I heard this product has been approved in Europe for 10 years. Are there any long-term safety studies? If yes, what are the results? Does Artefill gradually get absorbed into the body over time?
Long-term Effects of Artefill?
Doctor Answers 1
ArteFill should be taken seriously.
ArteFill is the third-generation, so to speak, of the modern PMMA fillers, and has only been approved in the U.S. since the end of 2006. [Note: it's available once again, now that another company, Suneva Medical, has purchased the rights to it here in the U.S. after Artes Medical filed for bankruptcy last fall.]
The first version in Europe was Arteplast, and it suffered from particle size, shape, and charge variation that increased the risk of complications. The second generation was Artecoll, sold largely in Canada, which improved on the mechanical properties of the microspheres. Lastly, is ArteFill, whose primary improvements were even finer control of particle size, shape, and electrostatic charge (and the collagen component of it is derived from U.S. cattle...ostensibly to avoid mad cow disease, I suppose, despite that never occurring with the earlier versions).
The permanent component of ArteFill is PMMA (polymethylmethacrylate), an acrylic plastic--the same plastic that's used in intraocular lenses in patients eyes who've had cataract surgery, and the same plastic that's been used to cement in hip joints in orthopedic surgery. It is never resorbed.
There is a lot of data over more than a decade now about the long-term effects of various PMMA fillers (not just the ones above). The most serious complication is the formation of granulomas--a serious inflammatory reaction that can occur even a few years after injection. It's a reaction that's difficult to treat and may require surgical removal.
It's detractors love to harp on this, but their scare tactics usually don't hold water. It's not for everyone, and it needs to be done in the right areas by properly trained surgeons with good technique. The risks make this riskier than temporary fillers, but arguably less risky than surgery (and yet it's detractors don't whine about the risks of surgery: scars, revisions, disfigurement, infection,...stroke, heart attack, death).
Take a look at RealSelf.com's "Was it worth it" response to ArteFill:
83% say it was worth it. Now compare that with a lot of other procedures. Pretty good, eh?
All the best,
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