Advocate For Allowing Americans the New ADRs

[ADR seeker]

Originally Posted by mmglobal

The m6 and neodisc are interesting designs. Whether or not they are better than other motion preservation devices remains to be seen.

I have seen many more m6 cervical discs needing explant revisions than I have of any other disc... not by just a little bit. And, this is in spite of the m6 being done in much, much smaller numbers. I like many of the design components, but questions about the materials, longevity, etc... will only be proven with time.

Mark

They have been proven superior. The M6 implants like a standard ball and socket ADR but once in place it cannot over rotate and it is motion limiting like a real disk. The only thing that can stop a the over rotation of a standard ADR are the facet joints.

The Neo Disc is a simple implant. Any surgeon who can do a ACDF can install a neo disk. Also there is no metal and if you have a titanium allergy they can use ceramic screws. The Neo sounds like the best design.

Both disks are tried and true and there are no valid reasons for why they are not available on American soil.

I spoke with a surgeon who did the clinical trial for the neo and he installed 13 of them. Only one went bad and that was because he used the wrong size.

Because the FDA owns my body I cannot buy a Neo Disk and get it installed. Imagine that. It is unlawful for me to own a chunk of silicone and fabric and allow a doctor to install it in my spine.

These ADRs have the C Mark and that is good enough for me. If the FDA app5oved them and C Mark didn't then they are probably junk like the Depuy hip implant.

I wish I could put a positive spin on this. I can't. It's tyranny.