Let me say up front that I went forward with VNS implantation after reading the manuals and reading many people's stories thanks to this forum. While it has not been beneficial for me, I did know the odds were against me going in by having this information available to me. I do not regret my decision to try VNS, even though it did not work for me, as it has really opened up my eyes and made me realize just how much as a patient I need to be a very strong advocate. I am thrilled that some people have gotten wonderful results from VNS and wish everyone was able to find positive results from VNS. Regardless of whether your condition is epilepsy or depression, if you have benefitted from VNS I do to see that this instrument can be positive and am very supportive of those who have benefitted.

But for over a year I have been reading and talking with those of you on here and have come to have many questions about why Cyberonics is not being held liable for the impact this device has caused to some patients' health who have been adversely affected due to implantation of VNS.

For some individuals VNS has caused more medical issues than the original diagnosis which lead them to VNS. This is where I think there needs to be more research. Answers need to be found as to why VNS works for some and does not for others. I know this is unlikely to happen (as it will weed out unlikely candidates which would mean less income for Cyberonics) but I do believe this is the route that needs to be reviewed. As a person with epilepsy I have wondered what similarities those who gained benefit might have, such as type of seizures, medication issues (such as could it be that those who gained no benefit from certain AEDs also gained no benefit from VNS), acquired versus genetic seizures, etc.

I believe if Cyberonics was more open to recognizing those who have had negative and even irreversible results rather than turning their back and refusing to accept their own liability is what has irritated many VNS implantees and their families. Why is responsibility and liability not being required of companies who make devices? The FDA would have required Cyberonics to do more research if this were a medication which caused this many reports of side affects/adverse reactions/deaths, so why is a medical device manufacturer being allowed to continue to profit? Does the idea that it is an "alternative medical treatment" to medication make the manufacturer less liable? What has to happen to make FDA require Cyberonics to do more research? Where is the dividing line between beneficial and harmful? How many MAUDE reports have to be on file before the FDA takes action?

These are just some of my thoughts and questions which have gone through my mind since going through this process. While I doubt Cyberonics will ever address them voluntarily, what about the FDA and the Supreme Court? It still boggles my mind that the governmental institutions which are supposed to protect the people have been bluffed by a manufacturer who profits from each implant, regardless of the outcome for the patient. Why have patients lost their rights to require medical institutions to be held accountable for their actions? While Cyberonics is a manufacturer, the items they make are being made for medical advancement, therefore as such are in the medical field and should be held to the same accountability as any other medical provider.

I have thought long and hard about doing this post, as I know some may see it as a complaint by a disgruntled employee. Please recognize that is not the issue here, as the last thing I would want is for VNS to be totally pulled for I do see the benefits many of you have gained. My view comes from being in the medical field where I am held accountable for my actions and I believe anyone and any company should be held to the same standards and laws. I see a conflict when a company makes a profit yet is not being held liable for damages. The iinequity here is my concern. If I acted in such a manner that would harm someone, I would be held accountable. Why is that not the case with Cyberonics and other medical device manufacturers?

Thanks for hearing my thoughts and I hope to hear yours on this issue.

Thank you for stating so eliquently what I have been saying for years. If I am ever asked to go up before a FDA or Congressional Hearing in reguards to VNS I want you to be my speech writter.

If you don't mind I'd like to move this to the legislative forum for EVERYONE to see.

Hi Cindy,

You've created a clear, concise statement questioning the accountability of Cyberonics, the medical establishment, and the government regarding VNS.

I fully agree with your statements. I wish anyone personally affected (patient and family) could unite in a positive, effective manner that would bring the facts to international attention.

In the past, people have done this via class action law suits. Since there are legal obstructions to that presently...I would think the other route would be via (UGH) the media.

Although he's not everyone's favorite guy...I think this needs a Michael Moore type to investigate and inform the public. I know people have mentioned Oprah, the Today Show, etc. I don't believe they have the right format to give this the justice it deserves.

I know this sounds like a "pie in the sky" idea, but without strong backing with resources, I fear many of us who have been spinning our wheels in one direction or another will just eventually run out of steam and give up.

So, those are a few of my thoughts. In my present circumstances with multiple family situations up in the air...I don't have much energy. There is a way to do this...and it does need to be done.

Thanks BB and Oreo for your feedback. I have no problems with moving this to Legislative Forum, BB. I wasn't sure if that was the appropriate location and knew you would find the right spot!!! :D

I agree Oreo that this issue needs to be addressed and as much as I hate to see the media run with it, I doubt many forms of addressing it would get the response that the media would get. As for Michael Moore, not too fond of him myself, but I have to admit he does make people take notice. I agree the right format must be found, but don't see it as "pie in the sky" - see it as a challenge!

Hugs,
Cindy

:D HI!

Gel, your post is so well thought out and very well stated. You have an awesome skill of writing, and you always have the right words. Thanks so much for starting this thread!

