Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
Certifications
Class III CE Marked injectable implantable medical device in the EU and Northern Ireland for aesthetic soft tissue augmentation indications in line with its labelling.
Recognised by the UK MHRA as a medical device for the indicated uses in Great Britain.
U.S. FDA Approved (as RADIESSE® (+) Lidocaine) 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.
Class III CE Marked injectable implantable medical device in the EU and Northern Ireland for aesthetic soft tissue augmentation indications in line with its labelling.
Recognised by the UK MHRA as a medical device for the indicated uses in Great Britain.
U.S. FDA Approved (as RADIESSE® (+) Lidocaine) 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 Good Manufacturing Practice (GMP) and ISO 13485–compliant quality management systems for medical devices.
Description
Radiesse + 1.5cc with Lidocaine is a premium, long-lasting calcium hydroxylapatite (CaHA)–based injectable implant from Merz Aesthetics, supplied in a 1.5 ml prefilled syringe with 0.3% lidocaine hydrochloride for improved injection comfort. It is designed for deep dermal and sub-dermal implantation to correct moderate to severe facial wrinkles and folds, restore and contour facial volume, and rejuvenate the dorsum of the hands. Tiny, smooth CaHA microspheres suspended in a carboxymethylcellulose gel carrier provide immediate volumisation while stimulating the body’s own collagen and elastin production over time, delivering a natural-looking, long-lasting rejuvenation.
Bnefits
Provides immediate volumising and contouring with visible correction at the time of treatment.
Biostimulatory CaHA microspheres stimulate the natural production of collagen (and elastin), improving skin firmness and quality over time.
Formulated with 0.3% lidocaine for increased patient comfort and reduced injection pain.
Effective for treatment of moderate to severe facial wrinkles and folds (e.g. nasolabial folds, marionette lines).
Restores lost volume and improves the appearance of age-related changes on the dorsum of the hands.
Delivers natural-looking, long-lasting results, typically persisting for 12–18 months depending on patient and treatment area.
Non–animal-derived, biocompatible and fully biodegradable implant.
Radiopaque CaHA microspheres are visible on imaging, which can aid radiologic interpretation when documented.
Cohesive, semi-solid gel implant reduces the risk of migration when injected correctly.
Indications
Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Deep injection (subdermal and/or supraperiosteal) in the face for the improvement of volume loss, contouring and structural support, in accordance with local regulatory approvals.
Hand augmentation to correct volume loss in the dorsum of the hands (where approved), reducing the visibility of tendons and veins.
Volumising and contouring procedures in suitable facial areas such as cheeks, jawline and chin when performed by appropriately trained professionals.
Manufactured under Good Manufacturing Practice (GMP) and ISO 13485–compliant quality management systems for medical devices.
Supplied with comprehensive Instructions for Use outlining safety information, indications, contraindications and injection techniques.
Supplied with comprehensive Instructions for Use outlining safety information, indications, contraindications and injection techniques.
Calcium hydroxylapatite (CaHA) biostimulatory filler with lidocaine
General improvement of skin quality via collagen biostimulation when used in appropriately selected, often diluted, protocols (off-label in some regions; subject to local regulations).
Composition
Principal component: synthetic calcium hydroxylapatite (CaHA) microspheres (approximately 30% by volume).
Gel carrier (approximately 70% by volume) composed of:
– Glycerin (USP).
– Sodium carboxymethylcellulose (CMC).
– Sterile water for injection.
Lidocaine hydrochloride 0.3% (for local anaesthetic effect).
Needle compatibility: designed for use with 25G to 27G needles as specified in the Instructions for Use; use of needles smaller than 27G is not recommended due to increased risk of clogging.
Device class: Class III injectable implantable medical device (EU/UK classification).
Packaging
One 1.5 ml prefilled glass syringe of Radiesse + Lidocaine per unit carton.
Typically supplied with two sterile single-use needles (commonly 27G thin-wall) in the blister pack, depending on market.
Sterile blister packaging with tamper-evident seals to maintain sterility until use.
Outer carton printed with product name (Radiesse +), volume, lot number, expiry date, and manufacturer details.
Package insert / Instructions for Use (IFU) included, detailing indications, contraindications, warnings and injection techniques.
Single-patient, single-use medical device; not to be resterilised or reused.
Usage
Radiesse + must only be administered by appropriately trained and licensed healthcare professionals experienced in injection techniques and familiar with facial and hand anatomy.
Before use, inspect the syringe, blister and packaging; do not use if packaging is damaged, if the syringe appears compromised, or if expiry date has passed.
Store and bring the product to room temperature before injection as per IFU; do not heat externally.
