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Belotero® Lips

Belotero® Lips

Belotero

Dermal filler
  • CE Marked Class III medical device for lip enhancement and soft tissue augmentation in the lips and perioral area.
  • Manufactured under ISO 13485 Compliant quality management system and Good Manufacturing Practice (GMP) for sterile medical devices.
  • Conforms to applicable EU and UK medical device regulations for resorbable hyaluronic acid implants.
  • Non Animal origin hyaluronic acid produced via controlled bacterial fermentation and purified according to validated processes.
Hyaluronic acid lip volume filler

Description

Belotero® Lips Shape with Lidocaine (1 x 0.6 ml) is a sterile, injectable, cross-linked hyaluronic acid dermal filler specifically developed for volumising and shaping the lips. Formulated using Belotero’s Cohesive Polydensified Matrix (CPM) technology, the gel integrates smoothly into the lip tissue to enhance the shape, structure and volume of both upper and lower lips while maintaining natural expression. The implant consists of cross-linked sodium hyaluronate at 25.5 mg/ml combined with lidocaine hydrochloride 3 mg/ml (0.3%) in a phosphate buffer (pH 7), supplied in a single-use 0.6 ml prefilled glass syringe with needles. It is intended for submucosal/deep dermal injection in the lips and perioral area, providing immediate, natural-looking results that typically last around 6–9 months, with a high level of patient comfort due to the inclusion of lidocaine.

Bnefits

  • Designed specifically for lip enhancement, restoring and increasing the volume of the upper and lower lips.
  • Improves lip shape, structure and projection while preserving a natural, soft look and feel.
  • Provides subtle yet effective volumisation for naturally fuller, more contoured lips.
  • Formulated with CPM (Cohesive Polydensified Matrix) technology for excellent tissue integration and reduced risk of lumps or irregularities.
  • Contains 25.5 mg/ml cross-linked hyaluronic acid of non-animal origin for reliable lifting and volume.
  • Includes 3 mg/ml (0.3%) lidocaine to reduce injection pain and improve treatment comfort.
  • Results are generally visible immediately after injection and typically last between 6 and 9 months, sometimes up to 12 months depending on individual factors.
  • Can be used in combination with Belotero® Lips Contour to simultaneously enhance volume and refine the lip border for a fully tailored result.
  • Biodegradable and resorbable filler that can be adjusted over time with maintenance treatments.
  • Suitable for creating harmonious, balanced lip augmentation in both younger and more mature patients.

Indications

  • Lip augmentation and volumisation of the upper and lower lips.
  • Restoration of lip volume lost due to ageing or weight loss.
  • Enhancement of lip shape and projection to improve overall facial balance.
  • Correction of severe or pronounced mouth commissure depressions (downturned mouth corners) when indicated.
  • Use as part of a combined treatment with Belotero® Lips Contour for comprehensive lip rejuvenation (volume plus border definition).

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 25.5 mg/ml (non-animal origin, produced by bacterial fermentation).
  • Lidocaine hydrochloride 3.0 mg/ml (0.3%) as a local anaesthetic to reduce injection discomfort.
  • Phosphate buffer solution at pH 7 q.s. to 0.6 ml.

Formulation

  • Sterile, non-pyrogenic, viscoelastic, colourless and homogeneous gel of cross-linked sodium hyaluronate with lidocaine.
  • Hyaluronic acid concentration: 25.5 mg/ml.
  • Lidocaine hydrochloride concentration: 3.0 mg/ml (0.3%).
  • Volume per syringe: 0.6 ml prefilled single-use glass syringe.
  • Developed with Cohesive Polydensified Matrix (CPM) technology for optimal balance of cohesivity, elasticity and plasticity.
  • Intended injection depth: submucosa of the lips and/or deep dermis of the perioral area, according to the instructions for use.

Packaging

  • 1 x 0.6 ml prefilled glass syringe of Belotero® Lips Shape with Lidocaine.
  • 2 x sterile single-use 27G ½" needles (needle sizes may vary by market, as specified on the outer box).
  • 2 x traceability labels for patient record and practice documentation.
  • 1 x instructions-for-use leaflet in the product carton.
  • Outer carton printed with product name, composition, batch number, expiry date, CE mark, manufacturer details and storage conditions.