Accountability and honesty is first and foremost two very important qualities my Mom instilled in me. She always said there are consequences to everything you do, good & bad. I believe with that in mind, I do hold some accountability in myself being implanted with VNS. I am a grown woman who made a decision. I researched what was made available to me by Cyberonics. I was given literature and a CD from Cyberonics. At that time, I had very little internet skills, so everything I did, I had to have an exact website address or I didn't know how to find it. I didn't know about google and yahoo searching. This may sound like an excuse, but it is the truth, and it is a good reason why I didn't know all there was to know about VNS.

I was very highly medicated just prior to implant. I couldn't make it thru the grocery store, and some days, wan't even capable of taking the dog outside. Everything took immense effort to accomplish. Depression medication played a great roll in this daily, and seizures compounded it. In the words of my Cyberonics Case Manager "I was swinging from pier to pier". The point to saying all of this is to show my frame of mind. I was also told VNS was safe, effective, and my "last hope" in dealing with depression, and I would get dual benefit for seizure control. This leads to the subject of false marketing which is being overlooked by our Government.

Patients are not being properly screened for VNS. Their literature and DVD do not say everything that can go wrong. What they provide does not tell you your heart can stop, you may quit breathing, your health history condition(s) may worsen, etc. They provide limited health hisotry exclusions to the patient, yet fully disclose in the Physicians manuals, yet when training the Physicians, still don't fully disclose. It's kinda like here, read this, then you are fully trained in VNS. Patients are not being told their insurance company may not cover VNS for depression. Patients are not being told the actual price for VNS, and are quoted the price of $25,000 including implanting costs. I discovered I was lied to and the actual cost of VNS and implant is well over $25,000 when I got the bill. Then to find out after implant the whole generator was going to need replaced and not simply just a battery...oh my gosh...the price billed for the generator alone was well over $25,000.

It has become clear to me since my implant that there have not been enough studies to show just exactly how effective VNS is for depression in a greater population. I can now understand why CMS made their Non-Coverage Determination in May 2007, and why private insurers follwed suit. But more than that, there have not been enough studies done to show VNS is safe. Why is it when the University of Michigan was recruiting for study participants, ALL health history exclusions were disclosed, yet Cyberonics will not disclose? Although it is very clear there are many with epilepsy & depression who have benefitted from VNS, it is also painfully clear those who have been injured or have had problems has to endure Cyberonics and some Physicians turning their backs on them, medial care denied due to non-coverage, financial distress, and loss of the "last hope" just to mention a few things.

I in no way will ask VNS to be taken off the market because it has been beneficial for many. My request is that our Government regulate this device and the manufacturer better than it has. FDA approval and complete Department of Justice regulation are two different things. Cyberonics needs to be held liable for their wrong doings. The FDA needs to follow thru on their threats when Cyberonics fails to answer Maude reports with anything other than "User Error", or "Sudden Epilepsy Death" or "Unexplained", or "Good Faith Attempt". Whether our voices have to be heard thru the media (I have no opinion about Michael Moore), this board, mass letters to our Government, the courts system, etc., our Government needs to be made completely aware that there are thousands of us out here who have been taken advantage of by a major manufacturer for a device that has been falsely marketed. Being taken advantage of when you are in a completely vunerable state is unethical, morally wrong, and shows this manufacturer does not practice these qualities, but is solely out to make a buck at the patients physical, emotional, & financial expense.

Thanks Dispatch and you too have made some very key points. I accept my own responsibility also but it amazes me how easily doctors are to implant VNS, even in children when the FDA did NOT approve it for use with children, and then just back off when there are complications. As for the cost, I did know ahead of time but only because I met with another person locally who had VNS and she was very upfront with me about the cost.

The point that you made about the Michigan study is a very good example of how Cyberonics does not reveal any information until afterwards. This is outrageous and totally unethical. I honestly do not know how they get away with that, I would think that full disclosure would be required PRIOR to implantation by the FDA. It is not like taking medication and not getting a print out of the side affects. You can choose not to take the medication after reading the print out, but with the VNS you have already had it implanted. I wonder if there is anything in the FDA approval of VNS which states about disclosure?

Thanks for your feedback! :D

Hugs,
Cindy

:D

I am feeling a strong urge to bring this thread back to life, so here's the : bumb : . Accountability is a big issue, and will always be in every aspect of everyones lives.

It seems accountability regarding anything bad with VNS still remains to soley lay within the patient, and the hope it won't always be this way lingers.

B)

Very good statements. Everyone needs to be informed BEFORE the VNS is implanted. I wasn't, but it has cured my depression with the help of 2 drugs compared to 13 and me attempting suicide. I came VERY close to dying needing dyalasis and brain swelling.

I wished it worked for everyone and hope that they find a way to know who needs it. Keep it away from children having it implanted!I thank God everyday that I got it implanted!