Posts Tagged ‘injectable fillers’

FDA Advisory Panel Recommends Restylane for Lip Enhancement

Monday, May 9th, 2011

While an advisory panel to the Food and Drug Administration (FDA) injectable filler Restylane for lip enhancement, it seems unlikely to make much difference even if the FDA does move to approval. Many doctors in the United States already find Restylane very effective in filling out their patients’ lips.

Restylane, like other hyaluronic acid fillers such as Juvederm and Elevess, temporarily smooths wrinkles by adding volume under the skin, and was approved for this use by the FDA in 2003. The effects of hyaluronic acid fillers typically last about six months.

Restylane is frequently used for off-label purposes, such as lip augmentation, since hyaluronic acid occurs naturally in the body and there are very few risks associated with the procedure. According to Dr. Farhad Rafizadeh, a New Jersey plastic surgeon who spoke with MyHealthNewsDaily, Restylane is the best filler for the lips because it remains in place. Other facial fillers, he says, tend to seep into other areas of the face.

This practice is not as unusual as one might think, since off-label use for a product is quite different from using a substance that has not been approved by the FDA. Experienced, conscientious doctors can legally and ethically use drugs and other products for alternative purposes, as long as these products have already been shown to be safe for human use, and the patient fully understands the nature of the use.

A move by the FDA to approve hyaluronic acid fillers for lip enhancement would most likely only impact doctors that are unaccustomed to using the products and hesitate to go off the beaten path. In the hands of an expert plastic surgeon, however, hyaluronic acid fillers can work wonders for smile lines, wrinkles, creases, lips, and hollow cheeks.

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