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FDA recommends Restylane for Lip Plumping

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An FDA advisory panel recommends Restylane, an injectable filler, for approval for lip enhancement. In 2003, the FDA approved Restylane for nasolabial wrinkles, the lines that form along the sides of the nose.

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.

Currently, many physicians already use Restylane in the lips and other “off-label” areas, so the FDA approval would be unlikely to significantly change treatment habits among cosmetic providers.  Restylane tends to last between 3-6 months with a single treatment.  It consists of a gel called hyaluronic acid, which is natural broken down by the body in the same way as sugar. Overdone lips are often the result of too much filler; natural-appearing lips can result from a well performed treatment.