Is Radiesse FDA-approved for the buttocks?

No. As of 11 November 2026, none of the 318 FDA approval records for Radiesse mentions the buttocks. Its approved uses are on the face (wrinkles and folds, facial fat loss in people with HIV, jawline contour), the back of the hands, and décolleté wrinkles in a 1:2 dilution. Injection into the buttocks is off-label: a licensed clinician may choose it, but FDA has not reviewed it.

What is a Radiesse BBL?

A clinic term for injecting Radiesse, usually diluted with saline, into the buttocks. It is not a Brazilian butt lift in the surgical sense: no fat is transferred and nothing is lifted surgically. One published technical report uses a trademarked 'Instant BBL' name for its method, and its authors disclose a patent filing on the technique and that one of them provides private training in it.

Does Radiesse add volume to the buttocks?

No published study read for this page measured buttock volume or projection after Radiesse. The clinical papers report cellulite dimples, skin laxity scores, photographs and patient satisfaction. A 2023 review of filler buttock augmentation found one calcium hydroxylapatite report among 12 and described the evidence overall as low-level and mostly strongly biased.

Does Radiesse help cellulite on the buttocks?

One open-label study of 24 women reported 54.0% fewer visible dimples and a 43.92% improvement in a cellulite severity score 14 weeks after three sessions of diluted Radiesse delivered with a subcision technique. It had no control group, so the filler's effect cannot be separated from the subcision's, and follow-up ended at week 14.

How many syringes of Radiesse are used for the buttocks?

There is no standard. The 2024 cellulite study used 12 syringes in total over three sessions. A 2017 study that combined the filler with focused ultrasound used 1 mL per buttock or thigh. Consensus papers give their own volumes for clinicians. The amount for any one person is a clinician's judgement, not something a study has settled.

What problems have been reported with Radiesse in the buttocks?

Eight FDA device reports describe problems after buttock injection: persistent hard nodules, an abscess that was drained more than once, tissue necrosis nine months after injection, an infection with fistulas, and indentation with movement of the product. Several of the eight concern the same patient. Reports to this database are unverified and cannot give a rate, because nobody knows how many people were treated.

Radiesse for Buttocks: What the Approvals, the Studies and the FDA Reports Show

Radiesse is not FDA-approved for the buttocks. What the 16 published papers on calcium hydroxylapatite in the gluteal area actually tested, which of them measured cellulite rather than volume, who funded them, and what eight FDA device reports describe.

"Radiesse BBL" and "Radiesse butt lift" are clinic names for injecting Radiesse, a calcium hydroxylapatite filler, into the buttocks, usually after diluting it with saline. This page sets the marketing aside and reads three records as they stood on 11 November 2026: what FDA has approved, what has been published, and what has been reported to FDA when something went wrong. It recommends nothing. Whether the treatment suits a particular person is a question for a qualified clinician.

What the product is, and how its approved uses were tested, is on our main Radiesse page. The diluted form has its own page, hyperdilute Radiesse.

Not an approved use

FDA's approval database lists every decision made under Radiesse's two premarket approvals, P050052 and P050037. On 11 November 2026 it held 318 records for them (170 and 148), the latest dated 26 June 2026. A text search of all 318 for "buttock", "gluteal", "thigh" and "cellulite" finds nothing.

Area	US status on 11 November 2026
Face: wrinkles and folds, facial fat loss in HIV, jawline contour	approved (jawline added 1 September 2021)
Back of the hands	approved 4 June 2015
Décolleté wrinkles, diluted 1:2 with saline, age 22 and over	approved 31 March 2026
Buttocks, hips, thighs, cellulite	not approved; off-label

The manufacturer says the same in its own filings. A 2025 report Merz submitted to FDA about a buttock case states: "Injection into the buttocks is no approved indication for Radiesse in US."

Off-label does not mean illegal. A licensed clinician may use an approved device in an area FDA has not reviewed. It does mean that no regulator has examined trial data for this use, and that the dilutions, volumes and injection depths used in clinics come from consensus papers and individual practice, not from labeling. A 2026 review in Dermatologic Surgery puts it plainly: "Most off-face applications remain off-label, although CaHA is FDA approved for the hands and décolletage."

Sixteen papers, and what kind they are

A PubMed search on 11 November 2026 for calcium hydroxylapatite or Radiesse together with the buttocks, gluteal region, hips or cellulite, and with filler or injection terms, returned 17 records. The same product terms with filler terms alone return 621, so the buttock literature is under 3% of the whole. Every title was read, and the PubMed entries for 13 were read in full. One record is unrelated (a case of calcium deposits in a hip tendon). The other 16 sort as follows.

Kind of paper	Count	What they are
Consensus statements, practice guidance and reviews	6	expert-panel recommendations (2016, 2018, 2019), a 2022 how-to guide from 12 injectors, a 2023 review of filler buttock augmentation, a 2026 review of off-face use
Randomized study	1	61 women; combinations of three treatments (below)
Prospective open-label study	1	24 women; cellulite dimples (below)
Retrospective series	1	20 women; filler plus focused ultrasound for cellulite, 90 days
Small case reports and technique papers	4	seven cases; two buttock patients in a four-patient report; a single case; a technical report
Cadaver imaging study	1	ultrasound of several fillers injected into a specimen
Neighbouring-area papers	2	an outer-thigh study and a stretch-mark study, by their titles

Six of the sixteen are opinion or review, and four more describe a handful of patients each. The 2018 global consensus paper describes itself as "preliminary guidelines for the novel off-label use" of the product for the face and body.

