Restylane, the most popular wrinkle filler in North America, is on track to gain FDA approval for lip augmentation. The injectable is currently approved to treat facial wrinkles and folds, like the nasolabial folds on the sides of the mouth, but an FDA panel has recommended that the FDA expand the approved use to include lip enhancement.
The FDA will make the final decision on Restylane for lip augmentation, but it usually follows the advice of its advisory panels. If the FDA does expand its use, then Restylane can be marketed for the lip procedure.
Jonah Shacknai, Chairman and Chief Executive Officer of Medicis, Restylane’s maker, said in a statement that the panel’s recommendation reflects its “confidence in the robust clinical data provided by Medicis.” FDA approval would make Restylane the first hyaluronic acid dermal filler in the U.S. indicated for use in the lips.
Restylane was the first hyaluronic acid dermal filler approved by the FDA for use in the United States (in 2003). It launched in the U.S. in January 2004, and according to Medicis, it has been used in over 10 million treatments worldwide.
Restylane is injected into the tissue and over time is resorbed by the body as the treatment results gradually wear off; results typically last about six months.
Off-Label Uses of Restylane
Many doctors are already using Restylane for the lips. Doctors can use drugs for off-label uses — meaning, uses that aren’t approved by the FDA — but for a drug maker to market it for a certain purpose, it must have FDA approval.
Plastic surgeon Dr. Farhad Rafizadeh, who uses Restylane for lip enhancement, said he often recommends it because it stays put and doesn’t seep into other areas of the face as other dermal fillers do. “Restylane allows me to define the shape of the lip in a more precise manner,” he added.
In addition to the lips, common off-label uses for Restylane include filling the tear trough (the saggy skin under the eyes), correcting marionette lines and facial contouring of the chin, cheeks and temples.
