Radiesse Plus Lidocaine 1.5ml
Radiesse
Injectable dermal fillerCalcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Certifications
- CE Marked Class III injectable implantable medical device in the EU and Northern Ireland for soft tissue augmentation indications consistent with its labelling.
- Recognised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a medical device for indicated aesthetic and reconstructive uses in Great Britain.
- FDA Approved (as RADIESSE (+) Lidocaine) for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for hand augmentation to correct volume loss in the dorsum of the hands.
- Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) for medical devices.
- Supplied with comprehensive Instructions for Use covering indications, contraindications, warnings, precautions and injection techniques.
- CE Marked Class III injectable implantable medical device in the EU and Northern Ireland for soft tissue augmentation indications consistent with its labelling.
- Recognised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a medical device for indicated aesthetic and reconstructive uses in Great Britain.
- FDA Approved (as RADIESSE (+) Lidocaine) for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for hand augmentation to correct volume loss in the dorsum of the hands.
- Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) for medical devices.
- Supplied with comprehensive Instructions for Use covering indications, contraindications, warnings, precautions and injection techniques.
Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Description
Radiesse Plus Lidocaine 1.5ml is a premium calcium hydroxylapatite (CaHA)–based injectable dermal filler from Merz Aesthetics, formulated with 0.3% integrated lidocaine for improved treatment comfort. Supplied as a 1.5 ml prefilled syringe, it is designed for subdermal and deep-dermal implantation to restore facial volume, smooth moderate to severe wrinkles and folds, contour facial features, and rejuvenate the dorsum of the hands. The CaHA microspheres provide an immediate volumising and lifting effect while stimulating the body’s own collagen production for long-term improvement in skin quality, firmness and elasticity. The product combines the proven efficacy and safety profile of Radiesse with the added comfort of built-in local anaesthetic.
Bnefits
- Immediate volumising and lifting effect with visible improvement at the time of injection.
- Biostimulatory CaHA microspheres stimulate natural collagen production for long-lasting improvement in skin firmness and elasticity.
- Integrated 0.3% lidocaine enhances patient comfort and reduces pain during injection.
- Effectively smooths moderate to severe facial wrinkles and folds such as nasolabial folds and marionette lines.
- Restores volume and improves contour in areas such as chin, jawline and cheeks.
- Suitable for hand rejuvenation to address age-related volume loss on the dorsum of the hands where approved.
- Long-lasting results typically around 12–18 months and in some cases up to 2 years, while remaining non-permanent and fully resorbable.
- Non–animal-derived, biocompatible, latex-free and non-pyrogenic implant with a strong international safety record.
- Cohesive, semi-solid gel allows precise placement and sculpting for natural-looking, well-defined contours.
- Triple effect: wrinkle filling, volumetric lifting, and long-term skin quality enhancement via collagen stimulation.
Indications
- Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (smile lines).
- Deep injection (subdermal and/or supraperiosteal) in the face to address volume loss and contour deficiencies in areas such as cheeks, chin and jawline.
- Hand augmentation to correct volume loss in the dorsum of the hands and reduce the visibility of veins and tendons, where approved.
- Restoration and/or correction of facial soft tissue volume loss in aesthetic and reconstructive indications, in line with local regulatory approvals and guidelines.
Composition
- Synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% by volume) as the active filler component.
- Aqueous gel carrier (approximately 70% by volume) consisting primarily of:
- – Sterile water for injection (USP).
- – Glycerin (USP).
- – Sodium carboxymethylcellulose (CMC) (USP).
- Lidocaine hydrochloride 0.3% (local anaesthetic) integrated into the gel.
- CaHA microsphere particle size range approximately 25–45 microns.
- Sterile, non-pyrogenic, latex-free, semi-solid, cohesive implant.
Formulation
- Type: Injectable dermal filler / subdermal implant.
- Active component: CaHA microspheres suspended in a CMC-based aqueous gel.
- Anaesthetic component: 0.3% lidocaine hydrochloride for increased injection comfort.
- Presentation: 1 x 1.5 ml (1.5cc) prefilled syringe.
- Device class: Class III implantable medical device (EU/UK).
- Physical characteristics: opaque, cohesive, semi-solid, non-pyrogenic and fully resorbable implant.
- Recommended needle: 25 gauge outer diameter to 27 gauge inner diameter needle, thin-wall, as per Instructions for Use.
- Recommended injection depth: subdermal and/or deep dermis (and supraperiosteal plane where appropriate) depending on anatomical site and indication.
Packaging
- One 1.5 ml prefilled glass syringe of Radiesse Plus Lidocaine per carton.
- Typically supplied with two sterile single-use thin-wall needles (commonly 25–27G; exact configuration per market labelling).
- Syringe and needles are sealed in a sterile blister or pouch, which is then placed inside a branded cardboard outer box.
- Outer carton labelled with product name (Radiesse Plus / Radiesse (+) Lidocaine 1.5 ml), batch/lot number, expiry date, manufacturer details and regulatory symbols.
- Includes Instructions for Use (IFU) with full details on indications, contraindications, warnings and injection technique.
- Single-patient, single-use packaging; not intended for resterilisation or reuse.
Usage
- Radiesse Plus Lidocaine must only be administered by appropriately trained and licensed healthcare professionals (e.g. dermatologists, plastic surgeons, aesthetic physicians) experienced in facial anatomy and injectable procedures.
