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Restylane Lyft

Restylane Lyft

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for cheek augmentation, correction of midface contour deficiencies, nasolabial folds and other indications in applicable markets under European medical device regulations.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in conformity with quality and safety standards for sterile injectable medical devices (Class III).
  • FDA Approved in the United States for deep dermal to superficial subcutaneous implantation for correction of moderate to severe facial folds and wrinkles (e.g. nasolabial folds), subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age Related midface contour deficiencies, injection into the dorsal hand for correction of volume deficit, and (more recently) augmentation of the chin region in adults over 21.
  • Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting obligations in territories where it is marketed.
Hyaluronic Acid Dermal Filler \u2013 Volumising Filler for Cheeks, Midface and Deep Folds

Description

Restylane Lyft with Lidocaine is a sterile, transparent, biodegradable injectable gel of non-animal stabilized hyaluronic acid (NASHA technology) designed for deep tissue augmentation. Using 20 mg/mL hyaluronic acid cross-linked with BDDE and 0.3% lidocaine, it is formulated to correct moderate to severe facial folds and wrinkles such as nasolabial folds, and to add volume for cheek augmentation and correction of age-related midface contour deficiencies. It is also indicated in many markets for dorsal hand volume restoration, and in some regions for chin augmentation. The product is supplied as a 1.0 ml pre-filled glass syringe for deep dermal, subcutaneous or supraperiosteal implantation by trained healthcare professionals, providing structure, lift and long-lasting volume in cheeks, midface and other deep facial planes while improving patient comfort during treatment.

Bnefits

  • Volumising filler specifically designed to add structure, lift and fullness to cheeks and midface, restoring youthful contours.
  • Effectively corrects moderate to severe facial folds and wrinkles, such as nasolabial folds and deeper lines around the mouth and nose.
  • Formulated for deep implantation (deep dermis to superficial subcutis, or subcutaneous to supraperiosteal) for robust lifting capacity and contouring.
  • Contains 0.3% lidocaine to provide local anaesthetic effect, improving patient comfort during and immediately after injection.
  • Non-animal stabilized hyaluronic acid (NASHA) with a firmer gel texture suitable for deep volume augmentation and contour sculpting.
  • Long clinical track record and multiple FDA / CE indications including cheek augmentation, midface contour correction, nasolabial folds and dorsal hand volume deficit.
  • Immediate visible volumising effect with natural-looking results when injected appropriately.
  • Biodegradable and reversible: the gel is gradually resorbed over time and can be dissolved with hyaluronidase if required.

Indications

  • Correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, via implantation into the deep dermis to superficial subcutis in adults over 21 years old.
  • Subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in adults over 21 years old.
  • Subcutaneous implantation in the dorsal hand to correct volume deficit and improve hand contour in adults over 21 years old (in markets where approved).
  • In some markets, subcutaneous and/or supraperiosteal implantation for augmentation of the chin region to improve the chin profile in patients with mild-to-moderate chin retrusion.
  • General facial contouring and volumisation in areas with adequate soft tissue support and cover (e.g. midface, jawline) when consistent with the official Instructions for Use and local regulations.

Composition

  • Stabilized sodium hyaluronate (hyaluronic acid), 20 mg/mL, non-animal origin (NASHA technology).
  • Lidocaine hydrochloride, 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
  • Phosphate buffered saline at approximately pH 7, q.s. to 1.0 mL.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether) used to stabilize the hyaluronic acid gel.
  • Sterile, clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel (20 mg/mL) of non-animal origin with 0.3% lidocaine hydrochloride in phosphate buffered saline at physiological pH, produced using NASHA technology to yield a firmer, high-lifting-capacity gel for deep dermal, subcutaneous or supraperiosteal injection. Supplied as a single-use, pre-filled 1.0 ml glass syringe.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Lyft with Lidocaine.
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Typically supplied with 2 x 27G or 29G thin-wall disposable sterile needles (gauge and length may vary by market, commonly 27G or 29G 1/2").
  • Luer-lock syringe with tamper-evident cap to maintain sterility until use.
  • Outer carton printed with product name, volume, batch/lot number, expiry date, manufacturer and regulatory markings.
  • Patient record and traceability labels attached to the syringe/carton for placement in patient medical records.

