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Oh god, not more CI deaths.

The FDA has just issued another health warning about cochlear implants and meningitis, following the deaths of TWO MORE deaf kids. This shouldn't be happening!

Children with Cochlear implants are at a higher risk for developing bacterial meningitis, a potentially deadly infection, and must be fully immunized against the disease. That warning came from the Food & Drug Administration (FDA) after it learned that two children with Cochlear implants had recently died from bacterial meningitis...

[SNIP]

...In its latest health alert, the FDA said that two children – ages 9 and 11 – with Cochlear implants had died from bacterial meningitis in the past year. Neither had been fully immunized against the disease, and both had Cochlear implants with positioners.

This isn't the first time this has happened. We vlogged about other cases in February and had a 3-day demo about it back in 2002, when it happened to loads of kids:

doors.jpg

More pics here.

How many deaths over how many years is it going to take before this kind of thing stops?! Their lives are not disposable.

jen

SEE ALSO:
Bacterial Meningitis Kills Two Children with Cochlear Implants, Prompting FDA Warning (newsinferno.com)
CI to blame for death by meningitis
Cochlear Implantation Increases Meningitis Risk

Comments (32)

my god. thanks for the news. i will definitely spread it.

Noni

I would appreciate it if you would provide the primary source of this story.
We do not accept any story without a source. Hope you understand
the excuse.

Jean, of course we don't publish unsubstantiated material - the story is full of links for you to click on (the red bits). Click onto them and you will find our primary sources. One is in the first line, and the other is at the top of the "SEE ALSO" list. Or perhaps you would like me to show you the full website addresses?

Who is "we", by the way? I am interested!

well, how about doing something about the parents for not vaccinating their kids in the first place?? Do not misplace the blame on the CI companies!

It is the surgeon's responsibility to ensure that the cochlear implant candidate be vaccinated first before undergoing the cochlear implant surgery. As well, parents should take measures to ensure their children be immunized prior to their CI surgeries. The two children in question would have lived if they were immunized in the first place. What's more, patients are often given antibotics prior to their major surgery (in general).

Yeah, just who the fuck is "We", Jean? And the excuse for what exactly?

This is not going to be contributed to CIs, but surgery in general since all procedures are risky, no matter how simple or complex.

Jon

But why the need for surgery in the first place? Companies have a responsibility because they market this as sometimes the only solution. Money is also driving these companies forward, and where there's money involved, marketing perhaps knows little boundaries.

"..patients are often given antibotics.."

Oh, right.. Antibiotics will damage the children's immune systems, making their bodies more vulnerable to other risky bacterias introduced into their "clean" bodies! The good bacterias are also killed off, meaning it would not be able to help fend off the bad ones later.

People need to think twice about antibiotics.

FYI-- the cochlear implant with positioner, made in the past by Advanced Bionics, is no longer used with the positioner. It was taken of the market several years ago.

Also, a study this year found that all deaf children, implant or not, are at an increased risk of meningitis. They all need the appropriate vaccinations and vigilance when they are sick, which includes parents being aware of the signs of meningitis and being cautious, etc.

Mother of CI kids

@ mother - would you mind elaborating how ALL deaf children are at an increased risk of meningitis, and what's the rationale? Please could you point us to the research.

Hmm, marketing bullshit fed by CI companies perchance?

I'm not mother of CI kids, but I can answer your question. It is not "marketing bullshit." Malformed cochleas lead to a higher risk of meningitis. Since malformed cochleas, such as in Mondini Syndrome, lead to hearing loss, this is why there is a higher incidence of meningitis among the deaf.

Umm... OK. But what about deafies who DON'T have malformed cochleas? That can't be the case for ALL deaf children, surely?

Parents with kids wearing this type of C.I. should be mandated to have them immunized for meningitis. They should be charged with negligence for failing to do this. This is grossly irresponsible.

