EU CE Marked Class III medical device for soft tissue augmentation under the Medical Device Directive/Regulation (EU) 2017/745
MHRA Recognised medical device for use in the United Kingdom
US FDA Approved for correction of moderate to severe facial wrinkles and folds (e.g. nasolabial folds) and for hand augmentation to correct volume loss in the dorsum of the hands
EU CE Marked Class III medical device for soft tissue augmentation under the Medical Device Directive/Regulation (EU) 2017/745
MHRA Recognised medical device for use in the United Kingdom
US FDA Approved for correction of moderate to severe facial wrinkles and folds (e.g. nasolabial folds) and for hand augmentation to correct volume loss in the dorsum of the hands
Manufactured under GMP and quality standards applicable to implantable medical devices
Radiesse is a premium, long-lasting, calcium hydroxyapatite (CaHA)–based injectable implant used for soft tissue augmentation. Supplied as a 1.5 ml prefilled syringe without lidocaine, it is designed for deep dermal and sub-dermal injection to restore facial volume, smooth moderate to severe wrinkles and folds, and rejuvenate the dorsum of the hands. The CaHA microspheres provide immediate volumisation while stimulating neocollagenesis and elastin production for progressive improvement in skin firmness and quality over time.
Bnefits
Immediate volume restoration and contouring of treated areas
Biostimulatory action with CaHA microspheres that stimulate collagen and elastin production
Improves skin elasticity, firmness and overall skin quality
Effective correction of moderate to severe wrinkles and folds (e.g. nasolabial folds, marionette lines)
Restores volume and reduces the appearance of tendons and veins on the dorsum of the hands
Long-lasting aesthetic results, typically 12–18 months depending on area and patient factors
Non–animal-derived, biocompatible and fully biodegradable implant
Radiopaque microspheres visible on imaging, aiding radiologic interpretation when disclosed
Indications
Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds
Restoration and/or correction of signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV)
Hand augmentation to correct volume loss in the dorsum of the hands
Facial contouring including cheeks, cheekbones, marionette lines, chin, and jawline
General improvement of skin quality and structure via collagen biostimulation when used in diluted protocols (off-label in some regions; follow local regulations)
Composition
Synthetic calcium hydroxylapatite (CaHA) microspheres (~30% of the formulation by volume)
CaHA microspheres (particle size approximately 25–45 microns) suspended in a CMC-based aqueous gel carrier
Single-use, prefilled 1.5 ml syringe for deep dermal or sub-dermal implantation
Latex-free medical device
Packaging
1 x 1.5 ml prefilled, sterile syringe of Radiesse injectable implant
Typically supplied with 2 sterile thin-wall needles (commonly 27G x 3/4", 0.4 x 20 mm) – check pack for exact configuration
Single-patient, single-use packaging with tamper-evident sterile barrier
Package insert / Instructions for Use (IFU) included
Usage
For professional use only: Radiesse must be administered exclusively by appropriately trained and licensed healthcare professionals familiar with facial and hand anatomy and injectable implant techniques.
Aseptic technique: Perform thorough skin cleansing and disinfection of the treatment area prior to injection. Maintain strict aseptic technique throughout the procedure.
Injection plane: Inject subdermally or in the deep dermis depending on indication and anatomical area (e.g. deep dermis/sub-dermis for facial folds, subdermal plane on dorsum of the hands).
Needle choice: Use a 25–27G needle (commonly 27G thin wall) as recommended in the IFU; do not use smaller-bore needles than recommended.
Technique: Insert the needle bevel-down at an appropriate angle (often around 30° to the skin for linear threading) and advance into the desired plane before injecting. Use linear threading, fanning, or depot techniques according to indication and training.
Correction factor: Use a 1:1 correction factor—overcorrection is not required. Do not overfill; Radiesse effects typically improve over subsequent weeks as collagen is produced.
Injection speed and pressure: Inject slowly with minimal pressure to reduce the risk of intravascular injection and tissue trauma. Aspirate as per practitioner protocol and follow all IFU safety recommendations.
Post-injection moulding: Gently massage and mould the treated area immediately post-injection to ensure even distribution and smooth contour, unless contraindicated by local protocol.
Post-treatment care: Advise patients to avoid excessive pressure, massage (beyond practitioner-directed), strenuous exercise, heat/sauna, and intense sun/UV exposure for approximately 24 hours or until swelling and redness resolve.
Repeat treatments: Schedule maintenance or touch-up sessions based on individual patient response, typically after 12–18 months or as clinically indicated. Always review prior treatment history and outcomes.
Contraindications
History of severe allergies, including anaphylaxis or multiple severe allergies
Known hypersensitivity to any component of the product (e.g. calcium hydroxylapatite, glycerin, sodium carboxymethylcellulose, or other excipients)
Patients with bleeding disorders or those with significant coagulopathy
Presence of active skin infection, inflammation, or dermatitis in or near the intended injection site
Use in lips and periorbital areas – safety and effectiveness have not been established for these indications
Pregnancy and breastfeeding – safety has not been established
Patients under 18 years of age – safety and effectiveness have not been established
Patients with a known tendency to keloid formation or hypertrophic scarring (safety not adequately studied)
Patients with active autoimmune or connective tissue disorders should be evaluated carefully and treated only at the clinician’s discretion, following local guidelines
Adverse Effects
Common, usually transient injection-site reactions: bruising (ecchymosis), oedema/swelling, erythema (redness), pain or tenderness, pruritus (itching), and local warmth
Nodules, palpable lumps, or contour irregularities at or near the injection site (usually transient but may rarely persist)
Injection-related reactions such as soreness, numbness, tightness, and irritation
Infection at the injection site (requires appropriate medical management)
Hypersensitivity or allergic reactions in susceptible individuals
Rare but serious complications from inadvertent intravascular injection, including embolisation, vascular occlusion, skin ischemia or necrosis, visual disturbance, blindness, stroke, and tissue infarction
Potential reactivation of herpes simplex in patients with a history of herpetic eruptions in or near the treated area
On the dorsum of the hands: temporary difficulty performing some activities, transient stiffness, or discomfort
Very rare granuloma formation or persistent inflammatory nodules
Storage Conditions
Store in original packaging at controlled room temperature, typically between 15 °C and 32 °C.
Protect from extreme heat and direct sunlight.
Do not freeze.
Do not use after the expiry date printed on the product label and carton.
Do not use if the sterile blister, syringe, end cap, or plunger is damaged or compromised.
Single-use only; do not resterilise. Dispose of used syringes and needles as clinical sharps waste according to local regulations.
Duration
Clinical and real-world data suggest results typically last around 12\u201318 months, depending on treatment area, injection technique, patient age, metabolism, lifestyle, and volume used.
Onset
Immediate visible volumisation and wrinkle correction at the time of injection, with additional gradual improvement over weeks to months as new collagen and elastin are formed.
