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. Artecoll has been used in Europe for many years. Artecoll is not approved by the FDA U.S. Food and Drug Administration and is not available legally in the United States. A next generation product Artefill was approved by the FDA in December, 2006, to treat nasolabial folds with the added condition that a five-year follow up study of patients using must be done.
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.
U.S. Food and Drug Administration approval
Before Artefill was approved by the U.S. FDA, it was studied in 251 subjects at eight medical centers in the United States. The subjects received 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.
- Cohen, S.; Holmes, R. (2004). "Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects". Plastic and reconstructive surgery 114 (4): 964–976; discussion 976–9. doi:10.1097/01.PRS.0000133169.16467.5F. PMID 15468406.
- 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. doi:10.1111/j.1365-2230.2005.01993.x. PMID 16487092.
- Rullan, P. P. (2004). "Soft Tissue Augmentation Using Artecoll: A Personal Experience". Facial Plastic Surgery 20 (2): 111. doi:10.1055/s-2004-861750. PMID 15643576.