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Belotero Volume

Belotero Volume

Belotero

Injectable dermal filler
  • CE Marked as a Class III medical device (injectable hyaluronic acid dermal filler) under applicable European and associated medical device regulatory frameworks.
  • Manufactured under Good Manufacturing Practice (GMP) compliant standards for medical devices by Merz Aesthetics.
  • Uses non Animal derived, bacterially fermented hyaluronic acid, meeting relevant purity and biocompatibility standards for injectable implants.
  • Part of the Belotero® family of HA fillers with a documented safety profile and clinical experience for volume restoration and aesthetic indication.
Hyaluronic acid volumizing filler with lidocaine

Description

Belotero Volume with Lidocaine is a high-density, cross-linked hyaluronic acid (HA) dermal filler designed for restoring facial volume and contouring areas like cheeks, temples, chin and other areas with volume loss. Produced using the brand’s proprietary Cohesive Polydensified Matrix (CPM) / Dynamic Cross-Linking Technology, the gel integrates smoothly into deep subcutaneous or supraperiosteal tissue, providing structural support and re-volumisation. Supplied as two 1.0 ml prefilled sterile syringes with lidocaine for patient comfort, it is intended for professional use only by trained healthcare providers.

Bnefits

  • Restores lost facial volume in areas such as cheeks, temples, chin — ideal for hollow or sunken facial features.
  • Provides structural support and deep tissue augmentation thanks to high-density HA and CPM gel matrix.
  • Offers natural-looking results with smooth integration and minimal lumpiness, preserving natural facial contours and expression.
  • Contains lidocaine (3 mg/ml) to reduce injection-associated discomfort.
  • Results can last up to 18 months depending on treatment area, injection technique, and patient factors.
  • High mouldability and optimal modelling capacity facilitate reshaping and contouring of cheekbones, temples, chin and mid-face.

Indications

  • Deep subcutaneous or supraperiosteal injection to restore facial volume in cheeks, temples, chin and mid-face.
  • Correction of volume loss due to age-related soft tissue atrophy or fat loss, including sunken cheeks or hollow temples.
  • Facial reshaping and contouring, such as cheek augmentation or chin enhancement, where additional volume and structural support is required.
  • Augmentation to smooth deep wrinkles or folds associated with volume loss (e.g. to soften deep nasolabial folds when combined with appropriate technique and filler selection).

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) approx. 26 mg/ml.
  • Lidocaine hydrochloride 3.0 mg/ml (local anaesthetic for patient comfort).
  • Phosphate buffer pH ~7, q.s. to 1 ml gel.
  • Sterile, apyrogenic viscoelastic gel with defined cohesivity for deep tissue implantation.

Formulation

  • Sterile, non-pyrogenic, viscoelastic cross-linked HA gel with lidocaine, designed for deep subdermal or supraperiosteal injection.
  • Two 1 ml prefilled syringes per kit, ready for professional injection.
  • High-density, cohesive gel matrix (CPM / dynamic cross-linking) optimized for structural support and volume restoration.

Packaging

  • 2 × 1.0 ml prefilled glass syringes containing HA gel + lidocaine.
  • Sterile disposable needles/cannulas supplied — typically 27G or 30G ½" (or as specified by distributor).
  • Syringes and needles sealed in sterile blister packs, within an outer carton marked with product information, lot number, expiry date and CE label.
  • Instructions for Use (IFU) leaflet included, with labelling required under medical device regulation.

Usage

  • For professional use only — injection must be performed by a trained and qualified healthcare professional familiar with facial anatomy and deep soft tissue filler placement.
  • Inject into deep subcutaneous tissue or supraperiosteal plane depending on targeted region (e.g. cheeks, temples, chin) using appropriate needle/cannula per IFU.
  • Use aseptic technique: clean and disinfect the treatment area thoroughly prior to injection, maintain sterility of syringe and needle.
  • Inject slowly with controlled pressure, avoid overcorrection; mould and shape gently after injection if required per practitioner technique.
  • Avoid intravascular injection: aspirate where appropriate and inject small aliquots slowly, mindful of local vascular anatomy.
  • Single-use device: do not reuse or resterilise; discard any unused product and used sharps per local regulations.
  • Provide patient aftercare instructions: avoid strenuous exercise, excessive pressure on treated areas, high heat (sauna/steam), and make-up for at least 24 hours; follow local protocol for post-treatment care. (Many practitioners recommend gentle skincare and sun protection.)

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, or any of the excipients.
  • Active skin infection, inflammation, or lesions at or near intended treatment site (e.g. acne, dermatitis, cold sores).
  • Patients with bleeding disorders or on anticoagulant therapy without careful risk assessment.
  • History of severe allergies, anaphylaxis, or multiple severe hypersensitivities (e.g. to Gram-positive bacterial proteins), as HA may contain trace proteins from manufacturing.
  • Pregnant or breastfeeding women, or individuals under 18 years of age (unless local regulatory labelling permits and with full risk/benefit evaluation).
  • Areas with prior permanent/non-resorbable fillers, unless carefully evaluated for interactions and potential complications.
  • Patients prone to hypertrophic scarring or keloids, or with poor wound healing capacity, significant immunosuppression, or active systemic infection.

Adverse Effects

  • Very common: injection-site reactions such as redness (erythema), swelling (edema), bruising (ecchymosis), pain or tenderness, itching, warmth.
  • Transient induration or firmness, palpable gel, mild discomfort or pressure at the injection site.
  • Local discoloration or hematoma, particularly in areas with thinner soft tissue.
  • Asymmetry or irregular contour, over- or under-correction, which may require remixing or additional adjustment.
  • Rarely, delayed swelling or prolonged edema lasting up to several weeks or months (noted in some clinical reports).
  • Infection or abscess formation at the injection site (rare), including possible biofilm-related complications.
  • In very rare and serious cases: inadvertent intravascular injection may lead to vascular occlusion, tissue ischemia or necrosis, and, especially in high-risk anatomical areas, risk of vision impairment or blindness — a medical emergency.

Storage Conditions

  • Store at controlled room temperature within the range specified by the manufacturer (usually ~2–25 °C) until use.
  • Do not freeze; avoid exposure to extreme heat, cold, or direct sunlight.
  • Keep the syringe in its original sterile blister and outer carton until use to maintain sterility and protect from light.
  • Do not use if expiry date has passed, or if packaging is damaged, syringe compromised, or gel appears cloudy or contains particulate matter.
  • After opening, use immediately for one patient only; do not resterilise or reuse; dispose of unused product and needles per local regulations and sharps disposal guidelines.

Duration

Up to approximately 12\u201318 months depending on treatment area, injection volume, patient metabolism, and lifestyle factors.

Onset

Immediate volumizing and contouring effect visible upon injection, with optimal integration and natural tissue adaptation over following days as swelling subsides.

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