Sculptra
History
Sculptra, Chinese: 舒顏萃, is a proprietary formulation of poly-L-lactic acid (PLLA) that is an FDA-approved dermal filler manufactured by Dermik Laboratories, which conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis (of Sanofi-Aventis). It was originally intended as a treatment for Human Immunodeficiency Virus (HIV) positive patients “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) (CITE STH HERE) when it was approved by the FDA in August, 2004. [1][2]
PLLA was approved by the FDA on August 3, 2004, for the treatment of facial fat loss (also called facial lipoatrophy or lipodystrophy). According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).[3][4] Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with HIV who take anti-HIV drugs may develop lipoatrophy. Sculptra was subsequently approved by the FDA for use with non-HIV patients with wrinkles, despite substantial complications reported to the FDA.[5]
Science & Purpose
Sculptra is a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. It is microparticles of lyophilized alpha-hydroxy acid polymers. One vial of sculptra contains 367.5g of the product itself combined with 4mL of sterile water and 1mL of lidocaine. The dilution can be adjusted as needed. Sculptra is a collagen stimulator. The increase in collagen production causes the collagen to wrap around particles in the body that would naturally break down, causing the area of injection to grow over time.[6]
Usage & Statistics
Sculptra was FDA approved for use in immunocompetent people to fill in facial wrinkles and volume loss and has been used off-label for the cheeks, hands, neck, thighs, the gluteal region, and chest wall deformities. In 2020, there were 134,123 sculptra procedures administered in the United States.[7]
Risks & Side Effects
After the injection, it will take around 1 to 1.5 months to grow natural collagen gradually. Right after the injection one's face may experience swelling and bruise, but after few days, the swelling will go down and the water will be absorbed. After the injection, patients must carries out a massage process in order to ensure that the injectable solution is smooth, level and evenly distributed inside the skin.
Possible risks and side effects include nodules with granuloma formation over time, swelling, bruising, redness, edema, discomfort, hematoma, and inflammation. Because it is a foreign substance, there can be a reaction to the skin after injection. For this reason, patients should be properly prepped and sanitized before the procedure. It is also recommended to massage the area to help avoid the formation of granulomas.
References
- ^ https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002c.pdf
- ^ https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050c.pdf
- ^ US FDA. "Sculptra Aesthetic Label". http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050c.pdf.
{{cite web}}: External link in|publisher=|url=(help) - ^ US FDA. "Medical Device User Fee and Modernization Act (MDUFMA) 2005". Retrieved 12 August 2013.
- ^ US FDA. "Sculptra Aesthetic Modified Label" (PDF). Retrieved 12 August 2013.
- ^ Sickles, Christine K.; Nassereddin, Ali; Gross, Gary P. (2021), "Poly-L-Lactic Acid", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 29939648, retrieved 2021-05-21
- ^ https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-report-2020.pdf