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Radiesse® + with Lidocaine (1.5ml)

Radiesse® + with Lidocaine (1.5ml)

Radiesse

Injectable dermal filler
  • Class III CE Marked injectable implantable medical device for soft tissue augmentation in line with its labelling.
  • Recognised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a medical device for indicated aesthetic and reconstructive uses.
  • Part of the Radiesse / Radiesse (+) Lidocaine product family, which is FDA Approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds and for hand augmentation to correct volume loss in the dorsum of the hands (market and pack Specific indications may vary).
  • Manufactured under ISO 13485 Compliant quality management systems and Good Manufacturing Practice (GMP) requirements for medical devices.
  • Subject to standard medical device safety assessments, including preclinical and clinical evaluation, stability and biocompatibility testing.
Calcium hydroxylapatite (CaHA) biostimulatory dermal filler with lidocaine

Description

Radiesse® + with Lidocaine (1.5ml) is a calcium-based, biostimulatory dermal filler designed to restore volume, contour facial features and smooth moderate to severe facial wrinkles and folds. It contains synthetic calcium hydroxylapatite (CaHA) microspheres suspended in a glycerin and sodium carboxymethylcellulose gel carrier with 0.3% lidocaine hydrochloride for improved treatment comfort. The filler provides immediate volumisation and lifting while stimulating the skin’s own collagen production for long-term improvement in firmness, elasticity and overall skin quality. It is widely used in aesthetic medicine to hydrate and rejuvenate the skin, contour the jawline and treat age-related facial volume loss.

Bnefits

  • Provides immediate restoration of facial volume and lifting of targeted areas.
  • Helps reduce the appearance of moderate to severe facial wrinkles and folds, including smile lines (nasolabial folds).
  • Stimulates natural collagen production, improving skin firmness, elasticity and texture over time.
  • Hydrates and rejuvenates the skin for a more youthful, refreshed appearance.
  • Contains lidocaine to enhance patient comfort and reduce pain during injection.
  • Can be used to contour and define the jawline, chin and cheeks for improved facial balance.
  • Long-lasting, yet non-permanent results, typically around 12–18 months depending on the patient and treatment area.
  • Biocompatible, synthetic CaHA-based filler that is gradually resorbed and replaced by newly formed collagen.
  • Versatile treatment suitable for multiple facial areas in a single session when administered by experienced clinicians.
  • Well-established safety profile when used according to the Instructions for Use and by qualified practitioners.

Indications

  • Correction of moderate to severe facial wrinkles and folds, such as nasolabial (smile) lines.
  • Restoration of facial volume loss associated with ageing or other factors.
  • Contour enhancement and definition of the jawline and lower face.
  • Volumising and shaping of the chin and cheeks.
  • General facial rejuvenation where improved firmness, hydration and structural support are desired.
  • Use in other approved aesthetic and reconstructive indications in accordance with local regulations and product labelling.

Composition

  • Synthetic calcium hydroxylapatite (CaHA) microspheres as the primary active ingredient.
  • Glycerin.
  • Sodium carboxymethylcellulose.
  • 0.3% lidocaine hydrochloride (local anaesthetic).
  • Sterile water for injection.
  • Latex-free, non-pyrogenic, semi-solid cohesive implant formulation.

Formulation

  • Injectable, semi-solid, cohesive gel containing CaHA microspheres in a glycerin and sodium carboxymethylcellulose carrier.
  • Includes 0.3% lidocaine hydrochloride for improved patient comfort during injection.
  • Presented as a single 1.5ml prefilled syringe for subdermal and deep dermal implantation.
  • Biodegradable and resorbable; the carrier gel is absorbed first, followed by gradual metabolism of CaHA microspheres with replacement by newly formed collagen.
  • Latex-free, non-pyrogenic, sterile implant for single-patient use.
  • Class III implantable medical device intended for use by trained healthcare professionals only.

Packaging

  • One 1.5ml prefilled glass syringe of Radiesse® + with Lidocaine per unit carton.
  • Supplied as a sterile, non-pyrogenic, single-use medical device.
  • Typically supplied with sterile thin-wall needles suitable for recommended injection techniques (exact gauge and quantity may vary by market).
  • Syringe and needles are sealed in a sterile blister or pouch and packed in an outer cardboard box for protection and storage.
  • Outer packaging includes product name, volume, batch/lot number, expiry date, manufacturer details and regulatory symbols.
  • Package insert / Instructions for Use (IFU) provided with full prescribing information, indications, contraindications, warnings and injection guidance.

