FDA: One C.I. Corporation Endangering Deaf People
FDA seeks $2.2 million fine against Advanced Bionics
The U.S. Food and Drug Administration said on Friday it wants to fine 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. For the full article, FDA seeks $2.2 mln fine against Advanced Bionics | U.S. | Reuters
Commentary: Kudos to FDA for catching the corporation’s failure to practice the quality controls. My regret is that the fine isn’t higher for skipping the rigorous check ups mandatory for the high-quality surgical products. The company are gambling on the physical, mental, and psychological welfare of the deaf people, including the children and infants. The incentive to save money is probably the reason for the shortcuts. So what’s news about corporation greed? Shame on Advanced Bionics! MZ
P.S. Jodi has a great coverage on this article in her blog An American Mom in Tuscany: Jordan’s Cochlear Implant Story . Included is one member’s negative experiences with the AB. Check it out at http://rallycapsdotnet.blogspot.com/2008/03/fda-seeks-to-fine-cochlear-implant.html
email contact: mishkazena@aol.com
FDA seeks $2.2 million fine against Advanced Bionics
The U.S. Food and Drug Administration said on Friday it wants to fine 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. For the full article, FDA seeks $2.2 mln fine against Advanced Bionics | U.S. | Reuters
Commentary: Kudos to FDA for catching the corporation’s failure to practice the quality controls. My regret is that the fine isn’t higher for skipping the rigorous check ups mandatory for the high-quality surgical products. The company are gambling on the physical, mental, and psychological welfare of the deaf people, including the children and infants. The incentive to save money is probably the reason for the shortcuts. So what’s news about corporation greed? Shame on Advanced Bionics! MZ
P.S. Jodi has a great coverage on this article in her blog An American Mom in Tuscany: Jordan’s Cochlear Implant Story . Included is one member’s negative experiences with the AB. Check it out at http://rallycapsdotnet.blogspot.com/2008/03/fda-seeks-to-fine-cochlear-implant.html
email contact: mishkazena@aol.com
March 30th, 2008 at 6:49 pm
PAH!
We already knew that all along, but about the time that FDA finding true colors of CI manufacturers.
March 30th, 2008 at 7:03 pm
Actually, this is a five year old issue and the FDA is just NOW catching up? 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.
This is a company that stands on the integrity of clients first before profit. There was no corporate greed, insufficient quality control or misappropriation of consumers general welfare as you are suggesting.
March 30th, 2008 at 7:21 pm
Abbie, then why is the FDA fining them 2.2 million now? I would think there is a statue of limitations on situations like this, if Advanced Bionics ARE taking steps to remedy like you claim.
March 30th, 2008 at 7:24 pm
What Abbie says is true…
as per AB staff;
The FDA fine is related to issues that are five years old. There are NO new issues or concerns. Advanced Bionics is actively participating with the FDA to reach agreement on this issue. This fine has no impact whatsoever on Advanced Bionics’ ability to operate. We are very strong financially. The HiRes 90K is extremely reliable and together with the Harmony makes up the most durable implant system on the market.
This is current official FDA press release;
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html
March 30th, 2008 at 7:25 pm
Deaf Pundit; FDA is playing a “catching up” game that’s all…
March 30th, 2008 at 7:25 pm
Abbie, I don’t agree. If FDA feels this company has high integrity, the fine wouldn’t be in millions.
Check this at Jodi’s blog on this article:
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).
An American Mom in Tuscany: Jordan’s Cochlear Implant Story: FDA Seeks to Fine Cochlear Implant Company
March 30th, 2008 at 7:32 pm
Figures - the CI companies are monitoring the blogs and spin doctoring in the comments of the blogs.
March 30th, 2008 at 7:37 pm
here’s my disclaimer: I don’t work for AB.
March 30th, 2008 at 7:37 pm
Boult: You speak the corporation talk.
You also said “This fine has no impact whatsoever on Advanced Bionics’ ability to operate. We are very strong financially“, implying your involvement with that company.
Gotcha.
March 30th, 2008 at 7:43 pm
Mishka, it is copy and paste so I didn’t speak the corporation talk.
