Malfoyish

Hey...

Went to see the implant specialist today - Dr. Hoffman...this is the guy who put the cochlear implant in my right ear. Got a couple of things to say...

First off, he believes that I had bacterial meningitis...it was always in question because when I went into the hospital on Jan 12, I was put on antibiotics right away...even before they did the spinal tap because they suspected meningitis based on the symptoms I had...stiff neck, vomiting, dizziness, the works...so because antibiotics were administered right away, they never were really able to tell whether it was viral or bacterial...but most cochlear implant recipients who contract meningitis come down with the bacterial type because of the positioner (more about that in a sec) in the ear...so...he believes this was the case with me too. Not to mention the company that manufactures the implant (Advanced Bionics) had sent me some paper work to fill out, permission slips authorizing them to research my meningitis case, ya know, I guess so they can "perfect" their implants...Get this too...the model I currently have inside of my ear is a model that they recently RECALLED...and I was NEVER notified by the company as to this fact and never told WHY it was recalled...so that pisses me off a little too.

But anyway. Now about the positioner. The implant I have has two pieces...the electrodes, which is wrapped within the cochlear...and then the positioner, which is a piece of plastic that "holds" the electrodes in. This piece is now not necessary...so they are not using them anymore. What Dr. Hoffman thinks happened was...the positioner being fastened into the ear created a platform or a "pocket" of some kind, which allowed the bacteria to fester there...and then eventually travel up to the brain, causing the meningitis. So...now he wants to remove the positioner that I have inside...which means that I will be going under the knife again, tentatively on March 29th.

I'm not really looking forward to it...but the good news is - this is a simple procedure...not like the implantation itself. I will be in and out of the hospital in a day, going under general anesthesia, and then the recovery shouldn't be too bad. The incision won't be as big as the one they needed to do for the implant...and ah...yes, there are some risks here too. Dr. Hoffman said that during his removal of the positioner, the electrodes may come out...he said that if this is the case, he will put them back in. There's also a possibility that they'll break too...in which case, he'll be prepared to put a whole new implant in...which I hope won't happen because then it becomes the same operation all over again.

I hope this fills you in on the details. Can we just skip 2004 and go to 2005? :/ I'm not likin' this year one bit!!!

Let me know if you have any questions.

Malfoyish

Deafness

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Deaf258

You gonna file a malpractice lawsuit?

Malfoyish

My family's considering it. I don't know. Too many headaches!!!!

Cheri

When U had the Ci did u have any problems at the begin or just later? Sorry for the Dumb Question... Im curious.

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Malfoyish

Nope, no problems up til now. It's been a bad year, I guess...

Malfoyish

Cheri

Awww Sorry to Hear that.. I hope everything Will go Smooth and Well for you... Keep us Post.. *Hugs*

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Cheri

And.. Youre in my prayers....

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Angel

Hi Malfoyish,

I'm really sorry to hear what you're going thru with you CI .....I think I somehow know what you're feeling about this whole thing....I can only image what you're going thru in all of this.....I know its frustrated and etc.....

I do have a question to ask you ....In your opinion, would you agree on having a baby or a small child to get CI...afterall you are experience of what it's like to have a CI....And U also did said it was no problem when you first got your CI but then you have problems a year later....

I would love to hear your opinion on this .....

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Angel

Oh one more thing I forgot to add...Do you feel it would be better if a baby or child shall wear hearing aids instead of CI....So they wouldnt have somewhat of what you're going thru yourself?....

