Calcium hydroxylapatite (CaHA) volumizing and lifting filler
Certifications
CE Marked Class III injectable implantable medical device in the European Union and Northern Ireland for soft Tissue augmentation indications in line with the labelling.
Recognised by the UK MHRA as a medical device for indicated aesthetic and reconstructive uses in Great Britain when supplied through authorised channels.
Part of the RADIESSE product family, which is FDA Approved 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 (specific pack volumes and indications may vary by market).
CE Marked Class III injectable implantable medical device in the European Union and Northern Ireland for soft Tissue augmentation indications in line with the labelling.
Recognised by the UK MHRA as a medical device for indicated aesthetic and reconstructive uses in Great Britain when supplied through authorised channels.
Part of the RADIESSE product family, which is FDA Approved 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 (specific pack volumes and indications may vary by market).
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) requirements for medical devices.
Description
RADIESSE (1x3ml) MERZ is a CE-marked, FDA-approved volumizing dermal filler and injectable implant composed of synthetic calcium hydroxylapatite (CaHA) microspheres suspended in a biodegradable carboxymethylcellulose (CMC) gel carrier. Supplied as a single 3 ml prefilled syringe, it is designed for deep dermal and subdermal implantation to correct moderate to severe facial wrinkles and folds such as nasolabial folds, restore and contour facial volumes, and treat selected reconstructive indications including HIV-associated lipoatrophy. The cohesive, semi-solid, latex-free, pyrogen-free, steam-sterilised implant provides immediate lifting and wrinkle correction while stimulating neocollagenesis and elastin production for long-lasting improvements in skin quality, firmness and facial contours.
Bnefits
Provides immediate volumising and lifting of treated areas with visible correction at the time of injection.
Reduces moderate to deep facial lines and folds, including nasolabial folds and marionette (puppet) lines.
Biostimulatory CaHA microspheres stimulate the skin’s natural collagen and elastin production, improving dermal thickness, firmness and elasticity over time.
Effectively restores lost facial volume and supports contouring of cheeks, jawline and midface structures.
Useful for volume replenishment on the dorsum of the hands, reducing visibility of tendons and veins where approved.
Triple effect: versatile wrinkle filling, volume lifting, and long-term skin rejuvenation via collagen stimulation.
Cohesive, semi-solid gel implant is mouldable and allows precise contouring with natural-looking results.
Resorbable and biodegradable; over time the carrier gel is absorbed and CaHA microspheres are metabolised, leaving newly formed collagen in place.
Long-lasting clinical results, generally around one year and potentially longer in some patients, while remaining non-permanent.
Favoured by dermatologists, plastic surgeons and aesthetic physicians worldwide for its lifting power, durability and safety profile.
Indications
Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) requirements for medical devices.
Subject to comprehensive preclinical and clinical evaluation demonstrating safety and efficacy for its labelled indications, and supplied with detailed Instructions for Use outlining required precautions and injection techniques.
Subject to comprehensive preclinical and clinical evaluation demonstrating safety and efficacy for its labelled indications, and supplied with detailed Instructions for Use outlining required precautions and injection techniques.
Calcium hydroxylapatite (CaHA) volumizing and lifting filler
Augmentation of the soft tissues of the deep dermis and subdermis of the facial region for contour restoration and structural support.
Plastic and reconstructive surgery indications requiring volume augmentation in the deep dermis and subdermal facial tissues.
Restoration and/or correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV), in accordance with local regulatory approvals.
Full facial lifting protocols where nasolabial folds, marionette lines and pre-jowl sulci are treated in a combined session by trained physicians.
Cheek augmentation and correction of midface volume loss associated with ageing or disease.
Treatment of marionette lines and chin folds to restore lower-face harmony and reduce sagging.
Jawline contouring to redefine drooping jawlines and jowls.
Volume replenishment in the dorsum of the hands where medically indicated and locally approved, to address age-related volume loss and improve skin quality.
Composition
Synthetic calcium hydroxylapatite (CaHA) microspheres (principal active component; approximately 30% by volume).
Carboxymethylcellulose (CMC) gel carrier (approximately 70% by volume) providing immediate volumising effect.
Sterile water for injection.
Glycerin (pharmacopoeial grade) within the gel matrix.
Recommended injection depth: deep dermis and subdermis of the facial region; subdermal plane on the dorsum of the hands where indicated.
Biodegradability: carrier gel is absorbed first while CaHA microspheres are gradually metabolised, leaving behind newly formed collagen.
Intended for professional use only under strict aseptic technique.
Packaging
One 3 ml prefilled glass syringe of RADIESSE injectable implant per unit carton (1x3ml).
Includes two sterile thin-wall needles: (2) x 25G T.W. x 1.0" (0.5 x 25 mm), or as specified in the packaging.
Syringe supplied sterile and non-pyrogenic in aluminium pouches or sealed sterile blisters.
Aluminium pouch/blister is placed inside a branded cardboard outer box for protection and storage.
Outer carton printed with product name (RADIESSE 1x3ml), volume, batch/lot number, expiry date, manufacturer details and regulatory symbols.
Package insert / Instructions for Use (IFU) included, detailing device description, indications, contraindications, warnings and injection techniques.
Single-patient, single-use packaging; not intended for resterilisation or reuse.
Usage
RADIESSE 1x3ml is for strict medical use only and must be injected exclusively by appropriately trained and licensed physicians (e.g. dermatologists, plastic surgeons, cosmetic physicians) experienced in facial anatomy and injectable implant techniques.
