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The FDA has now approved Restylane, a filler for the face, to be used in lip augmentations, according to GlobeNewswire.
The report states the Restylane was originally produced to treat wrinkles back in 2003, but now has added use for submucosal implantation for lip augmentations in patients ages 21 or older These changes will also be seen on the labeling for the product as well as include results from clinical trials.
Testing was also evaluated through a randomized, multi-center study of over 175 patients, for Restylane’s effectiveness and safety for both the upper and lower lips. Treatments were randomized from some patients receiving treatment at the beginning of the study and again after six months and some patients not receiving treatments until six months after the trial.
According to the company, Restylane was well tolerated and deemed highly effective for lip augmentation for up to six months. there were no serious adverse effects, some patients experienced pain, swelling, tenderness, bruising, and erythema.
To learn more about fillers including Restylane, please click our link to a video that discusses fillers: FILLERS: Restylane, Radiesse, Juvederm, Cosmoderm, Perlane etc