Sculptra is a cosmetic medication used to treat the facial wasting of patients who suffer from HIV and AIDS, as well as the facial wrinkles and folds that develop from the aging process.
Pre FDA Approval
The history of Sculptra begins with its approval in several European countries under the brand New Fill. It has been in use in these countries since 1999.
FDA Approval in 2004
In 2004, the FDA finally approved the use of Sculptra for HIV and AIDS patients suffering from lipoathopy?a wasting away of facial proportions due to facial fat loss. The approval process was expedited due to its positive benefit for these patients. No other treatment prior to this could benefit them. Sculptra was approved because there were no side effects due to a weakened immune system.
Off-Label Use
Although Sculptra was not approved initially for cosmetic use in healthy patients, cosmetic surgeons began to use Sculptra off-label on healthy patients to help reduce the signs of aging.
Sculptra Aesthetic
Finally, in 2009, the FDA approved the use of Sculptra for cosmetic uses in healthy patients. The product was then branded Sculptra Aesthetic. The FDA approved the use of Sculptra for patients who are not allergic to any of the ingredients, have no known history or scarring, and who do not have inflammation or infections in the treatment area.
