Radiesse | Designed for Definition - Merz Aesthetics Canada

Well Characterized Safety Profile

RADIESSE^® + saline (1:2) can help reduce the risk of nodules and proximal vascular occlusion, while enhancing tissue integration and regeneration of key ECM components.^1-11

Rheological flexibility of RADIESSE^® ^7,12,13

Data presented are from seperate rheological studies. No single study included all products shown.^7,12,13

Occurrence rate of vascular occlusions for RADIESSE^® was 0.0096%^14,*
(In a retrospective review of 104,517 aesthetic injections performed over 10 years by 370 injectors)

Incidence rate of nodules was estimated to be <1%^15,†
(In a retrospective review of 5,081 treatments with CaHA performed on 2,779 patients)

†A peer-reviewed journal article that screened for AEs of CaHA fillers across 21 studies published between 2004 and 2015, including 5,081 treatments in 2,779 patients, suggested that avoiding injections in dynamic facial areas may significantly reduce CaHA nodule risk, which had an estimated incidence of 0.61% (21 of 3,437).15

No long-term AEs and no delayed-onset AEs, including granulomas and nodules, up to 39 months after^16,‡
(In an extension phase of a pivotal study with 102 patients)

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* Disclaimers *

AE, adverse event, ECM, extracellular matrix. *A retrospective cohort study comparing rates of vascular occlusion following cosmetic filler injections using either needles or microcannulas, based on self-reported data from 370 board-certified dermatologists who collectively reported over 1.7 million syringes injected.¹⁴ †A peer-reviewed journal article that screened for AEs of CaHA fillers across 21 studies published between 2004 and 2015, including 5,081 treatments in 2,779 patients, suggested that avoiding injections in dynamic facial areas may significantly reduce CaHA nodule risk, which had an estimated incidence of 0.61% (21 of 3,437).¹⁵ ‡Long-term safety demonstrated in nasolabial folds through pre-market study (n=117) and extension phase (n=102).^16,17

RADIESSE^® and RADIESSE^® (+) are indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for the rejuvenation of the hand. RADIESSE^® injectable implant diluted 1:2 with 0.9% sterile saline for injections is intended for the treatment of moderate and severe décolleté wrinkles.

Warnings:

As with all dermal fillers, introduction of RADIESSE^® or RADIESSE^® (+) injectable implant into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.
Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.
Patients should receive prompt medical attention and possibly evaluation by an appropriate healthcare practitioner specialist should an intravascular injection occur.
Use of RADIESSE^® or RADIESSE^® (+) injectable implant in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
Injection procedure reactions have been observed consisting mainly of short-term (i.e., <7 days) bruising, redness, swelling, lumpiness, pain, itching, discolouration, and tenderness.
Do not overcorrect (overfill) a contour deficiency because the depression should gradually improve within several weeks as the treatment effect of RADIESSE^® (+) injectable implant occurs. In extreme cases site rupture could occur with overcorrection.
Not intended for use in the breasts or for use in the lips.

Consult the Instructions for Use for a complete list of warnings, precautions, and other important safety information. The Instructions for Use are available by calling us at 1-866-815-8715 or found here.

Aguilera SB, et al. Aesthet Surg J. 2023;43(10):1063-1090.
Yutskovskaya YA, et al. J Drugs Dermatol. 2017;16(1):68-74.
González N, Goldberg D. J Dermatol Surg. 2019;45(4):547-551.
Yutskovskaya YA, et al. J Drugs Dermatol. 2014;13(9):1047-1052.
Yutskovskaya YA, et al. J Drugs Dermatol. 2020;19(4):405-411.
Nowag B, et al. Presented at: AMWC 2019; Monte Carlo, Monaco; April 2-4, 2019.
McCarthy AD, van Loghem J, El-Banna R, Hagedorn N. J Cosmet Dermatol. 2025;24(1):e16649.
de Almeida AT, et al. Plast Reconstr Surg Glob Open. 2019;7(3):e2160.
Massidda E. Clin Cosmet Investig Dermatol. 2023;16:3427-3439.
Soares DJ, et al. Aesthet Surg J. 2025 Feb 19:sjaf028.
McCarthy AD, Soares DJ, Chandawarkar A, El-Banna R, Hagedorn N. Dilutional rheology of Radiesse: Implications for regeneration and vascular safety. J Cosmet Dermatol. 2024 Jun;23(6):1973-1984.
Sundaram H, et al. Dermatol Surg. 2010;36(Suppl 3):1859-1865.
Meland M, Groppi C, Lorenc ZP. J Drugs Dermatol. 2016;15(9):1107-1110.
Alam M, et al. JAMA Dermatol. 2021;157(2):174-180.
Kadouch JA. J Cosmet Dermatol. 2017;16:152-161.
Bass LS, Smith S, Busso M, McClaren M. Aesthet Surg J. 2010;30(2):235-238.
RADIESSE® Instructions for Use. Merz North America, Inc. July 2025.