Radiesse

Radiesse is a calcium hydroxylapatite (CaHA) injectable implant in which CaHA microspheres are suspended in a carboxymethylcellulose (CMC) gel carrier. The product combines an immediate carrier-related structural effect with a later tissue response discussed around the microspheres.

The brand includes distinct regulated presentations and use contexts. Standard Radiesse, Radiesse (+), and Radiesse diluted 1:2 for the décolleté should not be collapsed into one formulation or protocol.

Quick reference

Field	Radiesse
Particulate component	Approximately 30% CaHA microspheres
Carrier	Approximately 70% CMC gel carrier
Product forms	Radiesse; Radiesse (+) with 0.3% lidocaine; indication-specific diluted Radiesse
Presentation	Ready-to-use prefilled injectable implant; mixing applies only in defined contexts
Immediate correction	The CMC gel carrier contributes early structure
Company context	Merz Aesthetics; Merz North America appears as the current FDA applicant
Main material page	CaHA

Merz’s professional product page lists the approximate 30% CaHA and 70% CMC composition and distinguishes Radiesse, Radiesse (+), and 1:2 diluted Radiesse (Radiesse for Providers 🔗).

Product forms should remain separate

Product context	Composition or preparation	Current US context summarized by Merz
Radiesse	Approximately 30% CaHA microspheres in approximately 70% CMC gel carrier	Lower-face wrinkles and folds; hand volume correction
Radiesse (+)	Same broad CaHA/CMC system with 0.3% lidocaine	Lower-face and jawline context
Radiesse diluted 1:2	Standard implant diluted with 0.9% sterile saline	Décolleté wrinkles in adults 22 years and older

Use the current labeling for the exact syringe and indication. Radiesse without a variant or preparation is not enough information for a technique table.

Microspheres and carrier contribute different phases

The CMC carrier provides immediate physical correction. As the carrier changes over time, the CaHA microspheres remain the particulate component associated with later tissue-support and collagen-response discussions.

This two-part structure helps explain why:

standard structural use can produce immediate correction
dilution reduces the product’s structural concentration
a skin-quality objective is not identical to focal contour correction
the same syringe can require different evidence and instructions by indication

Do not describe the later response as proof that the carrier is irrelevant, or describe the immediate result as if it came only from newly produced collagen.

FDA approval context

On March 31, 2026, the FDA approved expansion of Radiesse’s indication to include the implant diluted 1:2 with 0.9% sterile saline for subdermal correction of décolleté wrinkles in patients aged 22 years and older (FDA PMA supplement P050052/S162 🔗).

The associated FDA IFU states that this décolleté preparation must be diluted 1:2 with sterile saline and used within 30 minutes after preparation, with immediate use recommended when feasible (FDA Instructions for Use 🔗).

These are indication-specific US instructions. They should not be generalized to:

every diluted CaHA technique
every anatomical area
Radiesse (+)
a non-US label
another CaHA product

Dilution terminology

Diluted and hyperdiluted are often used loosely in aesthetic practice. A Radiesse record should identify:

product variant
syringe volume
diluent
ratio
final volume
mixing method
use window
anatomy
intended structural or skin-quality objective
label, study, or consensus source

The new US décolleté indication provides one regulated 1:2 example; it does not convert every 1:2 use into an approved indication.

Imaging and material visibility

Merz notes that CaHA particles are radiopaque, clearly visible on CT, and potentially visible on standard X-rays (Radiesse provider information 🔗). This can matter when interpreting imaging history.

The FDA required a post-approval study after the 2026 décolleté indication to assess whether treatment interferes with breast-tissue radiographic imaging and to collect additional safety information (FDA post-approval study 🔗).

Radiopacity should not be confused with permanent persistence or with a contraindication to every imaging study.

Company and regulatory roles

Role	Supported relationship
Brand and aesthetic commercial context	Merz Aesthetics
Current US PMA applicant	Merz North America, Inc.
Product variants	Radiesse and Radiesse (+), with indication-specific preparation contexts
Legal manufacturer	Verify from the exact regional label
Local approval holder or distributor	Market-specific

The Merz Aesthetics company page explains how Radiesse entered the portfolio through the 2010 BioForm Medical acquisition.

Safety and limitations

Radiesse labeling and post-market information include expected injection-site effects and potentially serious complications. Practitioner interpretation should account for:

exact product and dilution
vascular anatomy and intravascular injection risk
inflammatory or non-inflammatory nodules
infection
overcorrection or product visibility
imaging context
absence of a simple product-wide enzymatic dissolving pathway

The presence of CMC does not make Radiesse an HA filler, and water-based carrier language does not imply easy reversibility.

Nearby reference pages

Structural correction separates focal carrier support from broader prepared-product objectives.
Skin quality defines measurable attributes and the limits of diluted-CaHA evidence.
Regional regulation separates US indication-bearing PMA supplements from Korean and European evidence.
Clinical practice framework connects the exact product state to consent, records, and escalation.
Vascular and visual emergencies provides the emergency pathway without assuming HA dissolution.
Ready-to-use vs reconstituted distinguishes presentation from indication-specific mixing or dilution.
CaHA explains the material and carrier distinction.
Ellansé is another particle-and-CMC-carrier implant using a different particulate material.
Juvelook is a PDLLA + HA hybrid rather than a CaHA implant.
Collagen Stimulators maps the broader comparison.