Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Certifications
CE Marked Class III medical device in the EU and Northern Ireland for soft Tissue augmentation in line with its labelling.
Recognised by the UK MHRA as a medical device for indicated aesthetic and reconstructive uses within 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.
CE Marked Class III medical device in the EU and Northern Ireland for soft Tissue augmentation in line with its labelling.
Recognised by the UK MHRA as a medical device for indicated aesthetic and reconstructive uses within 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.
Description
Radiesse+ Lidocaine 1.5 ml is a premium calcium hydroxylapatite (CaHA)–based injectable dermal filler from Merz Aesthetics, formulated with integrated 0.3% lidocaine for improved injection comfort. Supplied as a 1.5 ml prefilled syringe, it is designed for subdermal and deep-dermal implantation to restore volume, smooth moderate to severe wrinkles and folds, contour facial features, and rejuvenate the dorsum of the hands. The CaHA microspheres provide immediate structural volume and lifting, while stimulating the body’s natural collagen production for long-lasting, natural-looking results and improved skin quality over time.
Bnefits
Provides immediate volumising and wrinkle-smoothing by adding structural support under the skin.
Biostimulatory CaHA microspheres stimulate the body’s natural collagen production for long-term improvement in firmness and elasticity.
Integrated 0.3% lidocaine enhances patient comfort and reduces pain during injection.
Effective for treating moderate to severe facial wrinkles and folds, including nasolabial folds and marionette lines.
Restores and contours facial volume in areas such as chin, jawline and cheeks.
Suitable for hand rejuvenation by replenishing volume on the dorsum of the hands and reducing the appearance of veins and tendons (where approved).
Results typically last 12–18 months and can extend up to 2 years in some patients, depending on area treated and individual metabolism.
Non–animal-derived, biocompatible and fully biodegradable implant with a long safety record.
Delivers natural-looking outcomes with a lifting and contouring effect rather than excessive bulk.
Radiopaque CaHA microspheres are visible on imaging, aiding radiologic interpretation when documented.
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 for volumising and contouring procedures (e.g. chin, jawline, cheeks) in adults over 21 years of age, according to local regulatory approvals.
Hand augmentation to correct volume loss in the dorsum of the hands and reduce the visibility of veins and tendons, where approved.
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) for medical devices.
Supplied with comprehensive Instructions for Use and patient information materials detailing safety, indications, contraindications, warnings and injection protocol.
Supplied with comprehensive Instructions for Use and patient information materials detailing safety, indications, contraindications, warnings and injection protocol.
Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Restoration and/or correction of facial soft-tissue volume loss, including age-related changes and selected reconstructive indications such as HIV-associated lipoatrophy, in line with local guidelines.
Adjunctive use in cosmetic and reconstructive protocols where structural lifting, contour enhancement and skin quality improvement are desired.
Composition
Principal component: synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% by volume).
Gel carrier (approximately 70% by volume) composed 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.
Presentation: single 1.5 ml (1.5 cc) prefilled syringe.
Device class: Class III implantable medical device in EU/UK.
Recommended needle range: 25 gauge outer diameter to 27 gauge inner diameter needles (thin-wall), as specified in the Instructions for Use.
Injection depth: subdermal and/or deep dermis (and supraperiosteal plane where appropriate) depending on indication and anatomical site.
Resorbable and biodegradable: carrier gel is absorbed first, followed by gradual metabolism of CaHA microspheres, leaving newly formed collagen in place.
Packaging
One 1.5 ml prefilled glass syringe of Radiesse+ Lidocaine per unit carton.
Typically supplied with two sterile, single-use thin-wall needles (commonly 27G x 0.75" / 0.4 x 20 mm), depending on market.
Syringe and needles are sealed within a sterile blister or pouch, which is then placed inside a branded cardboard outer box.
Outer carton is printed with product name (Radiesse+ / Radiesse (+) Lidocaine), batch/lot number, expiry date, manufacturer details and regulatory symbols.
Package insert / Instructions for Use (IFU) included with full information on indications, contraindications, warnings and injection techniques.
Single-patient, single-use device; not intended for resterilisation or reuse.
Usage
Radiesse+ Lidocaine must only be administered by appropriately trained and licensed healthcare professionals (e.g. dermatologists, plastic surgeons, aesthetic physicians) experienced in injectable procedures and facial/hand anatomy.
