AJ, I'm sorry to say, but the FDA does NOT stand in the way of multi-level ADR. Devices are either approved or not approved. The FDA does not approve any number of levels. If the device is studied at one level and the approval is based on the single-level study, then multi-level procedures are considered off-label. Again, the FDA does not stand in the way. These decisions are usually based on reimbursement issues and when a doctor tells you that the FDA does not approve multi-level procedures he is providing information that is misleading (to be polite.... FALSE to be blunt.)
It breaks my heart to see people get a procedure that is known to be incomplete because of reimbursement issues, but that is the world we live in... that is the status quo for the last DECADE since the first FDA approval of a disc replacement, the Charite' in 2004.
The good news is that cervical ADR is coming around and I've heard of BCBS of California approving multi-level cervical. The bad news is that they are actually backing up on lumbar ADR's and some companies that used to approve single level lumbar are now denying.
I'm looking forward to discussing your surgery and recovery. Most of the cervical cases I've seen have come with quick recoveries. Even in the cases where the surgery hasn't resolved or reduced the pain, recovery from the surgery has been quick.
I'm still painting and doing projects around the house. I can't believe that I'm doing this well... the last few weeks have been miraculous after the last 4 years being pretty freaking bad. (yay thoracic epidural!)
Talk to you soon,
mark
|