RADIESSE: New FDA Approval and What It Means for You
If you have been paying attention to the world of regenerative aesthetics, you already know RADIESSE is not a traditional filler. It has always done something different. And as of April 2026, it has done something no other biostimulator in the United States has managed to do: earn FDA approval for both the face and the body.
Here is what the new approval means, how RADIESSE works, and who this treatment is for.
RADIESSE Just Reached a New Milestone
On April 8, 2026, Merz Aesthetics announced FDA approval of RADIESSE for the treatment of wrinkles in the décolleté area in patients 22 years of age and older.
This is RADIESSE's fourth FDA-approved indication in the United States. The product already holds approvals for moderate to severe facial wrinkles and folds, including nasolabial folds, volume loss in the back of the hands, and soft tissue augmentation for jawline contouring in adults over 21.
The décolleté approval rounds out an area of the body that has long been overlooked in both skincare routines and aesthetic treatments.
With this approval, RADIESSE becomes the first and only regenerative biostimulator approved in the United States for both the face and the body.
Why the Décolleté Is Different From Other Treatment Areas
The chest is one of the first places where aging becomes visible and one of the last places most people think to treat.
The skin in the décolleté is thin, frequently sun-exposed, and prone to crepiness and wrinkling well before other areas show similar changes. It lacks the density of facial tissue, which is part of why traditional volumizing fillers are not ideal here.
What this area needs is not more volume. It needs structural rebuilding at the skin level.
Collagen depletion and photodamage converge in the décolleté, making it particularly well suited for a biostimulatory approach that provides both immediate structural improvement and progressive improvement in skin quality over time.
That is exactly what RADIESSE is designed to do.
What RADIESSE Actually Is
RADIESSE is not a hyaluronic acid filler. It is a calcium hydroxylapatite (CaHA)-based biostimulator composed of synthetic CaHA microspheres suspended in a gel carrier.
The Ingredient Your Body Already Knows
Calcium hydroxylapatite is a mineral compound that exists naturally in the body, primarily in bones and teeth. When injected, the CaHA microspheres act as a scaffold, triggering the body's own fibroblasts to produce new collagen, elastin, and other structural proteins.
As the gel carrier is gradually absorbed, the newly generated tissue takes its place.
Immediate Results, Long-Term Rebuilding
The result is two-phase. Patients see an immediate improvement in skin texture and contour right after treatment. Over the following weeks and months, the regenerative process continues, progressively improving firmness and skin quality from within.
For the décolleté indication, RADIESSE is diluted with sterile saline, producing a lighter formulation suited to the thinner tissue of the chest area.
RADIESSE's Track Record
This is not a new product with limited data. RADIESSE has been in use for two decades and carries a body of evidence that few aesthetic injectables can match.
RADIESSE is the number one most researched biostimulator in regenerative aesthetics, with more than 250 scientific publications, over 20 million syringes shipped globally, and availability in more than 85 countries. It also carries a 98% patient satisfaction rate.
What the Clinical Data Shows
Clinical data supporting the décolleté approval showed that more than 80% of patients reported satisfaction with skin tightness, while 90% of healthcare providers reported visible improvement in treated patients.
The European Union approved RADIESSE for the décolleté in 2024, and Health Canada approved the indication in 2025, ahead of the U.S. approval.
American providers and patients now have access to a treatment that has already been used internationally.
What to Expect During a RADIESSE Treatment
RADIESSE treatments at Hayes Valley Medical Esthetics are performed by our Master Injectors and tailored to the specific area being treated.
How Treatment Is Customized by Area
For facial indications, RADIESSE is injected at full concentration to restore structure and volume in areas such as the nasolabial folds and jawline.
For the hands and décolleté, it is diluted with sterile saline before injection, creating a lighter consistency that is better suited for thinner tissue.
Sessions are typically completed in 30 to 60 minutes depending on the number of treatment areas. A topical numbing cream is applied beforehand, and RADIESSE with lidocaine is available to enhance patient comfort.
What Recovery Looks Like
Most patients notice immediate improvement after treatment. Over the following weeks, the biostimulatory process continues as new collagen and elastin develop beneath the surface.
Results may last up to two years, with maintenance treatments helping preserve long-term regenerative benefits.
Mild swelling, redness, or bruising may occur and generally resolves within several days. Patients are usually advised to avoid strenuous activity and excessive sun exposure for the first 24 hours after treatment.
Combining Treatment Areas
Because RADIESSE now spans four distinct FDA-approved treatment areas, some patients choose to address multiple concerns in a single visit, including the face, hands, and décolleté.
Your injector at Hayes Valley Medical Esthetics will help determine the most appropriate treatment plan based on your anatomy and aesthetic goals.
Where RADIESSE Can Now Be Used
RADIESSE currently has FDA clearance for:
- Facial wrinkles and folds, including nasolabial folds
- Volume loss in the hands
- Jawline contouring and soft tissue augmentation in adults 21 and older
- Décolleté wrinkle correction in patients 22 and older
This makes RADIESSE one of the most versatile regenerative injectable treatments available today.
An Important Safety Note
Because RADIESSE contains calcium hydroxylapatite microspheres, it may appear on certain imaging studies such as X-rays and CT scans.
Patients with upcoming mammograms or breast imaging studies should discuss treatment timing with their provider.
As with any injectable treatment, candidacy and results vary by individual, making a consultation the best place to begin.
RADIESSE at Hayes Valley Medical Esthetics
At Hayes Valley Medical Esthetics, our team of Master Injectors stays at the forefront of FDA approvals and clinical advancements so patients can access treatments that are both evidence-based and highly effective.
If you have been noticing changes in the skin on your chest or are interested in a more comprehensive approach to facial and body rejuvenation, RADIESSE may now be part of the conversation in a way it has never been before.
To learn more or schedule a consultation at our San Francisco or Larkspur locations, contact Hayes Valley Medical Esthetics today.
