Artefill
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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
Artecoll 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 6 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
Side 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
Like many companies working on injectable fillers, the company developing Artecoll went through several formulations before achieving one that had consistently high enough quality to pass regulatory review.[5] The 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
- ^ 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: 142e–153e. doi:10.1097/PRS.0b013e3182362c63. PMID 22186529.
{{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.
- ^ 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.
- ^ a b DeLorenzi C (2013). "Complications of injectable fillers, part I". Aesthet Surg J. 33: 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.
- ^ Rundle, Rhonda (2007-08-29), "Things Get Ugly Over a Beauty Injection", Wall Street Journal