Usage

  • Belotero® Lips Shape with Lidocaine must only be administered by suitably qualified and licensed healthcare professionals trained in dermal filler injection and facial anatomy.
  • Take a full medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics), bleeding disorders, autoimmune diseases, previous filler treatments, and current medications.
  • Assess lip anatomy and desired aesthetic outcome; mark the treatment areas where volume and shape correction are needed.
  • Cleanse and disinfect the lips and perioral region thoroughly with an appropriate antiseptic solution.
  • Remove the syringe from its blister, attach a supplied sterile 27G needle securely and expel any air, ensuring a small droplet of gel appears at the needle tip before injection.
  • Inject slowly into the submucosa of the lips and/or deep dermis of the perioral area using appropriate techniques such as linear threading, serial puncture or fanning, while avoiding intravascular injection.
  • Build volume gradually and avoid overcorrection; reassess during treatment to maintain a natural, harmonious result.
  • Gently massage the treated area if required to ensure even distribution of the gel and a smooth contour, unless local anatomy or technique dictates otherwise.
  • Dispose of any unused product, needles and syringes as clinical sharps in accordance with local regulations; the syringe is single-use for one patient only and must not be resterilised or reused.
  • Provide post-treatment advice: patients should avoid touching or massaging the treated area (unless instructed), avoid makeup on the lips for several hours, and refrain from excessive heat or cold exposure, sunbeds, saunas and strenuous exercise for about 24 hours.
  • Instruct patients to contact the clinic immediately if they experience intense pain, blanching of the skin, signs of infection, visual changes or any other unusual symptoms after treatment.
  • Record the product batch number, injection sites and volume used in the patient’s medical record and attach traceability labels as required.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anaesthetics or any excipients in the product (including phosphate buffer components).
  • History of severe allergies or anaphylactic reactions, or presence of multiple severe allergies.
  • Known allergy or hypersensitivity to gram-positive bacterial proteins (due to the fermentation origin of the hyaluronic acid).
  • Active infection, inflammation or skin disease (e.g. herpes labialis, dermatitis, acne, fungal infection) in or near the intended injection area.
  • Tendency to develop hypertrophic scars or keloids.
  • Bleeding disorders or current use of anticoagulant/antiplatelet therapy without careful assessment of risks and appropriate precautions.
  • Intravascular injection is strictly contraindicated due to the risk of vascular occlusion, ischaemia, necrosis or embolic complications.
  • Use during pregnancy or breastfeeding is not recommended because of insufficient clinical data in these populations.
  • Not recommended for patients under 18 years of age.
  • Caution or avoidance in areas previously treated with permanent or semi-permanent fillers, unless a qualified practitioner judges it safe and appropriate.

Adverse Effects

  • Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, local warmth or mild induration.
  • Bruising or haematoma at the injection sites, especially in highly vascular lip tissue.
  • Temporary oedema and sensitivity of the lips and perioral area, usually resolving within a few days.
  • Palpable nodules, lumpiness or irregularities, which may require massage, clinical monitoring or further intervention if persistent.
  • Hypersensitivity reactions or allergic responses (localised or systemic); severe reactions require prompt medical intervention.
  • Local infection (e.g. cellulitis, abscess) at the injection site if aseptic technique or aftercare are inadequate.
  • Rare but serious vascular events (e.g. arterial occlusion, tissue necrosis, visual disturbances or blindness) if product is inadvertently injected intravascularly; such events require urgent specialist management.
  • Delayed inflammatory reactions, granuloma formation or prolonged swelling, which have been rarely reported with hyaluronic acid fillers.

Storage Conditions

  • Store between 2°C and 25°C in a clean, dry place.
  • Do not freeze.
  • Keep the syringe in its original blister and outer carton to protect from light until immediately before use.
  • Do not use after the expiry date printed on the outer packaging and syringe label.
  • Do not use if the blister, outer carton or syringe is damaged, or if the gel appears cloudy, discoloured or contains visible particles.
  • Keep out of the sight and reach of children and unauthorised persons.

Duration

Clinical effects are typically maintained for approximately 6 to 9 months, and in some patients up to around 12 months, depending on age, skin type, metabolism, lifestyle factors (such as smoking and sun exposure) and injection technique. Maintenance or touch-up treatments are usually required to sustain optimal lip volume and shape.

Onset

Enhancement of lip volume and shape is generally visible immediately after injection, with the final aesthetic result stabilising over several days as initial swelling, redness or minor bruising resolve.

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