The Food and Drug Administration has approved Restylane for lip augmentation, the manufacturer announced Oct. 11.
The hyaluronic acid dermal filler was first approved in 2005 for mid to deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, and has been used off-label for lip augmentation. Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated by Streptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether.
At a meeting in April, an FDA advisory panel voted 6-0 with 1 abstention that the benefits of using the filler as a submucosal injection for lip augmentation outweighed its risks, and that the filler was safe and effective for the expanded indication.
At that meeting, the panel reviewed the results of a study of 135 patients who received lip augmentation with Restylane (with a mean filler volume of 2.9 cc per patient, with a range of 0.6-5.6 cc per patient) and 45 patients with no treatment. At 8 weeks, 92% of patients who received Restylane were considered responders; almost all patients (99%) experienced adverse events, which included expected treatment-emergent adverse events such as bruising, redness, swelling, pain, tenderness, itching, and skin exfoliation. Of those who were treated, 40% experienced adverse outcomes that they felt affected their daily activity or were disabling, and 15% experienced adverse events (typically swelling and tenderness) that lasted more than 15 days.
Among the concerns expressed by the panel was the lack of men and people with dark skin in the study.