The US FDA has approved use of the filler Radiesse for the treatment of wrinkles in the decolletage for individuals aged 22 years or older, despite concerns voiced by the agency’s staff and outside experts at an advisory committee meeting in 2025.

No other fillers have been approved for treating that area of the body, generally defined as the upper chest. Radiesse, Merz Aesthetics’ 20-year-old product, which largely contains calcium hydroxylapatite, will be the first in the US to have the indication.

In announcing the approval, Merz said that clinical trial data supporting approval of the decolletage indication (also referred to as the décolleté area in the press release) showed that more than 80% of patients felt satisfied with skin tightness and that 90% of healthcare providers reported patients had visible improvements by 4 months.

At an August 2025 meeting of the FDA’s General and Plastic Surgery Devices Panel, agency staff noted that fillers are often used off-label in the upper chest and raised the possibility that the products could migrate from the injection site or form nodules and/or granulomas and interfere with mammograms, cause false positive readings on breast imaging or clinical exams, or affect breast feeding and lymphatic drainage.

The advisers said there were many potential unknowns about filler use in the decolletage and agreed that patients who are breastfeeding or pregnant should be excluded from receiving injections. Individuals with darker skin types, known wound-healing issues, a history of radiotherapy, lymphoma, or other blood cancers were also seen as potentially higher-risk populations. They did not formally vote on whether or not to recommend approval.

The FDA has not updated its information page on dermal fillers since 2023, when it added information to reflect a risk for delayed-onset inflammation near dermal filler treatment sites following viral or bacterial illnesses or infections, vaccinations, or dental procedures.

At the panel meeting, Merz said that between 2018 and 2025, it received 44 reports of potential adverse events in the decolletage. None reported migration of material or radiological interference. The company is currently conducting a study to determine if Radiesse injections in the decolletage interfere with breast imaging.

The EU approved Radiesse for the decolletage in 2024 and Health Canada approved the indication in 2025.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.