With the field of plastic surgery more popular than ever, new products, techniques, and procedures are being developed every day. Researchers are constantly on the hunt for new and exciting ways to help patient’s achieve their body aesthetic and anti-aging goals, as simply and effectively as possible. As such, the FDA has recently recommended approval of a new product that looks to shake up the world of cosmetic treatments.
At a May 2nd meeting of the Food and Drug Administration’s General and Plastic Surgery Devices Panel, the group unanimously recommended approval of Juvederm Voluma XC. Voluma helps restore lost volume to areas of the mid-face unlike any other dermal filler before it. While the FDA is under no obligation to follow the recommendation of the panel, it often does. This recommendation could mean exciting news for cosmetic surgeons around the country.
What sets Voluma apart from other dermal fillers is that it is a combination of high and low molecular weight hyaluronic acids, which allows for a thicker product. Voluma has a more jam-like consistency and is designed for deeper injections. This allows for cosmetic treatment of deep areas in the mid-face and currently, there are no products available in the United States that can handle this loss of volume. Voluma has been approved for use in 65 other countries, including Canada and Australia, and the product has been received positively.
The recommendation of the FDA General and Plastic Surgery Devices Panel was based on data collected from a randomized clinical trial. The study consisted of adults ranging in ages from 35-65, with about 80% of the trial participants being women. At 6 months, patients were evaluated and 93% of patients treated, rated themselves as improved or much improved compared to photos taken prior to the injectable filler. That is a significant level of patient satisfaction. This indicates that Voluma could become an important part of non-surgical facial rejuvenation procedures.
While full FDA approval may still be some time away, the results of the clinical trial and the recommendation of the FDA General and Plastic Surgery Devices Panel is exciting news. Treatment of the mid-face with Voluma could provide an option for people who have been without. You can rest assured that Pinsky Plastic Surgery will be following the progress of Juvederm Voluma XC as it makes its way toward market readiness.
Your body transformation starts with a first step; new treatments and techniques are developing all the time. To find out which procedures are currently available to help you meet your body aesthetic goals, schedule a consultation at Pinsky Plastic Surgery today.