Why is ArteFill Still Being Advertised Even Though They're out of Business?
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Doctor Answers 3
Artefill back on market
Artefill was purchased by Suneva Medical, a privately held medical technology company in San Diego, Ca earlier this year and the product is back on the market. The original owner of the technology, Artes Medical, was a victim of the economy. Artefill was then temporarily out of production, but has since been relaunched and is back in many dermatology offices.
Artefill is the only FDA approved filler of it's type and is, for all practical purposes, a permanent filler that contains nondegradable polymer microspheres. The carrier, bovine collagen, breaks down, but the tiny beads do not. Thus Artefill is typically only encouraged for use by experienced filler patients who know how fillers have changed their appearance.
When used in the indicated areas, Artefill is a viable alternative to temporary fillers which typically break down over the course of 6 to 9 months.
Artefill is not indicated for use in the lips or in surface lines or wrinkles. Because of its permanency, I will often use a graduated approach and layer the product in several sessions over time to achieve a final desired correction.
Artefill requires pretesting because of the small potential sensitivity to bovine collagen gel used to suspend the beads for injection.
Artefill Is Very Much Available and On the Market
Polymethylmerthaculate or PMMA has been used in medicine, initially as a bone cement for artificial joints, for many, many years. It was then discovered that small particles of PMMA act as a bio stimulant to produce tissue around each particle. It was also found that it takes about the same time to make this tissue as it take for injected collagen to be absorbed and that the amount of tissue produced was similar to a certain volume of collagen.
The first generation if the product had very uneven particles of PMMA. The next generation used round microspheres and worked much better although it did produce lumps called granulomas in some cases. This product was called Artecoll.
The product was further refined when it was brought to the US for FDA approval. The microspheres were made uniform in size, (40 microns). They were all polished and round. They were also negatively charged and the collagen that makes up 85% of the volume of a syringe of Artefill was made from a hypoallergenic source to minimize any problems form the collagen.
The company that brought Artefill to market in 2006, did have some financial problems and the right to the product were taken over by Suneva Medical. Suneva is doing very well and Artefill is growing as a filler with its growth this year (2014) being up 140% to date.
The 5 years safety studies are currently being reviewed by the FDA and it looks like Artefill’s safety profile will surpass even that of the likes of Juvederm and Restylane.
I have include a link to some before and after Artefill pictures that you may be interested in.
Physicians are drawing down their stock of ArteFill.
You're correct that the company is no longer in business. But since the product is still FDA-approved, physicians can still offer their existing supply to patients.
Eventually, of course, that existing stock will be depleted and that'll be the end of its availability. That is unless another biotech concern resurrects the company or the manufacturing.
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These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.