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Was ArteFill Deemed Unsafe?

Artefill was on the market and was FDA approved. But now, it no longer has a website. What happened? Was it deemed unsafe?

Asked 34 months ago by suzg
Sort 3 expert answers by:
+2

Artefill will soon be available

Artefill which is similar to artecoll that has been used in Europe and Canada for 10 plus years has a long track record of patient safety. The company went bankrupt in November but the product continues to be FDA approved, and the lab where it is made has been kept in ready mode waiting for another pharmaceutical company to take them over. I am happy to say it will be available this month since another company paid over $200 million for the rights to produce the product. There are limited... more
Scott Trimas, MD
Jacksonville Facial Plastic Surgeon
+2

Never deemed unsafe. Company went bankrupt. But it's back!

ArteFill is still approved by the FDA. It never was taken off the market. What happened was that Artes Medical--the manufacturer of ArteFill and a company who really only had this single product--went out of business (Chapter 7) late last fall...along with a lot of other companies in the economic collapse of recent months. The product still exists, is still approved, and is shipping again now that the rights have been bought by a new company, Suneva Medical. Hope this helps answer your question, more
David C. Pearson, MD
Jacksonville Facial Plastic Surgeon
+1

Artefill is available from Suneva Medical

Unfortunately, Artes, the previous owners of Artefill, was not managed well and ran out of money.  Suneva Medical has had the product now since 2009 and is doing a much better job with it.  Artefill is an excellent product and I am glad it is available again.
Lorrie Klein, MD
Laguna Niguel Dermatologic Surgeon
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