Sculptra™ is poly-L-lactic acid, a safe synthetic bio-degradable material.
Sculptra™ is not made from human or animal sources and does not require a skin test. Poly-L-lactic acid (PLLA) is a bio-compatible (does not harm the body), biodegradable (able to be broken down by the body) material that has been widely used for many years in surgical products. Sculptra™ has been approved by the US FDA for restoration and/or correction of the signs of facial fat loss (lipoatrophy) since 2004. Sculptra™ has been used since 1999 in Europe on non-HIV cosmetic patients; it is known there as New-Fill. It was originally created as a product for healthy non-HIV patients, and is currently in process of a 5 year study to show it has longevity beyond 2 years. Dr. Marla Klein is the only physician in Oregon who has had the privilege of learning techniques and pearls of wisdom from the world's cosmetic Sculptra™ master, Dr. Danny Vleggaar in a one-on-one fashion during his trip to the US in the Spring of 2005. Sculptra™ is a relatively simple procedure for the patient. It takes about one hour for a 1-2 vial treatment session. Areas of the face that can be filled are the cheeks, temples, chin and nasolabial folds; but not inside the lips. A treatment session costs $500 (for a 1/2 vial or 2.5 cc of solution) - $2,000 (for 2 vials or 10 cc). This procedure is extremely technique dependent and the physician needs to have a thorough understanding of the layers of the skin, as well as experience and skill in hitting the exact level of placement for proper response and to avoid complications. IT is Dr. Klein's opinion that this procedure should not be performed by a midlevel provider or nurse at any time. The effects are long lasting; they were shown in a clinical study to last for up to 2 years or more after the first treatment session. Dr. Vleggaar from France, who has done more than 2000 patients, reports that his results from Sculptra™ were maintained for more than five years. The US studies were only 1 and 2 years long which is why they proclaim the 2 year length of duration. THe USA 5-year studies are due for completion in 2007, and I expect FDA approval and widespread marketing by the company to occur at that time. Sculptra is injected with a small needle so there is a risk of bruising, but otherwise there is minimal downtime after the procedure. The patient is instructed to massage the area treated for 5 minutes a minimum of twice daily for one week afterwards. Compliance with the massage is critical for avoiding clumping and bump formation. Important: Sculptra™ is prepared the day before the procedure. A $500 deposit is required to schedule the procedure. If the procedure is cancelled prior to the injectable's preparation, then the deposit is fully refundable. Lipoatrophy patients will be informed about Dermik's Patient Access Program at the time of their consultation.
It was granted its US FDA approval for aesthetic use in July 2009.