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"When we do the best we can, we never know what miracle is brought in our life, OR in the life of another." ~ Helen Keller

Malfoyish

Hi,

Well, I'll be honest with you...I saw a 1-year-old baby in the doctor's office yesterday...the baby was implanted...the scar was fresh and I could see that it's pretty recently that he got the implant. I didn't like that at all...for one, I do know that the recovery is very, VERY difficult. That's in no way fit for a baby that young to be going through. In some respects, it's good to do it early, this way the baby has a nice chance at learning language quicker, having as much of a normal life as he possibly can, but still...it's kind of...too much to put on a little one...I wouldn't do it. Personally, I'd wait until the child was a few years older...a toddler, even, and explain the procedure, see how the child felt about it. Toddler-age children might not be completely knowledgeable on it, but still, they might be able to say whether or not they want more out of their hearing...hearing aids worked for me for 23 years so i had no real desire to have the implant until I was a parent myself. My kids are all hearing, so I don't have any big choices like this to make unless it's for myself. So...ehhhh....No, I think kids should be a little older, preferably 7-8 years old before they get implanted...there's a lot of training involved, and a baby just deserves to be a baby!!!!!!

Malfoyish

Angel

Thank you so much for being honest with me Malfoyish...I appreciate that!...I agree with you on everything you had said.....

U know when I asked my hearing sister what she felt about CI...And how would she feel if she did that to her own children if they were deaf...She was honest and told me that she would do anything to make her children hear....if CI is a way of making her children hear more than regualar hearing aids she would get a CI for her child....She did admit that she wouldn't wait until the child is few years older to understand the procedure, see how the child felt about it...She wants what best for her children by being able to hear, speak, and develop into a better education and etc....So, I do understand where she is coming from on that which I do agree on that but however my only fear is what a child would feel after getting CI And he/she was NO part of that decision of getting a CI OR what if she/he no longer wear them or have problems later on the furture those are the fears I have about putting CI on babies or small children who are unable to have a choice in this....When I was 5 years old I have my first hearing aid , I was able to hear , talk and read lips and hearing amazing sounds ....I have never known about CI Until I grew up...But, my hearing aid did alot of help through out the years.....

So, I feel the same way as you 100% that I think children should be a little older, 7-8 years old before they get implanted....and Yes, I agree a baby deserves to be a baby!....

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deafdyke

Malfoyish...I totally agree with you! I think in cases where the benifit of implantation is ambigous, that kids should be a little older. There's nothing wrong with implanting kids with auditory nereopathy or kids who don't really get all that much benifit from hearing aids but when kids are being implanted who get a LOT of benifit from aids....that's just messed up.
Ah, yes....that is why I am against oralism in genral....it involves extensive, exhausting training and hyperinvolved parents...and kids deserve to just be kids for crying out loud!
However, the CI doesn't cause this...most parents are dedicated to oralism no matter WHAT!

Malfoyish

Yep...And my mother was one of those PITA parents who refused to allow me to learn to sign when I was growing up. She was scared that my signing would throw off the "intensive speech therapy" I was receiving. I didn't have many deaf friends because of this...and I didn't fit in the hearing world, either...so you know, that's pretty tough...not knowing where you stand sometimes. I do have good speech now, and I did learn to sign when I was in college...which makes me feel a little bit better...

...but who can give me back those years where I was around my deaf peers? I must have come off as stuck up or nasty because I couldn't communicate with them so I didn't try. I basically huddled off in corners by myself...so yeah, there's quite a bit of hostility within me aimed at my mother.

Honest mistake, maybe, but not one I'd make with my own kids...if they want to learn to sign, fine. If they want to become nudists, fine...I just don't want to see that.

Malfoyish.

deafdyke

Exactly...oralism gives a dhh kid some access to the hearing world....but it doesn't give them 100% access to the hearing world and it NEVER has.

Boult

malfoyish,

I was aware of the risk of meningitis before FDA reported it. and when I researched on CI, I was on AB (Clarion)'s mailing list as well as other maker's too.. I got mine last June 2003 and AB emailed this out to all clarion CI users and if you were on AB's mailing list: you would have gotten this as well... will paste it at bottom.

My Surgeon Dr. was aware of it. before I got it, i wanted the one with positioner because I knew it will give superb quality but AB took it off the market. NO it was not mandatory recall (meaning have to replace) It was a voluntary recall. NO one who is implanted with positioner are forced to have it replaced. It was just YOUR doctor's decision to have it replace to resolve your illness.

