FDA Seeks $2.2 Mln Fine Against Advanced Bionics
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it wants to fine Advanced Bionics LLC, a maker of cochlear implant hearing aids, $2.2 million for alleged manufacturing violations that put patients at risk.
The FDA accused Advanced Bionics of failing to follow manufacturing standards to ensure the safety and quality of the hearing aids.
The company allegedly failed to sufficiently evaluate and select a new vendor to supply a critical component, and failed to properly test hearing aids containing the unapproved vendor's component, the FDA said in a statement.
"The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss," the FDA said in a statement.
The FDA said it filed a complaint against Advanced Bionics and its co-chief executive officer, Jeffrey Greiner, last November and amended it on March 17. The company is based in Sylmar, California.
A company spokesman was not immediately available for comment.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a hearing aid surgically implanted under the skin behind the ear, to treat profound hearing loss in adults and children.
The hearing aid is considered a Class III device by the FDA, the most stringent regulatory category for medical devices.
(Reporting by Julie Vorman; Editing by Brian Moss)
(Note: "hearing aid" is cochlear implant) This article was posted on the Pediatric Cochlear Implant Circle and I felt the need to blog about it as a parent of a child with a cochlear implant. You need to know that in general, parents do not speak about ci companies, because obviously everyone thinks theirs is the best and people would just get into brand wars. The Circle is strictly about providing support regarding pediatric issues, therapy, communication methods and your basic kid life experiences. However, here, promoting awareness is not only about glorifying the ci experience, it's about providing relevant information for any and all parents reading my blog. One of the members of the CI Circle wrote the following response to this article:
I am going to chime in here and just tell what I am feeling after hearing
this news. When I first read this on here I was relieved and angry at the
same time. I have had two AB failures and this last one has not been
reimplanted yet because of fighting with insurance and the doctors to
reimplant it. I now feel like because the FDA has finally done something I
might be able to finally get reimplanted after waiting for a year and a
half. I have had many problems with my AB implants since being implanted and
hope that others do not experience the same things. I know that there are
people out there who are very happy with their AB implants and I hope that
you never have to deal with the setbacks that come from poor manufacturing
that results in failures. Hopefully as a result of this I will be able to
get reimplanted with a device that is not AB (which is what we have been
fighting for for the last year and a half).
When I contacted this person requesting permission to blog her response, she sent me this email:
Hi Jodi,
It has been a long and frustrating journey and I am hopeful to get it resolved soon. I am lucky to have had the opportunity to try one of the new hearing aids made my Starkey in my unimplanted ear which is giving me more benefit then any hearing aid ever has. However, it is still not enough to compare with the hearing that I was able to get with a functioning cochlear implant.
I would be more then happy to allow you to blog about my experiences. I also feel like you do. The more people I can help through my experiences the better. Yes, for me it has been such a struggle but I am a young adult who is able to lip read and communicate, it hurts me so much to hear and know that this is happening to children who can often not explain how it feels or what it sounds like.
Hearing parents of deaf children who are currently researching brands for implantation need to be informed. Thankfully, the FDA exists and is apparently doing their job to ensure that the newest generation of cochlear implants are effective and safer for our kids.
31 comments:
Thanks, Jodi, for posting this. I think the more we talk openly and frankly about the implants and the companies (or heck, anything related to raising deaf/hard of hearing kids), the more informed we are.
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! :)
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.
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.
Hi Jodi, thanks for bringing this up -- I haven't being very good about keeping up with my CI listservs lately.
We came across this incident (the fine is for a specific situation that occurred in 2004 and was in the papers quite a bit) when we were researching CI products, and the people we spoke with at AB were very open about it with us. Our surgeon was of two minds about the company: on one hand, he felt that AB was now going above and beyond in its approach to monitoring its vendors' quality standards because of what had happened, but on the other, he couldn't deny the difference in success rates, and the impact that these failures (few, yes, but they exist) had on the overall rates. When it came down to it, he admitted that safety was his number one concern, and so that weighed heavily in his mind.
