Practitioners may not have to use Restylane off-label for lip augmentation any longer. On April 27, 2011, an FDAn panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation.
The panel also voted 6-0 with 1 abstention that the filler is safe and effective for the expanded indication.
Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated by Streptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether. The filler was first approved in 2005 for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
Medicis recently conducted a clinical study (MA-1399-15) to evaluate the safety and effectiveness of the filler in the augmentation of soft tissue fullness of the lips. The study included 135 patients, who received lip augmentation with Restylane, and 45 patients with no treatment. The mean volume of filler was 2.9 cc per patient, with a range of 0.6-5.6 cc per patient. At 8 weeks, 92% of patients who received Restylane were considered responders.
Adverse events occurred in 99% of patients. Expected treatment-emergent adverse events included bruising, redness, swelling, pain, tenderness, itching, and skin exfoliation. Of note, herpes simplex virus 1 outbreaks occurred in 4% of patients. The outbreaks were determined to be associated with injection of the filler in 7 or 10 cases.
[Source: Internal Medicine News]