Artefill is a permanent injectable wrinkle filler, for the correction of smile lines. Artefill was approved by the U.S. Food and Drug Administration (FDA) as a medical device in October 2006. A prior version of the product called Artecoll has been marketed in Canada and Europe since the 1990s.
Medical use
editArtecoll is a gel suspension of 20% polymethylmethacrylate (PMMA) 30- to 42-micron microspheres, 3.5% collagen derived from cows, and 0.3% lidocaine.[1][2] The PMMA microspheres in Artecoll are not absorbed by the body and therefore provide a permanent scaffold into which the person's own soft tissue can grow; the PMMA microspheres can only be removed by cutting them out.[3]
Artecoll is a permanent injectable wrinkle filler used by dermatologists and plastic surgeons to fill smile lines.[1] The initial correction lasts about six months, until the bovine collagen degrades, but as the recipient's tissue grows in, filling may last for about five years[2] and there have been reports of ten years' duration.[3]
Side effects
editSide effects may include lumpiness at the injection site, persistent swelling or redness, increased sensitivity, and rash or itching more than 48 hours after injection.[1] The lumpiness (nodules), and granulomas, can be difficult for doctors to treat.[4]
If the recipient has allergies to bovine collagen or lidocaine, severe allergies, a susceptibility to form keloid or hypertrophic scars, or fails a small skin test, Artefill should not be used.[1] Because the device ultimately works by causing tissue to grow around the microsphere scaffold, there is a risk of overgrowth if too much Artefill is administered.[5]
History
editThe product was invented by German plastic surgeon Gottfried Lemperle and the first version was called Arteplast and clinical trials started in 1989. An unacceptable rate of complications led to a new formulation, Artecoll, for which the Dutch company Rofil Medical received European marketing approval in 1994 and for which Canderm Pharma received Canadian approval in 1996.[6] Artes Medical Inc. was formed in the US in 1999 by Lemperle and his two sons to bring the technology to the U.S. and secure FDA approval.[6][7]
References
edit- ^ a b c d "Medical Devices – Recently-Approved Devices – ArteFill - P020012". U.S. Food and Drug Administration.
- ^ a b Nguyen AT, Ahmad J, Fagien S, Rohrich RJ (2012). "Cosmetic medicine: facial resurfacing and injectables". Plast Reconstr Surg. 129 (1): 142e–153e. doi:10.1097/PRS.0b013e3182362c63. PMID 22186529. S2CID 1868135.
{{cite journal}}: CS1 maint: multiple names: authors list (link). is a gel suspension of 20% polymethylmethacrylate homogeneous 30- to 42-μm microspheres in 3.5% bovine collagen solution mixed with 0.3% lidocaine that may have durability over 5 years." - ^ a b Goldberg DJ (Dec 2009). "Breakthroughs in US dermal fillers for facial soft-tissue augmentation". J Cosmet Laser Ther. 11 (4): 240–7. doi:10.3109/14764170903341731. PMID 19951196. S2CID 29779094.
- ^ Sidwell, R. U.; McL Johnson, N.; Francis, N.; Bunker, C. B. (2006). "Cutaneous sarcoidal granulomas developing after facial cosmetic filler in a patient with newly diagnosed systemic sarcoidosis". Clinical and Experimental Dermatology. 31 (2): 208–11. doi:10.1111/j.1365-2230.2005.01993.x. PMID 16487092. S2CID 70719426.
- ^ DeLorenzi C (2013). "Complications of injectable fillers, part I". Aesthet Surg J. 33 (4): 561–75. doi:10.1177/1090820X13484492. PMID 23636629.
- ^ a b Lemperle, Gottfried; et al. (2003). "Soft Tissue Augmentation with Artecoll: 10-Year History, Indications, Technique and Complications". Dermatol Surg. 29 (6): 573–587. doi:10.1046/j.1524-4725.2003.29140.x. PMID 12786699. S2CID 20353524.
- ^ Rundle, Rhonda (2007-08-29), "Things Get Ugly Over a Beauty Injection", Wall Street Journal