FDA: "Children implanted with cochlear implants WITH A POSITIONER are at greater risk. This particular model of cochlear implant iis NO LONGER being manufactured and was WITHDRAWN from the market in July.2002. Also,"These children, ages 9 and 11, had completed ONLY PART of the recommended vaccinations for pneumococcal disease for their age group" Please present all of the facts,not opinions!

Otolaryngol Head Neck Surg. 2007 Mar;136(3):428-33.
Hearing loss diagnosis followed by meningitis in Danish children, 1995-2004.
Parner ET, Reefhuis J, Schendel D, Thomsen JL, Ovesen T, Thorsen P.

You can read the abstract on Pubmed or request a full copy from a medical doctor. It is clearly a study about the incidence of meningitis among the deaf, and clearly shows an increased risk.

In general, I don't know if they sequestered results for those with and without malformed cochleas-- or if they even knew, via a CT scan (a lot of deaf people would not know this without a head CT to check). So no, I don't know how they viewed results. But I do know that in general, they believe that the deaf population is at higher risk of meningitis. That's without cochlear implants.

I only say this to help prevent future meningitis incidents. I know my implanted AND my hearing kids have had all the vaccines they need. There's a new one for adolescents (hearing, too) which my 13 year old got this summer. It's important with summer camp and college in his future.

The incidence as of last winter (of meningitis in implanted patients) worldwide was about 90 cases in 60,000 implantees. AND, this did not sequester out cases which were in the opposite ear, etc. Not all cases would have been caused by the device. It is still only slightly higher than the average population, and is 90 cases-- not 90 deaths.

There are NO reported cases of vaccinated, implanted kids dying. Not only that, but the reported 90 cases above include many who could now be vaccinated.

Mom to CI (and hearing) kids

what the, i have just been ci ed and have and jab , so if this happening why are they nt having a jab for menigitus, a bit of a wooy is nt it?

and why are you tryig to bul crap other families? have you had one? i have friends in the usa and there has been no problems . why scare people with crap ?

Nikki - we aren't trying to "bullcrap" anyone. This info came from the FDA (American Food and Drug Administration). If you click on the red parts in the text (the links), you will see then info we are referring to.

"Mom", thanks for the reference. Interesting. I've Googled but I cannot find a way to get it unless I pay $30... does anyone have a ScienceDirect password!? Found it here: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WP4-4N43PVV-K&_user=10&_coverDate=03%2F31%2F2007&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=2a2363fa3ff82f475243809053710575

Jen,

Here's the abstract, it's the best I can do! I wish I had full text access as well. Sometimes I ask a friend who is a doctor to get full text for me. Otherwise, a university library may carry the journal and you could copy it there.

"OBJECTIVE: A higher risk of meningitis associated with cochlear implants may be explained in part by a generally higher risk of meningitis in children with severe to profound hearing loss. We investigated whether children with hearing loss have an increased risk of meningitis. STUDY DESIGN AND SETTING: A historical cohort study of all children born in Denmark between January 1, 1995, and December 31, 2004, was conducted. The cohort was selected through the Danish Medical Birth Registry, and information on hearing loss and meningitis was obtained from the National Hospital Registry. RESULTS: We identified 39 children with both hearing loss and meningitis. Of these children, five were diagnosed first with hearing loss and later with meningitis. The relative risk of meningitis in the group of children with a hearing loss diagnosis, as compared with the non-hearing loss group, was 5.0 (95% CI, 2.0 to 12.0). CONCLUSIONS: The study provides evidence for an association between hearing loss and the development of meningitis. Parents and health care providers of children with hearing loss should be more alert for possible signs and symptoms of meningitis, and vaccination should be considered."

Hope this helps. It's good to be aware. What will be interesting to see is new data after a few years, when most kids are receiving the appropriate vaccines. I am guessing that the risk will go down to what is approximately that of the general public-- or perhaps, even lower, since parents will be more aware. And, the number of implantees with positioners will not increase, but only go down over the decades as they are replaced with new devices (all CIs eventually need replacing, though usually not for a couple of decades).

