Radiesse Lifting & Volume Filler 1×1.5 ml
Radiesse
Injectable dermal fillerCalcium hydroxylapatite (CaHA) biostimulatory lifting and volumising filler
Certifications
- Class III CE Marked injectable implantable medical device in the European Union 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 in Great Britain when supplied through authorised channels.
- Part of the RADIESSE / RADIESSE+ family, which is FDA Approved in the United States 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.
- Subject to comprehensive preclinical and clinical testing demonstrating safety and efficacy for indicated uses, and supplied with detailed Instructions for Use and safety information.
- Class III CE Marked injectable implantable medical device in the European Union 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 in Great Britain when supplied through authorised channels.
- Part of the RADIESSE / RADIESSE+ family, which is FDA Approved in the United States 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.
- Subject to comprehensive preclinical and clinical testing demonstrating safety and efficacy for indicated uses, and supplied with detailed Instructions for Use and safety information.
Calcium hydroxylapatite (CaHA) biostimulatory lifting and volumising filler
Description
Radiesse Lifting & Volume Filler 1×1.5 ml is a premier biostimulatory dermal filler from Merz Aesthetics based on calcium hydroxylapatite (CaHA) microspheres suspended in a biodegradable carboxymethylcellulose (CMC) gel. Designed for deep dermal and subdermal implantation, it sculpts and rejuvenates facial contours, restores lost volume, and smooths deep wrinkles and folds while stimulating collagen synthesis for firmer, more youthful-looking skin. The cohesive, semi-solid implant has a unique, smooth gel consistency that allows easy injection and moulding, is latex-free, pyrogen-free and steam-sterilised, and is gradually resorbed and replaced by the patient’s own soft tissue for long-lasting yet non-permanent enhancement.
Bnefits
- Provides immediate lifting and volumising of treated areas with visible correction at the time of injection.
- Biostimulatory CaHA microspheres stimulate natural collagen synthesis, improving skin firmness, elasticity and density over time.
- Reshapes and defines facial contours, including cheeks, chin, zygomatic bone and jawline, for a more youthful profile.
- Effectively smooths moderate to deep wrinkles and folds such as nasolabial folds, puppet (marionette) lines and chin folds.
- Restores volume to the hands, reducing the visibility of veins and tendons and improving skin texture.
- Long-lasting results, with many patients experiencing improvements for 12–18 months and in some cases up to 2 years, while remaining fully resorbable.
- Cohesive, semi-solid, watery gel consistency enables precise placement, excellent mouldability and natural-looking results.
- Latex-free, pyrogen-free, steam-sterilised subdermal implant with a long international safety and performance track record.
- Triple effect: versatile wrinkle filling, volumetric lifting, and long-term skin quality improvement via collagen stimulation.
- Favoured by medical practitioners for its reliability, durability and consistent, natural-looking aesthetic outcomes.
Indications
- Subdermal and deep dermal augmentation of soft tissues in the facial region for aesthetic contouring and rejuvenation.
- Correction of moderate to severe facial wrinkles and folds such as nasolabial folds and puppet (marionette) lines.
- Cheek and zygomatic augmentation to restore or enhance midface volume and projection.
- Chin and lower jaw contouring for profile balancing and definition.
- Bridge of the nose contour refinement (non-surgical rhinoplasty) when performed by experienced injectors and in line with local guidelines.
- Full lower-face lifting protocols involving nasolabial folds, marionette lines and pre-jowl sulci.
- Hand rejuvenation (dorsum of the hands) to address age-related volume loss and improve skin texture where approved.
- Plastic and reconstructive indications requiring deep dermal or subdermal volume restoration, including selected cases of lipoatrophy, according to local regulations.
Composition
- Synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% by volume) as the active biostimulatory filler component.
- Carboxymethylcellulose (CMC) gel carrier (approximately 70% by volume) providing immediate volumising effect and suspension for CaHA microspheres.
- Sterile water for injection.
- Glycerin (pharmacopoeial grade) within the carrier matrix.
- Latex-free, non-pyrogenic, cohesive, semi-solid injectable implant.
- No added lidocaine in this Radiesse Lifting & Volume Filler variant (anaesthesia can be provided separately according to clinical preference).
Formulation
- Type: Injectable subdermal implant / dermal filler for lifting and volumising.
- Active filler: CaHA microspheres (25–45 μm) suspended in an aqueous CMC gel matrix.
- Consistency: Smooth, watery gel with cohesive semi-solid behaviour, optimised for sculpting and contouring.
- Sterility: Sterile, non-pyrogenic; implant and syringe components are steam-sterilised.
- Biodegradability: Fully resorbable; the carrier gel is absorbed first, followed by gradual metabolism of CaHA microspheres, leaving newly formed collagen.
- Device class: Class III implantable medical device under EU/UK medical device regulations.
- Recommended injection depth: Deep dermis and/or subdermis, and supraperiosteal in some contouring indications, depending on anatomy and clinical training.
Packaging
- One 1×1.5 ml prefilled glass syringe of Radiesse Lifting & Volume Filler per carton.
- Supplied as a single-use, ready-to-inject syringe calibrated for precise dosing.
- Typically accompanied by two sterile thin-wall needles (commonly 27G x 0.75" / 0.4 x 20 mm) in many markets; local configuration may vary.
