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.
Abbie said...
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
Jennifer said...
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! :)
Rachel said...
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:
http://www.fda.gov/bbs/topics/news/2004/NEW01119.html
http://www.medicalnewstoday.com/articles/14002.php.html
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!
19 comments:
;-)
:) :)
Interesting to read the blogs and comments.
So it is an old news? I know that there are always a few mechanical errors which force the companies to undergo the recall procedures. My van was recalled to repair one minor problem several years ago and my Dell laptop's battery was recalled and I sent it and got the new battery( the old battery heated up too quickly, increasing the chance of fires.)
Unfortunately, when the models always have mechanical faults and through trials of errors, the models get better... sometimes an unfair advantage over the people who have older models :-(
There are many factors. However, I did not pay much attention to the news about CI's in the early and middle 2000's since I was busy being a mom of two young kids.
This is so typical of our government...happens whenever companies come out with new medication, food labeling, products, autos, etc. We have got to arm ourselves with awareness and knowledge. How?? READ, RESEARCH, READ, ASK QUESTIONS as much as possible. Whether old or new news...we need to know about these things when deciding whether to choose products we put in or on our bodies!!
Thanks Jodi, for bringing up this issue to the forefront for those considering implants. Even if the company recalled and rectified their product, we ought to know.
Don't be gullible and believe everything that FDA, FAA, EPA...et al says, take it with a grain of salt.
Have a great trip Jodi & Jordan!!
Did you know that FDA recently issued cantaloupe recall from Hondura due to salmonella outbreak. sigh....remember to buy produce when in season and locally, if possible. Heck, just grow your own on your patio or in your yard!!
I just had to post this... :*)
Jodi,
I don't think you were part of the CI Circle when this issue first came up, but it was a major topic of conversation on the circle at that time. After the voluntary recall, AB came off the market for a short time to be sure that all of the defective product was fully recalled. They got FDA approval to continue marketing with the non-defective manufacturer. It was scary and disheartening at the time, but we were all well informed at the time.
If you type in "Advanced Bionics recall" in the search in CICircle, and after the results come up, click on "last" and then "previous." You'll find all the discussions that CICircle had in 2004 about the AB recall.
The voluntary recalls shouldn't have happened in the first place. A company of highest integrity would have made sure the rigorous testings of its products to ensure the highest quality of standards are conducted before the products were released to the public.
It didn't. Hence the whopping fine
That is the significance of this case.
It is disturbing to see many people downplaying the significance of the voluntary recalls of devices already implanted in people's bodies and the fine FDA wants to levy. A 2.2 million dollars fine isn't nothing to sneeze at.
If I have a beloved family member, especially a child, that I'll be sending to an operating room for whatever reason, I will make damn sure that the company of the surgical device has the highest safety records. I certainly will not pick a surgical product for which the company had been fined for failing to undergone its mandatory quality control testing. I want the very best for my loved one. If other people don't mind this big minus in the company's history including a steep fine from a regulating agency for producing out inferior surgicial products, that is their pregorative. I don't care if it happened last year or five years ago. Lives of patients were endangered needlessly, with implant failures, second surgeries and possible complications inherent with any surgery. This should never have happened.
What did the Cochlear Americas, Inc. react?
I just am wondering.....They will have to be solicitous and scrutinize with their products.
White Ghost
MishkaZena,
Trust me, we didn't downplay it. It was and is a very disturbing incident, and everyone on the circle felt for those who had to go through the failures. All I was saying, was that the CI Circle did an excellent job of keeping each other informed of what was going on.
Between the positioner situation, and the supplier B situation, AB had a lot of QC questions to answer for.
K.L.
I am aware that the parents are more forthcoming with the other parents in the ci listservs. The downplaying I observed in the blogs yesterday disturbs me, but I am seeing more people acknowledging the seriousness today, which is reassuring.
I am truly sorry for the people with AB implants dealing with this recall, especially with the parents of pediatric c.i. users. There is no doubt in my mind that the parents only want the best for their kids. Having their kids undergo a surgical procedure is a scary experience for the parents.
Now we're talking...
*prerogative* Excuse me for many errors. I am using my hubby's laptop temporarily until I get my new one.
Jodi, many Deaf people do understand that the parents want the best for their deaf kids. That's not the issue.
Elizabeth,
Taking a break from packing to let off some steam, I become a freaking lunatic when I have to prepare to travel for 20 hours. Jordan was like, "Tomorrow morning when it's time to leave, don't grab me and rush me out because I have some things I have to take." Even he knows I'm crazy.
Anyway, I understand the point of what you were saying. I just hope that the attention drawn to mechanical malfunctions forces the companies to pay closer attention to creating the best possible product. We, the parents, are informed as to the risks, and we make the choice anyway. You should read the discussions going on right now on the Circle, you would be blown away by the power of the parents to not only be diplomatic but informative. I am very lucky to have found such a support group, as I am fortunate to have found deafread.com.
Had I not been exposed to the preoccupations of the Deaf community, I would not be as sensitive to such issues, nor would I have ever posted about the fining of AB. Awareness is not only limited to the support groups. Perhaps when the Deaf community realizes that no one is trying to glorify cis, they will begin to see that parents are not trying to "fix" their kids, they're just trying to do the best they can to ensure that their kids have as many opportunities as possible, (with absolutely no intention of insulting or belittling the ASL Deaf experience-it's just a parental prerogative) and yes, we suffer throughout the entire process. We suffer, yet we are convinced that we are doing the best we can for our kids.
Thanks again for your invitation and I look forward to meeting you this summer. I am sure we will not be at a loss for conversation...hugs, Jodi (beyond stressed:))
It is old news. Even I heard about it. One of my SWC friends wears Advanced Bionics. :-)
Hey Kim,
I just wanted to tell you that your comment on the post I wrote about my grandfather really touched me. I believe that when the people we love pass, they are still with us, and your story about your grandma was beautiful. Actually, it's been a really strange period for me and I've been having some bizarre dreams myself. Thanks for posting that...I'm not surprised such a thing happened to you given the sensitive person you are...hugs, Jodi
just found your blog. . .thank you so much for your wisdom and thoughts and honesty. My 8 year old son is in the process of getting a ci, and Jordan's (and your) story has so many parallels to our own, down to the 5 year old drama queen. although mine is nicknamed "Miss Diva." :) thank you again.
From a parent affected by this issue: I am not for or against any company but this is not a five year old issue. I think it would be irresponsible for me not to share my experience. My child unfortunately has had two device failures. The first device was implanted in 2004 and then a second one in 2006. Both failed, both were recalled, both were from supplier B. The 2nd implant failed in 2008. I can't stop wondering why they gave my child an implant from supplier B a second time when they had these prior issues and recall. I'm trying to keep faith in the company that they are improving and this won't happen again.
It is not my intention to discourage anyone from a particular company. I know many people who have a CI from AB and they have not had the issues we have had, they have had great success with their implants and I am very happy for them. I am praying that our days of failure are over and we will finally share in the success that they have had. But I will never be able to not worry about failure again, and every time I hear my child scream I will feel that fear come over me wondering if the device failed again.
Through all of this, I still think the AB CI is the best technology out there and it is such a shame that they selected such a poor supplier and they made some very bad errors in judgment. You are right that this should not have happened to any of us but more importantly, this should not happen in the future!!! I hope the FDA fine will go a long way in assuring the company does not make these same choices again.
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