March 30th, 2008 at 7:44 pm
Actually, you are jumping to conclusions. He just merely copied the press release issued by AB.
March 30th, 2008 at 7:50 pm
$2.2 millions is chicken feed. They should close the company for willful harm and neglect. Capitalists have no patience for government. The whole concept of CI philosophy is dumb and wishful thinking.
March 30th, 2008 at 7:53 pm
I stand corrected about the quote.
However, that is pure corporation talk. Rule of thumb for public relations department of a corporation: do damage control to minimize the negative impact by FDA.
A 2.2 million dollars fine is a high fine from FDA, no matter how one looks at it.
I see no remorse from this corporation. It speaks to its stockholders, reassuring them that the corporation is in a good standing financially. So much for its integrity.
The reassurance of sound financial standing is a strong indicator of the corporation greed. The significances of implant failures, second surgeries to replace the defective implants and all the potential complications inherent in any surgery as a result are ermonous and reflects very poorly on the corporation. We are talking about the quality of people’s lives and their health.
By the way, I’ve seen other companies performing damage control after they were fined by DOJ. They never admited their guilt, either.
A fine from a regulatiing agency speaks volumes. It means the corporation has been found guilty. The higher the fine, the worse the offense.
March 30th, 2008 at 7:56 pm
Money and quibbling over semantics aside, we are talking about real people, their comfort and health, and real problems they are facing after putting their trust in a very controversial device. The last thing the companies need is to have that trust shattered by shoddy quality control and poorly done safety testing.
The fine cannot be too high to compensate for those people who are suffering loss and inconvenience, not to speak of years of delay waiting for repairs.
March 30th, 2008 at 9:04 pm
It’s my understanding that the highest fine the FDA charged was 3.8 million. So 2.2 million to AB is pretty high.
Something’s clearly wrong here.
March 30th, 2008 at 9:33 pm
Deaf Pundit, google this “FDA fines”
March 30th, 2008 at 9:55 pm
We are talking about implants, not about Red Cross.
We are going off a tangent. The topic is A.B in failing to maintain the safety and high quality of its products, for which FDA wants to penalize with a fine.
March 30th, 2008 at 9:56 pm
Let’s please not make hasty generalizations and blame capitalists for Advanced Bionics’ problems.
If they (Advanced Bionics) were good capitalists, then they would realize that they would be more successful if they respected their customers and were more careful about safety.
March 31st, 2008 at 12:06 am
Please.. speculating. AB should do the right thing by closing shop.
March 31st, 2008 at 12:09 am
Yes, probably. Cochlear implants are being falsely marketed. There should be a class action suit against the CI companies for false advertising.
March 31st, 2008 at 12:16 am
I thought that this was about hearing aids, not CIs, but I see that I misunderstood. It’s really about unsafe cochlear implants. The FDA calls there “hearing aids,” but that seems improper and confusing.
March 31st, 2008 at 12:17 am
I thought that this was about hearing aids, not CIs, but I see that I misunderstood. It’s really about unsafe cochlear implants. The FDA calls them “hearing aids,” but that seems improper and confusing.
March 31st, 2008 at 5:42 am
Advanced Bionics is an excellent company and caters to a large market. They are not going to shut down anytime soon. I was informed of this issue prior to and during my candidacy, it was never hidden.
With as many recalls as a company like FORD had, they have not shut down yet. Ford is infamous for having parts being recalled left and right that cause cars being blown up and brake failure. They are still going.
March 31st, 2008 at 7:27 am
Boult, do it yourself.
Abbie, that’s true, but it is quite disturbing to me to see you guys basically say, “It’s just a trivial thing. It happened five years ago. It’s all over.”
At least Ford took responsibility for its own actions and took steps to make sure it wouldn’t happen again, and avoid fines like this.
And what I’m reading from you guys is basically this: it doesn’t matter to you that patients were put at risk. It doesn’t matter to you that this is one of the highest fines the FDA has imposed.
And people wonder why there’s such a huge split between the CI and ASL Deaf communities?
I do not believe for one minute that the FDA would impose this fine if AB was doing something to correct this. And until you can prove otherwise, my stance will remain the same.
March 31st, 2008 at 11:24 am
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.
