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

[D-neen]

There's no if's or but's... CI is still at risks no matters what. Be a Deaf person is better that's who I am. There's no debate about it.

 

[R2D2]

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.

As a CI user, I would say that the CI has enhanced my quality of life so much that I would certainly compare it to the value obtained from driving a car. You might not, but lots of deaf people do. When I lost my hearing, I suffered depression for the very first time in my life for which I obtained counselling from a psychologist. Saying that getting a CI is an elective choice is very theoretical to me as an individual because the reality of the other alternative would have been to have completely changed my lifestyle and replace my friendship base. With a CI I can both keep my lifestyle and have access to a new one as well if that was my preference.

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.

I agree, but who are the people denying that there are surgical risks with getting a CI? There are people in this thread saying that it's "dangerous" to have a CI, do you feel that this is an accurate word to use?

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.

Yes, and it was an AB CI user who posted the information regarding this first off.

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.

I certainly agree that individuals need to make an informed choice. However, again I am uncertain of where the denial of access to the information is occuring since the information was first posted amd made available by a CI user?

 

[Pinky]

There's no if's or but's... CI is still at risks no matters what. Be a Deaf person is better that's who I am. There's no debate about it.

Did you read what R2D2 Said?? CI's surgery is little risk. It will get better. I don't like people who are paranoid about CI dangerous. :roll: Why you are buying the person's story about removed the CI?? The year was in 1996. This is OLD! Today is new technology to reduce the RISK. I suggest you to watch CI ASL youtube vlog. I agree with her 100% It's same with my feeling. I am still get a CI in future. That's my decide! I am same as R2D2's feeling. I was so depress being deaf in my whole life. I need to find a happy and be confidence about myself to get CI and Vision surgery too.

 

[R2D2]

Jillio,

I just want to make it clear that I was not actually comparing the actual weighted risks getting a CI to car usage in my first post but was making the point that people make uninformed choices about the dangers of car driving because they car drive all the time and every time they hop behind the wheel it does not even occur that a bad accident might happen to them (myself included). So they operate in a false sense of security.

I think we've gone a bit OT, but my point is that there is a relative perception of danger depending on the viewpoint of the individual. For example, people who are opposed to vaccination for children are more likely to believe that it's "very risky" compared to someone who has a neutral viewpoint.

I don't feel that people actually logically go around applying weights to their risky behaviour depending on whether it's critical to their daily living or elective or not. I think that people mislead and deceive themselves and often think that something that is relatively dangerous won't happen to them but when something comes along that they feel strongly about the perceived danger becomes bigger in their eyes.

That was my point. I hope this makes sense. I do realise that not every deaf person would apply the same weight as me to the ability to hear.

 

[sequoias]

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.

Yes I am aware everything out there is dangerous also. We don't live in a harmony world. :P

 

[sequoias]

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



.

Weather is dangerous also. We live on Danger Planet.

 

[jillio]

As a CI user, I would say that the CI has enhanced my quality of life so much that I would certainly compare it to the value obtained from driving a car. You might not, but lots of deaf people do. When I lost my hearing, I suffered depression for the very first time in my life for which I obtained counselling from a psychologist. Saying that getting a CI is an elective choice is very theoretical to me as an individual because the reality of the other alternative would have been to have completely changed my lifestyle and replace my friendship base. With a CI I can both keep my lifestyle and have access to a new one as well if that was my preference.

Ah, but now you are comparing the benefits, not the risks. That is quite different. Once is a subjective comparison, the other is objective. Subjectivley, you can compare your CI to whatever you choose in terms of benefit and you'll get no argument from me.
I agree, but who are the people denying that there are surgical risks with getting a CI? There are people in this thread saying that it's "dangerous" to have a CI, do you feel that this is an accurate word to use?

I counted several posts that attempted to discount the validity of the information.

No, I don't agree that it is "dangerous to have a CI" . Perhaps better wording would be that there is a danger of developing post surgical complications.


Yes, and it was an AB CI user who posted the information regarding this first off.

And that was a very ethical step to take.


I certainly agree that individuals need to make an informed choice. However, again I am uncertain of where the denial of access to the information is occuring since the information was first posted amd made available by a CI user?

The only thing that would be more ethical is if the CI manufacturers and the physicians were supplying this information, as well.

