FDA - potential risks associated with ADR?
 

I really appreciate the information that is being provided. Thank you!
On my quest for information regarding a possible link to prodisc C and autoimmune disease, I came across information from the FDA on the prodisc C. As with any medical procedure or medication, all potential risks are listed as possible. I found it interesting that the FDA lists autoimmune disease as a risk that is associated with TDR. Was I pre-disposed to autoimmune disease and this was triggered by surgery or is it possible that the disc itself caused the autoimmune response? I'm still not convinced on either possibility but find this very interesting.

FDA Under Labeling PDF - Page 9 paragraph 3
Risks associated with the total disc implant in the cervical spine are: early or late
loosening of the components; disassembly; bending or breakage of any or all of the
components; implant migration; malpositioning of the implant; loss of purchase; sizing
issues with components; anatomical or technical difficulties; implant fracture; bone
fracture; skin penetration; irritation, pain, bursitis resulting from pressure on the skin
from component parts in patients with inadequate tissue coverage; foreign body reaction
to the implants including possible tumor formation, autoimmune disease, metallosis,
and/or scarring; possible tissue reaction; bone resorption; bone formation that may reduce
spinal motion or result in a fusion, either at the treated level or at adjacent levels;
development of new radiculopathy; myelopathy or pain; tissue or nerve damage caused
by improper positioning and placement of implants or instruments; loss of neurological
function; decreased strength of extremities; decreased reflexes; appearance of cord or
nerve root injury; loss of bowel and/or bladder control; and interference with
radiographic imaging because of the presence of the implant;

I am on many medications now and find that if I do not take my nerve medication the pain is nearly unbearable. My Rheumy thinks a lot of my pain is associated to the nerves from my neck. Life is good, we just have to adapt!!