Panel Recommends FDA Approve Restylane as Lip Enhancer

FDA may approve Restylane as Lip Enhancer
An FDA panel has recommended that the FDA expand the approved use of Restylane to include lip augmentation. The injectable is currently approved to treat facial wrinkles and folds, like the nasolabial folds on the sides of the mouth.

The FDA usually follows the advice of its advisory panels, and if it does approve the expanded use, then 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.

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 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

Many surgeons are already using Restylane to enhance 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) and marionette lines and facial contouring of the chin, cheeks and temples.

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Dr. Michael J. Will cosmetic surgeon Maryland received his bachelor’s degree from Washington and Jefferson College, his dental degree from Georgetown University and his medical degree from the University of Texas.

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