Medicis, the makers of Restylane, announced last week that the FDA approved its premarket approval application supplement to expand the approved use of the popular dermal filler to include lip enhancement.

Restylane is an injectable gel that contains hyaluronic acid and adds volume to the skin. It is commonly used to fill in wrinkles and plump up the lips.

The FDA originally approved Restylane for use in the cosmetic treatment of the nasolabial folds, the vertical, curved creases that develop on either side of the mouth.

However, plastic surgeons and dermatologist have been using the product off the label for years. When injected into the lips, physicians found that the product safely and effectively added fullness to the upper and lower lips. Most surgeons find that Restylane lip injections look more natural than lip implants and offer more predictable results than fat transfer injections.

With the FDA approval, physicians and patients can feel more comfortable using Restylane injections to add volume to the lips; the FDA recommends that the product be used on patients that are 21 years of age or older.

"We are pleased with the FDA's decision to expand the RESTYLANE label to include lip augmentation," Medicis Chairman and CEO Jonah Shacknai said. "This marks another significant milestone for RESTYLANE, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months."

Prior to receiving the FDA approval, Medicis conducted a study of 180 patients. According to the conclusion of the study, Restylane injections were well tolerated by patients, and lip-enhancing results lasted for up to six months. After the six months were up, 80 percent of the patients included in the study elected to undergo Restylane lip injections again. Associated side effects were reported as mild, and included pain, swelling, bruising, and erythema.