[ADR seeker]

Originally Posted by mmglobal

ADR Seeker, I'm not sure I understand how you can deride the industry so severely and then take their word for it that something has been proven superior. There have been many technologies that were 'proven superior' and implemented widely, only to be halted or recalled later.

Here is why. M6 and Neo Disk are made by small companies and they are used by the best surgeons in the world Johnson & Johnson makes the disks and other orthopedic products that fail. Johnson & Johnson have paid all sorts of fines for wrong doing. I trust C Mark. I don't trust the FDA.

The marketing spin about devices is very interesting. This reminds me of the original Charite' versus Prodisc spin wars. One of the advantages constantly pointed to, of the keeled design was that it arrested rotation of the plates. (This is different from rotation you are referring to in the M6 discussion.) It is intuitively obvious that the plates cannot rotate with the keel encased in bone. However, if the Charite' plates don't rotate, then arresting rotation of the Prodisc plates is a non-issue.

In most cases a device that acts like a real disk is best. I can't see how a ball and socket can be much better than a fusion and I don't think that they have been proven better in most patients. Charite had a ton of failures and it's made by J&J.

IMHO, the jury is still out on the facet issue. I have seen both Charite' and Prodisc patients with poor facets going into the surgery, have good long-term outcomes. I have seen both Charite' and Prodisc patients with good facets going into the surgery, have facet problems later. This issue is so much more complicated than most of us can imagine. I have seen studies that show Charite' to be superior related to facet loading and I have seen studies that show Prodisc to be superior.

Manufacturers manipulate studies. How to you think the Johnson & Johnson hip implant made it out of clinical trials. The FDA knew it was a poor design. Again, if a device acts like the real thing and the surgeon installs it properly there is a very good chance that is will function properly.

The Bryan disc is a non-starter for virtually all of the spine surgeons I know. You know what? Medtronic presents data that clearly shows the bryan disc to be superior. That device is clearly inferior. That's why Medtronic bought the Bristol disc and renamed it to Prestige. They knew that the Bryan disc would not be successful. Yet the data shows it to be superior.

In any other industry other than the medical industry people would be in jail for that type of fraud. Imagine if Lockheed said their jet fighter was better than the General Dynamics fighter and they were lying. Somebody would be in deep trouble. The medical industry is above the law.



How is it that you are absolutely certain that these devices are so wonderful when you are so very skeptical about so many other issues in this field?

I have spoken with a surgeon who did the Neo Disk clinical study. He was trained by Luis Pimenta. He had spectacular results. He told me that he saw Pimenta do a 3 level with one incision with a great outcome.

M6 and Neo both have the C Mark approval. If the FDA approves something all it means that the FDA approved it. It does not mean that it is good. If it gets C Mark approval then chances are it is good.

IMO based on common sense and some background in engineering and construction the Neo Disk is the best design out right now. I suspect that the reason Spinal Kenetics went to the keel design was for patent reasons. A better solution would be a PCM coating and a post on each end that slide into a small oval shaped holes on the top of on vertebra and the bottom of the other. A monkey could do it. There would be zero chance of migration it would fuse.

Hooch, regarding M6 failures. Many of the failures I have seen are technical failures of the surgeon. Most of them from Stenum. they have the same types of failures with the M6 as they did with the prestige and other devices. You can't do a 5 hour surgery in 70 minutes and expect success. You can't take a neck with severe cord compression due to osteophytes and severe DDD at many levels; do a 3-level ADR without addressing the osteophytes. ADR surgery is more than opening, putting the disc in and closing. There is very tedious work that needs to be done. ADR surgery without performing the NECESSARY decompression is not a high success rate operation.

No doubt that Stenum is a surgery mill. Osteophytes are a whole other issue. When they are removed they grow back with a vengeance. Bone wax which is really bees wax stops them but in 2% of cases it causes bone necrosis.

One would think by now that there would be an alternative to retard bone grown other than bees wax.

In my case I have disk material pressing on the cord and the nerve roots. The disks are ossified and if the fragments were nibbled away I'd probably be OK. What may work is what Bonati advertizes but done by a skilled surgeon and not a hack that works on volume.

Gotta run... thanks all for the good discussion!

Mark

Hang in there Mark and I will do the same for a while.