STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine

Product Specifications

• Active ingredients: Cross-linked hyaluronic acid 18.5mg/g; lidocaine 0.3%
• Strength: 18.5mg/g HA | 0.3% lidocaine
• Dosage form: Injectable gel
• Format: 1 × 1mL prefilled syringe with BI-FLEX® syringe system, rebranded from Bi-SOFT®, + 2 × 30G ½ needles
• Packaging: Magenta/purple and white box — updated visual identity under the BI-FLEX® rebrand
• Manufacturer: Laboratories VIVACY
• Brand: STYLAGE®
• Country of origin: France
• Drug class: Cross-linked injectable hyaluronic acid filler for lip augmentation, 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: Intradermal, subdermal, or submucosal injection, depending on the lip 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® SPECIAL LIPS BI-FLEX® with Lidocaine?

STYLAGE® SPECIAL LIPS has transitioned from the older Bi-SOFT® system to the updated BI-FLEX® syringe platform, designed for enhanced injection precision and ergonomics. The product features an updated magenta/purple-and-white box to help practitioners identify the new inventory when reordering. Manufactured in France by Laboratories VIVACY, the core CE-marked formulation remains unchanged. It is formulated at 18.5mg/g HA. While this matches STYLAGE® LIPS PLUS, STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine is distinguished by a precise rheology tailored for shaping, contouring, and definition rather than heavy volume. Unlike the STYLAGE® M and L lines, this specific lip formulation contains no mannitol to preserve its tissue integration profile. It uses IPN-Like Technology™, which refers to interlocked polymer networks designed to provide structural cohesivity and resist gel deformation under constant lip movement. It is also co-formulated with 0.3% lidocaine to minimize discomfort in the highly sensitive perioral zone. Dermal filler approvals are highly region- and indication-specific. Because STYLAGE® is primarily a CE-marked European range, practitioners should independently verify the current US FDA status before procurement or use.

How does STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine work?

The lips present a uniquely demanding environment for injectable fillers. Constant movement during speech, eating, and expression places mechanical stress on the gel, requiring both structural integrity and pliability. STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine addresses this through cross-linked HA that integrates into lip tissue, binds water, and delivers immediate volume, definition, and hydration at the injection site. IPN-Like Technology™ uses interlocked polymer networks to resist deformation, helping the gel maintain shape and structure through repeated lip movement. Because this formulation does not contain mannitol, oxidative HA degradation is not modulated by a free radical scavenger. How long STYLAGE® filler lasts in the lips depends on factors such as tissue mobility, lifestyle, injection technique, and the condition of the patient's skin. Duration should be communicated as an expected range and confirmed against the product IFU. Like all HA fillers, the gel is gradually degraded by endogenous hyaluronidase and is reversible with hyaluronidase injection when clinically required.

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

• Lip augmentation: Controlled enhancement of lip body volume and fullness.
• Lip border definition: Vermillion border refinement and improved lip contour.
• Perioral volume restoration: Support for tissues around the mouth affected by age-related volume loss.
• Philtrum and Cupid's bow definition: Support for lip architecture and shape, where clinically appropriate.
• Perioral lines: May be used depending on injection depth, tissue quality, and product labeling.

Patient selection should consider lip tissue quality, skin condition, vascular anatomy, desired augmentation outcome, and factors such as skin type and lifestyle. This product is not indicated for deep structural correction or significant facial volume deficit.

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

STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine injection is placed in the lip body, vermillion border, philtrum columns, Cupid's bow, or perioral treatment area, depending on the clinical objective. The updated BI-FLEX® syringe supports controlled, precise delivery in this treatment area. Technique options include linear threading, serial puncture, microbolus placement, or fanning. Volume per session is determined by the practitioner, with overcorrection avoided, given the vascularity and mobility of lip tissue.

• Pre-treatment assessment: Review allergies, prior filler use, herpes history, active infection, inflammation, pregnancy or 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 0.3%; 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.
• 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 when administering this filler is inadvertent intravascular injection, which can lead to vascular occlusion. Because the lips are highly vascular and mobile, procedures in this area may produce more pronounced localized swelling than injections in some other facial zones.

Common and transient side effects

Most local reactions are mild to moderate and typically resolve within a few days. These include:

• Swelling and bruising at the injection site
• Redness, tenderness, and localized pain
• Itching, firmness, or temporary discoloration
• Mild nodularity in the treated lip tissue

Rare but serious risks

While uncommon when administered by a trained professional using correct technique, serious adverse events can occur and require immediate clinical evaluation:

• Vascular complications, including vascular occlusion, tissue ischemia, and skin necrosis
• Ocular emergencies, including visual disturbance or permanent vision loss from inadvertent embolization
• Inflammatory and immune responses, including granulomas, delayed-type inflammatory reactions, hypersensitivity reactions, or persistent nodules
• Infection or abscess formation at puncture sites
• Lidocaine-related systemic toxicity or hypersensitivity in sensitive patients

Legal status of STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine

Current as of May 2026, STYLAGE® SPECIAL LIPS 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 this product 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 and access of STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine

Access to STYLAGE® SPECIAL LIPS BI-FLEX® with Lidocaine should be restricted to licensed healthcare professionals, registered aesthetic clinics, and qualified injectors operating within local regulatory requirements. Practitioners evaluating how to buy STYLAGE® SPECIAL LIPS BI-FLEX® wholesale should review supplier qualification, authenticity documentation, storage conditions, lot number traceability, and 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 sourcing information and documentation support.