Kalista

FDA sues Advanced Bionics Cochlear Implant maker for 2.2 million in fines for manufacturing violations

Netsignnews.com - FDA sues Advanced Bionics Cochlear Implant maker for 2.2 million in fines for manufacturing violations

Posted By robert

May 02, 2008: 06:19 PM
hihow can i sue cochlea implant? i had ci in 1996 and i was very sick . i lost my balance and i now have balance disorder, lost half taste sense, double vision, pass out loss of wage at work and i do get ear infection that never go away always swollen then fine back and forth. i had ci in 1996 then remove in 1999 after remove ci i improve my health but i still get sick many time i did tried to sue but lawyer say cant sue and i dont understand but i still need help robert

Posted By Susan

May 02, 2008: 03:54 PM
Most parents "should not" force their childrens to have CI while children don't want it. They need to respect theri children wish. What is wrong with hearing aid is better until children grow up teenage if they wants it is up to them not parents control over deaf child body. I am still against to put baby ci it is not good because how can baby communicate with parents if baby had bad headaches or very high pitch sound who know can cause death..

Posted By Susan

May 02, 2008: 03:54 PM
Most parents "should not" force their childrens to have CI while children don't want it. They need to respect theri children wish. What is wrong with hearing aid is better until children grow up teenage if they wants it is up to them not parents control over deaf child body. I am still against to put baby ci it is not good because how can baby communicate with parents if baby had bad headaches or very high pitch sound who know can cause death..

Posted By j

Apr 30, 2008: 11:23 PM
My daughter, based on many decisions and a ;ot of prayer, has a ci. She speaks and signs very well. She loves books and being able to work with others. But, I am displeased with the ci system mostly because the company did not explain certain risks such as static electriciy from going down a slide or a minor ear infection that could cause major internal problems. That's dangerous and very scary. As a parent, I am very cautious about my daughter's health. She Loves her ci, but I give her choice to choose to wear it or not. It is her choice and she knows it. SHe is only 2 1/2.

Posted By Pam

Apr 29, 2008: 11:20 PM
That makes me angry that they are doing to babies and children. Babies cannot commuincate when it hurts. I strongly disagreed to have CI to children. Wait until they are old enough to understand the risks and decide for themselves not parents!!!

Deafness

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dreamchaser

From what I have read, I have to agree with you.

This main reason that CI makers and augiologists give for early implantation is that it takes time to learn to understand the sound that they are hearing.

On the other hand, it is proven that learning sign is easier for a baby that to learn speech. They learn speech 6 months earlier than speech if they are hearint to begin with. They have also proven that children, hearing or deaf, learn English and literacy skills faster and better if they have a foundation in sign language first..

I don't want to stop people from getting CI if it is their choice and they are willing to deal with the problems and pain and risks, but I don't think that we should be doing it to babies, and there is no age limit at all, because an audiologist can petition the FDA on a case to case basis to get them to waive the 12 month limit. Where will it end? I don't think that they can really asses the hearing loss in that age group, and it could be other problems that stop a child from responding to sound other than deafness. Will they be automatically doing implants as soon as they suspect a hearing loss? The younger they can give an implant, the more money they will make... CIs can be good for some people,, thank God,,, and I am happy for every successful one. But, it is getting scarey now...

Pinky

It say get a CI in 1996?? This is OLD! Today is NEW technology. I am not against on CI people. I have to respect their choice. I know parents suppose not force babies to get CI without use sign language or wear hearing aids. I am waiting for everyone to post comment my question in other thread about "My view on Sign language/Non sign language with CI" Not much posts. I need everyone to answer my question about how I feeling.

