FDA
FDA clears injectable medical device Radiesse to treat décolleté wrinkles
Radiesse (calcium hydroxylapatite; CaHA) —an FDA‑cleared injectable medical device (implant)—is now authorized for treatment of moderate to severe décolleté wrinkles in adults aged 22 years old and older. The clearance expands Radiesse indications beyond the face, making it the first regenerative biostimulator device in the U.S. cleared for both facial and body aesthetic use. Benefits are attributed to CaHA’s dual mechanism: immediate structural support combined with stimulation of endogenous collagen and elastin.
“The décolleté is one of the most visible—and earliest—areas to show signs of aging,” said Samantha Kerr, PhD, Chief Scientific Officer at Merz Aesthetics in a company statement. “FDA clearance underscores that this delicate area can be safely and effectively treated with Radiesse.”
The clearance reflects growing demand for minimally invasive, device‑based aesthetic treatments addressing both facial and body aging.
Efficacy
FDA clearance was supported by a randomized, controlled, evaluator‑blind, multicenter trial of 152 women aged 30 to 65 years with moderate to severe décolleté wrinkles, randomized to immediate treatment with Radiesse (n=116) or delayed‑treatment control (n=36). Effectiveness was assessed using validated Merz Aesthetic Scales, with the primary endpoint defined as ≥1‑point improvement at week 24. At that time point, a significantly greater proportion of treated patients achieved response vs. controls. Patient‑reported outcomes showed >80% satisfaction with skin tightness, while ~90% of evaluators observed visible improvement by 4 months. Durability was supported by patient feedback, with 83% willing to repeat treatment at one year.
Safety
FDA‑reviewed safety data for Radiesse used in the décolleté showed a safety profile consistent with previously approved indications. Reported adverse events were predominantly mild to moderate injection‑site reactions, including erythema, edema, tenderness, and bruising, which were generally transient and resolved without intervention. No new or unexpected device‑related safety signals were identified for the décolleté indication. Standard device warnings remain applicable, including the importance of proper injection technique to reduce risks such as vascular compromise or nodule formation.
Of note, experts at an August 2025 FDA advisory committee meeting raised concerns that calcium hydroxylapatite–based filler placed in the décolleté could appear radiopaque on breast imaging, potentially mimicking benign or malignant calcifications or obscuring small lesions, which might complicate interpretation of mammography or other screening studies when injected near breast tissue. An FDA‑mandated post‑marketing study (NCT07086248) is currently underway to evaluate whether Radiesse for décolleté treatment affects mammography or breast ultrasound interpretation.