FDA seeks to fine AB 2.2 mil

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dragon_image18

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Found this article in Yahoo news.

This scares me since we have ordered the AB processors for my daughter's upcoming surgery. We may need to rethink our choice since we still have time to change our minds and switch to Cochlear.

Not going to jump to any conclusions till I can do some more research on the subject.

But I also wonder about AB's future if they get multiple lawsuits like this.
 
I'd worry more about the safety of the devises they are selling, given the details in the article.
 
Information on the FDA’s recent announcement of intent to fine Advanced Bionics

Apr 7, 2008
Many of you have heard about the FDA's intent to fine Advanced Bionics. This announcement is about what happened five years ago in 2003. It's old news! We're trying to reach resolution with the FDA, but the process is complex and takes time. What you should take from these events is the following:


1. The fine is principally related to judgments the FDA is making about our quality system in 2003 --- five full years ago.


2. We are actively participating with the FDA to try and resolve these matters.


3. The process is complex and takes time.


4. The fine proposed by the FDA has no impact whatsoever on the ability of Advanced Bionics to operate its business.


5. The HiRes 90K is extremely reliable and, together with the Harmony, is the most durable implant system on the market.
 
This company failed to meet standards and consequently put patients at risk, no matter the time frame. Given a revenue of $56 million dollars in 2003, a fine in the amount the FDA proposes is small change, indeed.
 
That's scary!!! Hope nobody was harmed by this.
 
shel90 said:
That's scary!!! Hope nobody was harmed by this.
Click to expand...

The biggest risk was having to undergo additional surgery to replace a devise that failed because of inadequate manufacturing standards that caused the devise to malfunction from problems with moisture. At a revenue of $56 million dollars, I find that unacceptable, and just more evidence that the industry is making huge profits from these devises with little concern for patient consequences.
 
Yep, some people's Advanced Bionics implant failed due to mositure failure from faulty materials being used. I chatted with one such person, their child's Advanced Bonics implant failed and now the child cannot use the processor ( CI ) till surgery is schedlued and the internal implant is replaced ..So, I apllaue the FDA to do their job and help keep us Americans safe with quality medical devices..
 
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