What the clinical studies measured: cellulite and laxity, not size

The search phrase is about buttocks, and clinic pages talk about lift and volume. The studies measured something else.

Study	People	What was done	What was measured	Result reported
Durairaj et al., Aesthetic Plastic Surgery 2024	24 women completed (mean age 35)	three sessions, 12 syringes in total, diluted 1:1, placed with a cannula-based subcision technique	cellulite severity scale, 3D imaging of dimples, satisfaction	at week 14: 54.0% fewer visible dimples, 50.09% less dimple depth, cellulite score down 4.29 points (43.92%); 91.6% rated their cellulite improved; no serious complications
Bartsch et al., Journal of Drugs in Dermatology 2020	61 women (mean age 37.2)	randomized to different combinations and sequences of guided subcision, focused ultrasound and the filler	laxity and dimpling scores, rated by participants, physicians and 11 blinded experts	all three treatments together scored better than any two, with wide intervals (below); no adverse event needing more than standard care
Casabona and Pereira, Plastic and Reconstructive Surgery Global Open 2017	20 women, enrolled retrospectively	focused ultrasound, then 1 mL of diluted filler per buttock or thigh	five-item cellulite severity scale from photographs at 90 days	4.5-point mean improvement after one combined treatment
Teodoro et al., Clinical, Cosmetic and Investigational Dermatology 2023	6 women, 1 man	dilution, volume and depth chosen per patient	standardized photographs, satisfaction	"favorable results"; the authors call for prospective studies

Four limits stand out when the table is read as a whole.

Nobody measured volume. None of the abstracts reports a change in buttock volume, projection or circumference. The outcomes are cellulite dimples, laxity grades, photographs and satisfaction. The claim that diluted Radiesse enlarges or lifts the buttocks has no measured figure behind it in these papers.
The filler was rarely tested alone. The randomized study compared combinations; its abstract reports no arm that received the filler alone and none that received a placebo. In the 2024 study the filler was delivered with a subcision technique, which the randomized study treats as a cellulite treatment in its own right, and there was no control group. Neither design can say how much of the change came from calcium hydroxylapatite.
The intervals are wide. The randomized study's abstract gives its main comparison as 1.88 with a 95% interval of 0.66 to 5.37 for laxity and 1.31 with an interval of 0.61 to 2.81 for dimpling. Intervals that run from below 1 to several times above it describe an uncertain estimate.
Follow-up is short. The studies end at 90 days, 14 weeks, or six to nine months. How long any change lasts on the buttocks has not been followed in a controlled study.

Who paid

The 2024 study describes itself as investigator-initiated; its registry record (NCT05885035) lists the lead investigator as sponsor and Merz North America as collaborator (Radiesse is a Merz product), with 25 people enrolled. The 2017 paper's disclosure states that the publication charge "was paid for by Merz Pharmaceuticals GmbH". The 2022 technical report on a trademarked "Instant Brazilian Butt Lift" method discloses that it describes content from the authors' own patent filing and that one author provides private training in the methods. None of this makes a result wrong. It is the context a reader would want, and it is why the absence of an independent controlled trial matters.

What a review of filler buttock augmentation concluded

A 2023 systematic review looked at every soft-tissue filler used for buttock augmentation (Atiyeh et al., Aesthetic Plastic Surgery 2023). It found 12 clinical reports in total, "mostly strongly biased clinical reports providing a low level of evidence". One of the 12 involved calcium hydroxylapatite; five involved poly-L-lactic acid, the material in Sculptra. Its conclusion is cautious about the whole category: "Gluteal augmentation with soft tissue fillers is not as simple and innocuous as advertised. Serious complications may occur."

The record for the other collagen-stimulating filler is set out on our Sculptra butt lift page. Side by side, on each page's own search date:

	Radiesse (calcium hydroxylapatite)	Sculptra (poly-L-lactic acid)
FDA approval for the buttocks	none	none
PubMed records on the buttocks, hips or cellulite	17 (11 November 2026)	22 (6 October 2026)
Randomized studies among them	1	3
FDA device reports mentioning the buttocks	13 of 1,690 (8 describing a problem after buttock injection)	19

Neither product has a controlled trial of buttock volume. This is a comparison of how much has been published, not of which product works better.

Eight reports to FDA

FDA's MAUDE database collects reports of problems with medical devices. On 11 November 2026 it held 1,690 reports naming Radiesse (database updated 4 November 2026). Thirteen contain the words buttock, gluteal or glute. Each was read.

Five of the 13 are not buttock-treatment problems: the area is mentioned as part of a medical history, as the site of an unrelated injection, as one of several areas that swelled in a reaction after treatment elsewhere, or the reported event happened on the face.

