Dear Richard,
Your brief overview of the situation pretty much sums it up. The US is catching up and there are ADR options in the US, but the only 2 approved cervical discs are older versions. These may work well in some applications, but the newer devices do have improvements that simply make them better options. There are many devices that are variations on proven designs, and there are also some newer devices that have little or no long-term data.
Stenum does an excellent job at marketing, but they have a poor reputation because of the number of unnecessary problems that we've seen come from there. The do a lot of surgeries and have a lot of successful patients. Yes, even the best clinics have disasters. Unfortunately, too many of the failures we see from Stenum have to do with poor carpentry... just poor placement or poorly sized devices. I even know a failed Stenum patient with the device put in upside down. Too many of these patients would have had an excellent chance of success if they had been with a more careful surgeon.
If you need spine surgery, you are in trouble. Don't underestimate the importance of the decisions you'll make here. Do everything you can do to maximize your chances for success. Understand that under the best of circumstances, people who are excellent candidates still esperience problems. Conversly, I often see horrible candidates with spines that are train-wrecks, have excellent outcomes. There are reasons that spine surgery fail that cannot be anticipated or avoided. But, the unnecessary failures that would have been successes had they gone to a more experienced or more careful surgeon are very tough to watch.
I've scrubbed in on or observed surgeries at 7 different spine centers in Europe (including Stenum) and 8 centers in the US... there can be a big difference from one surgeon to the next. It's not always about experience... it's about getting consistent, high quality output. It's about being willing to take the extra time to do it right.
Do your homework.... make informed decisions! Whatever you decide... good luck!
Mark
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