This medical product should have not been released to the public where the safety of its patients are endangered due to shoddy work. Period. No exception.
March 31st, 2008 at 11:32 am
Jodi has a follow up article on this topic: http://rallycapsdotnet.blogspot.com/2008/03/response-to-mishka-and-myself.html
I agree with her sentiments. Personally, I am neutral about cochlear implants.
The importance of the parents being fully informed of both successes and failures is tremendous. We want the best for our beloved ones. After all, they deserve it.
March 31st, 2008 at 1:07 pm
I am not downplaying the severity of the fine and nor am I expressing blithe unconcern about the FDA fine. I am merely reiterating that this happened five years ago and not yesterday. Many things have happened in the past five years (such a split from Boston Scientific) that has proven to me that it has taken steps to correct this such as eliminating the Vendor B component from the manufacturing process. Their actions indicate that they put their consumers safety first, hence is the reason why I chose AB device for my implant. I’m not sugar coating that it was OK for that happen, but it did, its in the past, the implantee’s paid for the inconvenience of being re-implanted and AB are paid for it then and are apparently still are. I totally understand if people feel leery about going with a company that has a mark on their record but I opted for “once bitten, twice shy” perspective, others obviously won’t and I don’t blame them. I refuse to buy a Ford for that reason.
Deaf Pundit, you made the statement that AB has “One of the highest fines the FDA has imposed.” A quick google search would have found your statement erroneous. American Red Cross was fined 4.2 million, again for 4.6 million and AGAIN for 5.7 million, Warner-Lambert pharmaceutical manufacturer was fined $430 million and four-diet pill manufacturer was fined 25 million. Everyone has a habit of making statements without fact checking, we all do it to some extent but in this particular case I much rather state the facts then perpetuate myths.
Everyone can form their own opinions but I just wanted to make you all aware of the history behind it, whether it matters to you or not.
March 31st, 2008 at 1:16 pm
Thank you for your feedback, Abbie. I am glad you have faith in AB and are satisfied with your product. However, I won’t because it violated the compliance of quality assurance guidelines in the first place, a big no-no considering that it is a surgical device. I try to go with this motto: Fool me once, shame on you. Fool me twice, shame on me. With medical devices, I try to avoid any unnecessary gambles. Different strokes for different folks.
With the fines, we are not talking about Red Cross and pharmacucetical companies. We are focusing on medical devices requiring surgery.
March 31st, 2008 at 5:07 pm
This is not justice, this is an old issue and the company has taken all strides to remedy all the problems. There are so many worse companies who have not been fined and have not suffered this ridicule.
March 31st, 2008 at 11:56 pm
“With the fines, we are not talking about Red Cross and pharmacucetical companies. We are focusing on medical devices requiring surgery.”
So, the risk of getting donated blood that could cause health harm such as a patient who could receive donated blood that have HIV virus or the risk of taking a medicine that could cause harm including psychological or emotional effect or even death is not as important as medical devices requiring surgery?
“Lives of patients were endangered needlessly, with implant failures, second surgeries and possible complications inherent with any surgery. This should never have happened.”
It would be nice to go on a time machine and go back in time and have the company recheck all the recalled devices. However, unfortunately, we can’t do that. As I said, we can’t just sit, complain and cry over this problem as it wouldn’t accomplish anything and it’s really a negative attitude. Instead, it’s better to investigate and advocate for the improvements and the better quality of the implants as many of us CI users wouldn’t want CI companies to be shut down as we value the importance of having hearing. We just have to move on with life, and do our best to help improve the quality of life for those people who suffered it. Many parents who I know who went through this ordeal with their children have done quite well overcoming with this, and their children are doing fine now and that’s as far as we are concerned.
Just giving a company a fine doesn’t mean anything. I have no problem with FDA giving them a fine. What we’re more concerned is that the company is willing to take the full responsibility to improve their device, to learn from their mistakes, and to help people who are going through the failure. As some other commenters said, there are so many companies who continue to make very bad mistakes that can even cause medical risks whether they are surgeries or not.
Although, I will admit that I agree that I would not be comfortable with going with AB for awhile unless there’s a strong valid reason if I ever need a new CI. However, if people like Abbie are doing fine with their AB, I’m perfectly fine with it.
