Thursday, April 28, 2011

Will Wrinkle-Smoother Restylane Be Approved as Lip Enhancer?

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 Riley.

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.

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Article by: Amanda Chan, MyHealthNewsDaily Staff Writer

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