I have to admit that despite AB's successful efforts to improve its standards, its openness in discovering issues, reporting them and voluntarily recalling/replacing products, this incident was the primary reason we went with another company for the little one's first CI.
But, as we consider going bilateral, I've been so convinced that AB has eliminated situations such as the one described and for which they are being fined, that we're looking at products from both Cochlear Americas and Advanced Bionics, equally. I'm pretty disturbed to find that the recipient you quote has had difficulty getting reimplanted after 2 (!) failures.
I'd better check out the CI Circle to see if it's an issue with AB or insurance or the hospital -- was a bit confused about what's causing the delay in reimplantation. Let us know if you know any more.
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
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.
One of the link wasn't copied correctly -
http://www.fda.gov/bbs/topics/news/2004/NEW01119.html
I was made aware of this when I was going through the candidacy process. This is a link to the 2004 FDA press release of the voluntary recall that AB did. Here is is link
It is interesting that our government is just now "playing catch up" with stuff like this. A couple weeks ago it was Southwest Airlines getting slammed by a 10 million dollar fine by the FCC. I had to review the FDA press releases and I found that they fined Iowa Dairy for illegal drug residues found in cows in August of 2007 when the first case happened in 1992! Is anyone working over there or are they all asleep?
ugh! For some reasons the Blogger is still not posting my link right! Just make sure you put "html" at the end of the link.
Hi everyone,
I will post a response to and including many of your comments...the point of the post was to create awareness, not slam companies that are helping so many people. Making the ci choice is very difficult and I searched for all information, anything I can find, so I'll post your comments and comment on YOUR comments as soon as I get home. Freaking out with a million things to do before we leave tomorrow..hugs, Jodi
PS. Jenn- good to see you *smile*
Have a good trip to Maryland.
Thanks, Lisa! *smile*
Advanced Bionics has posted a statement on their website
http://www.bionicear.com/news_details.cfm?id=25&langid=1
I had my first AB implant done on the right in August of 2005. It worked great for a few months, then I started "hearing" loud popping, sounds like paper crinkling and the power cutting in and out. The device was failing. In December 2006 I had my left implant done an the right was a hit and miss. From the moment of activation the right didn't work right. A few electrodes were shorted out. I ended up having a bilateral revision done in March of 2007. The results, the right failed due to moisture and the left due to electrodes shorting out. Both AB products, made by two different manufacturers. I am the first bilateral failure the clinic I went to has ever seen. Not to mention a bilateral failure for two entirely differnt reasons. The implants I have now are stll AB. Franly I didn't want to use AB again, but my insurance wouldn't cover the other. As a result of the revision surgeries I lost what little natural hearing I had left. The blogger that said AB and the FDA are working this out...yep they sure are the FDA filed a 2.2 million dollar law suit. Sadly, the highest amount they could ask for. My opinion. AB got greedy and cut corners. At the expense of the very people they were suposed to provide a service to. They never even notified the FDA that they were using Vendor B, as Vendor B had not been approved by the FDA. If you want interesting reaading read the actual warning letter the FDA sent to AB and the lawsuit filed by AB. They can be read at http://www.pretiflaherty.com/mediacenter/news/items/2008_03_26_209.asp
I have never posted on a blog, but after reading some of the comments I was moved to do so.
Those who are saying that the whole AB fine is directed at something in the past are completely mistaken. It started in 2002 and AB continued to ship devices without the proper testing manufactured by a non FDA manufacturer until 2006. The prrof is in the FDA lawsuit filed recently. Again take the time to read all the information. AB didn't even notify the providers they had shipped the defective implants to...again do the reading. The FDA letter to AB spells it out as does their lawsuit. I can guarantee we will all be reading about private lawsuits being filed.
As a AB receipient it's said to say I can't recommend their product. I know what I've been through and am continuing to go through as a result of their poor QA/QI programs. While I certainly don't wish what I'm going through on anyone, I wish it had happened BEFORE I made my original decision on which company to go with. It certainly would NOT have been AB.
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