I wrote a long article about this company but it didn’t get through at all. Maybe it was too long. Maybe just the links will make it with a few words.
Atrium takes plain old polypropylene mesh and coats it with Omega 3 fish oil, a food supplement. Then partially cures it, turning some of it in to a polymeric coating. The new coated product was never tested in humans before being released to market. The 510(k) process was used, probably based on the fact that the starting materials were “substantially equivalent” to existing products, although I don’t think that “cured” Omega 3 oil is the same as uncured. But they slipped it through.
Just an example of how strange the mesh device field really is.
Sorry, there were no replies found.
Log in to reply.