Quote:
Originally Posted by Harrison
Brian, if you search Neodisc, pls share with us your impression of the outcomes. I have not done this in a while. That said, I've talked to a few patients with disastrous outcomes. I don't think the product is on the market -- I'll do a quick check and add another post.
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Sorry, i have never heard of a disastrous outcome with the Neodisc, but understand there were concerns (from forum members) regarding biofilm and HO risks with the design of the disc. A girl on this forum had the device implanted by Pimenta in 2010 and her most recent post in 2012 suggests she was very pleased with it. I had no idea of the disastrous outcomes and wonder if they could be worse than some of the other ADR failures. There are hundreds of Neodiscs out there including multilevel and I am surprised by the silence.
A little further research to see if the disc is still on the market and I think you are right. I only did a quick check before posting my above post and found a 2014 document suggesting a Dr Neel Anand uses it. I revisited it and it appears they are quoting old information. Thank you for taking the time to pick me up on that.
It appears the device completed FDA study but the "...sponsor of the study has[had] decided not to move forward with an FDA submission for approval" If I find out any further more up to date information I will let you know.