The US Food and Drug Administration has approved the dermal filler RADIESSE for the treatment of wrinkles in the décolleté area in patients aged 22 years and older, representing an additional indication for the injectable, which is approved for use in both facial and body applications.

The injectable functions as a biostimulator by promoting the production of collagen, elastin, and other structural proteins involved in dermal integrity, with effects reported to last up to 2 years. The dermal filler has been evaluated in more than 250 scientific publications and is used globally.

Data supporting the décolleté indication showed that more than 80% of patients reported satisfaction with their skin tightness following treatment, 83% reported they were likely to undergo repeat treatment after more than 1 year, and 93% expressed interest in additional RADIESSE treatments. Further, 90% of health care providers observed visible improvement by 4 months,

Jeremy Green, MD, a board-certified cosmetic dermatologist involved in the clinical studies, noted: “[The dermal filler] jump-starts the skin’s regenerative process, giving [patients] firmer, smoother, more radiant-looking results without surgery.”

Survey data cited in the press release indicated a 39% increase in demand for noninvasive skin-lifting treatments involving the face and body.

Reported adverse events include bruising, redness, swelling, pain, itching, difficulty chewing, and nodules at the injection site. Unintentional intravascular injection may result in complications such as vision abnormalities and stroke. The product shouldn't be used in patients with allergies to its components, a history of severe allergic reactions, or bleeding disorders. Safety and effectiveness haven't been established in certain anatomical areas, including the lips and periorbital region, or in specific populations such as patients who are pregnant or breastfeeding and those younger than 22 years for the décolleté indication.

Source: Merz Aesthetics