We have had several posts regarding the fact that there are those who maintain that they were not informed of possible complications, nor were they given an accurate portrayal of reasonable expectations from the referring physican or the implant center. And while it may not be actual restriction of information, to claim that an issue such as manufacturer negligence doesn't matter, is misleading.

 

[jillio]

Jillio,

I just want to make it clear that I was not actually comparing the actual weighted risks getting a CI to car usage in my first post but was making the point that people make uninformed choices about the dangers of car driving because they car drive all the time and every time they hop behind the wheel it does not even occur that a bad accident might happen to them (myself included). So they operate in a false sense of security.

I think we've gone a bit OT, but my point is that there is a relative perception of danger depending on the viewpoint of the individual. For example, people who are opposed to vaccination for children are more likely to believe that it's "very risky" compared to someone who has a neutral viewpoint.

I don't feel that people actually logically go around applying weights to their risky behaviour depending on whether it's critical to their daily living or elective or not. I think that people mislead and deceive themselves and often think that something that is relatively dangerous won't happen to them but when something comes along that they feel strongly about the perceived danger becomes bigger in their eyes.

That was my point. I hope this makes sense. I do realise that not every deaf person would apply the same weight as me to the ability to hear.

I replied to your other post before I saw this one. I will agree that the perception of the negative effects of a risk or danger is indeed subjective, or weighted according to one's situation. And, no, most do not consider risk or danger when going about one's daily living. We would all become incapacitated and unable to function if we were to do that, LOL!

Right. For you, the importance of hearing is high. That is what I meant when I said that expected benefit is of a subjective nature. What I meant by risk being objective is that it can be determined mathematically.

As always, R2D2, nice discussing the issues with you.

 

[jazzy]

 

[Gigabyte]

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

Excuse Me, but I have to disagree, many people have died because of deafness, or have you forgotten about the tragic death of Miss Teen Texas a few years ago, she was struck and killed by a train because she was Deaf and could not hear the train or the warning whistle! I do not have statistics, but every year there are several reports of deaf persons dieing (or being seriously injured) because they were not alerted to danger around them such as fire alarms, oncoming cars etc, so don't say deafness can't be fatal, it can easily be the major factor in death or serious injury.

 

[MomToDeafChild]

What's wrong with hearing aids?

Being deaf is not a disease.

Surgeon smell $$$ to implant CI.

FYI...

Straight from my daughter's $17,053 surgeon's bill for her implant in June, $14,554 was billed for 'surgery' and $2,499 was billed for 'lab pathology'. Of the $17,053 bill that came out of the surgeon's office, our insurance paid $2,219.

There's not exactly a ton of money to be had by doing implants. After paying the staff in the doctor's office and all the overhead, what's actually left for the doctor? It's ridiculous to think he doesn't even get $2,000 for something that requires such skill...

 

[jillio]

Excuse Me, but I have to disagree, many people have died because of deafness, or have you forgotten about the tragic death of Miss Teen Texas a few years ago, she was struck and killed by a train because she was Deaf and could not hear the train or the warning whistle! I do not have statistics, but every year there are several reports of deaf persons dieing (or being seriously injured) because they were not alerted to danger around them such as fire alarms, oncoming cars etc, so don't say deafness can't be fatal, it can easily be the major factor in death or serious injury.

No, I have not forgotten. And there was a bit more going on there than deafness. Like bad judgement for walking on a railroad track. That would hold true for deaf or hearing. It is dangerous to walk on a railroad track, period. Likewise, I know of no deaf individual that would not feel the tremendous vibration of an approaching train. Ever consider suicide? It is all to easy to claim this was an accident caused by her lack of hearing.

In the town where I live, a woman was killed last week by a train under the same circumstances. She was hearing. Did her hearing kill her?

Deafness is not fatal. Miss Teen Texas did not die because she was deaf. She died because she was walking on a railroad track. Perhaps it would have been better if someone had taught her the dangers of such an action. I amcertainly not worried that my son will be killed by a train because he is deaf. I taught him not to walk on railroad tracks.

 

[R2D2]

I have to agree - I'm not aware of any statistics that say that deaf people are more likely to be killed as a result of not being able to hear. I think that they learn to be more visual.