Prepare the patient by taking a full medical history, assessing indications and contraindications, and obtaining informed consent.
Clean and thoroughly disinfect the treatment area using an appropriate antiseptic solution; maintain strict aseptic technique during the procedure.
Attach the recommended sterile needle (e.g. 25–27G) securely to the Luer-lock of the syringe. Prime the needle to expel any air before injecting.
Injection plane: inject in the deep dermis or subdermal plane for wrinkle/fold correction, or in the appropriate deep plane on the dorsum of the hands, according to the IFU and training.
Techniques: use linear threading, serial puncture, fanning or depot techniques as appropriate to the indication and anatomic region. Inject slowly with minimal pressure and avoid bolus injections in high-risk areas.
Safety: aspirate according to clinician protocol prior to injection and avoid intravascular injection. Do not inject into blood vessels. Be particularly cautious in anatomically high-risk zones (e.g. glabella, nose, periocular region).
Correction: a 1:1 correction factor is generally recommended; do not overcorrect as further improvement may occur as collagen is stimulated.
Post-injection: gently massage and mould the treated area as required to achieve a smooth contour, unless local protocol suggests otherwise.
Aftercare: advise the patient to avoid touching or massaging the area (beyond practitioner instruction), avoid make-up for at least 12 hours, and refrain from excessive heat (sauna, sunbeds), vigorous exercise and alcohol for 24 hours or until any swelling and erythema resolve.
Follow-up: review the patient after the initial healing period (e.g. 2–4 weeks) to assess results and determine if additional treatment or refinement is required.
Disposal: after treatment, discard used needles, syringes and any unused 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, glycerin or sodium carboxymethylcellulose.
Patients with a history of severe allergies or anaphylaxis, or with multiple severe allergies.
Patients with bleeding disorders or those currently on significant anticoagulant therapy where the risk of bleeding/haematoma is unacceptable (clinical judgement required).
Presence of active infection, inflammation, or skin disease (e.g. herpes, acne, dermatitis) at or near the intended injection site.
Use in or near blood vessels; Radiesse must never be injected intravascularly.
Use in the lips, periorbital area, glabellar region, or breast augmentation – safety and effectiveness have not been established for these indications.
Pregnant or breastfeeding women – safety has not been established; treatment should be avoided unless specifically justified and in line with local guidelines.
Patients under 18 years of age – safety and effectiveness have not been established.
Patients with a known tendency to develop keloids or hypertrophic scars should be treated with caution or avoided.
Patients with uncontrolled autoimmune or connective tissue disorders should be carefully evaluated; treatment is at the clinician’s discretion in accordance with local regulations and guidelines.
Adverse Effects
Common transient injection-site reactions include erythema (redness), oedema (swelling), pain or tenderness, bruising (ecchymosis), pruritus (itching) and local warmth.
Palpable or visible nodules, lumps or bumps at or near the injection site, usually resolving with massage and time; in some cases further medical management may be required.
Induration, firmness or contour irregularities in the treated area.
Infection at the injection site, which may require antibiotic or other medical treatment.
Hypersensitivity or allergic reactions, including localised or more widespread swelling, redness or pruritus.
Rare granulomatous reactions or persistent inflammatory nodules.
Vascular complications from inadvertent intravascular injection or compression, potentially leading to blanching, livedo, tissue ischemia or necrosis; urgent intervention is required in such cases.
Very rare but serious events such as embolisation resulting in visual disturbances, blindness, stroke or other ischemic events when injected into or near vessels supplying critical structures.
On the dorsum of the hands: temporary stiffness, discomfort or difficulty performing some tasks immediately after treatment.
Any unexpected, persistent or severe adverse effects should be evaluated promptly by a healthcare professional.
Storage Conditions
Store in the original carton at controlled room temperature, typically between 15 °C and 32 °C (or as specified in the local IFU).
Do not freeze. Freezing can damage the product and render it unsuitable for use.
Protect from excessive heat and direct sunlight.
Do not use after the expiry date printed on the packaging.
Do not use if the blister pack is damaged, the sterility is in doubt, or the contents appear discoloured or otherwise abnormal.
Keep out of the reach of children.
Single-use only; once opened and used for a single patient, any remaining product must be discarded.
Duration
A single treatment session typically provides results lasting around 12\u201318 months, depending on the treatment area, volume injected, patient age, metabolism, lifestyle factors and injection technique. Maintenance or touch-up treatments may be performed as needed based on clinical assessment.
Onset
Immediate improvement in volume and wrinkle correction is visible at the time of injection due to the CaHA gel implant. Additional gradual improvement in skin firmness and quality occurs over the following weeks to months as neocollagenesis and elastin production are stimulated.