Kalista

Deaf Child with Implant in ICU, Fighting for His Life�For your eye wide-open...Wednesday, March 26, 2008Deaf Child with Implant in ICU, Fighting for His Life On Easter Sunday of 2008, a Deaf child was fighting for his life in the
intensive care unit at a hospital. One month ago his mother rushed him to the
emergency room after she discovered that his ear was bleeding. The doctors
quickly unwrapped the makeshift bandaging and discovered that there was a
cochlear implant in his left ear. One of the doctors discovered a clot in his
ear. He is now blind in his left eye and colorblind in his right eye. He will
never again see the color of the landscapes of this world. He's stuck with
needing to have gauze pads covering his eyes, otherwise he will throw up every time he opens his eyes. He can't walk. He has completely lost his ability to balance himself. And he is still experiencing intermittent bleeding in his ear. Internal bleeding in the brain is a dangerous possibility. His mother has a cochlear implant, but her implant is broken and she hasn't used it for many years. The boy's grandmother insisted that his mother get him implanted. The boy himself put pressure on his mother, claiming that it supposedly wasn't fair that other children were being implanted but that he wasn't. The grandmother's rationale was that CI technology has improved and that it will keep improving. Then mother then made the unfortunate decision to go ahead with the operation. Because of that decision, he is now in the ICU fighting for his life, and he may not live to see the world. It breaks my heart.When I was younger we didn't have to worry about whether or not we would die or become physically damaged. But today, we have to worry about which one of our children will be next to fall into the pit of physical and emotional despair, with their future being destroyed and taken away from them. How could we ignore the fact that the risk involved in cochlear implant surgery is unacceptably high? A certain percentage of children will experience life-altering and severe complications, and this is supposed to be acceptable?

It is not first time this has happened in my experience, and it will not be the last time that I will see such a thing. There will be more tragic incidents to come. I will not allow these children who are injured by CI surgery to be made invisible and be pushed the side where no one will think about them. If we do not do something to raise awareness on this issue, then the very real possibility exists that these institutions will be taken over in the future by the many ex-CI users to come whose bodies were damaged by the implantation surgery.

Is there anyone out there who wants to tell me to just forget about these
beautiful Deaf children whose health was ruined by either CI surgery or the
post-surgical effects?

I respect people who dedicate themselves and volunteer their time to make sure that Deaf babies have access to sign language. I support that 100 percent. They have a laudable passionate for ASL. And it should also be OK for others of us to dedicate our time to making sure the babies and children are kept absolutely SAFE and not subjected to RISK when they don't have to be! Right now, cochlear implants are not safe--not safe for all infants or children. Some are lucky and escape harm, others are not. The FDA should not approve anything that involves such a degree of random chance that it
puts infants and children at risk. The main thing is that the children be
protected from harm and be kept healthy. Healthy children still might encounter challenging issues in their lives, and that's OK, but we should not subject them to risk of this type.

posted by Aidan Mack at Wednesday, March 26, 2008
LINK: DEAF CINEMATIC FILMBLOG: Deaf Child with Implant in ICU, Fighting for His Life

vallee

Ms. Mack has not updated anything on this child. Because she refuses to post anything else I don't know what to believe. She also does not post all comments and monitors them.

Also the AB case is five years old and settled. It is really old news.

I have AB and knew about the recall before I had surgery. I am not worried.

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Right and Left Implanted July 19, 2007
Activated August 9, 2007
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jillio

An update will not change the fact that this child experienced severe complications.

shel90

Read this...


.


May 4, 2008
Reasons for CIs before 12 months…



Cochlear implant candidacy in the United States: Prevalence in children 12 months to 6 years of age.

Bradham T, Jones J.
Vanderbilt University, Hearing and Speech Sciences, Medical Center East, South Tower, 1215 21st Avenue South, Rm 6209, Nashville, TN 37232-8718, United States.


OBJECTIVE: Pediatric cochlear implantation has been demonstrated to be effective for children as well as cost effective for society. One of Healthy People 2010 goals is to increase the number of people who are deaf or significantly hard of hearing to begin to use a cochlear implant system. NIDCDs Healthy Hearing Progress Reports from 1999 reported that only 2 out of every 1000 adults who are deaf or hard of hearing received a cochlear implant. There were two main objectives for this study: (1) to estimate the number of children between the ages of 12 months and 6 years of age with severe to profound bilateral hearing loss who could benefit from a cochlear implant and (2) to determine if the number of children projected to be candidates received this medical care.

METHODS: Using the 2000 US Census Data from children 12 months to 6 years, the number of children with severe to profound bilateral hearing loss was calculated. Children who would be considered “neurologically devastated” and the children with absent eighth nerves were excluded from the calculations.

