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Old 01-08-2009, 02:27 PM
JJames JJames is offline
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Join Date: Nov 2008
Posts: 102
Default Bi-Level ADR FDA Approval in U.S.?

Although I too have many questions regarding the pros, cons, successes, and horror stories regarding ADR surgery, I am convinced after so many years in pain, so many different tests and treatments, medications, procedures, and the opinions of 5+ surgeons that my best option to treat the DDD which has left me with annular tears in my L4/L5 and L5/S1 discs is the bi-level ADR surgery on these. Especially, due to the pain and indications that I have other discs which already have more minor issues.

My question is, that after waiting for over a year (based upon when I believe the procedure was submitted to the U.S. FDA) for the procedure to be approved in the U.S. there does not appear to be any way to get the status of where this stands! I have not even been able to confirm it was ever submitted to the FDA! I've gone to the www.fda.gov website, and that is so confusing it is useless to me. I don't know where to look or who to ask.

Does anyone have any resources or answers for me to look into? I have researched the possibilities of going out-of-country and or paying out-of-pocket in the U.S. and neither make sense to me. Any complications from the procedure (which I would have to beg, borrow, and steal to pay for) would not be covered by my medical insurance! I am already living week-to-week and cannot leave my wife and children in such a financial bind.

Any information or suggestions would be greatly appreciated. Thank you so much, and good luck to all.
__________________
DDD diagnosed ~99
Chronic Pain since Aug 2006
Failed L4 Microdisctectomy Apr 2007
2008-Positive Disco (L4/L5&L5/S1 annular tears)
Herniated discs at L4/L5/S1, bulging T12
Began constant/severe neck & upper back pain 11/09
Jan 10-Cervical/Thoracic MRI:bone spurs+new disc probs
Cervical Spine issues causing terrible pain beginning in July 2021 - scheduled for 2 level C-Spine ADR on Oct 19th 2021 now!! Part of Clinical Trial so unsure if Mobi-C or Baguera C will be implanted ....
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