Radiesse is an injectable made of calcium hydroxylapatite — a mineral that also forms bone — in a soft gel. It is FDA-approved and is usually grouped with Sculptra as a "biostimulator". About 27,000 Americans a month search for it (clickstream estimate, October 2026). This page sets out what is in the syringe, the uses FDA has approved and when, what each pivotal trial measured, and what is known about duration and reversal, as of 20 October 2026. It makes no recommendation; whether a filler suits a face is a question for a licensed clinician.
What is in the syringe
The instructions for use that Merz North America filed with FDA describe Radiesse as synthetic calcium hydroxylapatite suspended in a gel carrier of glycerin, sodium carboxymethylcellulose and sterile water for injection. The particles measure 25 to 45 micrometres. Radiesse (+) is the same implant with 0.3% lidocaine mixed into the gel. Both come in 1.5 cc and 0.8 cc syringes.
The two parts are said to do different jobs. The gel gives volume immediately and is absorbed over the following weeks; the particles stay longer and are described as a scaffold around which the body lays down new collagen. That is why the product is grouped with poly-L-lactic acid (Sculptra) under the label biostimulators, although, unlike Sculptra, it also fills on the day of treatment.
The approvals, by date
FDA regulates Radiesse as a Class III device under two premarket approvals. Each new use came through a supplement with its own trial. The dates below were read from FDA's approval database on 20 October 2026.
| Date | Record | Use added |
|---|---|---|
| 22 Dec 2006 | P050052 | moderate to severe facial wrinkles and folds, such as nasolabial folds |
| 22 Dec 2006 | P050037 | facial fat loss (lipoatrophy) in people with HIV |
| 30 Jan 2015 | P050052/S052 | Radiesse (+): the lidocaine formulation, same facial indication |
| 4 Jun 2015 | P050052/S049 | volume loss in the backs of the hands |
| 1 Sep 2021 | P050052/S129 | Radiesse (+), deep injection for loss of jawline contour, adults over 21 |
| 31 Mar 2026 | P050052/S162 | diluted 1:2 with saline, décolleté wrinkles, age 22 and over |
Two areas often treated in practice are named in the label as unstudied: the lips, where it notes published reports of nodules, and the area around the eyes. The Aesthetic Society's 2019 consumer table nonetheless lists lips among the areas Radiesse is used for — a reminder that a survey of practice and an approved label answer different questions. Our page on hyperdilute Radiesse covers the diluted form and the décolleté trial; Radiesse for the jawline, neck and hands covers the hand and jaw trials and what is published about the neck.
What the pivotal trials measured
Every approval rests on a trial that compared Radiesse with something — another filler or no treatment — and scored the result on a grading scale read by an evaluator who did not know which side or group was which.
| Use | Trial | Comparison | Primary result |
|---|---|---|---|
| Nasolabial folds | 117 people, four US centres (Smith 2007) | Radiesse on one side, human collagen on the other | 79% had the better result on the Radiesse side through six months |
| Hands | 114 people randomized 3:1 (S049) | treatment vs delayed treatment | 75.3% vs 3.4% improved one grade or more at three months |
| Jawline | 180 people randomized 2:1 (S129, NCT03583359) | treatment vs no treatment until week 12 | 75.6% vs 8.8% responders at week 12 |
| Décolleté | 152 people randomized 3:1 (S162) | diluted Radiesse vs no treatment until week 24 | 71.2% vs 6.3% responders at week 24 |
Two things limit what the table says. The comparisons are against collagen, a product rarely used today, or against no treatment, which any filler would be expected to beat; none of the approval trials compared Radiesse with a hyaluronic-acid filler or with Sculptra. And the three supplement trials were submitted by the manufacturer, Merz North America, as its own approval evidence. PubMed lists 21 records tagged as randomized trials that name calcium hydroxylapatite or Radiesse alongside fillers or the face (search run 20 October 2026), most of them small and many of them comparisons of technique rather than of products.
How long it lasts
The trials report how many people still met a response definition at a later visit, which is not the same as how long the material stays in the tissue.
- Jawline: of 113 people who responded at week 12 and were assessed again at week 48, 67.3% still met the response definition, before any retreatment was offered.
