词条 | Artefill |
释义 |
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 useArtecoll 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 effectsSide 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.[10] HistoryLike 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] References1. ^1 2 3 {{cite web|title=Medical Devices {{ndash}} Recently-Approved Devices {{ndash}} ArteFill - P020012|website=U.S. Food and Drug Administration|url=http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm077416.htm}} 2. ^1 Nguyen AT et al. Cosmetic medicine: facial resurfacing and injectables. Plast Reconstr Surg. 2012 Jan;129(1):142e-153e. {{PMID|22186529}}. 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." 3. ^1 Goldberg DJ. Breakthroughs in US dermal fillers for facial soft-tissue augmentation. J Cosmet Laser Ther. 2009 Dec;11(4):240-7. Review. {{PMID|19951196}} 4. ^{{Cite journal | issue = 2 | volume = 31 | journal = Clinical and Experimental Dermatology | pages = 208–11 | year = 2006 | doi = 10.1111/j.1365-2230.2005.01993.x | pmid = 16487092 | title = Cutaneous sarcoidal granulomas developing after facial cosmetic filler in a patient with newly diagnosed systemic sarcoidosis | first4 = C. B. | last2 = McL Johnson | first1 = R. U. | first2 = N. | last3 = Francis | last4 = Bunker | first3 = N. | last1 = Sidwell}} 5. ^1 DeLorenzi C. Complications of injectable fillers, part I. Aesthet Surg J. 2013 May;33(4):561-75.Review. {{PMID|23636629}} 6. ^1 {{cite journal|last1=Lemperle|first1=Gottfried|title=Soft Tissue Augmentation with Artecoll: 10-Year History, Indications, Technique and Complications|journal=Dermatol Surg|date=2003|volume=29|pages=573–587|display-authors=etal|doi=10.1046/j.1524-4725.2003.29140.x}} 7. ^{{Citation | last = Rundle | first = Rhonda | title = Things Get Ugly Over a Beauty Injection | newspaper = Wall Street Journal | date = 2007-08-29 | url = https://www.wsj.com/articles/SB118834446251311594}} External links
1 : Plastic surgery filler |
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