Calcium hydroxylapatite (CaHA) biostimulatory volumising filler with lidocaine
Certifications
CE Marked Class III medical device for soft tissue augmentation indications in the European Union and Northern Ireland.
Recognised by the UK MHRA as a medical device for use within Great Britain for approved aesthetic and reconstructive indications.
FDA Approved (as RADIESSE and 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 for soft tissue augmentation indications in the European Union and Northern Ireland.
Recognised by the UK MHRA as a medical device for use within Great Britain for approved aesthetic and reconstructive indications.
FDA Approved (as RADIESSE and 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) requirements for medical devices.
Description
RADIESSE LIDO (1x1,5ml) MERZ is a CE-marked, FDA-approved biostimulatory dermal filler and injectable implant based on synthetic calcium hydroxylapatite (CaHA) microspheres suspended in a biodegradable carboxymethylcellulose (CMC) gel, with 0.3% lidocaine added for improved injection comfort. Supplied as a single 1.5 ml prefilled syringe with two 27G thin-wall needles, 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 volume, and treat age-related volume loss on the dorsum of the hands. RADIESSE provides immediate volumisation and lifting while its CaHA microspheres stimulate neocollagenesis and elastin production for long-lasting improvement in skin density, firmness and quality.
Bnefits
Volumising filler that provides immediate correction of moderate to deep wrinkles and folds.
Biostimulatory CaHA microspheres stimulate collagen and elastin production, improving skin firmness and elasticity over time.
Formulated with 0.3% lidocaine to enhance patient comfort and reduce pain during injection.
Powerful lifting and contouring capacity, often superior to many hyaluronic acid fillers for structural support.
Long-lasting yet fully resorbable results, typically around 12 months or more in many patients.
Improves overall skin quality by redensifying the dermis and enhancing skin texture.
Versatile use for facial contouring (cheeks, chin, jawline, marionette lines, nasolabial folds) and hand rejuvenation.
Cohesive, semi-solid implant that remains localised when properly injected, reducing risk of migration.
Non–animal-derived, biocompatible and biodegradable composition with a long clinical safety record.
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 contour restoration and structural support.
Restoration and/or correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV), according to local regulatory approvals.
Manufactured under ISO 13485–compliant quality management systems and Good Manufacturing Practice (GMP) requirements for medical devices.
Supplied with comprehensive Instructions for Use detailing device description, indications, contraindications, warnings and recommended injection techniques.
Supplied with comprehensive Instructions for Use detailing device description, indications, contraindications, warnings and recommended injection techniques.
Calcium hydroxylapatite (CaHA) biostimulatory volumising filler with lidocaine
Plastic and reconstructive surgery indications requiring increased volume in the deep dermis and subdermal facial tissues.
Hand augmentation to correct age-related volume loss in the dorsum of the hands and reduce visibility of veins and tendons where approved.
Facial contouring procedures including cheek augmentation, treatment of marionette lines, jawline contouring, chin projection, and full facial lifting protocols performed by trained physicians.
Composition
Synthetic calcium hydroxylapatite (CaHA) microspheres (principal active component; approximately 30% by volume).
Carboxymethylcellulose (CMC)–based gel carrier (approximately 70% by volume) providing immediate volumising effect.
Glycerin (USP-grade) within the carrier gel.
Sterile water for injection.
Lidocaine hydrochloride 0.3% as an integrated local anaesthetic for improved injection comfort.
Opaque, sterile, non-pyrogenic, semi-solid, cohesive, latex-free implant with CaHA particle size range approximately 25–45 microns.
Active filler component: synthetic calcium hydroxylapatite microspheres in a CMC aqueous gel carrier.
Anaesthetic component: 0.3% lidocaine hydrochloride incorporated into the carrier gel.
Presentation volume: single prefilled 1.5 ml (1x1,5 ml) syringe.
Sterility: sterile, non-pyrogenic, single-use medical device.
Recommended needle size: 25G outer diameter to 27G inner diameter needles; pack typically includes 2 x 27G thin-wall 0.4 x 20 mm needles.
Injection depth: deep dermis and/or subdermis depending on indication and treatment area.
Device class: Class III injectable implantable medical device under EU/UK medical device regulations.
Resorbable and biodegradable: carrier gel is absorbed first while CaHA microspheres are slowly metabolised, leaving newly formed collagen.
Packaging
Each unit contains one 1.5 ml prefilled syringe of RADIESSE LIDO injectable implant.
Includes two sterile 27G thin-wall needles (27G T.W. x 0.75" / 0.4 x 20 mm).
Syringes are supplied sterile and non-pyrogenic in sealed aluminium pouches for protection.
Aluminium pouches are packed within a branded cardboard outer box for storage and transport.
Outer packaging is clearly labelled with product name (RADIESSE LIDO 1x1,5ml), volume, lot number, expiry date, manufacturer details, and device symbols.
