STYLAGE® L BI-FLEX®

Product Specifications

• Active Ingredients: Cross-linked hyaluronic acid 24mg/g; mannitol 9mg/mL
• Strength: 24mg/g HA | 9mg/mL mannitol
• Dosage Form: Injectable gel
• Format: 2 × 1mL prefilled syringes + 4 × 27G ½ needles
• Manufacturer: Laboratories VIVACY
• Brand: STYLAGE®
• Alternative Name: BI-soft
• Country of Origin: France
• Drug Class: Cross-linked injectable hyaluronic acid dermal filler (no 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® L BI-FLEX®? A Versatile HA Dermal Filler

STYLAGE® L BI-FLEX® is a cross-linked HA dermal filler manufactured by Laboratories VIVACY in France and used in aesthetic medicine for deep wrinkle correction, volume restoration, and facial contouring. It is also known as BI-soft for practitioner and procurement reference. The product uses IPN-Like Technology™ (Interpenetrating Network technology) to support elasticity, cohesivity, and tissue integration. The BI-FLEX® designation refers to an optimized rheological profile for smooth, controlled injection across multiple treatment areas and injection planes. The product is formulated without lidocaine, giving practitioners the flexibility to manage anesthesia separately according to clinical preference and patient sensitivity. The STYLAGE® range is CE-marked for EU use; practitioners asking whether STYLAGE® is FDA-approved should verify the current US FDA status, as approval is product- and indication-specific. When assessing suitability as a STYLAGE® dermal filler, relevant considerations include its IPN-Like Technology™, mannitol-supported longevity, BI-FLEX® rheology, and clinical versatility across indications, all of which are evaluated alongside the treatment area, patient anatomy, and correction objective.

How Does STYLAGE® L BI-FLEX® Work?

STYLAGE® L BI-FLEX® works through cross-linked hyaluronic acid, which integrates into dermal tissue and binds water to restore volume and smooth deep wrinkles at the injection site. Its IPN-Like Technology™ uses interlocked HA polymer networks designed to support cohesivity, elasticity, and resistance to mechanical deformation, helping the gel maintain controlled behavior in the selected treatment area. Mannitol 9mg/mL acts as a free-radical scavenger and may help reduce oxidative degradation of HA, thereby supporting product longevity. STYLAGE® L BI-FLEX® does not contain lidocaine, so any local anesthesia should be managed separately according to practitioner preference. Like other HA fillers, it is gradually degraded by endogenous hyaluronidase and may be reversed with hyaluronidase injection when clinically required.

What Are the Indications and Clinical Use of STYLAGE® L BI-FLEX®?

STYLAGE® L BI-FLEX® is used in professional aesthetic settings where deep wrinkle correction, facial volume restoration, or contour support is required. It is generally selected for treatment areas that need structural support rather than superficial hydration or fine-line correction. Product selection should be based on the treatment area, the degree of volume loss, the injection plane, tissue quality, the condition of the patient's skin, and local labeling.

• Deep wrinkle correction: Used for deeper facial folds such as nasolabial folds, marionette lines, perioral rhytids, and glabellar lines, depending on local labeling and the practitioner's treatment plan.
• Facial volume restoration: Used in areas where age-related volume loss requires structural support and soft tissue replenishment, at the medium-to-deep dermis or subcutaneous plane.
• Facial contouring: Used for contour refinement in areas such as the cheeks, chin, and jawline when clinically appropriate.
• Versatile treatment areas: BI-soft's rheological profile supports use across multiple injection planes and treatment area requirements.
• Professional aesthetic procedures: Intended for trained aesthetic professionals familiar with injectable dermal fillers, facial anatomy, injection-depth selection, and complication management.

STYLAGE® L BI-FLEX® Administration & Injection Guidelines

STYLAGE® L BI-FLEX® injection is administered intradermally, subdermally, or subcutaneously depending on the treatment area and degree of volume loss. Injection depth may extend to the mid-to-deep dermis or the subcutaneous plane, with technique and volume determined by practitioner assessment, anatomy, product labeling, and the risk of overcorrection. Because this product does not contain lidocaine, topical or local anesthesia may be applied separately according to clinical 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.
• Injection technique: Linear threading, fanning, or cross-hatching may be used, depending on clinical preference and the treatment area.
• Anesthesia: STYLAGE® L BI-FLEX® does not contain lidocaine; any topical anesthesia or local anesthetic administration should be managed separately.
• 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, 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 & Safety Considerations of STYLAGE® L BI-FLEX®?

The most clinically significant safety concern with injectable dermal fillers is inadvertent intravascular injection and vascular occlusion, which can compromise tissue perfusion and may lead to severe outcomes if not recognized and managed promptly. Practitioners should be familiar with facial vascular anatomy and maintain protocols for urgent assessment and management. Common side effects are generally localized and transient. They may include bruising at the injection site, redness, swelling, tenderness, pain, itching, firmness, discoloration, or mild nodularity. These reactions commonly resolve within a few days, but persistence, worsening pain, blanching, livedo, delayed capillary refill, or visual symptoms require urgent clinical 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, and persistent nodules or inflammatory swelling. Before treatment, practitioners should review allergies, medications, anticoagulant use, autoimmune history, prior filler complications, and HA 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 information on contraindications, adverse events, and management.

Legal Status of STYLAGE® L BI-FLEX®

Current as of May 2026, STYLAGE® L BI-FLEX® is manufactured in France by Laboratories VIVACY and belongs to the CE-marked STYLAGE® range for professional aesthetic use in relevant European markets. Use remains subject to local regulatory requirements, professional scope of practice, and product-specific labeling. Regarding US regulatory status: FDA approval for dermal fillers is product- and indication-specific. STYLAGE® L BI-FLEX® should not be represented as FDA-approved unless confirmed through current FDA databases or official labeling. Practitioners should verify local regulatory status, formulary eligibility, and professional-use requirements before procuring, discussing, or administering the product.

Availability and Access

Access to STYLAGE® L BI-FLEX® should be limited to licensed healthcare professionals, registered aesthetic clinics, and qualified injectors working within applicable regulatory requirements. Product evaluation should include verification of professional eligibility, product documentation, handling conditions, expiry information, and jurisdiction-specific restrictions before use in aesthetic medicine. Professionals evaluating how to buy STYLAGE® L BI-FLEX® wholesale should avoid treating product availability as equivalent to authorization for use in a specific market. When buying online, authenticity checks should include batch documentation, packaging integrity, storage conditions, and confirmation that the product is being used only in licensed clinical settings. Practitioners who wish to buy dermal fillers or buy STYLAGE® may contact Doctor Medica's staff for information and documentation support.