They say here that they receive about 200 petitions a year.

How many Petitions can we submit to try to make a change?


FDA > CDRH > Freedom of Information Act > CDRH Petitions

CDRH Petitions

A petition is a way for individuals, regulated industry or consumer groups to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Additional information about petitions can be found on the page:
Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions

Note: All documents are in PDF format. [Accessibility]
• Petitions by Year
o 1994-2002
o 2003
o 2004
o 2005
o 2006
o 2007
o 2008

http://www.fda.gov/opacom/backgrounders/voice.html



Keith

Hi.
I'm new.
I'm also furious with Cyberonics and the doctor I was assigned to. I had the implant due to refractory depression. It's been almost 2 years since I've been implanted and I'm up to 2 amps and have tried 3 different settings. All to no avail. I'm also still on 6 medications in very high dosages. I was basically a guinea pig for the doctor I was assigned to, and since I showed no improvement, he totally lost interest in me. I found myself constantly calling Cyberonics only to be transferred a million times until I would get a voicemail and leave a message. Nobody ever called me back. I was implanted right before the whole Medicare/Insurance debacle, so my operation was paid for. And, I'm sure, there are others like me that got the implant just in time. The problem is, Cyberonics thought that the implant was going to be a major success for treatment-resistant depression, and they were wrong. So basically, they went back to just studying the epilepsy aspect of the device and turned their backs on people who were implanted before the insurance companies declined the operation. I have the most extreme shortness of breath of which I've never had in my life. All the time. I can only imagine what an asthmatic feels like. I constantly feel like I'm suffocating or that my head is being held under water. Just walking a block causes me to gasp for air. I'm having the machine turned off and am desperately hoping that the side effects go away. I was going to have it removed, yet I wasn't told initially that the coil around the nerve cannot come out. I'm infuriated about that. That means still no MRI's or ultrasounds allowed. I believe that there are enough implanted people out there (for TRD) that have been basically disregarded by Cyberonics. I think a class action lawsuit is in order.
I'm not one to complain but this is just ridiculous.
Thank you for listening.
Michele

Hi mlswings,

Welcome to the board. I was also implanted 2 years ago for TRD. I am fortunate to have developed some good benefits over time...also bothered by some significant side effects.

Take some time and search the board. You will find so much information that will be familiar to you.

Unfortunately at this time, a recent decision by the US Supreme Court (Riegel vs. Metronics) makes it "almost" impossible to sue Cyberonics. Again, search the board; there has been lots of discussion about this.

Several people who post are actively seeking ways to make Cyberonics accountable for its unethical actions. With people getting their heads together, we may find a way.

I find support and information every time I sign on here. Again, it's good to have you here....I know you'll hear from a bunch of others as they check in.

: party1 : It's a celebration when someone new joins the party!

Anne

Hello mlswings,

I was never told that the coils could not be removed. My Neurologist and Neurosurgeon both conveniently forgot to mention that important fact.

My VNS was shut off due to a malfunction (nearly killed me). Even during discussions of an explant my Neuro didn't mention it. I guess his plan was to have the Neurosurgeon break that bad news to me.

I did not learned the facts about the coils from my Neurologist or Neurosurgeon. I learned the facts right here on the VNS Message Board. With your VNS implant being less than two years old there is a possibilty that you would not have a lot of scar tissue. If that were the case the coils could be removed. The big problem is finding a surgeon willing to attempt the procedure.

There is a wealth of information on this site. Welcome aboard !

:Welcome: Michele! It is nice to have you here. I am sorry to hear of your struggles with VNS. Please read thru the board. You will find many with the same problems as you, but you will also read of success stories with VNS for epilepsy and TRD.

Complete explant is possible. I have had complete removal. I was told it depends on scar tissue, and the only way to determine that is to look at the vagus nerve.

Many of us have had the same problems with Cyberonics. That makes it totally worse to have them ignore you on top of the doctor loosing intrest. Is there another VNS doctor in your area that can re-evaluate your case? Maybe a re-adjustment may help your side effects. VNS takes time to work, and sometimes it takes a quite a few setting adjustments to get optimal relief. There is another member here who is set way above 2.0.

Please don't give up hope. You will find lots of support here, so please keep coming to visit. Hang in there!

Dispatch B)

:Thanx:


Thanks guys!!