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

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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!!!

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

 

[jillio]

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.

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]

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

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.

 

[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]

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.

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]

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.



.

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]

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.

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.


.

 

[IcedTeaRulz]

What's wrong with hearing aids?

Being deaf is not a disease.

Surgeon smell $$$ to implant CI.

 

[rick48]

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.



.

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.

 

[Pinky]

I agree with you. I know you're wear a CI. You're experience with it. Why the deaf people removed the CI due to headache?? It not making sense to me. My friend is from in my hometown. He is wearing his CI. When it was his first time to have a CI. In few month later. He got a headache by CI. He got re-surgery to adjust his implant. It's headache reduce. He is better from headache. He is doing fine so far. He is happy to hear anything like you do.

My cousin has 2 CI. His first CI wasn't work in 1 year later. This is old CI. He got re-surgery for free and get a new CI. It's helping him to hear better.

I agree with you about children toys recall. It's very dangerous than CI. The people are silly about this situation. You're right about deaf people do not good at English Grammar and Roots Word. That's why I want to learn a sound when I get CI. IT will help me recognize the word in my brain. You can imagine about deaf people whom anti-CI. They are so paranoid!

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.



.

 

[shel90]

All surgerys carry risks and varying degrees of dangers whether it is a minor out-patient surgery or in-patient surgery.

My aunt died from surgery that was so routine and so minor. In fact, it was an out-patient surgery.

Again, the anti-deaf crowd is trying to brush off those few who suffered.

 

[shel90]

I agree with you. I know you're wear a CI. You're experience with it. Why the deaf people removed the CI due to headache?? It not making sense to me. My friend is from in my hometown. He is wearing his CI. When it was his first time to have a CI. In few month later. He got a headache by CI. He got re-surgery to adjust his implant. It's headache reduce. He is better from headache. He is doing fine so far. He is happy to hear anything like you do.

My cousin has 2 CI. His first CI wasn't work in 1 year later. This is old CI. He got re-surgery for free and get a new CI. It's helping him to hear better.

I agree with you about children toys recall. It's very dangerous than CI. The people are silly about this situation. You're right about deaf people do not good at English Grammar and Roots Word. That's why I want to learn a sound when I get CI. IT will help me recognize the word in my brain. You can imagine about deaf people whom anti-CI. They are so paranoid![/QUOTE]

They are entitled to their feelings. It is a free country.

 

[R2D2]

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.

I think it's more about perspective. Sure, there's a risk in obtaining a CI (which we CI users are informed about by our surgeons) but then there is a risk with most activities. Car driving is a really good example. Sometimes it feels like the risks of getting a CI is being emphasized way above perspective e.g. "ooh ooh having a CI is sooo dangerous" and yet the same people making those comments probably hop into cars all the time without a second thought. It's just not balanced and we CI users can see that such perspectives about the relative risk and danger of CIs appear to co-relate with broader personal feelings about CIs, whether negative, skeptical and so on.

It would be like as if someone made a post saying how dangerous it was to be deaf because of the inability to hear. Sure, it's something that has to be considered and personal strategies employed which most deaf people do successfully but when someone goes on about it then you can see they have it out of perspective due to having a general negative viewpoint of deafness.

 

[rick48]

I think it's more about perspective. Sure, there's a risk in obtaining a CI (which we CI users are informed about by our surgeons) but then there is a risk with most activities. Car driving is a really good example. Sometimes it feels like the risks of getting a CI is being emphasized way above perspective e.g. "ooh ooh having a CI is sooo dangerous" and yet the same people making those comments probably hop into cars all the time without a second thought. It's just not balanced and we CI users can see that such perspectives about the relative risk and danger of CIs appear to co-relate with broader personal feelings about CIs, whether negative, skeptical and so on.

It would be like as if someone made a post saying how dangerous it was to be deaf because of the inability to hear. Sure, it's something that has to be considered and personal strategies employed which most deaf people do successfully but when someone goes on about it then you can see they have it out of perspective due to having a general negative viewpoint of deafness.

Agree.

