Rage against the FDA
…well, sort of.
The FDA is making the task of getting a simple MRI a serious pain in the rear. Don’t get me wrong, I am glad that we have such a safety system in place for us. However, when it comes to those small pockets of patients such as those with cochlear implants, they are way behind the times. In fact, this procedure is already allowed in Europe and Canada. Multiple cases of patients with Cochlear Implants safely undergoing MRI at 1.5 telsa or less have been published. Here in the US, however, it takes a potentially life-threatening case to even be considered for an MRI, and even then it only happens after submitting tons of paper work and signing consent forms.
It isn’t fair. In other countries, I would have the choice between having magnets surgically removed from my head versus simple having the MRI with them being left in. The risk of MRI with the magnets is still less than the risk associated with possible surgery complications. Plus, they would have to shave parts of my hair off to even access the implant site. So the FDA is basically forcing patients to undergo unneccessary surgery with risks. I know of several ENTs who are publishing article after article in hopes that the FDA will change their guidelines and stop their idiocy regarding so-called patient safety for folks like myself. I am hoping that once I have my MRI done, that I can join the long list of patients who undergo MRI with magnets left in, and suffer no ill-affects from it.
My doctor is trying diligently to get everything in line for me to have this done. She is taking time away from other seriously ill patients in order to deal with this mess. I am grateful for her efforts, and also that of my ENT surgeon.
Seriously, they are asking me to jump through hoops on this. The receptionist asked me kindly to please send her a copy of my implant device card, the serial numbers on both processors/implant, the make/model/year implanted, a list of every crayon I used in my childhood, and how many times I sneezed last year. (Well, maybe not those last two but it sure feels like it.)