On April 27th, the US Food and Drug Administration's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee recommended the injectable wrinkle-filler Restylane (Medicis Aesthetics Inc) for use as a lip enhancer. Restylane, one of the top three commonly used injectable gel composed of hyaluronic acid, is currently indicated for mid- to deep-dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. The company is seeking to amend the product's indication to include submucosal implantation for lip augmentation.
The panel voted 6 to 0 (1 abstaining) that Restylane for lip augmentation is generally safe and effective for this purpose and that the benefits outweigh the risks, but the FDA still has to make a final decision on Restylane injectable gel for lip augmentation, but the agency usually follows the advice of its advisory panels, which consist of outside experts. The side effects of the lip injection treatments in the study were mild and resolved quickly. Depending upon the area treated, and the effects wanted, there is variation in the amount of volume injected and that has to be decided with your individual provider who is doing your injections. So the FDA panel is not going to set a maximum dose. Men and women of color have been under represented in these studies, but it is felt that the injection of filler in these patients would be safe. In the recent study only a very few patients were in the 18-22 age range, but it has been tested safely in these few patients. Restylane is commonly used off-label to augment and contour the lips, so the ruling really just enhances current practices.
No comments:
Post a Comment