On April 27, 2011 the FDA has finally made a decision to approve the use of Restylane for all lip augmentation procedures.
“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.”
Restylane has been growing in popularity over some of it’s competitors like Juvéderm®, Radiesse® and Sculptra® in the dermal filler category and this advancement for the brand will make great strides in the plastic surgery community.
“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”