Popular Off-Label Use of Restylane May Soon Be Recommended By FDA

Posted on May 16, 2011 | by

A recent recommendation by a Food and Drug Administration (FDA) advisory panel that the injectable filler Restylane® be recommended for lip enhancement probably won’t have a significant effect on current practices by most plastic surgeons. Many doctors already find Restylane highly effective in filling out patients’ lips.

Restylane, like other hyaluronic acid fillers such as Juvéderm, adds volume under the skin to smooth wrinkles, with effects that last about six months. It was approved for this use by the FDA in 2003, but as MSNBC reports, Restylane is often used for off-label purposes such as lip augmentation. Hyaluronic acid is a naturally occurring substance in the body and there are very few risks associated with its use.

Restylane is the best injectable filler for lip augmentation because it stays in place, says New Jersey plastic surgeon Dr. Farhad Rafizadeh, who spoke with MyHealthNewsDaily. Other fillers tend to spread beneath the tissue more easily.

Off-label use for medical products is not unusual, and is very different from using a substance that hasn’t been approved by the FDA. Doctors can legally and ethically use and prescribe FDA-approved drugs for purposes not recognized by the FDA, as long as the patient fully understands the nature of the use. Off-label use is often broadly supported by existing medical literature and experience.

What would result from FDA approval of Restylane as a facial filler for lip enhancement? It would probably only impact doctors who aren’t accustomed to using the product and may not know how to employ it properly for alternative uses. In the hands of an experienced plastic surgeon, however, hyaluronic acid fillers such as Restylane can work wonders for wrinkles, creases, smile lines, hollow cheeks, and lips.