RESTYLANE® VOLYME with Lidocaine

Key Uses of Restylane Volyme with Lidocaine

This dermal filler is suitable for various aesthetic enhancements, offering natural and lasting results. It is commonly used for:

• Cheek augmentation: Restores volume and improves contouring.
• Jawline definition: Enhances structure for a more sculpted appearance.
• Chin enhancement: Provides symmetry and balance.
• Nasolabial fold correction: Reduces deep creases between the nose and mouth.
• Marionette line smoothing: Minimises lines extending from the mouth to the chin.
• Temporal hollowing correction: Restores lost volume in the temples.

Manufacturing Information for Restylane Volyme with Lidocaine

Restylane Volyme with Lidocaine is produced by Galderma based in Lausanne, Switzerland. Other products in the Restylane range include:

• Restylane Defyne with Lidocaine: Designed to correct deep wrinkles and folds while maintaining natural facial expressions.
• Restylane Lyft with Lidocaine: A firmer filler suitable for contouring and lifting effects, commonly used in the cheeks and hands.
• Restylane Kysse with Lidocaine: Specifically formulated for lip augmentation, providing flexible and natural-looking results.

Expected Benefits and Results of the Treatments

Restylane Volyme with Lidocaine delivers multiple benefits, including:

• Enhanced facial volume: Restores youthful fullness.
• Natural-looking results: Smooth integration into tissue.
• Long-lasting effects: Results can last over a year.
• Minimised discomfort: Lidocaine provides pain relief during injection.
• Customisable treatment: Adaptable for various facial areas.

Restylane Volyme with Lidocaine Key Ingredients and Device Properties

This advanced filler is composed of:

Key ingredients

• Hyaluronic acid (20 mg/ml): Provides hydration and volume.
• Lidocaine hydrochloride (3 mg/ml): Reduces injection discomfort.
• Phosphate-buffered saline pH 7 (1 ml): Maintains product stability.

Device properties:

• High elasticity for natural movement.
• Soft gel consistency for smooth application.
• Biodegradable formulation for safe absorption over time.

Included Items or Accessories

Each package contains:

• 1 x pre-filled syringe.
• 2 x 27G1/2” sterile needles.
• Patient record labels for traceability and documentation.
• Instructions for use with detailed guidelines for medical professionals.

Administration Method for Restylane Volyme with Lidocaine

Proper administration is essential for achieving optimal results while ensuring patient safety and comfort.

Pre-procedure:

• Conduct a patient consultation and assess suitability.
• Cleanse the treatment area thoroughly.
• Apply a topical anaesthetic if needed.

During procedure:

• Use the supplied 27G needle for precise injection.
• Inject slowly into the subcutaneous or supraperiosteal plane.
• Gently massage the treated area to distribute the product evenly.

After procedure:

• Provide aftercare instructions.
• Advise on possible swelling and minor discomfort.
• Schedule a follow-up appointment if needed.

Guidelines for Proper Aftercare

Patients should follow these guidelines post-treatment:

• Avoid intense physical activity for 24-48 hours.
• Refrain from touching or massaging the treated area.
• Stay away from saunas and excessive heat exposure.
• Apply a cold compress to reduce swelling.
• Use broad-spectrum sunscreen to protect treated skin.

Duration of Restylane Volyme with Lidocaine Effects

Results typically last between 12 to 18 months, depending on individual metabolism and lifestyle factors. Patients may require a touch-up treatment after 9–12 months to maintain optimal results.

Potential Risks and Side Effects

While Restylane Volyme with Lidocaine is generally safe, patients may experience side effects ranging from mild to rare complications.

Common side effects:

• Redness and swelling: Temporary inflammation at the injection site.
• Bruising: Minor bruising may occur, especially in sensitive areas.
• Tenderness or discomfort: Some sensitivity or mild pain after injection.
• Itching or irritation: Temporary reaction to the filler.

Less common side effects:

• Hard lumps or nodules: Small, firm bumps under the skin that may require massage or dissolution.
• Asymmetry: Uneven distribution of filler, requiring touch-ups.
• Prolonged swelling: Lasting more than a few days in some individuals.
• Temporary numbness: Due to lidocaine in the filler.

Rare but serious side effects:

• Allergic reactions: Severe swelling, rash, or anaphylaxis (though uncommon).
• Infection at the injection site: Redness, heat, or pus formation requiring medical attention.
• Delayed inflammatory reactions: Swelling or redness weeks after treatment.
• Vascular occlusion: Accidental injection into a blood vessel, leading to skin necrosis or complications.
• Blurred vision or blindness: Extremely rare but possible if injected near the eye area.

Restylane Volyme with Lidocaine Treatment Contraindications

Restylane Volyme with Lidocaine is not suitable for certain individuals due to potential health risks. A thorough patient consultation should be conducted before treatment to establish if there are the following contraindications:

• Patients with active skin infections: Individuals with bacterial, viral (e.g., herpes simplex), or fungal infections at or near the treatment site should wait until the infection has fully cleared.
• People with autoimmune disorders: Conditions such as lupus, rheumatoid arthritis, or multiple sclerosis may cause unpredictable reactions to dermal fillers.
• Patients with severe allergies: Those with a history of anaphylaxis or known hypersensitivity to hyaluronic acid, lidocaine, or other filler ingredients should avoid treatment.
• Individuals prone to keloid or hypertrophic scarring: People with a history of excessive scar formation may develop lumps or prolonged swelling post-injection.
• Those on blood-thinning medications: Anticoagulants like aspirin, warfarin, and certain supplements (e.g., omega-3, vitamin E) increase the risk of bruising and excessive bleeding.
• Patients undergoing immunosuppressive therapy: Chemotherapy, radiation, or long-term corticosteroid treatments may impair healing and increase infection risks.
• Pregnant or breastfeeding women: The safety of dermal fillers during pregnancy or lactation has not been established, making it unsuitable for these individuals.
• Individuals with uncontrolled diabetes: Poor wound healing and a higher susceptibility to infections make filler treatments unsafe for diabetics with uncontrolled glucose levels.
• People with a history of vascular occlusion or circulatory disorders: Patients with poor circulation are at greater risk of complications, including skin necrosis.
• Those with neuromuscular disorders: Conditions like myasthenia gravis or Lambert-Eaton syndrome may interact with lidocaine, leading to complications.
• Patients who have had recent facial surgery or treatments: Individuals recovering from laser resurfacing, chemical peels, or surgical procedures should wait until full healing before undergoing dermal filler injections.