April 1st, 2008 at 9:10 am
30. Rachel, Mishka is doing a good service by informing others of what’s happening, especially for parents who may want access to information about different CI companies. Why are you attacking her? Shut up and take your uppity attitude back to your little blog and stay there! Now I see why nobody visits your blog anymore. “Just giving a company a fine doesn’t mean anything.” Jesus Christ!
April 1st, 2008 at 2:11 pm
The actions of Red Cross and the pharmaceutical organizations were atrocious, of course. However, the current topic is on FDA fines and implants, not Red Cross and pharmaceutical companies.
As a former scientist, I frown on the failure of any medical corporation in ensuring that their surgical products are of highest quality. Any defective product necessitating removal through another surgery is worrisome, especially when anesthesia is involved. As anyone knows, it is the anesthesia that presents risks. So unnecessary surgeries are nothing to be sneezed at. Cochlear implant failures do happen unexpectedly, sometimes as a result of ignorance and sometimes for no known reason. That’s not the issue. Failures of cochlear implant devices due to the shoddiness of the company in maintaining high quality control standards are guaranteed, endangering people needlessly. Hence the steep fine of 2.2 million dollars.
Of course the parents and the deaf people need to move ahead, making the best of the bad deal they receive. However, this doesn’t excuse the company of its wrongdoings. This shouldn’t have happened in the first place. I am glad it is held accountable by FDA. If the parents and/or deaf people want to sue this company for damages, especially if they experience complications with the follow-up surgeries, the blame goes to the company alone.
April 1st, 2008 at 10:13 pm
Let me try to re-explain my point -
I was just trying to explain that it’s not just about fining the company. In other words, FDA shouldn’t just ask for money from the company. FDA needs to keep their eyes close at AB. An analogy would be that when people drink and drive, they only get fined and go to the jail. That’s not enough. Police need to get them to rehabilitation and give any tough measures to make sure that they’re not doing this again in the future. Asking these drunken drivers for fine is not enough because they can get back on the road and repeat the actions. That’s what I mean. AB needs to be told that they need to improve their manufacturing, not just to be asked for money. Giving AB just a fine doesn’t mean anything. They can repeat these errors again unless they are watched closely by FDA until FDA feel satisfied with AB.
April 2nd, 2008 at 7:47 pm
Mishka Zena,
Why would you let Shari’s post stay? That is troublesome. Here I am a mom to a deaf child interested in your article, and bam….same ol’ same ol’. Guess what….I still read Rachel’s blog everyday. Go figure…attacking Rachel and others like her.
Shari,
People like me and Rachel are not going to shut up and go away.
April 7th, 2008 at 1:25 pm
Advanced Bionics has posted a statement on their website
http://www.bionicear.com/news_details.cfm?id=25&langid=1
April 8th, 2008 at 6:32 pm
Hello to all: I was researching legal information about this FDA news and wanted to let you know about a lawyer at Weitz & Luxenberg P.C. who is taking cases involving these defective implants. Teresa Curtin, who is Deaf and fluent in ASL, has taken on many issues related to the Deaf community. Here is the link to our website if you would like more information: http://www.weitzlux.com/cochlearimplants/lawsuit_1933467.html
April 12th, 2008 at 8:25 pm
Hello to everyone. I have read through this issue about the FDA fining Advanced Bionics and I have noticed that many people are saying this is a five year old issue. This issue is much more recent than that. The FDA is claiming that Advanced Bionics sent out 2 of the supplier B (the ones with the high failure rate) devices after the recall in March 2006. These two devices were implanted after the recall date! This makes it a two year old issue at best. Also, to be clear on the failure rate of the supplier B device — it is greater than 1 in 4 that have failed so far, which by my reckoning is unacceptable.
June 5th, 2008 at 11:18 am
Hi All: After following Advanced Bionics in the news for two years, a law firm has decided to review potential cases involving some cochlear implant patients who have experienced adverse events after being implanted with an Advanced Bionics HiRes90k Implantable Cochlear Stimulator. Please visit our website if you are interested in learning more:
http://www.weitzlux.com/cochlearimplants/lawsuit_1933467.html