FDA Warns of Cochlear Implant Risks

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WASHINGTON - Children with an early version of the cochlear implant face an increased risk of bacterial meningitis beyond just the first two years following implantation of the hearing devices, the Food and Drug Administration warned Monday.

The increased risk means the young implant patients should be monitored as long as the electronic devices are in place for signs of the sometime fatal infection of the fluid surrounding the brain and spinal cord.

Deaf children fitted with the implants and a positioner get bacterial meningitis more often than either children with the implants that don't have the small rubber wedge or those without implants at all, the FDA said in separate letters to patients and doctors.

The rubber wedge originally was used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to sell implants with positioners. None has been implanted since July 2002.

An original study found 26 of 4,264 children with the implants developed meningitis during the first two years following surgery, with those with positioners at greater risk. Now, a new study that followed the same children for an additional two years found another six _ all with positioners _ developed meningitis. The results appear in this month's issue of the journal Pediatrics.

It remains unclear how the positioner increases the risk, the FDA said. Nor does the agency have enough information to recommend surgically removing the devices, given the risk of postoperative infection.

Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends the children receive the proper vaccinations.

___

On the Net: FDA cochlear implant information: http://www.fda.gov/cdrh/cochlear/
 
Do you also realize that is also .6% - If the numbers were like at 10% were developing megnintis then I would be alarmed and worried. But this is only .6 percent of those who had been evaluated.
 
I agree that the percentages are too small at this point to warrant mass-hysteria. Obviously, caution is the byword and making sure these children have their meningitis shots.

Also, note that the impact of the positioner will be very limited as they have not used it since 2002.
 
There are other things that lead to a meningitis risk as well...I don't know if anybody else was told this when they went to college, but university students seem to have an increased risk. My school required me to get the shot before I started classes there. What is that saying--"An ounce of prevention is worth a pound of cure" ?
 
Rose Immortal said:
There are other things that lead to a meningitis risk as well...I don't know if anybody else was told this when they went to college, but university students seem to have an increased risk. My school required me to get the shot before I started classes there. What is that saying--"An ounce of prevention is worth a pound of cure" ?
Click to expand...

This is true. I'm hearing, and I contracted meningitis as the age of 18 mos old from a contaminated blood product. Thankfully, I was treated with the proper antibiotics and incurred no ill effects from the infection.

But, back to the CI link to the illness. I would like to add that adults should also be concerned about meningitis; especially if they received an early version of the CI from Advanced Bionics. Those people should be vaccinated accordingly.
 
There's always a risk of anything that's related to your body.
 
Why does the meningitis risk only affect Advanced Biotics but not other brands such as Cochlear? Does anyone know?

R2D2
 
R2D2 said:
Why does the meningitis risk only affect Advanced Biotics but not other brands such as Cochlear? Does anyone know?

R2D2
Click to expand...

Er...the article stated that only Advanced Bionics used the positioner for young implantees for a while there. Apparently, they are connecting the increased risk of meningitis to that. As to why? Who knows and that is something they are trying to ascertain. Possibly the "rubber" positioner could absorb from its surroundings and potentially lead to infection.

However, I do recall some earlier article stating some risks in very young implantees in general. I will have to find that...
 
i thought everyone allready knew about that risk, i knew about it quiet a few years ago and got another shot. (bout 4 years ago).
 
I'm not surprised about this that's why I rather to not take risk on my children until they are oldest enough...
 
Here is another article with a link...

On February 6, 2006 the Center for Disease Control (CDC) published the
results of a follow-up investigation1 to a 2002 report on the relationship
between meningitis and cochlear implants in children. The study included
over 4000 implanted children (the same group of children who were studied in
2002) and evaluated all new reports of bacterial meningitis.
After following these children for two more years, the authors concluded
that the children who received cochlear implants with electrode positioners
remained at a higher risk for meningitis and, importantly, that this
elevated risk continued for as long as 48 months, post-implant.
Specifically, the study found that the incidence of meningitis (occurring 24
months or longer, post-implant) was 450 cases per 100,000 persons years in
children implanted with devices with positioners, compared to no cases in
children implanted with devices without positioners.
Based on this finding, the CDC recommended that parents and health care
providers continue to monitor implanted children for symptoms of meningitis
for up to 48 months post-implant, particularly children with electrode
positioners, and that health care professionals continue to immunize both
current and potential cochlear implant recipients.
The official letter can be found on:

http://www.fda.gov/cdrh/safety/020606-cochlear.html/URL
 
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