Wednesday, July 16, 2008
Advanced Bionics Complaint...and Letter RE: FDA Settlement
Two months after my post FDA Seeks to Fine Cochlear Implant Company, a reader, Kimberly, posted the following comment:
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. Frankly 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 proof 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 sad 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.
May 28, 2008 3:14 PM
I debated for a couple of weeks whether or not to post this comment. Then, at the NHS 2008 Conference I met a gentleman who works for Advanced Bionics, who suggested that I email him the complaint and he would send me some type of response. I sent him the complaint two weeks ago and still haven't received a response. I am not a very patient person, so I apologize for not having waited another two weeks for a response.
I will assume that the letter issued by Advanced Bionics on July 14th is a sort of response. It was issued here, I'm going to re-write it because I can't copy it from the pdf. Here goes...
Dear Patients and Professionals,
Today, Advanced Bionics agreed to settle a matter with the U.S. Food and Drug Administration (FDA), resulting from a decision we made in 2003. That decision concerned a determination that no formal FDA submission was needed when we added a new vendor (Vendor B, later terminated in March 2006)to our manufacturing operation. Four years later, in 2007, the FDA filed an administrative complaint against us stating the FDA's belief that a formal submission should have been filed. We responded to the Agency, pointing out that it had already approved both vendors when it approved the system.
While we do not agree with the FDA, we do believe that accepting its terms is in the best interest of our patients, our company and our need for a long-standing relationship with the Agency. So, we have decided to settle the matter, with the company paying 1,1 million dollars, and me, as CEO, paying 75 thousand dollars.
Over the years, we have increased our focus on the reliability of our entire implant system. At present, our internal device (Vendor A)has a 2 1/2 year CSR of 99.1%, and our external product durability leads the industry. That being said, we expect that the quality of our products will only get better in the years to come.
As we move forward, we are stronger than at any moment in our history: singularly focused on cochlear implants, well funded, possessing better leadership in key positions, and having a strategic plan built around patient care.
We very much look forward to continuing our partnership in this community. Please call me if you have any questions about these or other matters.
Jeffrey H. Greiner
President and Co-CEO
*Wonder how Kimberly will take the news...*