STYLAGE® XXL BI-FLEX® with Mepivacaine

STYLAGE® XXL BI-FLEX® with Mepivacaine — Injectable HA Dermal Filler for Extreme Volume Loss & Maximum-Depth Structural Facial Volumisation

Product Specifications

• Drug Class: Injectable hyaluronic acid dermal filler (cross-linked, supraperiosteal/maximum depth, with mannitol and mepivacaine)
• Active Ingredients: Hyaluronic acid (cross-linked) 21mg/g; Mannitol 9mg/g; Mepivacaine Hydrochloride 3mg/mL
• Manufacturer: Laboratories VIVACY
• Brand: STYLAGE®
• Country of Origin: France
• Strength: 21mg/g HA; 9mg/g Mannitol; 3mg/mL Mepivacaine Hydrochloride
• Dosage Form: Injectable gel — 2 × 1mL prefilled syringes (BI-FLEX® syringe system) + 2 × 25G 40mm needles + 2 × 27G ½” needles + 1 × 23G ½” needle
• FDA Status: Not currently approved by the US FDA
• Regulatory Status: CE-marked (EU); current as of 2026

Mechanism of Action & Mepivacaine: Why This Anesthetic at Maximum Depth

STYLAGE® XXL BI-FLEX® with Mepivacaine is engineered specifically for maximum-depth structural volumisation. When placed into the deep subcutaneous or supraperiosteal planes, the cross-linked HA matrix integrates into deep tissue compartments, binding water to deliver immediate projection and high-load structural support.

The advanced performance of this maximum-depth filler relies on three distinct formulation pillars:

• IPN-Like Technology™ (Dual-Network Matrix): By interlocking two distinct HA polymer networks within a single gel, this technology delivers superior cohesivity, elasticity, and resistance to mechanical deformation compared to conventional single-network fillers. This dual architecture is essential for maintaining crisp structural contours under the heavy muscle and tissue loads found at the supraperiosteal depth.
• Antioxidant Shielding (9mg/g Mannitol): Injections into deep structural planes are subject to intense localized oxidative stress. Mannitol acts as a powerful free radical scavenger, absorbing the initial wave of post-injection free radicals to prevent premature degradation of the HA chains. This protection helps stabilize the gel matrix, directly supporting an expected clinical longevity of up to 12 months.
• Purpose-Selected Local Anesthetic (3mg/mL Mepivacaine HCl): Unlike shallower fillers that utilize lidocaine, STYLAGE® XXL uses mepivacaine, an amide-type anesthetic uniquely optimized for deep-plane procedures.
  • Rapid Onset & Low pH: Delivers a faster tissue onset and requires less tissue buffering at the injection site.
  • No Intrinsic Vasodilation: Helps minimize procedural bruising and ensures more predictable deep-plane pharmacokinetics.
  • Strategic Duration: Features a shorter anesthetic duration than lidocaine, giving practitioners a clinically useful window to evaluate early structural contours before the anesthesia has fully dissipated.

Five-Needle Configuration Logic

The versatile, five-needle configuration supplied with each box is specifically matched to the varied technical demands of maximum-depth placement and high extrusion forces:

• 2 × 25G 40mm Needles: Tailored for deep bolus delivery directly onto the supraperiosteal plane or into deep fat compartments.
• 2 × 27G ½” Needles: Optimized for controlled, high-precision product placement in subcutaneous zones.
• 1 × 23G ½” Needle: Provides a high-bore option for initial entry points or when navigating high-resistance dense tissue.

Clinical Management

The high-density matrix gradually degrades through natural endogenous hyaluronidase activity and remains fully and rapidly reversible via exogenous hyaluronidase injection if clinical modification is required.

About STYLAGE® XXL BI-FLEX® with Mepivacaine — Rebrand & Position in the STYLAGE® Line

STYLAGE® XXL BI-FLEX® with Mepivacaine replaces the previous STYLAGE® XXL Bi-SOFT® presentation while maintaining the same indication for severe structural volume restoration. The updated BI-FLEX® syringe was designed to improve grip, extrusion control, and injection precision during high-viscosity filler placement. The deep green and white packaging helps practitioners distinguish the product from earlier Bi-SOFT® stock when re-ordering or when buying online.

