep injection depths.
• Reversal: HA filler may be dissolved with hyaluronidase when clinically indicated.
• Storage: Store below 25°C, protect from direct sunlight, and do not freeze.

Rare but serious risks include vascular occlusion, skin necrosis, visual disturbance or vision loss, infection or abscess formation, granuloma, delayed inflammatory reaction, hypersensitivity, and lidocaine-related systemic reactions in sensitive patients. Bleeding risk may increase in patients taking anticoagulants, antiplatelet agents, NSAIDs, or supplements affecting coagulation. Refer to the product IFU and local clinical protocols for complete information on contraindications, adverse events, and management.

Legal Status of STYLAGE® XL BI-FLEX® with Lidocaine

Current as of May 2026, STYLAGE® XL BI-FLEX® with Lidocaine is manufactured in France by Laboratories VIVACY and is CE-marked for professional aesthetic use in the EU. Use remains subject to local regulatory requirements, professional scope of practice, and product-specific labeling. Current US FDA status should be verified before procurement or use. FDA approval for dermal fillers is product- and indication-specific, and STYLAGE® XL BI-FLEX® with Lidocaine should not be represented as FDA-approved unless confirmed through current FDA databases or official labeling. Practitioners should also verify importation rules and local scope-of-practice requirements before procurement, discussion, or administration.

Availability & Access to STYLAGE® XL BI-FLEX® with Lidocaine

Access to STYLAGE® XL BI-FLEX® with Lidocaine should be restricted to licensed healthcare professionals, registered aesthetic clinics, and qualified injectors operating within local regulatory requirements. Professionals evaluating how to buy STYLAGE® XL BI-FLEX® wholesale should confirm supplier authorization, authenticity documentation, storage conditions, lot number traceability, and jurisdiction-specific regulatory status before procurement. When buying online, product documentation and handling standards should be verified before placing any order. Practitioners who wish to buy dermal fillers or buy STYLAGE® products may contact Doctor Medica's staff for information and documentation support.