About FDA Approving Restylane for Lip Augmentation.


An advisory panel to the Food and Drug Administration will vote today (April 27) on whether to recommend the injectable filler Restylane for use as a lip enhancer. But future FDA approval may not make a difference in how the dermal filler is used in clinical practice, doctors say. If the advisory panel votes to recommend Restylane for use in the lips, that information will then go to the FDA, which will then vote for final approval, said FDA spokeswoman Karen Rile Restylane works by adding volume to facial tissue with injections of hyaluronic acid, which is produced by bacteria. The results last for about six months, according to the FDA. The filler was approved by the FDA in 2003 to smooth deep wrinkles like the nasolabial fold -- the line that forms between the side of the nose and the corner of the mouth -- but it's often used for off-label purposes, like to enhance, define and plump up the lips, said Dr. Farhad Rafizadeh, a plastic surgeon who has a private practice in Morristown, N.J. However, FDA approval for Restylane to be used in the lips likely wouldn't make a difference in his own practice, said Rafizadeh, who already uses it for that purpose with his patients. "It doesn’t make it any safer or any more dangerous," Rafizadeh told MyHealthNewsDaily. "It is what it is." Injectable dermal fillers like Restylane are extremely popular in the United States, with more than 1.2 million people getting hyaluronic acid injections in 2010, according to the American Society of Plastic Surgeons. What Restylane does Rafizadeh sees at least a couple patients a month who are seeking plumper lips. He often recommends Restylane because it stays put and doesn't seep into other areas of the face as other dermal fillers, such as Juvederm, do. "The difference is Restylane is like Jell-O and Juvederm is like honey, which is a liquid and it tends to diffuse more," he said. While Juvederm is also effective at plumping the lips, "Restylane allows me to define the shape of the lip in a more precise manner." Rafizadeh always has a conversation with his patients before the procedure to explain that Restylane is only FDA-approved for the nasolabial fold, but is effective for other uses as well, he said. The filler can also be used for the tear trough (the saggy skin under the eyes) and frown lines, he said. It can also be used to make earlobes appear more youthful.

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Morristown Plastic Surgeon