Hi Harrison,
I really appreciate your opinion and advice. However, based on my experience in the US and the profession/sport I need to continue, I feel I would be crazy
not to go overseas for ADR.
Due to my profession, 2-level fusion is not an ideal option. I teach Brazilian Jiu-Jitsu for a living. I need to be able to return to teaching and participating in a sport where an opponent pulling and pushing on the head and getting caught in chokes and headlocks is normal on a daily basis. How do I know the M6 can handle this? Do a Google search for a gentleman named Braulio Estima. Braulio is a good friend of mine and quite literally one of the best athletes in the world in the sport of Brazilian Jiu-Jitsu. Braulio had two cervical M6's placed in his neck at c4/5 and c5/6 around 2010 in the UK (where he lives). Since then, he has won the European, World, and Pan American Jiu-Jitsu Championships, as well as many world-level grappling tournaments and also competed in MMA. He trains in the same art as myself every day and experiences the same physical stresses I put myself though. It's been about four years and his M6's have held up perfectly thus far to this super-normal usage and he experiences no problems from the implants at all. Everyone I have spoken to in my sport who had two level fusion has said that they are not as functional as they were before the surgery, and have experienced problems due to the stresses from training with the fusion. Due to this, I have used Braulio as a model for what the M6 is capable of and how it will stand up to the rigors of my sport with it's very specific physical demands. I have no such proof or model to follow with the Mobi-C. Hence, I feel the M6 is my best option.
My experience here in the US has been very frustrating thus far. I have consulted with many spine and neurosurgeons, including four top spine surgeons at the Hospital for Special Surgery in NYC - two of whom are in the M6 trials. As you probably know, the Hospital for Special Surgery (HSS) is an "elite" hospital that is among the best in the US, especially for orthopedic surgery. All four HSS doctors have offered fusion or a hybrid ADR. The first doctor at HSS told me he had done "one" two-level Mobi-C replacement and that my insurance wouldn't cover it anyway. The second doctor told me he didn't believe in ADR and that fusion was best, stating that the artificial discs would probably "pop out" if I did sports with them in. The third doctor was in the M6 trials, but didn't accept insurance. He said he could do a hybrid Mobi-C/fusion, however he said he had done thousands of fusions, but less than a dozen Mobi-C disc replacements. He had only placed the M6 in dogs, never in humans. The last HSS doctor was also part of the M6 trials and had placed a few of them. He was quite familiar with the Mobi-C and the M6 and said he would do some specific research on how the discs would handle in athletes and call me back, which he did. It was in the phone conversation that he said the M6 was "far stronger" than the Mobi-C in terms of the mechanical stresses it can handle. The mechanical testing data from both companies seems to confirm this:
Mobi-C: from the LDR website
http://us.ldr.com/Portals/1/MECHTESTtwolevel.pdf
The Mobi-C resisted 497 Newtons of sheer force before it failed mechanically.
M6: Spine Surgery London has the data
M6-C artificial disc information
The M6-c resisted roughly 6,700 Newtons of sheer force before it failed mechanically.
Other directional load tests from the same sources show the M6 to be far stronger.
Now, I do understand that each company has different testing machinery, different methods, different measuring devices, etc. and that the various methods of testing are not exactly alike, but even accounting for that would not show such differences in results. The respective numbers of what each device can take are not even close. I also understand that these numbers are supposed to be stronger than a normal human disc, but I want the strongest mechanical option possible with my profession and sport.
Hence, after all my research, I feel the M6 in Europe is my best option.
As for Germany, that is some valuable advice regarding the laws. I met Malte back in February and he seems like a nice guy, but I have been disappointed with communication. I believe Dr. Bierstedt to be excellent, but because of the poor communication with Malte, I have been leaning towards Dr. Hamlyn in the UK or Dr. Clavel in Spain. Both Dr. Clavel and Dr. Hamlyn skyped with me individually and they were excellent - both coming to the same conclusion. However, the UK option is not set up for medical tourism, so the cost estimate is not clear and there is no coverage for a revision or longer stay in the hospital. It would seem that Dr. Clavel is the best option.