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Artecoll, used in cosmetic plastic surgery as permanent soft tissue filler, is injected under the skin to plump up wrinkles and reduce folds of skin associated with aging such as the nasolabial fold which runs from the corner of the nose to the edges of the mouth. Now produced for Americans in San Diego, California, by Artes Medical, Inc, Artecoll has been used in Europe for many years. It was approved by the U.S. FDA in December, 2006, to treat nasolabial folds with the added condition that a five-year follow up study of patients using Artecoll must be done.
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Composition
Artecoll is mostly collagen, one of the most abundant substances in all mammals. The thinning of collagen in human faces is responsible for aging, wrinkles and lines on the face.[1]
Artecoll consists of 25 percent microscopic Plexiglas plastic beads made of a substance known as polymethylmethacrylate suspended in a solution of 75 percent bovine collagen. The microspheres are 32–40 micrometers in diameter (500 micrometers could fit in the period at the end of this sentence).
Potential risks and side effects
Some researchers have found that large lumps under the skin known as granulomas developed after Artecoll injections. The lumps are a reaction to the injections and can be difficult for doctors to treat.[2]
U.S. Food and Drug Administration approval
Before Artecoll was approved by the U.S. FDA, it was studied in 251 subjects at eight medical centers in the United States. The subjects received Artecoll injections in 1334 wrinkles of the glabella, the heavy wrinkles between the eyebrows, in the corner-of-the-mouth lines, in upper lips and in the nasolabial folds. A similar group of patients received injections of ordinary collagen (with the trade name Zyplast™) in the same places in their faces.
Researchers then studied the patients' improved appearance and the reactions of research subjects to the injections. At the six-month follow up, the researchers found the Artecoll group showed 86.7 percent better augmentation of loose skin than the group which received only collagen. Adverse reactions to collagen and to Artecoll among both groups of patients was reported as about equal.[3]
References
- ^ Cohen SR, Homes RE. Artecoll: A long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects. Plast Reconstr Surg. 2004; 114:964-976
- ^ Sidwell, R.U.; Mcl Johnson, N; Francis, N. +; Bunker, C.B. Cutaneous sarcoidal granulomas developing after Artecoll® facial cosmetic filler in a patients with newly diagnosed system sarcoidosis. Clinical & Experimental Dermatology, 31(2):208-211. March 2006.
- ^ Rullan, Peter Paul M.D. Soft Tissue Augmentation using Artecoll: A Personal Experience. Facial Plastic Surgery. 20(2):111-116, May 2004.
External links
- Artecoll before and after pictures
- Landmark U.S. FDA Clinical Trial Results for First Permanent Injectable Wrinkle Filler Published in Journal of Plastic and Reconstructive Surgery
- Artes Medical
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