The chest has long been treated off-label. In April, Merz Aesthetics secured FDA approval of RADIESSE for wrinkles in the decollete, giving a popular but previously unapproved area its first on-label injectable.
In April 2026, Merz Aesthetics received FDA approval for RADIESSE, a calcium hydroxylapatite biostimulator, to treat wrinkles in the decollete (chest) area. The decollete had long been treated off-label, and this approval gives the area its first on-label injectable, addressing a gap regulators had previously flagged.
The chest, or decollete, shows aging early but has lacked an FDA-approved injectable, leaving treatment off-label.
An April approval changed that for one widely used product.
Merz Aesthetics announced in early April 2026 that the FDA approved RADIESSE, a calcium hydroxylapatite (CaHA) injectable, for the treatment of wrinkles in the decollete area. RADIESSE is a biostimulator: rather than only adding volume, CaHA stimulates the body to produce its own collagen over time. The decollete approval is notable because U.S. regulators had previously discussed the lack of approved fillers for the chest and the need for better safety data, given the area thin skin and proximity to the breast.
On-label approval means the product has been reviewed specifically for this use, with studied dosing and safety, rather than being applied off-label at a provider discretion. It does not change the fundamentals of who should perform the treatment or how patients should be selected, but it does give clinicians and patients a regulated option for an area that previously had none.
For consumers, an FDA-approved option for the decollete is a meaningful upgrade in clarity and oversight: it signals reviewed evidence for that specific use and reduces reliance on purely off-label practice. It does not make the treatment universally appropriate, results and risks still depend on skin quality, technique, and patient selection, but it gives patients a clearer basis to ask whether a proposed chest treatment uses an approved product for an approved purpose.
Watch whether other manufacturers pursue decollete or chest approvals, and how guidance evolves for this delicate area. The broader trend, biostimulators like RADIESSE moving into mainstream, on-label use, is likely to continue. For patients, the practical step is to confirm that any chest treatment uses an FDA-approved product for that indication, and to choose a provider experienced with the decollete specifically, where anatomy and skin behave differently than on the face.