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

Oceanbreeze said:
My best friend contracted meningitis due to AB's model having a positioner. It trapped fluid and she got infected. It nearly killed her, so I digress when you say that people weren't harmed. People were. My friend was.
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People need to realize that each person who got harmed are individuals not just numbers.
 
oh my god now i dont know what to do!! My 14 month old is scheduled for a surgery on jan 5..and he will get advanced bionics.. Well I have to say my 3 yr old daughter has advanced bionics and they think theres something wrong with her implant ..but they were the "risks" they told us before she got it..but now i dont know what to do. He's scheduled for an MRI tomorrow and on the 5th he would get his surgery.. Personally I wouldnt do the surgery I would wait till he gets older and he can make that decision himself but my husband doesnt agree ..he says that he will resent us because his sister got one but he didnt.. i dont know.. does anyone have any advice?
 
*ROSIE said:
oh my god now i dont know what to do!! My 14 month old is scheduled for a surgery on jan 5..and he will get advanced bionics.. Well I have to say my 3 yr old daughter has advanced bionics and they think theres something wrong with her implant ..but they were the "risks" they told us before she got it..but now i dont know what to do. He's scheduled for an MRI tomorrow and on the 5th he would get his surgery.. Personally I wouldnt do the surgery I would wait till he gets older and he can make that decision himself but my husband doesnt agree ..he says that he will resent us because his sister got one but he didnt.. i dont know.. does anyone have any advice?
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AB has supposedly fixed the problems they were having with their implants. What kind of problems is your daughter having?
 
*ROSIE said:
oh my god now i dont know what to do!! My 14 month old is scheduled for a surgery on jan 5..and he will get advanced bionics.. Well I have to say my 3 yr old daughter has advanced bionics and they think theres something wrong with her implant ..but they were the "risks" they told us before she got it..but now i dont know what to do. He's scheduled for an MRI tomorrow and on the 5th he would get his surgery.. Personally I wouldnt do the surgery I would wait till he gets older and he can make that decision himself but my husband doesnt agree ..he says that he will resent us because his sister got one but he didnt.. i dont know.. does anyone have any advice?
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Rosie,

The issues regarding the AB device that are the subject of this thread are old and have been resolved.

The best advice I can give you right now is for you to get yourself over to the ci circle forum which is comprised mostly of other parents of ci kids and is a great source for information and support.

I know from your other posts that your duaghter has not made much progress with her ci and that they suspect there may be some problems with it. Can you provide some more information and some specifics as it would be helpful in offering advice?

for example, was your daughter born deaf? Are you and/or your husband hearing? In the year and a half since your daughter has had the ci, what are her oral skills/langauge development? Why does your implant center suspect that there may be a problem with the internal device? Have they tested it to determine that?

I know its a lot of questions but it helps to focus on what may be an issue and what may not. Good luck and get over to the ci circle!
Rick
 
rick48 said:
Rosie,

The issues regarding the AB device that are the subject of this thread are old and have been resolved.

The best advice I can give you right now is for you to get yourself over to the ci circle forum which is comprised mostly of other parents of ci kids and is a great source for information and support.

I know from your other posts that your duaghter has not made much progress with her ci and that they suspect there may be some problems with it. Can you provide some more information and some specifics as it would be helpful in offering advice?

for example, was your daughter born deaf? Are you and/or your husband hearing? In the year and a half since your daughter has had the ci, what are her oral skills/langauge development? Why does your implant center suspect that there may be a problem with the internal device? Have they tested it to determine that?

I know its a lot of questions but it helps to focus on what may be an issue and what may not. Good luck and get over to the ci circle!
Rick
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your right..it just got my attention the topic they were talking about here. And yes my daughter was born deaf and there's no hoh or deaf people in my family but there's only one in my husbands side but hes not deaf either. I also have a son that was born deaf so all this is new to me and that's why i try to get a lot of information and try to learn. And the implant center think there's a problem with her implant because she didnt learn how to speak..she doesnt know much sign language only like less than 10 signs , she got her implant at 1 1/2 yrs and they told us to stop signing. Well thanks rick for your reply.
 
*ROSIE said:
your right..it just got my attention the topic they were talking about here. And yes my daughter was born deaf and there's no hoh or deaf people in my family but there's only one in my husbands side but hes not deaf either. I also have a son that was born deaf so all this is new to me and that's why i try to get a lot of information and try to learn. And the implant center think there's a problem with her implant because she didnt learn how to speak..she doesnt know much sign language only like less than 10 signs , she got her implant at 1 1/2 yrs and they told us to stop signing. Well thanks rick for your reply.
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I think that's a shame that the doctors told you to stop signing with your daughter. So many other deaf children with CIs suffered from the same garbage and because of that, they are struggling with literacy skills. I am so glad you came to this site and asked for help. Most parents do not seek out the Deaf community for help until it is too late. Any questions you have, feel free to ask since I am a teacher for the deaf. hang in there!
 
shel90 said:
I think that's a shame that the doctors told you to stop signing with your daughter. So many other deaf children with CIs suffered from the same garbage and because of that, they are struggling with literacy skills. I am so glad you came to this site and asked for help. Most parents do not seek out the Deaf community for help until it is too late. Any questions you have, feel free to ask since I am a teacher for the deaf. hang in there!
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Ditto!
 
and the stupid hippa law states that doctors shouldnt be able to disclose information on who might have gotten hurt.
 
seriously this stuff is crazy.