RESULTS: Based on the total population of slightly over 231 million, 15,219 children presented with severe to profound hearing loss. Taking into account some exclusions, 12,816 children would be considered cochlear implant candidates. Based on the number of children who were implanted in 2000, approximately 55% of the projected number of candidates received a cochlear implant.

CONCLUSION: Even though the estimates do not reflect a direct measure of actual candidates in the targeted age groups, the population who could benefit from this technology is still being significantly underserved in the United States. With a continued shortage of qualified personnel to serve these children, insufficient reimbursement rates, and disparities in implantation rates based on ethnicity and socioeconomic status, the question remains can we truly meet the needs of these children?


See the red font? I think that just makes me sick...this kind of view is ****ed up. Cost effective to society? What if I implant my baby just to save society a few measly dollars and my baby has complications from the surgery (yes it CAN happen!)? Is that worth it? Maybe one baby to society is nothing but to me or my family, it would mean the world. This article makes me SICK!

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jillio

Yep, that cost effectiveness to society argument always makes me want to scream! Where the hell are our priorties?

shel90

It is all about greed and money...this is why I dont trust the medical community. Their views are just wayyy too pathological.

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jillio

**nodding** No one has ever died from deafness, nor has sign language use ever proven to be fatal.

Freaky Cat

not if there are complications and child could end up blind and cant smell or taste .. then it will be cost effective to the society. sheesh. i dont think child should be implanted iwth ci as young as 12 months old. i believe they should make their own decisions later on when they are more older. if they want one then fine with me.. i dont want to force ci on them.

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sequoias

I don't believe in Ci, period. See how dangerous CI is?

Boult

Yes, I agree, it's OLD news! It is just that FDA is catching up and trying to collect the $...


There's a thread on this topic... It's silly to rehash this old news...
FDA seeks to fine AB 2.2 mil

see my posts in this thread;
FDA seeks to fine AB 2.2 mil

Why does the title of this topic contain the word "sues" ? There's no lawsuit and FDA is not suing A.B. FDA is merely fining A.B. for $2.2mil. for a case from 5 yrs ago. that's it.

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vallee

The point is there is not information that this child is even real! That the complications are even real. Don't draw an opinion from a blog. It is not the news. (Even though the news does a terrible job with implants) It would be updated daily with info.

__________________
Right and Left Implanted July 19, 2007
Activated August 9, 2007
Both Advanced Bionics Harmony

vallee

I can agree. The bottom line is it is all about money - education, medical, credit, life.

As an adult I did not feel the push for greed and money. I'm not sure about children. The posting on the blog, I'm not sure I agree with it. You have to remember I am going through changes. While I am very strong in my belief that it is the family's rights, I don't believe the push should be for "saving money" or "educational choices." I just wish there was a middle ground. My opinion is until the educational system, all education, then there will be more and more implants by 12 months.

__________________
Right and Left Implanted July 19, 2007
Activated August 9, 2007
Both Advanced Bionics Harmony

Liebling:-)))

*shake my head sigh sadly after read article where Shel90 provided here*

Why should we have unnecassary surgery for when we knew there're risk and have better techology for HA here?

That's why I beleive in support/respect child's choice.

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Cheri

Everything in life is dangerous if not cautious, even when you get behind the wheels of the car, when you step a foot outside your house, cooked food can be dangerous and so much more.

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jillio

I think sequoias' point is that you don't have to have a CI. You do have to go outside your house, eat food, and travel to some extent (such as back and forth to work) in order to survive. In one you have a choice. In the other you don't.

TechBill

There are more childern dead in home by household items per year than there are by CI. See how dangerous your own home is?



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jillio

There are more children exposed to household items than children with CI. Of course the number would be higher. Its proportional. All children live in homes where cleaning supplies, etc. are in the home. Only deaf children receive CI, and not even all deaf children are implanted. There are also probably more children injured on bicycles, or skateboards, or dog bites, as well, and for the same reason. That has nothing to do with the issue.