Usage

  • For professional use only; Radiesse® + with Lidocaine must be administered exclusively by appropriately trained and licensed healthcare professionals experienced in facial anatomy and injectable techniques.
  • Before treatment, obtain a full medical history, assess suitability, discuss potential benefits and risks, and obtain informed consent from the patient.
  • Inspect the packaging and syringe to ensure the sterile barrier is intact and check the expiry date; do not use if compromised or expired.
  • Allow the syringe to reach room temperature as directed in the IFU; do not heat externally and do not freeze.
  • Cleanse and thoroughly disinfect the treatment area with an appropriate antiseptic solution and maintain strict aseptic technique throughout the procedure.
  • Attach an appropriate sterile needle (as specified in the IFU) securely to the Luer-lock syringe and prime to remove air before injection.
  • Inject into the deep dermis, subdermal or supraperiosteal plane depending on the treatment area and indication, using linear threading, serial puncture, fanning or depot techniques as clinically appropriate.
  • Inject slowly with minimal pressure and aspirate according to practitioner protocol to help reduce the risk of intravascular injection; never inject directly into blood vessels.
  • Apply a conservative correction approach, avoiding overfilling, as additional volume and lifting may develop over time due to collagen stimulation.
  • After injection, gently massage and mould the treated area if needed to achieve a smooth and even contour, unless contraindicated in the specific anatomical region.
  • Advise patients to avoid touching or massaging the treated area (other than practitioner-directed), strenuous exercise, alcohol and intense heat exposure (sauna, steam room, sunbeds) for at least 24 hours or until any redness and swelling resolve.
  • Inform patients of expected transient reactions (such as swelling, redness, bruising and tenderness) and instruct them to seek immediate medical attention if they experience severe pain, blanching, visual changes, signs of infection or other unusual symptoms.
  • Schedule a follow-up appointment to review outcomes and determine if any refinement or maintenance treatment is required.
  • Dispose of used needles, syringes and any remaining product as clinical sharps waste in accordance with local regulations; do not resterilise or reuse.

Contraindications

  • Pregnancy or breastfeeding.
  • History of severe allergies or anaphylactic reactions.
  • Known bleeding disorders or significant coagulopathy.
  • Known hypersensitivity or allergy to lidocaine or other amide-type local anaesthetics.
  • Known hypersensitivity to any component of the product, including calcium hydroxylapatite, glycerin, sodium carboxymethylcellulose or other excipients.
  • Presence of active infection, inflammation or skin disease at or near the intended injection site.
  • Patients under 18 years of age, as safety and efficacy have not been established.
  • Use in anatomical areas where safety and efficacy have not been established (such as lips, periorbital region or glabella), unless specifically approved and performed by highly experienced injectors in line with local labelling.
  • Patients with a known tendency to form keloids or hypertrophic scars should be treated with extreme caution or avoided.
  • Patients with uncontrolled autoimmune or connective tissue disorders should only be treated after careful risk–benefit assessment and in accordance with current clinical guidelines.

Adverse Effects

  • Common, typically transient injection-site reactions such as redness (erythema), swelling (oedema), pain or tenderness, bruising (ecchymosis), itching (pruritus) and local warmth.
  • Palpable or visible nodules, lumps or bumps at or near the injection site, which may resolve over time or with massage; persistent nodules may require further medical management.
  • Contour irregularities or asymmetry if the product is unevenly distributed or over/under-corrected.
  • Localised infection at the injection site, which may present with increasing pain, redness, swelling or warmth and may require antibiotic therapy.
  • Hypersensitivity or allergic reactions, including prolonged swelling, redness, itching or induration.
  • Rare granulomatous or chronic inflammatory reactions presenting as persistent firm nodules.
  • Vascular complications from inadvertent intravascular injection or vessel compression, potentially resulting in blanching, livedo, severe pain, tissue ischaemia or necrosis; urgent recognition and management are essential.
  • Very rare but serious events such as embolisation leading to visual disturbances, vision loss, stroke or other ischaemic complications if filler enters or compresses vessels supplying critical structures.
  • Temporary stiffness, discomfort or altered sensation in the treated area, particularly in high-mobility regions, which usually resolves spontaneously.
  • Any severe, unexpected or persistent adverse reaction should prompt immediate clinical evaluation and appropriate treatment.

Storage Conditions

  • Store in the original carton at the temperature range specified in the Instructions for Use, typically controlled room temperature.
  • Do not freeze; freezing can damage the product and compromise its performance.
  • Protect from excessive heat and direct sunlight.
  • Keep the syringe in its sealed sterile blister or pouch until ready for use to maintain sterility.
  • Do not use after the expiry date printed on the packaging.
  • Do not use if the packaging is damaged, the sterile barrier is compromised or the product appears discoloured or otherwise abnormal.
  • Keep out of the reach of children.
  • Single-use device; discard any remaining product and all used components immediately after treatment in accordance with local regulations.

Duration

Clinical effects typically last around 12\u201318 months, and may extend up to 2 years in some patients and treatment areas, depending on factors such as injection site, volume used, patient age, metabolism and lifestyle. Maintenance or touch-up treatments can be performed as needed based on clinical assessment and patient preference.

Onset

Provides immediate volumising and wrinkle-smoothing at the time of injection due to the CaHA gel implant, with further improvement in skin firmness, elasticity and overall quality over the following weeks and months as collagen production is stimulated.

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