FDA Approves Dermal Filler for Injection via Cannula
The FDA has approved Restylane Silk (Galderma) for lip augmentation through the use of a small tip cannula. This is the first FDA-approved hyaluronic acid (HA) dermal filler for lip augmentation and the smoothing of wrinkles around the mouth, and is also the first HA dermal filler to be approved for lip injection via cannula. Restylane Silk is for patients 21 years and older.
The approval was based off the results of a multicenter, open-label, prospective study that assessed the safety and efficacy of the injection. The 12-week study took place in 4 centers across the country. Researchers observed 60 male and female participants 23 years of age or older. At 12 weeks, 98% of the participants had improvement in both the upper and lower lip, as assessed by the Global Aesthetic Improvement Scale.
According to the study, no severe related adverse events were observed. Further, a majority of the participants did not experience a treatment emergency adverse event, and a majority of reported symptoms were assessed as mild with the exception of swelling. Most of the reported symptoms were resolved within 7 days.