Country

Merz Aesthetics Receives FDA Approval for RADIESSE® for the Treatment of Wrinkles in the Décolleté Area

The treatment becomes the first and only biostimulator in the U.S. approved for the face and body*

RALEIGH, NC – April 8, 2026

Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the FDA approval for RADIESSE® for the treatment of wrinkles in the décolleté area in patients 22 years of age and older.1 As the first and only regenerative biostimulator approved in the U.S. for face and body*, this marks the fourth indication for the aesthetic product, offering a customized, tailored approach to improving the appearance of the skin and signs of aging for visible results.1-8

RADIESSE® is a regenerative biostimulator designed to firm and tighten the skin by addressing the visible signs of aging at their source. Using an ingredient that is also naturally found in the body RADIESSE® helps stimulate the production of collagen, elastin, and other essential proteins—supporting healthier looking skin with results that can last up to two years.2,5,8-12 Backed by two decades of scientific research and clinical experience, RADIESSE® is the #1 most researched biostimulator in regenerative aesthetics, with more than 250 scientific publications, 20+ million syringes shipped globally, and availability in over 85 countries. It also boasts a 98% patient satisfaction rate, highlighting consumer trust and demand.13,14

“The décolleté is one of the most visible—and earliest—areas to show signs of aging,” says Samantha Kerr, Chief Scientific Officer at Merz Aesthetics. “Because it’s often overlooked in skincare routines and aesthetic care, this delicate area can benefit from RADIESSE® to help improve the appearance of wrinkles.”

“Collagen and elastin decline is a major driver of aging skin,” says board-certified cosmetic dermatologist Dr. Jeremy Green, who was part of clinical studies conducted by Merz Aesthetics. “Patients love RADIESSE® because it jump-starts the skin’s regenerative process, giving them firmer, smoother, more radiant-looking results without surgery.”

In the last few years, there has been an increase in consumers wanting to improve the look of both the face and body. According to data referencing the ISAPS Global Survey, there has been a 39% increase in demand for non-invasive skin lifting treatments (in the face and body).16 Data supporting the décolleté approval demonstrated significant evidence of RADIESSE®’s effectiveness14:

  • More than 80% of RADIESSE® patients felt satisfied with skin tightness.14
  • 83% of patients reported they were likely to get RADIESSE® treatment again, over a year after their initial treatment.14
  • 90% of healthcare providers reported RADIESSE® patients with visible improvements by 4 months.14
  • 93% of patients were interested in other RADIESSE® treatments.14

“The new décolleté indication helps address increasing patient demand as today’s aesthetics market evolves towards regenerative biostimulation, or ‘reversing visible signs of aging from within’,” says Patrick Urban, President, North America, Merz Aesthetics.

To learn more about RADIESSE® and locate a provider in your area, visit RADIESSE.com to access the Find a Provider tool. Sign up for Xperience+ at xperiencemerz.com to receive instant and future rewards on RADIESSE® and additional Merz Aesthetics treatments.

Keep up with RADIESSE® on Instagram @RADIESSE.

* Radiesse body indications include hands and décolleté

References

  1. RADIESSE® [Instructions for Use] 2026.
  2. Bass LS, et al. Aesthet Surg J. 2010;30(2):235-238.
  3. Cogorno Wasylkowski V. Clin Cosmet Investig Dermatol. 2015;8:267-273.
  4. Draoui O. Chapter 1: The Story of Calcium Hydroxylapatite. In: van Loghem J, ed. Calcium Hydroxylapatite Soft Tissue Fillers, Expert Treatment Techniques. 1st ed. Taylor & Francis Group; 2020.
  5. González N, et al. Dermatol Surg. 2019;45:547-551.
  6. Kim J. Clin Cosmet Investig Dermatol. 2019;12:771-784.
  7. Silvers SL, et al. Plast Reconst Surg. 2006;118(3 suppl):34S-45S.
  8. Yutskovskaya YA, et al. J Drugs Dermatol. 2017;16(1):68-74.
  9. Aguilera SB, et al. Aesthet Surg J. 2023;43(10):1063-1090.
  10. Yutskovskaya Y, et al. J Drugs Dermatol. 2014;13(9):1047-1052.
  11. Nowag B, et al. CaHA microspheres: contact with fibroblasts and amount of spheres are key factors for collagen stimulation. Presented at: AMWC 2020; Monte Carlo, Monaco; April 2-4, 2020.
  12. Yutskovskaya YA, et al. J Drugs Dermatol. 2020;19(4):405-411.
  13. Data on file. Merz North America, Inc. October 2021.
  14. Data on file. Merz North America, Inc. 2025.
  15. Radiesse Publications Memo. Data on file. Merz North America, Inc. September 2021.
  16. International Society of Aesthetic Plastic Surgery (ISAPS). (2025). ISAPS international survey on aesthetic/cosmetic procedures performed in 2024. https://www.isaps.org/media/oogpzodr/isaps-global-survey_2024.pdf.