- Prior to treatment, perform a full medical history and examination, assess indications and contraindications, discuss expected results, risks and benefits, and obtain informed consent.
- Inspect the packaging and syringe; do not use if the sterile barrier is compromised, the syringe is damaged, or the product is past its expiry date.
- Allow the product to reach room temperature in accordance with the IFU; do not heat externally or freeze.
- Cleanse and disinfect the treatment area thoroughly with an appropriate antiseptic and maintain strict aseptic technique throughout the procedure.
- Attach an appropriate sterile needle (typically 25–27G thin-wall) securely to the Luer-lock syringe and prime to expel air before injection.
- Inject into the deep dermis, subdermal and/or supraperiosteal plane depending on the indication and anatomical site, using linear threading, serial puncture, fanning or depot techniques as clinically appropriate.
- Inject slowly with minimal pressure, aspirating according to practitioner protocol to minimise the risk of intravascular injection. Never inject directly into blood vessels and take extra care in high-risk anatomical regions.
- Use a conservative 1:1 correction strategy; do not overcorrect, as additional lifting and volumising develop over time with collagen stimulation.
- After injection, gently massage and mould the treated area to ensure even distribution and smooth contours, unless local protocol or anatomical considerations suggest otherwise.
- Advise patients to avoid touching or massaging the treated area (beyond practitioner guidance), strenuous exercise, alcohol and intense heat (sauna, steam room, sunbeds) for at least 24 hours or until any swelling and redness resolve.
- Inform patients about expected transient effects (e.g. swelling, redness, bruising) and instruct them to contact the clinic immediately if they experience severe pain, blanching, visual changes, signs of infection or other concerning symptoms.
- Arrange a follow-up appointment (e.g. 2–4 weeks after treatment) to assess results, address any minor asymmetries or palpable nodules and determine the need for touch-up or maintenance treatment.
- Dispose of used needles, syringes and any remaining product as clinical sharps waste in accordance with local regulations; do not resterilise or reuse.
Contraindications
- Known hypersensitivity or allergy to any component of the product, including calcium hydroxylapatite, lidocaine hydrochloride, sodium carboxymethylcellulose, glycerin or other excipients.
- History of severe allergies, including anaphylaxis or multiple severe allergic reactions.
- Presence of active infection, inflammation or dermatologic disease at or near the intended injection site (e.g. herpes labialis, cellulitis, severe acne, active dermatitis).
- Patients with bleeding disorders or those on significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is considered unacceptable (clinical judgement required).
- Use in anatomical regions where safety and efficacy have not been established (e.g. lips, periorbital region, glabella, breast augmentation), unless specifically approved in local labelling and undertaken by highly experienced injectors.
- Pregnancy or breastfeeding, as safety has not been established; treatment is generally not recommended.
- Patients under 18 years of age (safety and effectiveness not established).
- Patients with a known tendency to develop keloids or hypertrophic scarring should be treated with great caution or avoided.
- Patients with uncontrolled autoimmune or connective tissue disorders should be carefully evaluated; use only if potential benefits clearly outweigh risks and in accordance with current guidelines.
- Known hypersensitivity to amide-type local anaesthetics such as lidocaine, or other contraindications to lidocaine-containing products.
Adverse Effects
- Common transient injection-site reactions including redness (erythema), swelling (oedema), pain or tenderness, bruising (ecchymosis), itching (pruritus) and local warmth.
- Palpable or visible nodules, lumps, bumps or firmness at or near the injection site; these often diminish over time and may respond to massage or conservative management, though some cases may require further medical intervention.
- Contour irregularities or asymmetry if product placement or volume distribution is suboptimal.
- Localised infection at the injection site, which may present with increasing pain, redness, swelling or warmth and may require antibiotic or other medical treatment.
- Hypersensitivity or allergic reactions, including prolonged swelling, redness, itching or induration.
- Rare granulomatous or chronic inflammatory reactions presenting as persistent firm nodules.
- Vascular complications resulting from inadvertent intravascular injection or vascular compression, potentially leading to blanching, livedo, severe pain, tissue ischaemia or necrosis; urgent recognition and management are critical.
- Very rare but serious adverse events such as embolisation causing visual disturbances, vision loss, stroke or other ischaemic events if filler enters or compresses vessels supplying critical structures.
- On the dorsum of the hands, temporary stiffness, discomfort or reduced range of motion may occur following treatment, usually resolving with time.
- Any unexpected, persistent or severe adverse effect should prompt immediate clinical evaluation and appropriate management.
Storage Conditions
- Store in the original carton at controlled room temperature as specified in the Instructions for Use (typically between approximately 15 °C and 32 °C).
- 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 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 only; discard any remaining product and all used materials immediately after use in accordance with local clinical waste regulations.
Duration
Results typically last around 12\u201318 months, and in some patients and treatment areas up to 2 years, depending on the area treated, injected volume, patient age, metabolism and lifestyle. Maintenance or touch-up treatments may be scheduled based on individual response and clinical assessment.
Onset
Immediate visible volumising and wrinkle-smoothing at the time of injection due to the CaHA gel implant, with further gradual improvement in contour, firmness and skin quality over subsequent weeks and months as new collagen is produced.
