Calcium hydroxylapatite (CaHA) biostimulatory volumising filler without lidocaine
Certifications
CE Marked Class III injectable implantable medical device in the European Union and Northern Ireland 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 its indicated aesthetic and reconstructive uses in Great Britain.
Part of the Radiesse 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 formats and indications vary by market).
CE Marked Class III injectable implantable medical device in the European Union and Northern Ireland 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 its indicated aesthetic and reconstructive uses in Great Britain.
Part of the Radiesse 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 formats and indications vary by market).
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) standards for medical devices.
Description
Radiesse 1.5ml (Without Lidocaine) is a calcium hydroxylapatite (CaHA)–based injectable dermal filler from Merz Aesthetics designed to add volume, smooth and reduce moderate to severe facial wrinkles and folds, and provide an immediate lifting and firming effect to the skin. Supplied as a single 1.5 ml prefilled syringe with no added lidocaine, this sterile, non-pyrogenic, semi-solid, cohesive implant is intended for deep dermal and subdermal implantation. The CaHA microspheres suspended in a carboxymethylcellulose (CMC) gel carrier provide instant structural support while stimulating the body’s own collagen production for long-lasting, natural-looking rejuvenation that can persist for up to 18 months before being fully resorbed.
Bnefits
Provides immediate volume restoration and lifting of treated areas at the time of injection.
Smooths and reduces the appearance of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Delivers a noticeable firming effect, improving skin support and contour.
Stimulates neocollagenesis and neoelastinogenesis, enhancing skin firmness, elasticity and texture over time.
Longer-lasting than many hyaluronic acid fillers, with effects that can persist for up to 18 months in many patients.
Biocompatible CaHA microspheres gradually resorb and are replaced by the patient’s own collagen, providing a non-permanent but enduring improvement.
Cohesive, semi-solid implant is mouldable for refined contouring and natural-looking results.
Latex-free, non-pyrogenic and fully biodegradable, with a long international safety record when used correctly.
Versatile usage in multiple facial regions (e.g. midface, lower face) for lifting, contouring and structural support.
Available without lidocaine, allowing practitioners to tailor anaesthesia (e.g. separate topical or injected local anaesthetic) according to patient needs.
Indications
Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Augmentation of soft tissues of the deep dermis and subdermis of the facial region for aesthetic contouring and structural support.
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) standards for medical devices.
Supplied with comprehensive Instructions for Use and patient information leaflets detailing safety, indications, contraindications, warnings and recommended injection protocols.
Supplied with comprehensive Instructions for Use and patient information leaflets detailing safety, indications, contraindications, warnings and recommended injection protocols.
Calcium hydroxylapatite (CaHA) biostimulatory volumising filler without lidocaine
Restoration of age- or disease-related facial volume loss, including cheek and midface hollowing.
Lifting and contouring of facial features in plastic and reconstructive procedures, according to local regulations and labelling.
Use in full-face rejuvenation protocols where targeted lifting of nasolabial folds, marionette lines and pre-jowl sulci is required, performed by trained physicians.
Selected reconstructive indications such as correction of facial lipoatrophy in people with HIV, in line with local approvals and guidelines.
Volume replenishment in the dorsum of the hands where Radiesse is approved and when the variant without lidocaine is chosen by the treating clinician.
Composition
Principal component: synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% by volume).
Gel carrier (approximately 70% by volume) consisting primarily of:
– Sterile water for injection (USP).
– Glycerin (USP).
– Sodium carboxymethylcellulose (CMC) (USP).
CaHA microsphere particle size range: approximately 25–45 microns.
Mechanism of action: immediate volumising and lifting, followed by collagen and elastin stimulation for long-term tissue remodelling.
Recommended needle: 25 gauge outer diameter or 27 gauge inner diameter needle, thin-wall, as specified in the Instructions for Use.
Recommended injection depth: deep dermis and/or subdermal plane, and where appropriate supraperiosteal, depending on anatomical site and indication.
Device class: Class III implantable medical device under EU/UK medical device regulations.
Packaging
One 1.5 ml prefilled glass syringe of Radiesse injectable implant (without lidocaine) per carton.
Typically supplied with two sterile single-use thin-wall needles (commonly 25G x 1.0" / 0.5 x 25 mm), depending on market configuration.
Syringe and needles packaged in a sterile blister or aluminium pouch to maintain sterility.
Outer cardboard box printed with product name (Radiesse 1.5 ml), batch/lot number, expiry date, manufacturer details and regulatory symbols.
Includes Instructions for Use (IFU) detailing device description, indications, contraindications, warnings, injection techniques and post-treatment guidance.
Single-patient, single-use packaging; not intended for resterilisation or reuse.
Usage
Radiesse 1.5 ml (without lidocaine) must only be injected by suitably trained and licensed physicians or healthcare professionals experienced in facial and hand anatomy and injectable implant techniques.