I hope one day you guys find out how many people get hurt undergoing the CI operation.. The numbers will be shocking.
 
posts from hell said:
seriously this stuff is crazy.

I hope one day you guys find out how many people get hurt undergoing the CI operation.. The numbers will be shocking.
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No more shocking than any other surgery. Any operation comes with risks. CI surgery is no different. S__t happens, people are human and it just comes with the territory.
 
etalton said:
No more shocking than any other surgery. Any operation comes with risks. CI surgery is no different. S__t happens, people are human and it just comes with the territory.
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exactly. a rib surgery isnt as bad as a CI surgery.

I know people have died from a knee surgery.

But the fact still stands: CI probably has more issues than most of other surgeries
 
posts from hell said:
But the fact still stands: CI probably has more issues than most of other surgeries
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not really. ci surgery is considered one of the safest outpatient surgeries there is -- especially given the fact that it only takes 2-3 hours to complete.
 
*ROSIE said:
your right..it just got my attention the topic they were talking about here. And yes my daughter was born deaf and there's no hoh or deaf people in my family but there's only one in my husbands side but hes not deaf either. I also have a son that was born deaf so all this is new to me and that's why i try to get a lot of information and try to learn. And the implant center think there's a problem with her implant because she didnt learn how to speak..she doesnt know much sign language only like less than 10 signs , she got her implant at 1 1/2 yrs and they told us to stop signing. Well thanks rick for your reply.
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Rosie,

Merry Christmas!

The advice Hear Again gave you on another thread about having an intergrity test performed on your daughter's ci, is very good advice and should be done before there is any further talk about surgery for a re-implant.

As for therapy, exactly how much speech and language therapy is your daughter presently getting and what does it typically involve? I will tell you as the parent of a ci child, implanted in 1989, re-implanted in 2001 and who will graduate college this spring and who knows hundreds of other ci families and thier children, that while S&L therapy is very important, most important of all is what you and your husband do at home with both your children.

If developing oral skills is important for your children then the advice I would give you is to take the lessons learned at S&L therapy as a starting point and then re-inforce them at home on a daily basis. Talk, talk, talk and then read, read, read to your children.

And remember that this does not have to be at the expense of your children developing signing skills as well.
Good luck,
Rick
 
posts from hell said:
and the stupid hippa law states that doctors shouldnt be able to disclose information on who might have gotten hurt.
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Hippa laws don't prevent disclosing the numbers, just the names. Hippa is a confidentiality law to prevent an individual's medical history being released without their permission. That doesn't mean the details of a case can't be released as long as the patient is not specifically identified.
 
jillio said:
Hippa laws don't prevent disclosing the numbers, just the names. Hippa is a confidentiality law to prevent an individual's medical history being released without their permission. That doesn't mean the details of a case can't be released as long as the patient is not specifically identified.
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exactly.

in fact, the fda website lists examples of specific cases where ci recipients have been affected by damaged ci's.
 
rick48 said:
Rosie,

Merry Christmas!

The advice Hear Again gave you on another thread about having an intergrity test performed on your daughter's ci, is very good advice and should be done before there is any further talk about surgery for a re-implant.

As for therapy, exactly how much speech and language therapy is your daughter presently getting and what does it typically involve? I will tell you as the parent of a ci child, implanted in 1989, re-implanted in 2001 and who will graduate college this spring and who knows hundreds of other ci families and thier children, that while S&L therapy is very important, most important of all is what you and your husband do at home with both your children.

If developing oral skills is important for your children then the advice I would give you is to take the lessons learned at S&L therapy as a starting point and then re-inforce them at home on a daily basis. Talk, talk, talk and then read, read, read to your children.

And remember that this does not have to be at the expense of your children developing signing skills as well.
Good luck,
Rick
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well rick my daughter was recieving auditory verbal therapy once a week for 1 hr. and we would do lessons daily with her. Besides that a teacher would come 4 times a week. and all we did was talk talk talk to her because like i said before we never signed to her. By the way , what does s&l mean? I'm sorry it might be a dumb question. So that's why we decided that signing was the thing for her since having no communication was driving me crazy.
 
*ROSIE said:
well rick my daughter was recieving auditory verbal therapy once a week for 1 hr. and we would do lessons daily with her. Besides that a teacher would come 4 times a week. and all we did was talk talk talk to her because like i said before we never signed to her. By the way , what does s&l mean? I'm sorry it might be a dumb question. So that's why we decided that signing was the thing for her since having no communication was driving me crazy.
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It doesnt have to be either signing or speaking only...u can do both (not at the same time since both languages are different) but like establish a strong first language using ASL and then build a 2nd language using English in whatever form your child can master. The most important thing here is the first language and if she isnt picking up spoken English, do use ASL so that way she can develop conceptual understanding of her world and be ready to develop literacy skills when she goes to school. Hope that helps!
 
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