The other eight describe a problem after Radiesse was injected into the buttocks:

Received	What the report describes
2014	hardened deep nodules after "filling in gluteus" about nine months earlier; surgical drainage "without success"; fistulas; infection found on culture
2021 (two reports, one patient)	a man injected in the gluteal area with product diluted 1:4; hard nodules, four still present almost seven months later
2024 (three reports that appear to describe one patient, one of them filed by the patient)	soft-tissue necrosis nine months after injection into the "max glutes"; began as cellulitis; drained three times; antibiotics
2024	a 43-year-old woman injected for a "BBL"; delayed nodules, then an abscess on the left buttock drained twice
2025	indentation at the injection site and product reported to have moved into surrounding tissue

So the eight reports cover about five people. Four of the five involved nodules, infection or both. In two, the problem appeared or was still unresolved about nine months after the injection.

What these reports can and cannot show. MAUDE reports are submitted by manufacturers, clinicians and patients; they are not verified, and a report does not prove the device caused the event. They also cannot give a rate: the number of people who have had Radiesse injected into the buttocks is unknown. What they show is the kind of problem that has occurred. Two properties of the product explained on our Radiesse page bear on that: it cannot be dissolved the way a hyaluronic-acid filler can, and it shows up on scans. The general side-effect record from the approved uses is on Radiesse side effects.

How this differs from the surgical BBL

The surgical Brazilian butt lift moves a person's own fat into the buttocks, and it carries a documented risk of fat embolism that our Sculptra butt lift page reports from the surgeons' own task-force survey. Filler injection avoids surgery and fat transfer, which is the basis of the "non-surgical BBL" name. It is not the same procedure at smaller scale: the studies above did not measure volume at all, and the 2023 review's warning was written about fillers specifically. Fee figures for Radiesse and their sources are on our Radiesse cost page; none of them is specific to the buttocks.

What is and is not established

Established: Radiesse is not FDA-approved for the buttocks, hips, thighs or cellulite, and its maker says so in its own FDA filings.
Established: one uncontrolled 24-person study reported fewer and shallower cellulite dimples 14 weeks after diluted Radiesse delivered with subcision.
Not established: that Radiesse increases buttock volume or projection. No study read here measured it.
Not established: how much of the reported cellulite change is due to the filler rather than the subcision or ultrasound used with it.
Not established: how long any effect lasts on the buttocks, or how often complications occur.
Not tested: Radiesse against Sculptra, against fat transfer, or against a placebo, on the buttocks.

For the wider picture of what these collagen-stimulating fillers are and how the approved uses compare, see biostimulators and Sculptra vs Radiesse.

Sources

FDA premarket approval database via openFDA: P050052, 170 records, and P050037, 148 records; database updated 2026-11-02, read 2026-11-11 (supplements S049, S129 and S162 of P050052 for the hands, jawline and décolleté decisions).
FDA MAUDE via the openFDA device-event records, brand name Radiesse: 1,690 reports, database updated 2026-11-04, read 2026-11-11. The 13 reports mentioning buttock, gluteal or glute were read in full, including 2135225-2014-00046, 3013840437-2021-00242 and -00243, MW5150548, 3013840437-2024-00013 and -00014, 3013840437-2024-00100 and 3013840437-2025-00037.
PubMed (National Library of Medicine), search run 2026-11-11; terms as described in the text. All 17 titles read; the entries for 13 read in full.
Durairaj K, et al. Safety and Efficacy of Diluted Calcium Hydroxylapatite for the Treatment of Cellulite Dimpling on the Buttocks. Aesthetic Plastic Surgery 2024;48(9):1797-1806. Abstract read. Registry record NCT05885035 read 2026-11-11.
Bartsch R, et al. The Influence of Different Treatment Combinations on Skin Laxity and Dimpling. Journal of Drugs in Dermatology 2020;19(11):1030-1038. Abstract read.
Casabona G, Pereira G. Microfocused Ultrasound with Visualization and Calcium Hydroxylapatite for Improving Skin Laxity and Cellulite Appearance. Plastic and Reconstructive Surgery Global Open 2017. Abstract and disclosure read.
Teodoro MDS, et al. Buttocks Beautification 3D with Calcium Hydroxylapatite. Clinical, Cosmetic and Investigational Dermatology 2023. Abstract read.
Silveira I, Martinez B. Bilateral Gluteal Augmentation With Hyperdilute Calcium Hydroxylapatite Microspheres. Cureus 2022. Abstract and conflict-of-interest statement read.
Atiyeh B, et al. Safety and Efficiency of Minimally Invasive Buttock Augmentation: A Review. Aesthetic Plastic Surgery 2023;47(1):245-259. Abstract read.
Goldie K, et al. Global Consensus Guidelines for the Injection of Diluted and Hyperdiluted Calcium Hydroxylapatite for Skin Tightening. Dermatologic Surgery 2018. Abstract read.
Butterwick KJ, et al. The FDA-Approved and Non-FDA-Approved Indications for Biostimulatory Fillers off the Face. Dermatologic Surgery 2026 (online ahead of print). Abstract read.