Another recall for AB

Device failure/replacement rate in CI is in the single digit percentage in all implants.
 
I obvs know yhat all companies implants have probs and its great you still trust a company BUT it shouldn't happen in the first place for someone to have to go through explantation and reimplantation I think it plain sucks ..I'd rather have a proper device put in my head the first time thanks:)
 
It would seem AB has long standing issues with their product. All these recalls makes me a bit twitchy; even though they seem to be recalls over "minor" issues. A recall is a recall. If I am ever in the position of needing a CI, I'd think twice about going with AB. Seriously. Wow!!!

Having said that, it does seem like this recall might ONLY affect new implantees and not someone who's had this device long term. But, who knows?

Before everyone gets all twitchy and defensive about PFH posting this, it's worth noting AB's history. Everyone considering a CI has to take things into consideration BEFORE deciding IF they will implant, or, WHICH company they'd consider. I believe that's all he's implying here and I agree with him.
 
Oceanbreeze said:
It would seem AB has long standing issues with their product. All these recalls makes me a bit twitchy; even though they seem to be recalls over "minor" issues. A recall is a recall. If I am ever in the position of needing a CI, I'd think twice about going with AB. Seriously. Wow!!!

Having said that, it does seem like this recall might ONLY affect new implantees and not someone who's had this device long term. But, who knows?

Before everyone gets all twitchy and defensive about PFH posting this, it's worth noting AB's history. Everyone considering a CI has to take things into consideration BEFORE deciding IF they will implant, or, WHICH company they'd consider. I believe that's all he's implying here and I agree with him.
Click to expand...

Exactly.
 
AliciaM said:
I obvs know yhat all companies implants have probs and its great you still trust a company BUT it shouldn't happen in the first place for someone to have to go through explantation and reimplantation I think it plain sucks ..I'd rather have a proper device put in my head the first time thanks:)
Click to expand...

I know someone who's had to do that. She had to be re-implanted after the whole meningitis thing came to light. She was NOT told that meningitis was a possiblity when she was implanted in '02. It was and she got sick. She was reimplanted with the newer model (at the time). I sent her a link to this article to make her aware. I'm HOPING LIKE HELL she's not going to be affected by this. It would make me sick to think she'd have to undergo a SECOND reimplatation after all she's gone through already!
 
From what I can tell this is a recent development that happens 8 to 10 days after activation so you can not really compare it to the total AB population.
It does not appear to affect users that had working implants for a time. I have not heard how big this issue is since it is just two users impact so far. Some news sources indicate that this may delay new surgeries for AB six months but that is subject to change. I have heard a few case that surgeries were canceled on the day before the surgery.

deafgal001 said:
from the article "This action is being taken in response to two instances thus far where the product experienced a rare malfunction requiring explantation"


I think she got the 50,000 worldwide from AB website

Still, I felt that some cochlear companies like to experiment to make their product better. I wanted a company that make their product reliable and safe as long as it works.
Click to expand...
 
As an Advanced Bionics-Harmony implanted user of over 3 years now-still no problem with the "internal processor". PFH- you are correct -there are only 3 companies at the moment which make them. As mentioned before-the Sunnybrook/Toronto Cochlear Implant team chose AB Harmony as best suited for me. As I said then, I would not be in any position to determine which was best-at the time. They have been involved over 18 years-a bit of valuable experience-to say the least. I received the Meningitis shot before being implanted. To date I have received no information from AB on any problem.

Implanted Advanced Bionics-Harmony activated Aug/07
 
Ya know.. this made me curious... A lot of people here complain about the number of CI failing. What exactly is an acceptable "success rate" to you guys? 100% 99%? 90%?

Just for comparison:
Hip Replacement Surgery Success Rate (after 10 years): 90-95%
Hip Replacement Surgery Success Rate (after 20 years): 80-85%
Pacemaker success rate: 88-92%
Microfracture knee surgery: 75%-80%
And so on.....
 
this is a voluntary recall.. AB is recalling the device to figure out why the 2 newly activated folks are having such problems with their devices, and they want to get the issue taken cared of before more people get the AB devices, to prevent similar problems. That's my understanding of this recall. I have already heard of at least 2 folks at hearingjourney.com that have had their surgeries delayed due to this recall so far.
 
AliciaM said:
I obvs know yhat all companies implants have probs and its great you still trust a company BUT it shouldn't happen in the first place for someone to have to go through explantation and reimplantation I think it plain sucks ..I'd rather have a proper device put in my head the first time thanks:)
Click to expand...

Every brand has failures, that is just a fact. AB is doing recall and checking every single device, so that the problem doesn't happen again. I think that is much better than just implanting them and crossing your fingers.
 
posts from hell said:
Alright, believe what you want. :) It's actually in the tens.
Click to expand...

Not when you average them out...it comes in single digit percentages when you include Maude and other papers that I'm looking at. For example:

Studies give an idea of how frequently reimplantation takes place.

•In one study of 500 implant recipients at one implant center between 1989 and 2006, 51 out of the 500 (10.2%) had to have revision surgery.
•In another study of 720 patients in South Korea between 1990 and 2007, 30 (4.2%) had to have revision surgery. Of these, 12 were reimplanted.

Between 10.2% and 4.2% when averaged...single digit percentage result.

MAUDE - Manufacturer and User Facility Device Experience
:)
 
Oceanbreeze said:
I know someone who's had to do that. She had to be re-implanted after the whole meningitis thing came to light. She was NOT told that meningitis was a possiblity when she was implanted in '02. It was and she got sick. She was reimplanted with the newer model (at the time). I sent her a link to this article to make her aware. I'm HOPING LIKE HELL she's not going to be affected by this. It would make me sick to think she'd have to undergo a SECOND reimplatation after all she's gone through already!
Click to expand...

If you have the device, and it is activated, and working, there is NOT a problem. These issues happened when they started the activation process (in the first to weeks of use).
 
Daredevel7 said:
Ya know.. this made me curious... A lot of people here complain about the number of CI failing. What exactly is an acceptable "success rate" to you guys? 100% 99%? 90%?

Just for comparison:
Hip Replacement Surgery Success Rate (after 10 years): 90-95%
Hip Replacement Surgery Success Rate (after 20 years): 80-85%
Pacemaker success rate: 88-92%
Microfracture knee surgery: 75%-80%
And so on.....
Click to expand...

Doesn't matter. They don't want to see any CI in kids. Period. Using the "failure rate" is just a cover. We know that medical devices do fail. Just as we have problems with cars failing or are recalled because of certain defects found out later.
 
Daredevel7 said:
Ya know.. this made me curious... A lot of people here complain about the number of CI failing. What exactly is an acceptable "success rate" to you guys? 100% 99%? 90%?

Just for comparison:
Hip Replacement Surgery Success Rate (after 10 years): 90-95%
Hip Replacement Surgery Success Rate (after 20 years): 80-85%
Pacemaker success rate: 88-92%
Microfracture knee surgery: 75%-80%
And so on.....
Click to expand...

Implants are doing as good as, if not better than these devices.
 
Back
Top