Before treatment, take a comprehensive medical history, assess indications and contraindications, review patient expectations and obtain informed consent.
Inspect the packaging and syringe; 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 syringe to reach room temperature as per the IFU; do not heat externally and do not freeze.
As the formulation does not contain lidocaine, select and administer appropriate anaesthesia (e.g. topical anaesthetic, nerve block or local infiltration) according to patient needs and clinician preference.
Cleanse and thoroughly disinfect the treatment area with an appropriate antiseptic solution 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 expel any air before injection.
Inject Radiesse into the deep dermis and/or subdermal plane (and supraperiosteal when indicated) using linear threading, serial puncture, fanning or depot techniques adapted to the anatomical region and desired outcome.
Inject slowly with minimal pressure; aspirate according to practitioner protocol to reduce the risk of intravascular injection. Never inject directly into blood vessels and exercise particular care in high-risk vascular areas.
Use a conservative correction strategy and avoid overfilling, as further lifting and volume develop over time through collagen stimulation.
After injection, gently massage and mould the treated area as required to ensure even distribution and smooth contours, unless contraindicated in the specific region.
Provide post-treatment instructions: advise patients to avoid excessive touching or massaging of the treated area, strenuous exercise, alcohol and intense heat exposure (saunas, steam rooms, sunbeds) for at least 24 hours or until local reactions subside.
Inform patients of common transient side effects (redness, swelling, bruising, tenderness) and instruct them to seek immediate medical attention if they experience severe pain, blanching, visual changes, signs of infection or any other unusual symptoms.
Arrange follow-up (e.g. after 2–4 weeks) to assess treatment results, address minor asymmetries or nodules if present and plan any touch-up or maintenance treatments.
Dispose of used needles, syringes and any remaining product as clinical sharps waste in accordance with local regulations; never resterilise or reuse.
Contraindications
Known hypersensitivity or allergy to any component of the product, including calcium hydroxylapatite, glycerin or sodium carboxymethylcellulose.
History of severe allergies or anaphylactic reactions.
Presence of active infection, inflammation or skin disease at or near the intended injection site (e.g. herpes simplex lesions, cellulitis, severe acne, active dermatitis).
Patients with bleeding disorders or those receiving significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is considered unacceptable (clinician judgement required).
Use in anatomical sites where safety and efficacy have not been established (such as lips, periorbital region, glabella or for breast augmentation), unless specifically authorised and undertaken only by highly experienced injectors in line with local labelling.
Pregnancy or breastfeeding, as adequate safety data are lacking and treatment is generally not recommended.
Patients under 18 years of age, as safety and effectiveness have not been established.
Patients with a known tendency to develop keloids or hypertrophic scars should be treated with extreme caution or may be unsuitable candidates.
Patients with uncontrolled autoimmune or connective tissue diseases should be carefully evaluated; treatment should only be considered if potential benefits clearly outweigh risks and in accordance with current guidance.
Any contraindications listed in the official Instructions for Use must be strictly followed.
Adverse Effects
Common transient injection-site reactions such as 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 diminish over time and may respond to massage; persistent nodules may require additional medical management.
Contour irregularities or asymmetry if product placement, plane or volume distribution is suboptimal.
Localised infection at the injection site, presenting with increasing pain, redness, swelling or warmth and potentially requiring antibiotic or other medical treatment.
Hypersensitivity or allergic reactions, including prolonged swelling, redness, itching or induration.
Rare granulomatous or chronic inflammatory reactions manifesting as persistent firm nodules.
Vascular complications due to inadvertent intravascular injection or vessel compression, which may lead to blanching, livedo, severe pain, tissue ischaemia or necrosis; these require urgent recognition and intervention.
Very rare but serious events such as embolisation causing visual disturbances, vision loss, stroke or other ischaemic complications if filler enters or compresses vessels supplying critical structures.
In hand treatments, temporary stiffness, discomfort or reduced range of motion may occur, typically resolving spontaneously.
Any unexpected, severe or persistent 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 within a recommended range such as approximately 15–32 °C).
Do not freeze; freezing can damage the product and impair 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 outer 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 immediately after treating a single patient in accordance with local clinical waste regulations.
Duration
Clinical effects generally last around 12\u201318 months, with many patients experiencing sustained improvement for up to 18 months before the product is fully resorbed, depending on treatment area, injected volume, patient age, metabolism and lifestyle. Maintenance or repeat treatments may be scheduled according to clinical assessment and patient preference.
Onset
Immediate volumising, lifting and wrinkle-smoothing are visible at the time of injection due to the CaHA gel implant, with further progressive improvement in firmness, elasticity and skin quality over subsequent weeks and months as new collagen and elastin are stimulated.
