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Fda Clearance For Injectable Lip Augmentation

Restylane (hyaluronic acid) is a cosmetic facial filler approved by the US FDA in 2003 to treat moderate to severe facial wrinkles and folds, but in October 2011 the FDA cleared Restylane for lip augmentation in patients over the age of 21.  Lip augmentation is the process of enhancing the lower and upper lip to make them appear fuller and more prominent on the face restoring lost volume due to natural aging.  Though the FDA recently cleared Restylane for lip augmentation in select patients, cosmetic and plastic experts such as Dr. Michael Eisemann and other have been using Restylane off label for this purpose with great success.  However, now that a clinical trial with definitive, empirical evidence shows that Restylane is effective for lip augmentation for periods of six months, the package insert may make this claim on its packaging and literature.  The lip augmentation clinical trial involving Restylane was performed at multiple clinical locations with 12 physicians on approximately 180 patients using a randomized controlled trial where cases received Restylane injections in the lips and controls received a placebo.  Researchers were not aware of which patients received the actual Restylane injections.  Patients were carefully followed at multiple points following treatment and they kept journals about their experiences for at least two weeks following treatment.  At the conclusion of the trial, researchers confirmed that Restylane was in fact effective.  Effectiveness was measured by independent photo reviews of before and after treatment as well as a lip fullness scale.  The clinical trial also concluded that lip augmentation using Restylane was safe for patients.  Minor adverse events in treatment included mild pain, tenderness, swelling, erythema (i.e., inflammation) and bruising.

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