GarnetTigerMom

Form what I read they are not talking all CI that are dangerous they are talking about one speific C.I. called " Advanced Bionics Cochlear Implant " makers. So not all CI are bad. But that news is a bit old. Anything we do is dangerous in a crazy world. Smile

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GarnetTigerMom

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I'm so glad that you're my friend.
I know our friendship will never end."
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jillio

There is no information that this child is not real, either.

CI supporters use blog posts to support their claims of tremendous successes all the time. You see those links all over this forum. So it is okay to use a blog post to support successes, but not okay to use a blog post to inform about complications and unsuccessful occurrances? That's rather hypocritical, isn't it?

Cheri

Yep, I agree and children's toys are on recall due to choking hazards and lead paint.

People find ways to say CI is dangerous, when life itself is a dangerous road, that's why life is full of risks.

While I don't agree with children implant without their decision, but I can't do anything if other parents make that choice for their own children.

__________________
Avoid being a victim of a stroke, a stroke can happen to anyone at anytime. You will never know how devastating this could be until you had live through it. It affects everybody. So Support Stroke Awareness to find a cure and hope.

HorseRace

yup life aways has thing to risk... oh well deal with it..
but about this topic.. rme it is all about money that goes to thier profit..
nothing new in this country..

they want us money , not us.. that all

TechBill

It have everything to do with the issue if someone is going to come here and post "CI is dangerous?" on a deaf commuity board full knowing that high percent of deaf people are not well versed in english grammer languages is going to fall for this statement.

CI is not dangerous and if CI was dangerous then CI would had never been approved by the FDA for human uses and the other countries like Canada or England or Germany etc would not have even approve it either for human uses either.

And as for this topic AB being sued if you had researched that AB put their trust in a manfacturer to manfacture the implant that wasn't on FDA approved list to being with. I totally agree that AB should be fined for this even if the manfacturer may had lied to AB saying that they are on FDA approved list because AB should have taken the responiblty to research it beforehand and signing a contract to have them manfactured an medicial device.

But companies are being fined everyday by FDA or EGA and even Meat Inpection for releasing a product that are at high risk to human being in the first place.

At least I feel safe knowing the government is on the look out for me and fining those companies for their greedy mistakes even it may be a slap on the hand but at least their reputaition will be tarished in some way.



.

jillio

Try telling people who have lost a child to meningitis after implantation, or those who suffer from facial paralysis, or a myriad of othe complications that it isn't dangerous. It can be, and is dangerous for some.

A slap on the hand isn't much consolation to those that have already experienced the negative consequences of a company's negligence.

The only misleading statement was your statement that more children are dead from hosuehold products. To compare ALL children and household accidents to a smaller population of implanted children and negative side effects is misleading. It implies that the household accidents are more frequent, when it is just a higher proportion.

To state that CI is not dangerous, in light of the fact that there are risks associated with the surgery, and that complications can and do occur is also misleading. People need to know all of the truth in order to make informed decisions. To hide the negatives from them is dishonest.

TechBill

Nobody is hiding negatives about the CI. Doctor must warn the risk and negitive and you also see them everywhere - internet book dvds tv shows.

But to take the negatives and twist it around to use it to campaign againist CI is dishonest IMO.


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IcedTeaRulz

What's wrong with hearing aids?

Being deaf is not a disease.

Surgeon smell $$$ to implant CI.

rick48

TechBill,

You are so right.

The cochlear implant surgery is not dangerous. This is the scare tactic used ad infinitum by the anti-ci crowd. It is a false argument. The fact that the FDA and dozens of other countries around the world have approved the procedure, demonstrates that fact. In fact, a friend of mine whose son is implanted and who is himself an anesthesiologist (sp), told me it is not a complicated surgical procedure.

To maintain that cochlear implant surgery is dangerous by ignoring its nearly quarter of a century track record, all the while focusing on one or two isolated and hand-picked examples, is just additional evidence of an individual's anti-ci bias.

The good news is that since the number of individuals getting implants for either themselves or for their children continues to increase every year, it is evident that they are not falling for these scare tactics but instead listenting to the explanations of possible risks by their cochlear implant surgeon and then making an informed and reasoned decision.
Rick

jillio

To maintain that there are no risks, and that complications do not happen in spite of the evidence to the contrary is to, quite simply, be in denial. To attempt to hide that from others is dishonest.