However, I have noticed that safety assessment is less hard work when one can hear. I was more hypervigilent when I lost my hearing e.g. walking on the street I would have to check, check and check before I crossed the road. It helps to be able to hear a car coming. It's also good to know that if I forget to turn on the baby's monitor that I can hear a baby crying etc.

 

[R2D2]

As always, R2D2, nice discussing the issues with you.

And you! I'm still not sure what the posts you are referring to that say there are no risks. I had interpreted the "old news" remarks to mean that it was a thread repost and am not even sure if those were the ones you had in mind. However, I sense you are reluctant to single out specific posters and respect that.

Have we been entertaining enough for you? LOL!

 

[shel90]

No, I have not forgotten. And there was a bit more going on there than deafness. Like bad judgement for walking on a railroad track. That would hold true for deaf or hearing. It is dangerous to walk on a railroad track, period. Likewise, I know of no deaf individual that would not feel the tremendous vibration of an approaching train. Ever consider suicide? It is all to easy to claim this was an accident caused by her lack of hearing.

In the town where I live, a woman was killed last week by a train under the same circumstances. She was hearing. Did her hearing kill her?

Deafness is not fatal. Miss Teen Texas did not die because she was deaf. She died because she was walking on a railroad track. Perhaps it would have been better if someone had taught her the dangers of such an action. I amcertainly not worried that my son will be killed by a train because he is deaf. I taught him not to walk on railroad tracks.

Let's say that Miss Texas died from lack of common sense. Sounds harsh but if she wasnt commiting suicide, that there was some serious lack of common sense going on. Same thing goes for those hearing people who do the same.

 

[jillio]

Let's say that Miss Texas died from lack of common sense. Sounds harsh but if she wasnt commiting suicide, that there was some serious lack of common sense going on. Same thing goes for those hearing people who do the same.

Yep. My point exactly.

 

[SouthFella]

Advanced Bionics as of today STILL have NOT respond to the FDA fine.. And it have been over a month , almost 2 months now since the FDA made the annoucement . So no it is not old news.. It is one of the MAIN reason's I did not chose Advanced Bionics for my CI 3 weeks ago.. It made my wifey very uncomfortable that the company didnt come out with a satisifactory explanation nor response.. Oh Well AB bites the dust in the PR dept... It is very important for companies to follow the FDA guidelines for the sake of the public's health... My hat's off to FDA for a job well done..

 

[GarnetTigerMom]

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 that really sound stupid by the director to say that to you of a deaf person status. I think the director need to get hit by a bus! ha

 

[GarnetTigerMom]

No, I have not forgotten. And there was a bit more going on there than deafness. Like bad judgement for walking on a railroad track. That would hold true for deaf or hearing. It is dangerous to walk on a railroad track, period. Likewise, I know of no deaf individual that would not feel the tremendous vibration of an approaching train. Ever consider suicide? It is all to easy to claim this was an accident caused by her lack of hearing.

In the town where I live, a woman was killed last week by a train under the same circumstances. She was hearing. Did her hearing kill her?

Deafness is not fatal. Miss Teen Texas did not die because she was deaf. She died because she was walking on a railroad track. Perhaps it would have been better if someone had taught her the dangers of such an action. I amcertainly not worried that my son will be killed by a train because he is deaf. I taught him not to walk on railroad tracks.

I have to agree with Jilo on this one and it was a bad judgment walking on rail road tracks. I think miss teen Texas knew the train was coming because you can strongly feel the vibrations to feel that powerful force. I think she was pretty suicidal and she must have been very despress person.

 

[Boult]

Advanced Bionics as of today STILL have NOT respond to the FDA fine.. And it have been over a month , almost 2 months now since the FDA made the annoucement . So no it is not old news.. It is one of the MAIN reason's I did not chose Advanced Bionics for my CI 3 weeks ago.. It made my wifey very uncomfortable that the company didnt come out with a satisifactory explanation nor response.. Oh Well AB bites the dust in the PR dept... It is very important for companies to follow the FDA guidelines for the sake of the public's health... My hat's off to FDA for a job well done..

Tsk on jumping to conclusion...

I posted the response by AB in other thread...
http://www.alldeaf.com/hearing-aids...689-fda-seeks-fine-ab-2-2-mil.html#post952238

also see my post #13 on this thread (page 1)