One of the reasons I posted yesterday's blog was to reinforce to the Deaf community that hearing and deaf parents of children with cis are aware of the risks involved in implantation. We support each other not only by sharing our experiences, but by discussing controversial information, this is a fundamental part of the Cochlear Implant Community. As I said in the previous post, my purpose for posting was not to create insecurities or brand wars, it was merely to provide information. Fellow bloggers and concerned AB ci wearers left important comments on my blog that I would like to share, because their comments promote awareness, as well, especially regarding the integrity of Advanced Bionics.
Just like Jennifer said, this is a five year old issue and there are NO new issues or concerns. Advanced Bionics is actively participating with the FDA to reach agreement on this issue.
Five years ago, Advanced Bionics issued the voluntary recall on their accord the minute that they noticed the rate with Vendor B component was prone to moisture issues was 1% lower then the Vendor A component. Not all of the Vendor B implants had this problem. Advanced Bionics issued a voluntary recall themselves and followed up with issuing letters to the implantees that received a Vendor B Implant and footed the bill for the re-implantation with a Vendor A implant.
The FDA is just playing catch up.
March 30, 2008 8:43 PM
Jodi, just thought I'd let you know that this fine is directed at something that happened four years ago, not something that's currently going on. AB voluntarily recalled all their defective implants at that particular time and it is just now being addressed. AB and the FDA are on good terms and this is all being worked out. I can send you more information on this if you'd like! :)
I do appreciate your willingness to share information such as this on your blog...but I feel that AB is a good, reliable, sound company and I'm very proud to be associated with it! :)
Jennifer and Abbie are both right - This issue is not new and FDA is just playing catch up like all the other government related stuff. A similar analogy - I have a friend who got a speeding ticket a few years ago, and his insurance didn't increase his rates until a few years later.
Here are the news that was posted in 2004:
AB could have made this situation worse by not notifying all of their clients about the vendor B issue. So, I would say good for AB being honest about their products by voluntarily recalling the products and willing to pay for the re-implantation before FDA had a chance to fine AB.
My issue was not at all with Advanced Bionics, I just want parents to have access to ALL information.
This was what I posted on the CI Circle in response to the news release:
I don't know what to think after reading all of this. First of all,
it really angers me that already parents have spoken up about
these failures, yet when new parents come to the list asking about
experiences and information, we all become delicate and diplomatic
so as not to have implant wars. I can understand the need for
diplomacy, but I at least hope that parents who have had such
experiences email these new parents off-group to give them a heads-
up at least to do more research. It's stressful enough implanting
for the first time, my heart goes out to all of these parents who
have to go through it again because of device failures. This is
really unsettling news, and I am so glad that the FDA has
investigated this. I hope they do fine, so it will serve as a
heads up to all other ci companies to create the best possible
products for OUR kids.
Discussing CI companies is a very delicate issue because for every implant failure, there is a parent who will defend their company until the end because that is how successful the cis are when they work without failure, but we do need to
realize there are failures and apparently more than I even imagined.
I don't know, when I was researching I wanted to know the good and
the bad, the uglier the better so I knew I could make an educated
decision...this is a tough issue for this group. The important thing
is that we support each other, provide relevant information in a
responsible way and try to avoid scaring other parents, who already
have to make such difficult decisions. I'm really sorry to hear
about this situation with Advanced Bionics and I hope they produce
an even stronger product as a result...Jodi
Paula left this comment:
If this issue is 4 or 5 years old, how come we are first hearing about it now? I'm usually very "up" on all the latest news, especially pertaining to cochlear implants and I was not aware of this particular AB recall.
I'm glad it is resolved at this point but I am concerned about the fact that when people are making decisions on implant manufacturers for themselves or their children they are not fully aware of current issues.
This was my point for posting...
PS. Happy Anniversary, Honey!
PSS. I'm outta here, don't know when I'll post again, until then - Be Good!