As per FDA requirements, Merz Aesthetics North America provides an indication-specific training program regarding jawline contour injections.
Merz Aesthetics is launching Radiesse (+) Lidocaine for jawline contouring in adults over the age of 21.
Radiesse (+) is the first and only U.S. Food and Drug Administration (FDA)-approved injectable treatment for jawline contour improvement. The FDA approved the supplemental Premarket Approval Application in September 2021.
“The jawline is an important structural component of the face and has a profound effect on an individual’s appearance. This approval provides our customers and their patients a non-surgical, effective and safe option to address loss of jawline contour,” says Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics, in a news release.
The first product in the portfolio, Radiesse, is an injectable biostimulator indicated for correction of moderate to severe lower face wrinkles and folds and for the improvement of volume loss in the dorsum of the hands. Radiesse (+) is also approved for moderate to severe lower face wrinkles and folds, and the new indication brings the unique properties of calcium hydroxylapatite (CaHA) to jawline treatment.
“A sagging jawline is a primary indicator of facial aging, and I regularly treat women and men who seek a well-contoured jawline for a more defined profile,” says Jeremy B. Green, MD, of Skin Associates of South Florida/Skin Research Institute. “With the approval of Radiesse (+), I can now offer my patients an FDA-approved, non-surgical treatment option that will immediately improve the appearance of their jawline.”
“Over the past decade, aesthetics professionals have seen a steady rise in the number of patients seeking a more defined and contoured jawline. To meet this demand and tap into the unique attributes of Radiesse (+), Merz Aesthetics is excited to announce the commercial launch and FDA approval of the jawline indication,” adds Patrick Urban, President, North America, Merz Aesthetics.
The Radiesse (+) jawline indication is based on a pivotal, prospective, randomized, controlled, evaluator-blinded study evaluating the safety and effectiveness of Radiesse (+) in 180 subjects aged 26-65 years of age, who presented with moderate to severe jawline volume loss and desired improvement of jawline volume and contour. The study duration was 60 weeks. The primary endpoint was defined as a subject who obtained ≥1-point improvement on the Merz Jawline Assessment Scale (MJAS) on both jawlines compared to baseline.
Radiesse (+) provided a clinically and statistically significant improvement in the contour of the jawline and overall satisfaction, with 75.6 percent of the treated subjects achieving at least a 1-point improvement on the MJAS on both jawlines at Week 12. No treatment-related serious adverse events (AEs) occurred. The most common (>3%) treatment-related AEs were injection site reactions (mass, bruising, pain, nodule, edema, or swelling) and were mild, transient (duration of less than 15 days) and resolved without sequelae.
The FDA now requires specific training on the newly-approved jawline indication be made available by the manufacturer. Successful completion of this indication-specific training by providers is necessary prior to their administration of fillers for such new indications.
Merz Aesthetics North America provides an indication-specific training program (facial anatomy and vasculature, consideration for safe injection techniques, and identification and management of potential adverse events, including intravascular complications) regarding jawline contour injections. Radiesse (+) treatments of jawline contour should only be administered by providers who have appropriate training and experience, and who are knowledgeable about the anatomy at and around the site of injection.
The device-specific use training program for Jawline is now available to all health care providers on the company’s website.