- Hands: 68.2% still showed at least a one-point improvement 12 months after the first treatment, by masked live evaluation.
- Survey of practice: the Aesthetic Society's 2019 consumer table gives "repeat treatments 2 years or longer". It does not say how that figure was derived.
Average injected volumes differ by site: a median of 1.8 mL per side of the jaw at the first session, and a mean of 5.18 cc across both hands. Volumes drive cost, which our Radiesse cost page sets out against the last published national fees.
Why it cannot be dissolved like a hyaluronic-acid filler
A hyaluronic-acid filler that blocks a vessel or sits badly can be broken down with hyaluronidase. That enzyme does not act on calcium hydroxylapatite. The candidate most studied as a reversal agent is sodium thiosulfate, a drug used for calcium deposits in other conditions. PubMed returns 8 records pairing it with calcium hydroxylapatite or Radiesse (20 October 2026). In a 2021 study, segments of human facial artery from cadavers were filled with the product and soaked for 24 hours in sodium thiosulfate at several strengths, with and without hyaluronidase; the filler remained inside every artery, although increasing concentrations broke the material down when in direct contact in the laboratory. The authors concluded that intra-arterial calcium hydroxylapatite "still lacks a suitable antidote". No controlled trial in people has tested a reversal method. The label's warning on injection into a blood vessel — vision loss, stroke, skin necrosis — and the harm reports are covered in Radiesse side effects.
It shows up on scans
The label states that the particles are radiopaque: clearly visible on CT scans and possibly visible on plain X-rays. It summarises a radiographic study of 58 patients in which the implant was not read as masking abnormal tissue or as a tumour, and it asks patients to tell anyone reading their imaging that they have been treated. That matters most where Radiesse now has a chest indication, as our hyperdilute Radiesse page explains.
Radiesse beside the other biostimulators
The full comparison with poly-L-lactic acid, including who funded which study, is in Sculptra vs Radiesse. In short: Radiesse fills on the day and stimulates collagen over months; Sculptra does only the second. Neither can be dissolved with hyaluronidase. Polycaprolactone fillers such as Ellansé work on a similar principle but have no US approval.
What is and is not established
Established: what the syringe contains; the five uses FDA has approved, with dates; that each pivotal trial beat no treatment or human collagen on a blinded grading scale; that response persisted in about two-thirds of responders at 48 weeks (jaw) and 12 months (hands); that the particles are visible on CT.
Not established: how Radiesse compares with a hyaluronic-acid filler or with Sculptra in an approval-grade trial; its safety in the lips and around the eyes; how long the particles persist in people; and any proven way to reverse it. Anyone weighing it against other options should do so with a licensed clinician.
Sources
- US FDA premarket approval database (openFDA), PMA P050052 and P050037 with supplements S049, S052, S129 and S162; decision dates and approval statements read 2026-10-20.
- US FDA. Summary of Safety and Effectiveness Data: P050052/S129 (jawline), P050052/S049 (hands), P050052/S162 (décolleté); RADIESSE (+) Lidocaine Injectable Implant instructions for use (P050052/S129). accessdata.fda.gov, read 2026-10-20.
- Smith S, Busso M, McClaren M, Bass LS. A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds. Dermatol Surg 2007;33 Suppl 2:S112-21. PMID 18086048.
- Yankova M, Pavicic T, Frank K, et al. Intraarterial degradation of calcium hydroxylapatite using sodium thiosulfate — an in vitro and cadaveric study. Aesthet Surg J 2021;41(5):NP226-NP236. PMID 33544840.
- Merkel EA, Worley B, Christensen RE, et al. In vitro and ex vivo investigation of intralesional sodium thiosulfate as a reversal agent for calcium hydroxylapatite soft tissue filler. J Invest Dermatol 2022;142(11):3125-3127. PMID 35526562.
- The Aesthetic Society. Aesthetic Plastic Surgery National Databank Statistics 2019 (nonsurgical procedure table), read 2026-10-20.
- ClinicalTrials.gov record NCT03583359, read 2026-10-20. PubMed searches as stated in the text, run 2026-10-20.