Within the STYLAGE® dermal filler portfolio, XXL occupies the highest structural tier for severe-to-extreme volume deficits requiring supraperiosteal correction. STYLAGE® XL (26mg/g) is used for substantial volumisation, while STYLAGE® L and M target moderate volume loss, deep wrinkle correction, and nasolabial folds and marionette lines. More superficial formulations address perioral lines and lip enhancement. STYLAGE® XXL BI-FLEX® is also the only formulation in the range to use mepivacaine rather than lidocaine. This is a deliberate formulation choice for the depths at which it is indicated.

Practitioners evaluating whether STYLAGE® is a good filler will find that the range is CE-marked, manufactured in France to pharmaceutical-grade standards, and built on IPN-Like Technology™, supported by the aesthetic medicine literature.

Indications, Clinical Use & When to Choose STYLAGE® XXL

STYLAGE® XXL BI-FLEX® is indicated for severe-to-extreme facial volume loss affecting the cheeks, temples, jawline, and midface. At supraperiosteal depth, the product functions as a structural scaffold capable of restoring projection and contour in advanced skeletal and deep-fat compartment deficits.

Common applications include cheekbone augmentation, chin projection, and jawline definition. The filler may also serve as the deepest correction layer in complex multi-plane protocols addressing advanced nasolabial folds and marionette lines with a significant structural component.

STYLAGE® XXL BI-FLEX® is generally selected when STYLAGE® XL or lighter formulations cannot provide the required lift or volumisation. It is not indicated for superficial rhytides, moderate correction, or minor contour refinement. Patient selection should consider the condition of the patient’s skin, factors such as skin type and prior filler history, and the degree of structural deficiency. This product is for licensed aesthetic medicine professionals with experience in supraperiosteal injections.

Administration, Side Effects & Safety

STYLAGE® XXL BI-FLEX® with Mepivacaine is supplied with a five-needle configuration to accommodate the varied technical demands of maximum-depth placement.

• The 25G 40mm needles support deep bolus delivery at the supraperiosteal plane; the 27G ½” needles allow more controlled subcutaneous placement.
• The 23G ½” needle provides an option for initial entry or high-resistance tissue.

Needle selection should reflect injection depth, technique, and the target treatment area. Mepivacaine is co-formulated at 3mg/mL, although practitioners may still incorporate regional block anesthesia depending on treatment extent and patient sensitivity.

Following treatment, patients should be advised to avoid sun exposure until redness and swelling resolve. Patients should also avoid strenuous physical activity, alcohol, and facial heat treatments in the immediate post-treatment period.

Common side effects include:

• Transient swelling
• Redness
• Tenderness
• Bruising at the injection site

These mild concerns usually resolve within a few days. Furthermore, deep-plane edema may persist longer than with superficial fillers. Rare but serious complications include vascular occlusion, skin necrosis, and visual disturbance, requiring immediate management according to current filler-complication protocols and the official IFU.

Patients should be screened for hypersensitivity to hyaluronic acid or amide-type anesthetics, including mepivacaine, before treatment.

Legal & Regulatory Status

STYLAGE® XXL BI-FLEX® with Mepivacaine is CE-marked and manufactured in France by Laboratories VIVACY for professional aesthetic medicine use within the European Union. The product is intended exclusively for licensed medical professionals and registered aesthetic clinics. As of 2026, STYLAGE® fillers are not approved by the US FDA for cosmetic indications. Practitioners should verify local importation requirements and regulatory status before ordering. Information on this page is current as of 2026 and is subject to change.

When buying online, practitioners should source exclusively from verified, authorized distributors who can provide documentation of product authenticity and supply chain compliance. Those interested in wholesale arrangements for STYLAGE® XXL BI-FLEX® with Mepivacaine should confirm sourcing arrangements through approved professional supply channels and contact Medica Depot’s support representatives for sourcing information and documentation support.

Practitioners wishing to buy STYLAGE® or buy dermal fillers through an authorized channel should confirm product authenticity and documentation with their chosen distributor. For sourcing guidance, contact Medica Depot’s support representatives.

References

1. Prager W, Micheels P, Bonnet S, Vigneron J. Long-term follow-up of the behavior of facial volumizing cross-linked hyaluronic acid gels. J Clin Cosmet Dermatol. 2024;8(1):114-122. doi: 10.16966/2576-2826.180
2. Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012;59(2):90-102. doi: 10.2344/0003-3006-59.2.90
3. European Regulation (EU) 2017/745 on Medical Devices (MDR). Annex VIII: Classification Rules for Active Injectable Implants.

The contents of this page are meant for licensed medical professionals. They serve informational purposes only and are not to be taken as medical advice.