Juvederm could be FDA approved for cheek augmentation later this year.
A US Food and Drug Administration (FDA) panel has recommended that the agency approve Juvéderm Voluma XC (Allergen) for cheek augmentation. The product would be the first injectable dermal filler permitted in the US for the mid-face. If approval takes place – and the FDA generally follows advisory committee recommendations — it should be available as soon as late 2013.
A gel composed of hyaluronic acid suspended in phosphate buffered saline with 0.3 percent Lidocaine, Juvéderm Voluma helps restore deep volume loss and smooths the mid-face, rejuvenating sunken areas around the cheeks, re-creating youthful contour and fullness in the cheeks. The results are instant, natural looking and can last up to 18 months. There’s little if any downtime – most people resume normal activities immediately.
Based on the clinical trial data presented, the FDA’s General and Plastic Surgery Devices Panel agreed that the product is effective and safe and the benefits outweigh the risks. The most frequent common treatment site responses (CTRs) reported in the trial were tenderness, swelling, and firmness.
FDA reviewers noted that the incidence of CTRs decreased for subjects receiving touch-up and repeat treatments. More than half (52.8 percent) of subjects received the optional retreatment at the end of the extended follow-up period “suggesting these subjects perceived an acceptable benefit/risk profile for [its] continued use,” the reviewers said.
An additional consensus was that Juvéderm Voluma XC fills more than cheeks, meeting the needs of what people want in plastic surgery. According to the American Society for Dermatologic Surgery (ASDS), in 2012 nearly 2 million people had soft tissue filler augmentation, representing a 205 percent increase since 2000.
Photo: by Alaskan Dude on Flickr