Friday, March 11, 2022

What is the FDA status of total disc replacement (lumbar) in the US?


full image - Repost: What is the FDA status of total disc replacement (lumbar) in the US? (from Reddit.com, What is the FDA status of total disc replacement (lumbar) in the US?)
Probably unattainable anyway but I am questioning what my son's provider keeps saying (actually the nurse). She said first that lumbar disc replacement is not approved in the US, only cervical. I responded (messaging) that there are definitely 2 FDA approved devices in the US. Then she said they are only approved for studies. I'm pretty sure the FDA approves devices and drugs, not what surgeons actually do. I see plenty of .com sites including spine centers where they say they DO do TDR, and none of them say it is only available via a study.I mean, probably impossible anyway. His network doesn't do it for sure, and even if a doctor is found and he meets criteria there's a snowflake's chance in hell insurance would approve and not like he's sitting on an extra 100 grand.Anyone know what the status is in the US for this surgery? My son has asked me to participate in his visits and asking questions and sorting the info because he is overwhelmed and also has ADHD and a very short fuse because of a LOT of health care frustration along with pain in recent months. And when doctors say things I know aren't true (yes, it happens!) it is harder to believe anything else they say. (I'm fine with someone saying "I don't know, or "this is my opinion and the reason for it", that's all good).So what is the current status in the US for TDR?


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