http://www.weitzlux.com/cochlearimplants/lawsuit_1933467.html

http://www.bionicear.com/news_details.cfm?id=25&langid=1

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.

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.

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.

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.