Merz Aesthetics
Radiesse
An injectable calcium hydroxylapatite filler that provides immediate gel-carrier volume and a longer tissue response around resorbable microspheres.
Calcium hydroxylapatite dermal filler and biostimulatorReviewed 7/30/2026Source recorded
At a glance
| Primary purpose | Correction of moderate to severe facial wrinkles and folds, selected lower-face or jawline contour indications under current product labelling, and correction of dorsal-hand volume loss. |
|---|---|
| Mechanism | Calcium hydroxylapatite microspheres suspended in a gel carrier provide immediate fill; the carrier dissipates as tissue forms around the microspheres, which are gradually resorbed. |
| When results appear | Immediate volume, followed by evolution as the carrier dissipates and tissue response develops. |
| Typical sessions | Often one treatment with individualized amount; additional treatment depends on area, response, and label. |
| Downtime | Swelling, bruising, redness, pain, itching, and tenderness can occur; hand and facial recovery differ. |
| Longevity | FDA consumer guidance describes calcium hydroxylapatite filler effects as approximately 18 months; individual product, area, and patient results vary. |
| Reversibility | Not dissolvable with hyaluronidase; correction of unwanted placement can be difficult. |
| Documented risks | Injection reactions, nodules, infection, material visibility or palpability, and rare intravascular injection with necrosis, visual loss, or stroke. |
| Most common disappointment | Immediate correction can evolve as the carrier dissipates, and unwanted product cannot be simply enzymatically dissolved. |
| Common marketing misconception | Radiesse is not interchangeable with Sculptra or HA filler; hyperdilute protocols may be off-label and should not redefine the approved product profile. |
| What varies by provider | Product version, dilution if any, plane, area, amount, anatomy, and complication management. |
| When this treatment may not be appropriate | When a reversible HA option is required, the desired area is not in the product labelling, or product contraindications or active infection apply. |
| United States regulatory status | FDA-approved by PMA and supplements for product-specific facial and hand indications; current Radiesse (+) labelling must be checked for the exact area. |
| Canadian regulatory status | Health Canada MDALL lists active Class III licences for Radiesse (78893) and Radiesse (+) (95140). |
| Evidence status | High for composition, approved-use framework, immediate filler action, and serious risks; off-label dilution outcomes are not generalized. |
Sources
- FDA PMA database: Radiesse P050052FDA PMA record · regulatory-primary · supports 2 profile fields
- FDA-Approved Dermal FillersFDA device guidance · regulatory-primary
- Health Canada MDALL: Merz Radiesse licencesHealth Canada MDALL · regulatory-primary
- Radiesse (+) Instructions for Useofficial manufacturer IFU · manufacturer-primary · supports 22 profile fields
- RADIESSE summary of safety and effectivenessregulator
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