The mere fact that there is a risk associated with a surgery does not equate to elevating that surgery to a dangerous status. Likewise, stating the fact that the cochlear implant surgery is not dangerous is not denying the existence of the risks associated with the surgery.
Rick

 

[jillio]

I think it's more about perspective. Sure, there's a risk in obtaining a CI (which we CI users are informed about by our surgeons) but then there is a risk with most activities. Car driving is a really good example. Sometimes it feels like the risks of getting a CI is being emphasized way above perspective e.g. "ooh ooh having a CI is sooo dangerous" and yet the same people making those comments probably hop into cars all the time without a second thought. It's just not balanced and we CI users can see that such perspectives about the relative risk and danger of CIs appear to co-relate with broader personal feelings about CIs, whether negative, skeptical and so on.

It would be like as if someone made a post saying how dangerous it was to be deaf because of the inability to hear. Sure, it's something that has to be considered and personal strategies employed which most deaf people do successfully but when someone goes on about it then you can see they have it out of perspective due to having a general negative viewpoint of deafness.

I agree that it is a matter of perspective. But the habit of comparing the sugery to other activities that are necessary to to life, such as traveling back and forth to work, is fallicious, and it is an attempt to divert the issue of choice. One does not have much of a choice regarding travel to necessary activities. Whether one walks to work and the market, and doctor's appointments, and all of the other activiites that are necessary in our daily existence, or rides a bicycle, or takes some form of public trasportation, there is a degree of risk in that activity. However, one must engage in these activities to sustain their lifestyle, or become an agoraphobic, which is decidely a negative alternative. There are some risks which are inherent in simply being alive. There are others that are accepted by choice. Choosing to undergo an elective surgery is a decision in which the risks are accepted by choice. It is not a mandatory activity in which all must engage, such as traveling to and from work or going to the market to purchase food.

If we are going to reasonably discuss the risks involved, then cases of less than acceptable outcomes are important in that discussion. They are a part of the whole picture. If one cares to compare the risks of CI surgery to another form of elective surgery, it would be a more reasonable comparison, simply because of the nature of the surgeries. But to make statements such as "More children die of household accidents" is simply incorrect comparison, and it is very misleading statistically.

I agree that each individual has the right to consider these risks and benefits, and to analyze for themself what the trade off is for them, and if they are willing to accept the possible risks in order to reap the possible benefits. But in order to do so, and to have made a truly informed decision, a realistic portrayal of risks is necessary, as well as a realistic portrayl of benefits. To deny the negative side is to prevent others from actually weighing the pros and cons and making an informed decision. Likewise, to deny the benefits possible is also misleading. I am suggesting that both pros and cons be presented realistically, and that both good outcomes, and less than good outcomes all be a part of the discussion in order to present a realistic picture. For instance, the inforamtion regarding the FDA's actions against Advance Bionics has been discounted by some as being old news, and unimportant. Yes, it is "old news" to an extent. However, it is information that should be available to all. The individual can decide for themselves how much weight they give the inforamtion, and how important it is to them in the decision making process. But we cannot deny them access to the information, simply because it disputes one particular viewpopint. The access to all pertinent information is the issue. The decision of how to consider that information is an individual choice, just as freedom to choose to be implanted is a matter of individual choice.

 

[Cheri]

It would be like as if someone made a post saying how dangerous it was to be deaf because of the inability to hear .

I've been told that before by a director at co-op Preschool, she wouldn't allow my son enrolled unless there's a hearing person that could come in and help, that's where parents are teachers, she did not want a deaf parent because having a deaf parent around young kids can be dangerous, so she says.

 

[jillio]

I've been told that before by a director at co-op Preschool, she wouldn't allow my son enrolled unless there's a hearing person that could come in and help, that's where parents are teachers, she did not want a deaf parent because having a deaf parent around young kids can be dangerous, so she says.

Now, she is just silly!

 

[D-neen]

Any surgery can be dangerous so is CI. There's no dangerous worse than CI. CI can be at risks for anybody. There's no if's about it. Once any deaf person who have CI .. that person will always be a deaf person. You can go to the website and listen what a guy explaining to you . Go to www.icthusdeafies.com or just typing it ICTHUS DEAFIES. He is a very good explaination.

 

[shel90]

I've been told that before by a director at co-op Preschool, she wouldn't allow my son enrolled unless there's a hearing person that could come in and help, that's where parents are teachers, she did not want a deaf parent because having a deaf parent around young kids can be dangerous, so she says.

That's awful and discrimination big time! I hope that director has learned more about deafness since then.