So today I looked on the FDA’s Web site on cochlear implants. I was particularly interested in finding out what all the risks are and if anyone has died from the surgery or the cochlear implant itself.
The risks the FDA lists are:
- Injury to the facial nerve. I knew about this one. My audiologists told me that they take a CAT Scan for this purpose. They want to know if you have any abnormal facial nerves and they want to know where they are. This way, you know your own unique personal risks before you go into surgery as the doctors will sit down and discuss them with you. So they already know where the nerves are. Not only that but they will monitor them during surgery. I think because of this, there is probably less and less of a risk of this actually happening, particularly if you have a good doctor and good genes.
- Meningitis. I don’t think I’m at risk for this. It sounds like it’s mostly in children up to five years of age. I couldn’t find the exact years, just studies done on that age group. So I don’t know if anyone older has gotten meningitis as a result. But basically if you give the kid a vaccine before surgery, and monitor for the symptoms of meningitis then it should be fine. But then again, parents should be doing these things for their children anyways (hearing or deaf!). I found a study done in the United States on the risk factors. (see below). The number of cases in Clarion users (and two deaths) in this case (of 18,000 surgeries of 60,000 total out there) was a concern among professionals. It was found that the higher risk was because of the “positioner” part of the implant – a positioner is meant to keep the electrodes in place and position them during surgery. The Clairon with the positioner has since been voluntarily recalled and is no longer made. The FDA did not recommend re-implanting children who already had these implants. Remember that the below numbers are from 2002 and are a bit old. There has been another study done in 2004 using the same people from a 2002 study – I’m not sure if the 2002 study involved in this study is the same one that I’ve been talking about. They found that the individuals who had the positioners even two years after the study were at a greater risk of Meningitis than the rest of the population. Remember that the numbers below are from the 2002 study in the first link I posted. Mel-El doesn’t have a risk in the United States, because not many doctors will recommend it (this is my theory).
- Advanced Bionics ‘Clarion’-8 cases of 7,271 implant
- Cochlear Corporation ‘Nucleus’-14 cases of 16,617 implants
- MedEl Corporation ‘Combi 40+’-0 cases
- Cerebrospinal Fluid Leakage. The FDA Web site said this was the result of a hole in the inner ear or another hole in the covering of the brain as a result of the surgical procedure. Get a good doctor. I doubt this would happen.
- Perilymph Fluid Leak. The perilymph is the fluid in the inner ear. I believe it is partly responsible for balance. The FDA said it may leak as a result of the hole they have to make to insert the electrodes. From what it sounded like, my audiologist said that the surgeon will fill this hole with muscle tissue and then your body will heal itself back up. So again, get a good surgeon.
- Infection of the Skin Wound. Keep it clean, follow the doc’s orders and this shouldn’t happen. If it does you’ll go back to the doc and he/she will probably fix it.
- Blood or Fluid Collection. Again this is probably something that the doc can fix.
- Attacks of Dizziness or Vertigo. From what I’ve seen, this will go away as you heal. You just might have to take some pain killers or something. Again, talk to the doc.
- Tinnitus. This is the one I’m worried about. Some people report more tinnitus. I don’t think there’s a way to fix it, unless you take some medicine. But it’s something that may be a part of your life from then on.
- Taste Disturbances. Usually these are temporary (that’s what my audiologist made it sound like). I’ve seen articles about how sometimes you can lose taste in half of the taste buds in your tongue. Talk to the doc if you experience this, of course.
- Numbness. Just like with any cut, scrap, surgery, etc. etc. It’ll be swollen. Ask your doctor when the numbness should go away.
- Reparative Granuloma. This is inflammation that happens if the body rejects the implant. I’ve heard of docs taking implants out as a result of a malfunction, so I imagine they can take it out if your body rejects it. I have yet to hear about this occurring to anyone. Titanium is well suited for biological things, and your body is not likely to reject it.
So my conclusion so far is that no one has died from the surgery. The only thing a person may die of is Meningitis. I’ll let you know if that is not the case. Also, the surgery is pretty low risk. For the most part, complications can be corrected.
**Again, I am not a medical person. This is why in most every risk I list here, I recommend that you talk to your doctor. So even if I say it may be temporary, I don’t want you waiting for it to go away. Listen to your doctor and talk to your doctor about both the risks before surgery and if you’re experiencing them after surgery. I have found that it’s good to have an idea of what the risks are so you can have more questions ready for your doctor. That is my purpose of posting this list in my blog.