FDA Approval Status for ArteFill

ArteFill is a compound that is popularly called a “dermal filler” and is injected subcutaneously to alter a patient's face by filling in the area behind wrinkles or lines in the skin. Dermatologists generally recognize collagen as being effective in filling in spaces and erasing wrinkles. In an ArteFill injection procedure, a combination of bovine collagen and PMMA, a medical grade substance, is used. The PMMA elements are called ‘microspheres’ – according to medical experts, these remain in the body to provide long term effects.

FDA Approval for ArteFill

Current resources show that Artefill was approved by the FDA in October 2006 after a 12 month double-blind clinical trial showed some positive results for this kind of procedure. Trials showing this kind of “wrinkle correction” with ArteFill have been published and provide some basis for the approval of this product by doctors. However, medical sources show that not all doctors approve the use of ArteFill. Some have argued that the product can cause disfigurement in the form of lumps that may develop after the procedure.

An unofficial record shows that the FDA approval for was 4 to 1, with a dissenting opinion on approving ArteFill for “nasolabial” facial use. As with all products, consult your doctor before deciding on an ArteFill injection.

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