Usage

  • For professional use only: Restylane Lyft with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals with experience in dermal filler injection and facial anatomy.
  • Before use, inspect the outer carton, blister and syringe for damage and verify the expiry date. Do not use if packaging is compromised, if the gel appears cloudy or contains particulates, or if expired.
  • Obtain a thorough medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune disease, previous filler/implant procedures and current medications (especially anticoagulants and antiplatelet agents).
  • Cleanse and disinfect the intended treatment area according to clinic protocol for injectable procedures.
  • Attach a suitable sterile needle (e.g. 27G or 29G thin-wall needle) or small-bore blunt cannula to the luer-lock syringe using aseptic technique, and expel any air prior to injection.
  • For moderate to severe facial folds and wrinkles such as nasolabial folds, implant Restylane Lyft into the deep dermis to superficial subcutis using appropriate injection techniques (e.g. linear threading, serial puncture, fanning), injecting slowly with gentle, steady pressure while aspirating where appropriate to reduce the risk of intravascular injection.
  • For cheek augmentation and midface contour correction, implant subcutaneously to supraperiosteally in the cheek/midface region, using a needle or blunt cannula as indicated and consistent with the Instructions for Use; place small, controlled aliquots to shape and lift the midface and restore volume.
  • For dorsal hand volume restoration (where approved), inject into the subcutaneous plane on the back of the hand using an ultrafine needle or small blunt-tipped cannula, distributing the product evenly to avoid lumps and irregularities.
  • Avoid injection into blood vessels, muscles or areas with active skin disease or infection. If blanching, intense pain, visual disturbance or other signs suggestive of vascular compromise occur, stop injection immediately and institute appropriate management according to current clinical guidelines.
  • Do not overcorrect; aim for conservative initial correction and, if needed, schedule a follow-up session for refinement.
  • After injection, gently mould or massage the treated area if necessary to ensure even distribution and natural contours, avoiding excessive pressure especially in delicate areas.
  • Provide the patient with post-treatment care instructions (e.g. avoid makeup on treated area for several hours, avoid extremes of temperature, intense exercise, alcohol, and manipulation of the treated area for a short period).
  • Document the treatment thoroughly, including product name, batch/lot number, injection sites and volumes, and any immediate reactions, using the supplied traceability labels in the patient’s medical record.

Contraindications

  • Severe allergies characterized by a history of anaphylaxis or multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any excipients including gram-positive bacterial proteins.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin or mucosal disease, inflammation or infection at or near the intended injection site (e.g. dermatitis, acne, rashes, herpes lesions).
  • Intravascular injection is strictly contraindicated; the product must not be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended for dermal, subcutaneous or supraperiosteal implantation only as directed in the Instructions for Use.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers.
  • Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
  • Use in patients below the minimum age specified in local regulations and the product’s approved labelling (typically adults over 21 years for facial and hand indications).

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Localized lumps, bumps, nodules or palpable irregularities at or near the injection site.
  • Injection-site hematoma or ecchymosis, especially in patients with a tendency to bruise or on anticoagulant/antiplatelet therapy.
  • Temporary alterations in sensation (numbness, tingling, tightness) at the treatment site due to lidocaine and/or injection trauma.
  • Localized inflammatory reactions, including swelling and redness, which may occur immediately or be delayed and typically resolve spontaneously within days to a few weeks.
  • Infection at or near the injection site if aseptic technique is not strictly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules requiring additional medical intervention.
  • Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbances/vision loss, requiring urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or changes in skin texture, particularly in susceptible individuals.
  • Unsatisfactory cosmetic result or asymmetry that may necessitate further adjustment, additional treatment or product dissolution with hyaluronidase.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at controlled temperature, typically between 2°C and 25°C, as specified on the product packaging and Instructions for Use.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the sterile blister or syringe packaging has been opened or damaged prior to use.

Duration

Clinical effects typically last around 9 to 12 months in cheeks and midface, and about 6 to 12 months in deep folds and dorsal hands, depending on treatment area, injection technique, quantity used and individual patient metabolism.

Onset

Volume restoration and contour improvement are usually visible immediately after injection, with the final aesthetic outcome apparent once initial swelling and redness have resolved, typically within several days up to about 2 weeks.

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