- Syringe and needles are packed in sterile blister or aluminium pouches, placed within a branded cardboard outer box for protection and storage.
- Outer packaging clearly displays product name, volume, batch/lot number, expiry date, manufacturer details and regulatory symbols.
- Includes Instructions for Use (IFU) detailing product description, indications, contraindications, warnings and injection techniques.
- Pack size is optimised for single-patient use in clinic-based aesthetic and reconstructive procedures.
Usage
- Radiesse Lifting & Volume Filler is for strict medical use only and must be injected exclusively by suitably trained and licensed physicians (e.g. dermatologists, plastic surgeons, aesthetic doctors) experienced in facial anatomy and injection techniques.
- Before treatment, perform a thorough medical history and examination, assess indications and contraindications, discuss realistic expectations, risks and benefits, and obtain informed consent.
- Inspect the packaging and syringe prior to use; do not use if the sterile barrier is compromised, if the syringe or contents appear damaged, or if 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 or freeze.
- Cleanse and rigorously disinfect the treatment area with an appropriate skin antiseptic and maintain strict aseptic technique throughout the procedure.
- Attach the recommended sterile needle (e.g. 25–27G thin-wall) securely to the Luer-lock syringe and prime to eliminate air prior to injection.
- Inject into the deep dermis or subdermal plane, and where appropriate the supraperiosteal plane, using techniques such as linear threading, serial puncture, fanning or depot injections tailored to the treatment area (cheeks, chin, jawline, nasolabial folds, puppet lines, hands, etc.).
- Inject slowly with minimal pressure and aspirate according to practitioner protocol to help avoid intravascular injection. Never inject directly into blood vessels, and exercise particular caution in high-risk anatomical zones.
- Use a conservative 1:1 correction approach rather than overcorrection, as additional lifting and volume develop over time through collagen stimulation.
- After injection, gently massage and mould the treated area to ensure even distribution and smooth contouring, unless local protocol or specific anatomical considerations advise otherwise.
- Provide post-treatment advice: avoid touching or massaging the treated area (other than practitioner-directed), heavy exercise, alcohol, and intense heat exposure (sauna, steam rooms, sunbeds) for at least 24 hours or until any swelling and redness resolve.
- Inform patients of expected transient reactions (swelling, redness, bruising, tenderness) and instruct them to report immediately any severe pain, blanching, visual changes, signs of infection or other concerning symptoms.
- Schedule a follow-up visit (e.g. 2–4 weeks) to evaluate results, manage any minor asymmetries or nodules and decide on any further refinement or maintenance treatment.
- Dispose of all 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, carboxymethylcellulose, glycerin or other excipients.
- History of severe allergies, anaphylaxis or multiple severe allergic reactions.
- Presence of active skin infections, inflammatory lesions or dermatological conditions at or near the intended injection site (e.g. herpes labialis, cellulitis, severe acne, active dermatitis).
- Bleeding disorders or patients on significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is unacceptable (clinical judgement required).
- Use in anatomical areas 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, because adequate safety data are lacking; treatment should generally be deferred.
- Patients under 18 years of age, as safety and efficacy have not been established.
- Patients with a known tendency to develop keloids or hypertrophic scars should be treated with extreme caution, if at all.
- Patients with uncontrolled autoimmune or connective tissue diseases should be carefully evaluated; use only if the anticipated benefits clearly outweigh potential risks and in line with current clinical guidance.
- Any contraindication specified in the official Instructions for Use should be strictly observed.
Adverse Effects
- Common, usually transient injection-site reactions: 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, which often lessen over time and may respond to massage; persistent nodules may require further medical management.
- Contour irregularities or asymmetry if product placement or volume distribution is suboptimal.
- Localized infection at the injection site, potentially presenting with increasing pain, redness, swelling, warmth or purulent discharge and requiring appropriate 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 due to inadvertent intravascular injection or vascular compression, including blanching, livedo, pain, tissue ischaemia and necrosis; urgent recognition and intervention are essential.
- Very rare but serious adverse events such as embolisation that may result in visual disturbance, vision loss, stroke or other ischaemic events if filler enters or compresses blood vessels supplying critical structures.
- On the hands, transient stiffness, discomfort or reduced range of motion may occur following treatment, usually resolving with time.
- Any severe, unexpected or persistent adverse reaction should prompt immediate clinical evaluation and management in line with current safety guidelines.
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 gel and compromise product 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 contents appear discoloured or otherwise abnormal.
- Keep out of the reach of children.
- Single-use device: after treating a single patient, discard any remaining product and all used components as clinical waste in accordance with local regulations.
Duration
Radiesse Lifting & Volume Filler typically provides long-lasting results of approximately 12\u201318 months, with some patients and treatment areas demonstrating visible benefits for up to 2 years, depending on injection site, volume used, individual metabolism, age and lifestyle. Maintenance or touch-up treatments may be scheduled according to clinical assessment and patient preference.
Onset
Immediate volumising and lifting effects are visible at the time of injection due to the CMC gel and CaHA microspheres providing structural support. Over subsequent weeks to months, neocollagenesis stimulated by the CaHA microspheres further improves skin texture, firmness and elasticity, enhancing and prolonging the overall aesthetic result.