Mother

JEN, YOU ARE PROVIDING A VERY DANGEROUS ALERT TO NEW CI PATIENTS, PLEASE REFRAIN FROM YOUR PERSONAL COMMENTS THAT ARE NOT BASED ON FACT. SHAME ON YOU!

@Tom Tino: If I was about to down the CI road, I will want to alerted to the dangers surroundings C implantation. It is called transparency and making a fully informed personal choice. G.O.D. is only higlighting the latest information FDA have released, surrounding CIs, so there is no need to get personal. Personal comments on blogs are just that - take it or leave it.

@ stupid people around here. A CI manufacturer has even admitted re the increased risk.

Red = link, click on it!

"Meningitis, specifically Pneumococcal (bacterial) meningitis, is one of the most serious and life threatening risks for cochlear implant recipients". (Advanced Bionics quote not mine).

Then goes onto say:

"Unfortunately, many cochlear implant recipients do not get vaccinated, leaving them unnecessarily exposed to the potential health risks associated with bacterial meningitis."

It then says that it will provide a FINANCIAL REWARD for parents to get their kids a meningitis vaccination.

"The program provides a financial award to parents or guardians of all children (18 years of age and younger) implanted with Advanced Bionics cochlear implants, to vaccinate their children against Pneumococcal meningitis."

Not sure why people need to be given money to encourage them to stay well, however one thing. Its probably cheaper for the manufacturer to do this, than cope with the adverse publicity that comes with each death, and its not good for future business.

Or do corporations and shareholders suddenly care about something other than their wallet?

I am a little disappointed with some of the rationalisations here and I would like to re-assertain some considerations:
1. One death is one too many because a child can not 'die' from deafness, it is not a life threatening condition - the fact that death can be connected with CI gives me cause to worry no matter what the circumstances are.
2. If the difference could be rectified by a vacination, why were these parents allowed not to vacinate their children?

I am personally aware of a similar death in the UK as recent as last year although I am not aware why (meningitis or otherwise) - it is connected with a recent CI operation. This fact is not made public in the UK and we are not able to receive the facts - only the occasional research papers that may or may not reflect reality.

I congratulate FDA and GOD for publishing this information that seem to be conveniently lost in hospitals and CI centres.

Perhaps there is a need to make a freedom of information act request to DoH to receive some hard facts. Some questions such as:
1. Numbers of CI operations resulting in death within the last 5 years.
2. Numbers of CI operations resulting with side affects in the last 5 years.
3. Number of children/people who have received a CI and no longer using it.
4. Number of children/people who have received a CI and later requested for it to be removed (which is rejected due to increase risk of meningitis infection).
5. Number of CI children/people whose benefit is no better than behind-the-ear hearing aids.
6. Number of CI children/people whose benefit is greater than behind-the-ear hearing aids.

Until these facts are made public, I doubt there will be much trust.

All surgery is a risk of death. That is a reality!

If my child died from an operation for non-life threatening condition where I made the decision as a parent; that would be a very difficult burden to bear.

"All surgery is a risk of death" is just another rationalisation to make something unacceptable, ok.

The decision for a CI implant on a profoundly deaf person
is based on the quality of life for any child or adult.

Not much of a quality of life if you're dead?

'The decision for a CI implant on a profoundly deaf person
is based on the quality of life for any child or adult.'

Profoundly Deaf person who doesn't has CI having the quality of life too like me. Just remember for new CI users, there's always 50-50 for quality of life because it wouldn't benefits ALL new CI users 100%.

Excuse me, but where did you get that 50-50-ratio? Please list your sources! Thank you.

That is just a another way of saying it could go both ways, worse or better after implantation. Ashton is just saying it is not guarantee of improved your hearing but it is known to have improved people's hearing. If it is in your case, good for you.

If you can start providing comments that goes more than 3 lines and supplying quotes and links, I am sure you will find a healthy debate here otherwise they are gonna ignore ya.

I didn't know there was a minimum on replies to the comments at this blog.I find that most comments require only three lines. What debate? All the comments agree with each other.

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