Injectable collagen stimulation treatment Sculptra receives FDA approval
(16/10/2009)
There are currently over 160 injectable cosmetic treatments available in the UK of which only 7 have received FDA approval.
Injectable collagen stimulation treatment Sculptra® has been granted approval by the U.S Food and Drug administration (FDA) for correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients.
Wendy Lewis, President, Wendy Lewis & Co Ltd, Global Aesthetics Consultancy commented "The long awaited FDA approval for cosmetic indications in the USA is a milestone for the Sculptra brand. Sculptra was the first technology among rejuvenation treatments to create an entirely new category of tissue stimulators that are preventative as well as restorative. American dermatologists and cosmetic surgeons are delighted with this news as at long last consumers will get educated on the innovative uses and I expect to see a lot more doctors featuring Sculptra in their clinics now.”
Sculptra is an injectable volumising treatment that works by stimulating the build up of the body’s natural collagen to help smooth out lines and wrinkles. It is the only collagen stimulation treatment of its kind to receive FDA approval. Clinical research has shown that results with Sculptra last for two years after the final treatment.
Los Angeles dermatologist Rebecca Fitzgerald commented “This is great news for Sculptra. In the United States, an injectable cannot be marketed without FDA approval. While the UK has less stringent regulations, consumers are ever more eager to find out about a treatment before they have it and this approval will confirm to them that Sculptra is a treatment to be trusted.”
Sculptra is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the alpha-hydroxy-acid family that has been widely used for many years in dissolvable stitches, bone screws and facial implants. It has been used for 10 years for cosmetic purposes to gradually restore lost volume and produce long lasting natural looking results.
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