To be honest, I feel sad that you have to go thru this. just wondering, if you have had a meningitis as result of your deafness in the past way before you got your cochlear implant? According to the FDA report( http://www.fda.gov/cdrh/safety/cochlear.html ) that most deaf child and adult may be predisposed to this meningitis before or after. So it is really hard to place blame on the positioner alone. I do have a friend who has same device as you have and implanted two years ago. she does not have meningitis but did receive meningitis vaccine as soon as she was informed of this such happening.

before my surgery date, my Dr. said I would get a vaccine. so far to my knowledge, I do not know if I got it or not. but I believe I may have gotten the vaccine at start of surgery. And I was treated with antibiotic prescription post-op.

This url is where you can sign up to get on their mailing list so you can be aware of what's happening and their future developments.: http://www.bionicear.com/support/teamclarion.html
and
http://www.bionicear.com/support/bea.html


Ok here's the email I got from AB as I promised.... I got it on same day and I posted it in my forum same day.
++++++++

Bionic Bulletin Announcement July 31, 2003

Update on Bacterial Meningitis

Advanced Bionics® is committed to providing up-to-date and accurate information to our users. Approximately one year ago, reports first emerged about the potential risk of bacterial meningitis for cochlear implant users. Even though the evidence was unclear, it was suggested that the electrode Positioner might be an additional risk factor for contracting meningitis.

RISK FACTORS FOR MENINGITIS

Meningitis is a bacterial infection and is a common cause of deafness. It can be a complication of otitis media and other clinical conditions commonly found in deafness, and can recur. The risk can be associated with surgery and/or implantation of a foreign device where there is a higher chance of infection from bacteria causing meningitis. In addition to general surgical risk, other risk factors contributing to meningitis in cochlear implant users include:

- Young age (highest risk for those under the age of six)
- History of otitis media
- Cochlear malformations
- Previous meningitis
- Middle ear inflammation at time of surgery
- Ventriculoperitoneal shunt
- Cerebrospinal Fluid Leak
- Use of a Positioner
- Exposure to smoking in the household

ADVANCED BIONICS TOOK DECISIVE ACTION

In July 2002, we voluntarily took a number of immediate steps to address the possible risk of meningitis in cochlear implant users, including:

- Discontinued distribution of the Clarion with Positioner until more data became available
- Sent letters to cochlear implant users, surgeons and audiologists to:
--- Alert them to the potential risk of meningitis
--- Recommend that users and candidates consult their healthcare providers about vaccinations against the common causes of bacterial meningitis
--- Educate them on the signs and symptoms of the disease and urge that they seek immediate treatment if symptoms appear
--- Recommend immediate and aggressive treatment of otitis media in any user
--- Solicit information on any cases of bacterial meningitis that may have occurred in a user of our cochlear implant systems

PREVENTION, SYMPTOMS, AND RECOMMENDATIONS

The best prevention of meningitis includes vaccination and education. Vaccination records should be reviewed by your healthcare provider to ensure that they are current, and appropriate vaccinations should be obtained if needed. Cochlear implant users should also become educated to recognize the signs and symptoms to ensure early detection, which is vital to successful treatment. Signs of meningitis include stiff neck, high fever, nausea or vomiting, discomfort looking into bright lights, sleepiness or confusion, decrease in appetite, and otitis media. Immediate treatment should be obtained for any of these symptoms. Finally, antibiotic treatment before and after cochlear implant surgery, may also reduce the risk of contracting meningitis. For more information, please talk to your healthcare provider.

NEW DATA SHEDS LIGHT ON MENINGITIS RISK

In an effort to investigate the potential risk of bacterial meningitis for cochlear implant users, the U.S. Centers for Disease Control and Prevention (C.D.C.) and the U.S. Food and Drug Administration (F.D.A.) began a large epidemiological study of bacterial meningitis among children who had received cochlear implants in the U.S. before the age of six. Young children are known to be at the highest risk of contracting meningitis in the general population. The study was not designed to determine whether the risk of contracting meningitis is higher in children with cochlear implants than in deaf children without cochlear implants. The study showed that:

1) Of the 4,264 study participants, 26 children were identified with bacterial meningitis (16 with a Positioner and 10 without).
2) Post-implantation bacterial meningitis is associated with a variety of risk factors.
3) The use of a Clarion with Positioner was also associated with a greater risk of contracting post-implantation bacterial meningitis.