Before treatment, obtain a full medical history, assess indications and contraindications, discuss risks and benefits with the patient and obtain informed consent.
Inspect the syringe, needles and packaging prior to use; do not use if the sterile barrier is damaged, if the syringe appears compromised, or if the product is past its expiry date.
Allow the product to reach room temperature prior to injection as per the IFU; do not heat externally and do not freeze.
Cleanse and thoroughly disinfect the treatment area using an appropriate antiseptic solution, maintaining strict aseptic technique throughout the procedure.
Attach the recommended sterile needle (e.g. 25–27G) securely to the Luer-lock syringe and prime it to expel any air before injection.
Inject Radiesse+ into the appropriate plane (deep dermis, subdermal and/or supraperiosteal) using techniques such as linear threading, serial puncture, fanning or depot injections, depending on the area and indication.
Inject slowly with minimal pressure, taking care to avoid intravascular injection. Aspirate according to practitioner protocol and avoid high-risk vascular areas.
Use a 1:1 correction approach; do not overcorrect, as additional volume and lifting develop over time with collagen stimulation.
After injection, gently massage and mould the treated area as required to achieve a smooth, even contour, unless local protocol or specific anatomic considerations advise otherwise.
Provide post-treatment advice: avoid strenuous exercise, excessive heat (sauna, steam room, sunbeds), alcohol, and touching or massaging the treated area (beyond practitioner instructions) for at least 24 hours or until swelling and redness have resolved.
Advise patients to report immediately any severe pain, blanching, visual changes, or signs of infection (increasing redness, swelling, warmth, or pus).
Schedule a follow-up visit (e.g. 2–4 weeks post-treatment) to assess clinical outcome, patient satisfaction and any need for touch-up treatment.
Dispose of used needles, syringes and any remaining product as clinical sharps waste in accordance with local regulations; do not reuse or resterilise.
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 allergies.
Presence of active infection, inflammation or skin disease at or near the intended injection site (e.g. herpes labialis, cellulitis, severe acne, dermatitis).
Patients with bleeding disorders or those receiving significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is deemed unacceptable (clinical judgement required).
Use in anatomical regions where safety and effectiveness have not been established (e.g. lips, periorbital area, glabella, breast augmentation).
Pregnancy or breastfeeding, as safety has not been established in these populations.
Patients under 18 years of age (safety and efficacy not established).
Patients with a known tendency to keloid formation or hypertrophic scarring should generally not be treated or should be treated with extreme caution.
Patients with uncontrolled autoimmune or connective tissue disorders should be carefully evaluated; treatment is at the physician’s discretion, following current guidance and individual risk–benefit assessment.
Known hypersensitivity to local anaesthetics of the amide type (lidocaine) or other contraindications to lidocaine-containing products.
Adverse Effects
Common, usually 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 often diminish over time and may respond to massage; some cases may require additional medical management.
Induration, firmness or contour irregularities if product placement or volume distribution is suboptimal.
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 redness, swelling or pruritus.
Rare granulomatous or chronic inflammatory reactions presenting as persistent nodules or induration.
Vascular complications due to inadvertent intravascular injection or vessel compression, potentially leading to blanching, livedo, pain, tissue ischaemia or necrosis; urgent recognition and management are required.
Very rare but serious events such as embolisation causing visual disturbances, vision loss, stroke or other ischaemic events if filler enters or compresses blood 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, severe or persistent adverse reaction 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 about 15 °C and 32 °C).
Do not freeze; freezing can damage the product and compromise performance.
Protect from excessive heat and direct sunlight.
Keep the syringe within its 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: discard all used materials and any remaining product as clinical waste immediately after treating a single patient.
Duration
Typical clinical duration of effect is approximately 12\u201318 months, and may be up to 2 years in some patients, depending on treatment area, injected volume, patient age, metabolism and lifestyle. Maintenance or touch-up treatments can be performed based on individual response and clinical assessment.
Onset
Immediate volumising and wrinkle-smoothing effects are visible at the time of injection due to the CaHA gel implant, with additional gradual improvement in contour, firmness and skin quality over subsequent weeks to months as the CaHA microspheres stimulate new collagen production.
