FDA Approves dermal filler Radiesse for Wrinkles in neck and chest area Despite Imaging Concerns

The FDA has approved the subdermal implant Radiesse for treating wrinkles and adding volume in the décolleté area (neck and upper chest) in adults aged 22 and above. While effective, the filler contains hydroxylapatite microspheres that can appear on X-rays and CT scans, potentially interfering with breast imaging-an issue that prompted prior FDA advisory review.

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. 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.

“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 effectiveness:

• More than 80% of RADIESSE® patients felt satisfied with skin tightness.

• 83% of patients reported they were likely to get RADIESSE® treatment again, over a year after their initial treatment.

• 90% of healthcare providers reported RADIESSE® patients with visible improvements by 4 months.

• 93% of patients were interested in other RADIESSE® treatments.

“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.