STYLAGE® M BI-FLEX® with Lidocaine

Product Specifications

• Active Ingredients: Cross-linked hyaluronic acid 20mg/g; mannitol 9mg/mL; lidocaine 3mg/mL
• Strength: 20mg/g HA | 9mg/mL mannitol | 3mg/mL lidocaine
• Dosage Form: Injectable gel
• Format: 2 × 1mL prefilled syringes (patented syringe system; formerly known as Bi-SOFT®) + 2 × 30G ½ needles
• Manufacturer: Laboratories VIVACY
• Brand: STYLAGE®
• Country of Origin: France
• Drug Class: Cross-linked injectable hyaluronic acid dermal filler with mannitol and 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: Intradermal, subdermal, or subcutaneous 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® M BI-FLEX® with Lidocaine?

STYLAGE® M BI-FLEX® with Lidocaine is a cross-linked hyaluronic acid dermal filler manufactured by Laboratories VIVACY in France, indicated for moderate wrinkle correction, facial volume restoration, and hand rejuvenation. It uses IPN-Like Technology™ (Interpenetrating Network technology) that creates interlocked HA polymer networks designed to support elasticity, cohesivity, and resistance to deformation. Practitioners looking to buy STYLAGE® products can contact Doctor Medica's staff for assistance on comparing formulations by indication and correction depth. Mannitol 9mg/mL is included as an antioxidant and free radical scavenger that may help limit oxidative degradation of HA. The patented syringe system, formerly known as Bi-SOFT®, is designed to support controlled, smooth injection and precise product placement. The BI-FLEX® designation refers to an optimized rheological profile for controlled injection across multiple treatment areas, and lidocaine 3mg/mL is co-formulated to reduce discomfort during injection. The STYLAGE® range is CE-marked for EU use; practitioners asking whether STYLAGE® is FDA approved should verify current US FDA status, as approval is product- and indication-specific.

How does STYLAGE® M BI-FLEX® with Lidocaine work?

STYLAGE® M BI-FLEX® with Lidocaine works through cross-linked hyaluronic acid, which integrates into dermal tissue and binds water to create immediate volume restoration and wrinkle-filling support at the injection site. IPN-Like Technology™ uses interlocked HA polymer networks designed to improve gel cohesivity, elasticity, and resistance to mechanical deformation. Mannitol 9mg/mL acts as a free radical scavenger and may help slow oxidative HA degradation, supporting product longevity. Lidocaine 3mg/mL is co-formulated as a local anesthetic to reduce discomfort during injection. Like other HA-based injectable dermal fillers, STYLAGE® M BI-FLEX® with Lidocaine is gradually degraded by endogenous hyaluronidase and may be reversed with hyaluronidase injection when clinically appropriate.

What is STYLAGE® M BI-FLEX® with Lidocaine used for?

• Moderate wrinkle correction: Used for moderate facial wrinkles and folds, including nasolabial folds, marionette lines, and perioral rhytids, depending on local labeling and treatment plan.
• Volume restoration: Used where facial volume loss requires structural support at the mid-to-deep dermis or subcutaneous plane.
• Lip augmentation: Suitable for lip augmentation and contour support where appropriate per clinical assessment and local labeling.
• Hand rejuvenation: Used for correction of volume loss on the dorsum of the hands as a distinct treatment area.
• Professional aesthetic procedures: Intended for trained aesthetic professionals familiar with injectable dermal fillers, facial anatomy, hand anatomy, and complication management.

How is STYLAGE® M BI-FLEX® with Lidocaine injection administered?

STYLAGE® M BI-FLEX® with Lidocaine injection is administered intradermally, subdermally, or subcutaneously depending on the treatment area and degree of volume loss. Injection depth may range from the mid-dermis for moderate wrinkle correction to the subcutaneous plane for volume restoration or hand rejuvenation. Technique options include linear threading, fanning, serial puncture, or cross-hatching, depending on anatomy and practitioner preference.

• Pre-treatment assessment: Evaluate medical history, allergies, prior filler use, active infection, inflammation, pregnancy/lactation status, anticoagulant use, autoimmune history, and risk factors for vascular compromise.
• Aseptic technique: Use sterile technique and select the appropriate injection plane.
• Lidocaine: Co-formulated at 3mg/mL; 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: Swelling, bruising at the injection site, redness, tenderness, and mild discomfort may occur and typically resolve within a few days.
• Follow-up: Touch-up or follow-up sessions should be determined by practitioner assessment and treatment objectives.
• Reversal: HA filler may be dissolved with hyaluronidase when clinically indicated.
• Storage: Store below 25°C, protect from direct sunlight, and do not freeze.

What are the side effects and safety considerations?

The most clinically significant safety concern with STYLAGE® M BI-FLEX® with Lidocaine injection is inadvertent intravascular injection and vascular occlusion, requiring appropriate anatomical knowledge, injection technique, early recognition, and emergency management protocols. Common side effects are generally localized and transient, and may include swelling, bruising at the injection site, redness, tenderness, pain, itching, firmness, discoloration, or mild nodularity. These typically resolve within a few days, but persistence, worsening pain, blanching, livedo, delayed capillary refill, or visual symptoms require urgent evaluation. Rare but serious risks include vascular occlusion, skin necrosis, visual disturbance or vision loss, infection or abscess formation, granuloma or delayed inflammatory reaction, hypersensitivity reaction, persistent nodules or inflammatory swelling, and lidocaine-related systemic reactions in sensitive patients. Before treatment, practitioners should review allergies, medications, anticoagulant use, autoimmune history, prior filler complications, and lidocaine sensitivity. Bleeding risk may increase in patients using anticoagulants, antiplatelet agents, NSAIDs, or supplements that affect coagulation. Refer to the product IFU and local clinical protocols for complete contraindication, adverse event, and management information.

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

Current as of May 2026, STYLAGE® M BI-FLEX® with Lidocaine is manufactured in France by Laboratories VIVACY and belongs to the STYLAGE® range, which is CE-marked for professional aesthetic use in Europe. 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® M BI-FLEX® with Lidocaine should not be represented as FDA-approved unless confirmed in current FDA databases or official labeling. Supply and administration should be restricted to licensed medical professionals and registered aesthetic clinics operating within local regulations.

Availability and Access of STYLAGE® M BI-FLEX® with Lidocaine

Access to STYLAGE® M BI-FLEX® with Lidocaine should be restricted to licensed healthcare professionals, registered aesthetic clinics, and qualified injectors operating within local regulatory requirements. Product evaluation should include professional eligibility, batch documentation, packaging integrity, expiry information, storage requirements, and jurisdiction-specific restrictions. Professionals evaluating how to buy STYLAGE® M BI-FLEX® wholesale should avoid treating product availability as equivalent to clinical authorization in a specific market. When buying online, practitioners should verify authenticity documentation, product traceability, and storage conditions. Practitioners who wish to buy dermal fillers or other STYLAGE® products may contact Doctor Medica's staff for sourcing information and documentation support.