Package insert / Instructions for Use (IFU) included with full information on indications, contraindications, warnings and injection technique.
Single-patient, single-use packaging; not intended for resterilisation or reuse.
Usage
RADIESSE LIDO must only be injected by appropriately trained and licensed physicians (e.g. dermatologists, plastic surgeons, cosmetic physicians) experienced in facial anatomy and injectable procedures.
Before treatment, obtain a complete medical history, assess indications and contraindications, discuss risks and benefits, and obtain informed consent.
Inspect the packaging, syringe and needles prior to use; do not use if the blister, pouch or syringe is damaged, if sterility is compromised, or if the product is past its expiry date.
Bring the product to room temperature before injection as per the Instructions for Use; do not apply external heat or freeze the product.
Clean and thoroughly disinfect the treatment area with an appropriate antiseptic solution; maintain strict aseptic technique throughout the procedure.
Attach the supplied sterile needle (e.g. 27G thin-wall) securely to the Luer-lock syringe and prime to expel air before injection.
Inject into the deep dermis or subdermal plane of the facial region, or into the appropriate subdermal plane on the dorsum of the hands, using recommended techniques such as linear threading, serial puncture, fanning or depot injections.
Inject slowly with minimal pressure, aspirating according to practitioner protocol to minimise the risk of intravascular injection; never inject directly into blood vessels.
Use a 1:1 correction approach—overcorrection is generally not required because additional collagen-induced volume develops over time.
After injection, gently massage and mould the area to ensure even distribution and smooth contours, unless local protocol or specific treatment area suggests otherwise.
Advise patients to avoid strenuous exercise, excessive heat (sauna, sunbeds), alcohol and rubbing or massaging the treated area for at least 24 hours or until any swelling and redness have resolved.
Inform patients of typical transient reactions (e.g. swelling, redness, bruising) and instruct them to contact the clinic immediately if they experience severe pain, blanching, visual changes or signs of infection.
Schedule a follow-up visit (e.g. after 2–4 weeks) to assess results, review patient satisfaction and determine whether additional touch-up treatment is required.
Dispose of all used needles, syringes and 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, sodium carboxymethylcellulose, glycerin or other excipients.
History of severe allergies or anaphylactic reactions, or multiple severe allergies.
Presence of active skin infection, inflammation, or pathology at or near the intended injection site (e.g. herpes simplex lesions, cellulitis, severe acne, dermatitis).
Bleeding disorders or patients on significant anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is considered unacceptable (clinical judgement required).
Use in high-risk or unapproved anatomical areas such as the lips, periorbital region, glabella or for breast augmentation, where safety and efficacy have not been established.
Pregnancy and breastfeeding, as safety has not been established in these populations.
Patients under 18 years of age (safety and effectiveness not established).
Patients with a known tendency to keloid formation or hypertrophic scarring should be treated with great caution or avoided.
Patients with uncontrolled autoimmune or connective tissue diseases should be carefully evaluated; treatment is at the physician’s discretion based on current guidelines and individual risk–benefit assessment.
Adverse Effects
Common transient injection-site reactions such as redness (erythema), swelling (oedema), pain or tenderness, bruising (ecchymosis), itching (pruritus) and local warmth, which typically resolve spontaneously within days.
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 management, but occasionally require further medical intervention.
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 or other medical treatment.
Hypersensitivity or allergic reactions including prolonged redness, swelling, itching or induration.
Rare granulomatous or chronic inflammatory reactions presenting as persistent nodules or induration.
Vascular complications due to inadvertent intravascular injection or compression, including blanching, livedo, pain, tissue ischemia and necrosis; urgent recognition and management are required.
Very rare but serious events such as embolisation leading to visual disturbances, vision loss, stroke or other ischemic events when filler enters or compresses blood vessels supplying critical structures.
On the dorsum of the hands, temporary stiffness, discomfort or reduced range of motion can occur immediately after treatment but usually resolves.
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 gel structure and render the product unsuitable for use.
Protect from excessive heat and direct sunlight.
Keep the syringe in its sealed sterile 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, if the sterile barrier has been compromised, or if the product appears discoloured or otherwise abnormal.
Keep out of the reach of children.
Single-use device; discard any leftover product and all used components as clinical waste immediately after treating a single patient.
Duration
Clinical experience and published data indicate that single treatment results typically last around 12 months, and in some patients longer, depending on injection site, volume used, patient age, metabolism, lifestyle and indication. Maintenance or touch-up treatments can be performed as needed following adequate evaluation at follow-up visits.
Onset
Volumising and wrinkle-correcting effects are visible immediately at the time of injection due to the CaHA gel implant. Progressive improvement in skin quality, firmness and elasticity develops over subsequent weeks and months as the CaHA microspheres stimulate neocollagenesis and elastin production, with many patients showing peak improvement around 3\u20134 months post-treatment.