About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics®’ global headquarters is in Raleigh, N.C., with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at us.merzaesthetics.com.

What are RADIESSE® and RADIESSE® (+)?
RADIESSE® and RADIESSE® (+) are dermal fillers that are used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth). RADIESSE® is also used for correcting volume loss in the back of the hands and, when diluted with saline to smooth away wrinkles such as those in the décolleté in patients 22 years of age and older. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.

RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION

Who should not use RADIESSE® or RADIESSE® (+)?
You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.

What is the most important information I should know about RADIESSE® and RADIESSE® (+)?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.

As with all procedures that involve an injection through the skin, there is a risk of infection.

Do not use RADIESSE® or RADIESSE® (+) if you have a skin infection until it has healed.

It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes, or if you are pregnant or breastfeeding.

It is not known if RADIESSE® or RADIESSE® (+) is safe or effective beyond 3 years in the face,1 year in the hand, and 84 weeks in the décolleté.

Injection of RADIESSE® (+) into the jawline may temporarily alter jaw function.

The safety of RADIESSE® in the décolleté in patients under 22 years of age has not been established.

The microspheres in RADIESSE® and RADIESSE® (+) can be seen in X-rays and CT scans. It is very important that you tell your health care provider that you have had RADIESSE® or RADIESSE® (+) dermal filler. A clinical study found no evidence of RADIESSE® injected in the décolleté being visible on mammograms or breast ultrasounds, but you should still inform your doctor and radiologist that you have received RADIESSE® in the treated area so they can interpret your imaging appropriately.

If you have a history of herpes, you may experience a herpes breakout after receiving RADIESSE® or RADIESSE® (+).

Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.

You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.

What should I tell my doctor before using RADIESSE® or RADIESSE® (+)?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site. Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history forming large, raised scars or if you have had any other skin treatments such as skin peels.

What are the most common adverse events with RADIESSE® or RADIESSE® (+)?
The most common adverse events seen in clinical studies of RADIESSE® used in the hands include bruising, redness, swelling, pain, itching, nodules or bumps/lumps, difficulty performing activities, loss of sensation and other local side effects. The most common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching, difficulty chewing, and other local side effects.

Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.

These are not all of the possible side effects with RADIESSE® or RADIESSE® (+). Merz collects information about adverse events seen with RADIESSE® and RADIESSE® (+) outside of clinical studies. These events are included in the RADIESSE® and RADIESSE® (+) Patient Information Guide based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the Patient Information Guide available at www.radiesse.com for list of these events. Tell your health care provider about any side effects that bother you or do not go away.

Important: For full safety information, please visit www.Radiesse.com or call MyMerz Solutions at 1-844-469-6379

RADIESSE® and RADIESSE® (+) are available by prescription only.

© 2026 Merz North America, Inc. All rights reserved. MERZ AESTHETICS is a registered trademark of Merz Pharma GmbH & Co. KGaA in the U.S. RADIESSE® and the R Logo are registered trademarks of Merz North America, Inc. in the U.S. US-RAD-2600048

Contacts:
Dan Strickford
Senior Director, U.S. Brand Communications, Merz Aesthetics
dan.strickford@merz.com

Maria Jensen
Vice President, DeVries Global
mjensen@devriesglobal.com