Panel Recommends FDA Approve Restylane for Lip Augmentation

An FDA panel has recommended that the FDA expand the approved use of Restylane® to include lip enhancement. It’s currently approved to treat facial wrinkles and folds — such as the nasolabial folds on the sides of the mouth.

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, Restylane® can be marketed for the lip procedure. 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.

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.”

Restylane® is injected into the tissue and over time is gradually degraded and absorbed by the body; 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 uses Restylane® for lip enhancement and 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 the tear trough (the saggy skin under the eyes), marionette lines and facial contouring of the chin, cheeks and temples.