Radiesse Lidocaine 1x1.5ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
RADIESSE® (+) Lidocaine is the version of Merz Aesthetics' injectable calcium hydroxyapatite implant pre-mixed with 0.3 % lidocaine. It is not a hyaluronic acid filler: its CaHA microspheres of 25–45 µm — 30 % v/v of the product — remain at the injection site while the carrier gel dissipates in vivo and is replaced by soft tissue growth. Unlike the version without lidocaine, it includes the jawline and marionette lines among the indications on its data sheet.
- Active substance CaHA 25–45 µm
- Ratio 30 % CaHA / 70 % gel (v/v)
- Lidocaine 0.3 % HCl
- Contents 1 syringe × 1.5 ml
- Needles 2 × 27G thin wall
Composition and technology
Sterile, pyrogen-free, latex-free, semi-solid and cohesive implant: CaHA particles suspended in a carrier gel of sodium carboxymethylcellulose with glycerine and lidocaine hydrochloride at 0.3 % (w/v), buffered with sodium phosphate salts.
| CaHA particles (25–45 µm) | 30 % (v/v) — 55.6–56.5 % (w/w) |
|---|---|
| Carrier gel | 70 % (v/v) |
| Sterile water for injection | 35.4–36.2 % (w/w) |
| Glycerine | 6.3–6.5 % (w/w) |
| NaCMC | 1.06–1.36 % (w/w) |
| Lidocaine HCl monohydrate | 0.22–0.23 % (w/w) |
| Phosphates | 0.30–0.31 % (w/w) |
- Mechanism: the carrier gel dissipates in vivo and is replaced by soft tissue growth; the calcium hydroxyapatite particles remain at the injection site. The result is a long-lasting, though not permanent, restoration and augmentation.
- Placement profile: the highly viscoelastic CaHA is suitable for supraperiosteal, subdermal and deep dermal placement, with a considerable volumising effect.
- Radiopacity: the CaHA particles are radiopaque and visible on computed tomography. The patient should report their presence before any imaging examination.
Indications and treatment areas
Injectable implant intended for the augmentation of dermal and deep subdermal soft tissue in adults.
| Nasolabial folds | At least 6–7 months |
|---|---|
| Cheek augmentation | At least 12 months |
| Marionette lines | At least 6–7 months |
| Jawline | At least 12 months |
| Hand augmentation (dorsum) | At least 12 months |
Durations documented by the manufacturer on the basis of clinical data.
It is not indicated for the correction of glabellar folds or the area of the nose: a higher incidence of localised necrosis has been associated with injection in these areas. The manufacturer further states that the safety and efficacy of the product in the lips have not been established, and that cases of nodules have been published following its injection into the lips.
Technique and treatment protocol
- Injection plane: subdermal and deep dermal; supraperiosteal according to the indication. Introduce the needle with the bevel facing downwards, at an angle of approximately 30° to the skin.
- Technique: slow, continuous and uniform pressure on the plunger while withdrawing the needle, leaving a fine thread of material completely surrounded by soft tissue, without globular deposits. The threads are applied in parallel and may be cross-hatched in layers over a deeper plane for structural support.
- Correction factor 1:1. Do not overcorrect — the volume of the soft tissue increases over several weeks.
- Maximum annual dose: 10 ml for facial and hand indications, adaptable according to indication, tissue, age, injection depth and technique.
- Hands: advance between the subcutaneous layer and the superficial fascia using a skin tenting technique; boluses of 0.2–0.5 ml, not exceeding 0.5 ml per bolus. Aspirate before injecting each bolus.
- Jawline: the safety and efficacy of cannula use for deep injection (subdermal and/or supraperiosteal) in this indication have only been evaluated with a 25G cannula.
- Lidocaine: in healthy adults, the maximum total recommended dose of lidocaine HCl without epinephrine should not exceed 300 mg (or 4.5 mg/kg) per session, taking into account any other local anaesthetic administered in the same procedure.
- If significant resistance is felt when pushing the plunger, move the needle slightly, change position or replace the needle or the syringe. Massage the treated area to achieve a uniform distribution.
Technical data
| Manufacturer | Merz North America, Inc., Franksville, WI, USA |
|---|---|
| EU representative | Merz Aesthetics GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Germany |
| Active substance | Synthetic calcium hydroxyapatite (CaHA), particles of 25–45 µm |
| Carrier gel | Sterile water for injection, glycerine and sodium carboxymethylcellulose, buffered with sodium phosphate salts |
| Anaesthetic | Lidocaine hydrochloride 0.3 % (w/v) |
| Presentation | 1 pre-filled syringe of 1.5 ml |
| Needles | 2 Terumo K-Pack II thin-wall 27G needles |
| Sterilisation | Steam with parametric release cycle, SAL ≥ 10⁻⁶ |
| Classification | CE-marked medical device; product without an intended medical purpose |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: inside its wrapping, at a controlled room temperature between 15 °C and 25 °C. Keep dry and away from sunlight.
- Do not use after the expiry date printed on the product labels.
- Do not use if the pack, the pouch or the syringe is damaged, or if the cap or the plunger is not intact.
- Single-use product, for one person and one treatment only. Do not re-sterilise or reuse.
- The pack contains: 1 pre-filled syringe of 1.5 ml of RADIESSE® (+) Lidocaine and 2 Terumo K-Pack II thin-wall 27G needles.
Contraindications and warnings
Contraindications: chronic and/or acute inflammation or infection in the area to be treated; severe allergies manifested by a history of anaphylaxis or the presence of multiple severe allergies; known hypersensitivity to any of the components; known hypersensitivity to lidocaine or to amide-type anaesthetics; tendency to develop inflammatory skin conditions, hypertrophic scars or keloids; presence of foreign bodies such as liquid silicone or other particulate materials; areas without healthy, well-vascularised tissue; systemic disorders causing poor wound healing; bleeding disorders; patients under 18 years of age; pregnancy and breastfeeding.
Do not apply in the epidermis or the superficial dermis (risk of fistulas, infection, lumps, nodules and induration). Not indicated in glabellar folds or the nasal area.
Warnings: introduction of the implant into the vascular system can cause embolisation or thrombosis, vascular occlusion, ischaemia or infarction; rare but serious cases of temporary or permanent loss of vision, blindness, cerebral ischaemia or haemorrhage resulting in stroke, and skin necrosis have been reported. Stop the injection immediately if changes in vision, signs of stroke, skin blanching or unusual pain occur. Do not inject into organs or structures that may be damaged by a space-occupying implant. Do not overcorrect. It must not be injected into people taking aspirin or other medicines that may impair wound healing. Injection into the dorsum of the hand may cause intense swelling; take extreme care to avoid vessels and tendons.
Lidocaine: may be associated with numbness (hypoaesthesia) and with allergic reactions. An overdose usually gives rise to signs of central nervous system or cardiovascular toxicity; if signs of toxicity occur, stop administration and seek urgent medical assistance.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official instructions for use of the RADIESSE® (+) Lidocaine injectable implant (Merz North America, Inc. / Merz Aesthetics GmbH, Spanish version, January 2025) and on the US instructions for use of the product with regard to labial use. This data sheet does not replace the instructions for use accompanying the product.