What is Radiesse made of, and how far does FDA approval go?

Radiesse is an injectable filler used to fill facial wrinkles or improve volume in the hands. It is also used as a procedure for skin elasticity, but approval status and supporting evidence differ by area and purpose.

The main ingredient is calcium hydroxylapatite (CaHA) microparticles, the same mineral that makes up bone and teeth. At Cellinique, the official procedure name is Signature Radiesse.

3-line summary

Radiesse is a filler made by mixing CaHA microparticles into a gel.

Areas approved in the United States are facial wrinkles and the hands. Areas often advertised, such as the neck, arms, and abdomen, are not included in that approval.

In data pooling 5,081 procedures, 173 adverse events were reported, most of them nodules.

The filling role and skin elasticity are examined together

Radiesse is used to fill hollow areas or deeply folded wrinkles. The literature has also addressed skin elasticity and a tighter-looking appearance of the skin.

What was studied was not CaHA isolated as an ingredient on its own, but the actual formulation in which CaHA microparticles are mixed into a gel. It should therefore be judged by checking the product’s ingredients and intended use, rather than grouping it with “collagen boosters” of other ingredients as the same procedure.

Approved areas and studied areas are not the same

In the United States, the areas for which Radiesse is approved are facial wrinkles and the hands. Correction of facial fat loss due to HIV infection has also been approved separately.

Area and condition	U.S. approval status	What to check
Facial wrinkles and folds	Approved	Correction of moderate to severe facial wrinkles, including nasolabial folds
Facial fat loss due to HIV infection	Separate approval	Correction of reduced facial fat
Hands	Approved	The area outside the face with confirmed U.S. approval
Décolleté	Not included in U.S. approval	The area below the neck and above the chest; approved in the European Union
Neck, feet, arms, thighs, abdomen, and others	Not included in U.S. approval	Used in clinical practice, and a tighter-looking appearance has been reported, but evidence confirmed by comparative studies is limited

Nasolabial folds are an area included in U.S. approval. Using it for elasticity is judged on separate research data, not because that use is an approved indication.

The most frequently reported adverse event is nodules

In data pooling 5,081 procedures from 21 papers, 173 adverse events were reported. That corresponds to 3% of all procedures.

Reported adverse event	Count	Share of 173 adverse events
Nodules	166 cases	96%
Persistent inflammation and edema	4 cases	2%
Persistent redness	2 cases	1%
Overcorrection	1 case	1%

A nodule is a lump-like clustering. Most reported nodules were not visible on the surface and resolved without separate treatment. Of these, 49% occurred in areas with a lot of movement.

This dataset assessed Radiesse’s overall safety as favorable, while also recording actual adverse-event cases, including nodules.

In consultation, confirm the ingredient, area, and purpose

The name “collagen booster” alone does not make clear which ingredient is used. If the ingredient differs, the studies to consult and the adverse events also differ.

In the clinic, you can check the following.

• □ “What is the ingredient name used in this procedure?”
• □ “Is the area I would receive it in an approved area?”
• □ “Is the procedure for filling wrinkles or for skin elasticity — which purpose?”
• □ “How do you respond if a nodule forms?”

Frequently asked questions

Q1. Is Radiesse a regular filler, or a collagen booster?

It is an injectable filler made by mixing CaHA microparticles into a gel. It is used to fill hollow areas and wrinkles, and because skin elasticity and a tighter-looking appearance have also been studied, it is commonly called a collagen booster.

Q2. Can it be used for nasolabial folds?

Nasolabial folds are facial wrinkles included in the U.S. approval scope. Whether it is actually applied is decided after looking at wrinkle depth and facial condition.

Q3. Can it also be used in the neck or arms?

There is data on clinical use in the neck, arms, abdomen, and similar areas, but they are not included among areas approved in the United States. Before a procedure, the evidence for that area and the intended use should be confirmed.

Q4. Does the CaHA placed with Radiesse stay in the body permanently?

CaHA is a material that breaks down inside the body over time.

Q5. Can nodules form?

In the pooled analysis, the most frequently reported adverse event was nodules. Most were not visible on the surface and resolved without separate treatment, and they were often reported in areas with a lot of movement.

Results, duration, and suitability vary with individual skin condition, age, and lifestyle, and the same outcome cannot be guaranteed.

Procedures may cause temporary redness or swelling, and contraindications may apply, so please confirm these during your consultation.

This article is general information and does not replace individual medical care. Please confirm diagnosis and treatment suited to your condition during a consultation.

Source materials

1. U.S. FDA: PMA P050052, Radiesse Injectable Implant — Basis for the December 2006 approval for correction of moderate to severe facial wrinkles and folds. Correction of facial fat loss in people with HIV infection is recorded in a separate document, P050037, in the same FDA database.
2. J Cosmet Dermatol 2017, PMID 28247924 — 21 papers, 5,081 procedures, 2,779 actual people, and the types and rates of 173 adverse events, the course and sites of nodules, an overall safety assessment, and evidence on the biodegradability of CaHA. Included papers were published in 2004~2015.
3. Int J Dermatol 2024, PMID 38390986 — Material on the biostimulatory and tightening properties of a CaHA-in-gel formulation, approval status for the hands and décolleté, and studies using diluted formulations in other areas such as the neck, feet, arms, thighs, and abdomen, plus the lack of randomized controlled trial evidence.

Related reading

More detailed information on ingredients, wrinkles, elasticity, and safety continues below.

• Signature Radiesse treatment information
• How to increase collagen
• Nasolabial fold guide
• Skin elasticity guide
• Treatment safety information