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FDA ADVISORY PANEL RECOMMENDS APPROVAL OF NEW FILLERSOn November 21, in Gaithersburg, Md., the FDA's General and Plastic Surgery Devices Panel met and recommended agency approval, with conditions, of pre-market applications for two Injectable wrinkle fillers devices. If approved by the FDA, these new products represent a new class of dermal fillers in the United States for the treatment of lines and wrinkles. The FDA has not released a timeline for a final decision but generally follows the recommendations of its advisory panels. Restylane®, a Hyaluronic acid-based product, has been in use in more than 60 countries since 1996 and has been under clinical studies in the U.S. After reviewing the company's data, the advisory panel voted 6 to 3 in favor of approval with conditions, including cautionary language on use of the product with persons of color and those with certain skin types, a study on the safety and efficacy of the product for persons of color, and physician education. If approved by the FDA, Restylane will be marketed and sold in the U.S. by Medicis Aesthetics. When this product is approved by the FDA and made available, the Palm Harbor Plastic Surgery Centre will have it and make it available to our patients. Hylaform®, another Hyaluronic acid-based product, was also reviewed by the FDA advisory panel. By a vote of 6 to 3, the panel recommended approval with conditions, including cautionary labeling as safety and efficacy had not been demonstrated for lip augmentation, or repeated usage and use in certain skin types and persons of color. The panel also called for physician education, a study on the safety and efficacy of the product for persons of color and assessment of patient hypersensitivity to the product. When this product is approved by the FDA and made available, the Palm Harbor Plastic Surgery Centre will have it and make it available to our patients.
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