[NJ Gene]

Originally Posted by TPatti

Have you looked into the Kineflex disc? It is a hard disc as well but unlike the prodisc it has a restraining ring to stop movement before the facet joints are forced to do so. Dr. Cappuccino, the doctor that is doing my follow-up stateside, had given me this disc as a hybrid option. He would have fused L4/L5 and implanted a disc below and above. It is also not fda approved but Dr. Cappuccino is a member of AIMIS and could have performed the surgery in Cypress. He discussed both options, his hybrid or 3 M6's, said they both had pros and cons and the final choice would be up to me and that he would follow up with me if I choose to find a doctor to implant the M6's.

Todd, are you sure that U.S surgeons can't implant the M6 off-label? Just because it's not FDA approved doesn't mean it's illegal. Vitamin supplements and many over-the-counter meds are not FDA approved, yet they're still sold in stores. Furthermore, if you recall, there was a problem with many people who received epidural injections, where the medicine came from a compounding facility in New England. Apparently compounding facilities are not subject to FDA approval, and this facility was more interested in profit than the well-being of the patients. They were ultimately shut-down. However, their mere existence was legal. I was also told by surgeons in the U.S. that they could do 2 level fusions "off-label" before it became FDA approved. Don't get me wrong, I would rather stick with a device that is FDA approved or well documented by experienced surgeons in Europe. BTW, my spine surgeon advised against AIMIS. He was one of the founders of it. Once he heard that it consisted of mostly U.S. surgeons doing risky operations outside the umbrella of the FDA and without risk of U.S. malpractice, he divested his funds from it and no longer has anything to do with it. That being said, I'm sure many of those surgeons are excellent, and I would consider using them here in the U.S.

Gene