STYLAGE® XXL BI-SOFT®

Description

Name: STYLAGE® XXL BI-SOFT®
Manufacturer: Vivacy
Active Substance(s): CROSS LINKED HYALURONIC ACID
Strength: 21mg/g
Pack Size: 1ML – 2 Pre-Filled Syringes
Accessories: 2 x 1ml Pre-Filled Syringes, 1 x 25G 40mm Cannula and 2 x 27 G ½ Needles , 1 x 23 G ½ Needle

STYLAGE® XXL BI-SOFT® is a high-density injectable cross-linked hyaluronic acid (HA) gel, specifically formulated to restore or augment facial volume in areas with significant volume loss. Developed by Laboratoires VIVACY, this product incorporates Mannitol, an antioxidant that reduces free radical damage and enhances the filler’s stability and duration. With a physiological pH and osmolarity, the product is well tolerated and provides natural-looking, immediate, and durable results, lasting up to 12–18 months depending on patient physiology and treatment area.

Administered using the ergonomic BI-SOFT® syringe system, STYLAGE® XXL ensures optimized injection precision, controlled flow, and improved comfort for both patient and practitioner. It is ideal for facial contouring procedures in the cheeks, temples, jawline, and chin, where structural support and long-lasting volume are desired.

Key Features:

• 21 mg/g of cross-linked hyaluronic acid combined with Mannitol for enhanced longevity and protection
• Ideal for deep dermis or subcutaneous injection in high-volume facial zones
• Supplied with BI-SOFT® ergonomic syringes, sterile needles, and cannula for controlled, safe application
  

STYLAGE® XXL BI-SOFT® is supplied in single-use sterile syringes and available in two formats to meet clinical needs: 2 x 1 ml syringes or 1 x 2.2 ml syringe. Each unit is equipped with sterile needles and a cannula, and is packaged with product labels for traceability and patient documentation.

Packaging Details:

• Available formats:
  • 2 x 1 ml pre-filled syringes, or
  • 1 x 2.2 ml pre-filled syringe
    
• Includes 3 sterile needles and 1 sterile cannula
• Packaged with instruction leaflet, batch labels, and secured in tamper-evident sterile blisters
  

Ingredients:

• Cross-linked Hyaluronic Acid (21 mg/g) using BDDE technology
• Mannitol as an antioxidant
• Phosphate buffer, pH 7.2 for physiological compatibility
• Contains no Lidocaine (unlike other STYLAGE® variants)
  

STYLAGE® XXL BI-SOFT® is indicated for the restoration of facial volume and contouring of large surface areas, especially in cases of pronounced age-related volume loss. It is particularly effective for injecting into the cheeks, temples, chin, and jawline, where robust structural support is required.

Indications:

• Facial volume restoration in aging or hollow areas
• Chin and jawline sculpting
• Cheekbone augmentation
• Temple filling for balanced facial proportions
  

Contraindications:

• Hypersensitivity to hyaluronic acid or any component of the formulation
• Pregnancy and breastfeeding
• Active skin infections or inflammation (e.g. acne, herpes) in or near the treatment site
• Use in thin-skinned areas (e.g. lips, periorbital zone) or vascularly rich regions like the glabella
• Use in patients prone to hypertrophic scarring or with autoimmune disorders, unless under close supervision
  

Possible Side Effects:

• Common: Redness, swelling, pain, bruising, or induration at the injection site
• Rare: Nodules, discoloration, granuloma, or hypersensitivity reactions
• Very rare: Vascular occlusion, tissue necrosis, vision disturbances
  

The product must be administered by a qualified medical professional trained in facial anatomy and dermal filler techniques. Injection into the deep dermis or subcutaneous plane is performed using either the included needle or cannula, following strict aseptic conditions.

Administration Technique:

• Preferred techniques:
  
  • Linear retro-tracing
  • Multipoint injection
  • Combination of both
    
• Max dosage:
  
  • 2 ml per treatment area per session
  • Do not exceed 20 ml per patient annually
    
• Always inject slowly to avoid overcorrection
• Massage the area gently post-injection to ensure even product distribution
  

Storage Recommendations:

• Store between 2°C and 25°C in original packaging
• Protect from frost and direct sunlight
• Use before the expiration date indicated on the syringe and outer box
• Do not re-sterilize or reuse; discard any unused material after injection
  

STYLAGE® XXL BI-SOFT® offers a powerful and safe option for facial volumization, with proven aesthetic outcomes and a favorable safety profile. Its high-density HA formulation and advanced delivery system make it ideal for practitioners seeking natural, sculpted, and long-lasting results.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.