Before treatment, perform a comprehensive medical history and facial assessment, evaluate indications and contraindications, discuss realistic expectations, potential risks and benefits, and obtain informed consent.
Inspect the outer carton, sterile pouch/blister and syringe prior to use; do not use if the sterile barrier is compromised, the syringe is damaged, or the product is past its expiry date.
Allow the syringe to reach room temperature before injection in accordance with the IFU; do not heat externally and do not freeze.
Cleanse and thoroughly disinfect the treatment area using an appropriate antiseptic solution and maintain strict aseptic technique throughout the procedure.
Attach a recommended sterile needle (e.g. 25G thin-wall 0.5 x 25 mm) securely to the Luer-lock syringe and prime to expel air before injection.
Inject RADIESSE into the deep dermis and/or subdermal plane of the facial region, or into the subdermal plane on the dorsum of the hands as indicated, using appropriate techniques (linear threading, serial puncture, fanning or depot injections) based on the anatomical area and clinical training.
Inject slowly with minimal pressure and aspirate according to practitioner protocol to minimise the risk of intravascular injection. Never inject directly into blood vessels and take particular care in high-risk vascular zones.
Use a conservative 1:1 correction strategy; do not overcorrect, as additional volume and lifting arise over time due to collagen stimulation.
After injection, gently massage and mould the treated area as necessary to achieve a smooth, even contour, unless local protocol or specific anatomical considerations advise otherwise.
Provide post-treatment advice: avoid unnecessary touching or massaging of the treated area (beyond practitioner instruction), strenuous exercise, alcohol, and intense heat exposure (such as saunas, steam rooms or sunbeds) for at least 24 hours or until any swelling and redness have resolved.
Inform patients that temporary side effects such as redness, swelling, bruising and tenderness at injection sites are common and usually self-limiting; instruct them to seek immediate medical advice if they experience severe pain, blanching, visual changes, signs of infection or any other concerning symptoms.
Schedule follow-up (e.g. 2–4 weeks post-procedure) to assess outcomes, address minor asymmetries or nodules if present, and determine the need for additional or maintenance treatments.
Dispose of used needles, syringes and any remaining product as clinical sharps waste according to local regulations; never resterilise or reuse.
Contraindications
Known hypersensitivity or allergy to any component of the product, including calcium hydroxylapatite, sodium carboxymethylcellulose, glycerin or other excipients.
History of severe allergies, including anaphylaxis or multiple severe allergic reactions.
Presence of active skin infections, inflammation or dermatological conditions at or near the intended injection site (e.g. herpes simplex lesions, cellulitis, severe acne, active dermatitis).
Patients with bleeding disorders or receiving significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is judged unacceptable (clinical judgement required).
Use in anatomical regions where safety and efficacy have not been established (such as lips, periorbital region, glabella or for breast augmentation), unless specifically approved and undertaken only by highly experienced injectors in line with local labelling.
Pregnancy or breastfeeding, as adequate safety data are not available; treatment should generally be avoided.
Patients under 18 years of age, for whom safety and effectiveness have not been established.
Patients with a known tendency to develop keloids or hypertrophic scars should not generally be treated or should be treated with extreme caution.
Patients with uncontrolled autoimmune or connective tissue diseases should be carefully evaluated; use only if the potential benefits clearly outweigh the risks, consistent with current clinical guidance.
Any additional contraindications listed in the official Instructions for Use must be strictly observed.
Adverse Effects
Common transient injection-site reactions including erythema (redness), oedema (swelling), pain or tenderness, bruising (ecchymosis), pruritus (itching) 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 treatment, though persistent nodules may require further medical management.
Contour irregularities or asymmetry if product placement or volume distribution is suboptimal.
Infection at the injection site, which may present with increasing pain, redness, swelling or warmth and can require antibiotic therapy or other medical treatment.
Hypersensitivity or allergic reactions, including prolonged redness, swelling, pruritus or induration.
Rare granulomatous or chronic inflammatory reactions presenting as persistent firm nodules.
Vascular complications from inadvertent intravascular injection or vascular compression, which may lead to blanching, livedo, severe pain, tissue ischaemia and necrosis; urgent recognition and appropriate management are critical.
Very rare but serious events such as embolisation causing visual disturbances, vision loss, stroke or other ischaemic complications if filler enters or compresses blood vessels supplying critical structures.
On the hands, transient stiffness, discomfort or reduced range of motion may occur after treatment, usually resolving spontaneously.
Any unexpected, severe or persistent adverse effects should prompt immediate clinical evaluation and management in line with current safety recommendations.
Storage Conditions
Store in the original carton at controlled room temperature according to the Instructions for Use (typically between approximately 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 in its sealed sterile pouch or blister 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 has been 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 treating a single patient, in accordance with local clinical waste regulations.
Duration
Typical clinical duration of effect is around 12 months, with many patients experiencing sustained aesthetic benefits for up to 12\u201318 months depending on the treatment area, volume injected, patient age, metabolism and lifestyle. Repeat or maintenance treatments may be performed based on clinical evaluation and patient preference.
Onset
Immediate volumising and wrinkle-smoothing effects are visible at the time of injection due to the CaHA gel implant, with additional progressive improvement in skin quality, firmness and contour over subsequent weeks and months as neocollagenesis and elastin production are stimulated.
