Hi Ya'll!

Since I had found out that my problems with my VNS were not disclosed and/or delt with appropriately by my Doctors or completely investigated by Cyberonics, my Husband and I did some research and this is what we have come up with.

I contacted a man with the FDA who has the title "Consumer Complaint Coordinator". I told him my story. After the shortest scenario I could tell him, he then referred me to the FDA website to make a Medwatch report. I told him I had done this twice, and also added that everything I had stated was not investigated by Cyberonics-and I added they chose what they wanted to investigate and disclose to the FDA. He then asked me to write a detailed letter to the FDA/Consumer Complaint Coordinator in my state giving all the information regarding what has happened to me, and what I know was and was not investigated. Once he receives my letter, an investigation will be opened as to why my adverse events/side effects were not thuroughly investigated and reported to the FDA, including why I was implanted with a TBI. He also recommended to request a report/investigation # and outcome of the investigation.

To find out where your state's FDA Consumer Complaint Coordinator office is located, you can google search FDA and the name of your state, or possibly find it thru the FDA website.

Maybe if the FDA is flooded with letters something will be done.

Dispatch B)

I am glad you could do this, as you had trouble with your implant. All of these government agencies need someone over them as an administrative watch. The trouble with any branch of government, no one has ANY jurisdiction over them, and they get away with much stuff that they shouldn't.

Let us know what occurs.

Sincerely,
Bonnie
PS. Sorry about my last post.

Hi Bonnie!

I'm glad we found this information out as well. I hope others will read this thread and decide to take this route for action to help themselves.

Dispatch B)
P.S. Please read what I posted to you in The Vent regarding the apology.