Advanced Bionics voluntarily removed the Clarion with Positioner from the market in July 2002 when speculation first arose. We also reviewed our worldwide database of children under the age of six, through June 2003. Our data demonstrate that the risk associated with the Positioner dramatically decreases over time. Majority of the cases occurred within one year. No cases of meningitis have been identified after two years. Moreover, all of the Clarion children with Positioners have been implanted for more than one year, and over 60% have been implanted longer than two years. Meningitis can still occur at all ages as a complication of known clinical factors such as a previous episode of meningitis, cochlear malformation, history of otitis media, cerebrospinal fluid leak, other surgeries, etc. Our data show that the risk associated with the Positioner for the implanted pediatric population is lessening dramatically with the passage of time.

CONCLUSION AND RECOMMENDATIONS FOR USERS

In conclusion, the risk of meningitis as it occurs in the cochlear implant population can be appropriately mitigated with proper education, treatment and vaccination. Our company took prudent action one year ago, and our recommendations from that time, which the CDC and the FDA have now affirmed, still stand. All cochlear implant users should:

- Consult their healthcare providers about vaccinations against the common causes of bacterial meningitis.
- Seek immediate and aggressive treatment of otitis media.
- Become educated on the signs and symptoms of the disease.

Advanced Bionics endorses the CDC?s recommendations for all cochlear implant users, which are consistent with the recommendations we have made to clinicians and consumers since July 2002. We will also continue to provide up-to-date information on our website and through our e-newsletter.

We are committed to our cochlear implant users and hope that this information is useful. Please feel free to contact Advanced Bionics if you have additional questions.

Best Regards,

Advanced Bionics

Advanced Bionics Corporation
Mann Biomedical Park
25129 Rye Canyon Loop
Valencia, CA 91355 USA
Phone: (+1) 661-362-1400 Fax: (+1) 661-362-1500
Phone: (+1) 800-678-2575 TDD: (+1) 800-678-3575
Email: info@advancedbionics.com
www.bionicear.com

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Malfoyish

Hey Boult..

Thanks for the info!!! I did have a meningitis vaccination...but ahh, a lot of good that did me!!! I'm wondering whether they gave me a shot for something other than meningitis...but who knows...I came down with it and I'm quite lucky to be alive...so I'm just happy for that much.

What chafes me though, is....I did not know a THING about the meningitis risk until AFTER I had the surgery...and then when the model implant I have been using was recalled, I was not notified. If they had said something and I was stupid enough to ignore it, then it would be a different story...but no one said a word...so...I don't know what to think here.

Not sure what will happen, but I'll keep you guys posted.

Thanks for the info, Boult. I think I've seen this somewhere...I've been doing a bit of looking around myself.

Malfoyish

Boult

You are welcome...

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WBHarley

Malfoyish..

your doctor "suggest" to have it replaced instead of say "recall" ? because I checked with AB where I got mine too, as I knew there was no recall for it because I would have done it if it was. Altho I did got the letter as she explained it more clearly.

So I hope this were very clear.. and here's what she had gave to me.


Just a though to let you know, and to be clearly for OTHER people too!

Wendy

Malfoyish

Hi, Wendy!

The doctor wanted to remove the positioner, but it was the audiologist who suggested replacing the AB model I have in my ear with a Nucleus, which may give me better sound quality. The doctor's goal is to reduce the meningitis risk as much as he possibly can...The audiologist figured that since the doctor was going in anyway, he might as well re-implant.

Thanks for the info. HUGS!

Malfoyish

Ziusudra

Hmm, the meningitis risk is one reason I chose not to have a CI when I went for an assessment a few years ago. Also the minimal risk of nerve damage. It's way too much hassle for me right now.