FDA officially approves Restylane.

The U.S. Food and Drug Administration (FDA) has approved another use for Restylane Injectable Gel: this week the agency gave its official blessing to use the filler for lip augmentation.     

Restylane was previously approved to treat facial wrinkles. While we have long used it for lip augmentation, this was known as an unofficial or "off-label" use. Restylane is the first filler to get the FDA's approval for this particular use.

In the multi-center study that Medicis, the makers of Restylane, presented to the FDA, Restylane was found to be highly effective for lip augmentation, for up to 6 months. It did not have any serious side effects. About 80% of patients liked the results so much that they signed up for a second treatment after 6 months.

This is certainly our experience at my practice: both restylane and juvederm work very nicely to shape and fill the lips in a pleasing and natural-looking way. Patients love it!