My WebMD Sign In

Please enter email address

Enter your password

Keep me signed in on this computer

Show more Information

If you select "Keep me signed in on this computer", every time you visit WebMD.com you won't have to type your email address and password. This means that a cookie will stay on your computer even when you exit or close your browser which may reduce your levels of privacy and security. You should never select this option if you're using a publicly accessible computer, or if you're sharing a computer with others. Even if you select this option there are some features of our site that still require you to log in for privacy reasons.

Forget your password? Having trouble signing in?

Why should I
sign up for WebMD?

With a WebMD Account you can:

Track your way to weight loss success
Manage your family's vaccinations
Join the conversation

See more benefits Sign Up

Why WebMD?

My WebMD

Show Menu

Facebook Twitter Pinterest

WebMD Home

Epilepsy Community

Reply: Vagus Nerve Stimulator

My theory of all the problems created my the VNS is that the most important nerve in...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator My theory of all the problems created my the VNS is that the most important nerve in...

Reply: Vagus Nerve Stimulator

Excerpt from the BMJ article: Denominators, study bias, and failure to report 2nd...

Posted by dennisfegan

Excerpt from the BMJ article:

Denominators, study bias, and failure to report
2nd paragraph

In the case of the vagus nerve stimulator the denominator depends not only on the number of patients implanted with the device but also on how many devices are still functioning. Cyberonics reports that by 10 March 2010, they had received registrations for 57284 patients worldwide implanted with the device, yet it acknowledges that it is impossible to know how many patients have had their devices deactivated because it has no way to collect these data. The combination of possible under-reporting of adverse events (the numerator) and possible over-reporting of the number of active devices (the denominator) could mean that the rate of deaths among device users is higher than is apparent. The more than 900 deaths among relatively young people (most of those with implants are 15 to 44 years old) 3 did not trigger a request for further investigation.

And what of the post-approval study, known as XE05, ordered by the FDA as a condition of approval? A spokeswoman for the FDA cited XE05 as part of the evidence that "supported the long term safety and effectiveness of the device." Cyberonics confirmed that only 50 patients were enrolled in the open label study and deaths were not recorded. When asked how such a small study that didn't include mortality data could show the device's "long term safety," Cyberonics replied that "the purpose of that study wasn't to look at SUDEP or mortality rates" but to evaluate other long term safety issues.

The FDA gave the BMJ references to five additional post-approval studies as evidence of the device's safety. Yet the five studies do not establish that the device wasn't responsible for deaths because none of them included mortality data. The largest study consisted of 4743 patients in the company's outcome registry. The other studies evaluated subsets of registry patients. Cyberonics acknowledged that "mortality was not an endpoint collected as part of the Epilepsy Patient Outcomes Registry."15

http://newamerica.net/publications/articles/2011/why_the_fda_can_t_protect_the_public_42817 View Thread

Posted bydennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator Excerpt from the BMJ article: Denominators, study bias, and failure to report 2nd...

Reply: Vagus Nerve Stimulator

Candi, I read the 1997 CDRH Neurological Devices Panel and Dr. Piantadosi seemed to be...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator Candi, I read the 1997 CDRH Neurological Devices Panel and Dr. Piantadosi seemed to be...

Reply: Vagus Nerve Stimulator

You are very welcome Candi. Someone sure has to get the word out because the FDA isn't...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator You are very welcome Candi. Someone sure has to get the word out because the FDA isn't...

Reply: Vagus Nerve Stimulator

It is highly recommended to visit a healthcare specialist as soon as possible if a...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator It is highly recommended to visit a healthcare specialist as soon as possible if a...

Reply: Vagus Nerve Stimulator

Vagus Nerve Damage Symptoms The symptoms of vagus nerve damage vary from the area of...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator Vagus Nerve Damage Symptoms The symptoms of vagus nerve damage vary from the area of...

Reply: Vagus Nerve Stimulator

As ya'll know what I thought were drop attacks actually were 30 seconds of cardiac...

Posted by dennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator As ya'll know what I thought were drop attacks actually were 30 seconds of cardiac...

Reply: Vagus Nerve Stimulator

Hi Candi, Right now I'm taking Felbamate, Lyrica, Sertraline & Clonazepam. The...

Posted by dennisfegan

Hi Candi, Right now I'm taking Felbamate, Lyrica, Sertraline & Clonazepam. The Felbamate is causing some problems and it also has a black box warning so I plan to get off of it soon. My seizures have never been completely controlled. I average 6 to 8 complex partials a month and a few tonic clonics a year. Without meds I'll have over 300 a year.

A little more info for Hula

1997 FDA CDRH Neurological Devices Panel

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.

pg. 125
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

DR. PIANTADOSI: Yes; well, one of the things that's concerning me is that the endpoint being measured in all of these studies is, in some sense, a surrogate, counting the number of seizures. I realize that to the patient and to others, it is a very important endpoint, but it may not be as definitive as some other things that we could measure. And there are numerous examples in the methodologic literature about the weaknesses of accepting clinical trial data based on surrogate outcomes, and I would point to, as a recent and a very dramatic example, the cardiac arrhythmia suppression trial, in which the study was designed and the endpoint was selected on the basis of looking at arrhythmias and suppressing them with a drug. And the studies originally seemed to show that the drug was effective in suppressing arrhythmias. The problem was that it was so good in suppressing arrhythmias that it was killing people, and the mechanism was not understood until much later and wasn't even believed until the results of the randomized trial. So, I am very nervous when I see high mortality rates associated with a supposed benefit, even though we don't have a way biologically right now to connect the two. So, that is why I have harped on this this morning and why I am still very nervous with this high death rate. What's your sense of that? I mean, I'm struggling to get some reassurance that my concerns are not well-founded.

Pg. 135
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

FDA's failure to enforce it's stated requirement of the manufacturer that the company track patients deaths and because the manufacturer has acknowledged that it did not track deaths in any of the five studies it alleges shows its safety record.The FDA should live up to its commitment to oversee the safety of this device and demand new studies of the manufacturer that actually track deaths.

BMJ
http://newamerica.net/publications/articles/2011/why_the_fda_can_t_protect_the_public_42817

My personal opinion is that the VNS is nothing more than a placebo. Cyberonics touts a success rate of 33%. The success rate of the placebo effect can run as high as 35%.View Thread

Posted bydennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator Hi Candi, Right now I'm taking Felbamate, Lyrica, Sertraline & Clonazepam. The...

Vagus Nerve Stimulator

On July 2 2006 I had what I thought was a bad run of atonic seizures. My parents just...

Posted by dennisfegan

On July 2 2006 I had what I thought was a bad run of atonic seizures. My parents just happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neurologist and EMS.

My last memory of that morning was being inside of the ambulance the next thing I knew I was in the ICU.

The Vagus Nerve Stimulator was stopping my heart (asystole) every 3 minutes during the 30 second stimulation cycles. If my parents hadn't happened to stop by that day I would have died and my death would have probably just been written off as a fatal seizure or SUDEP. No one would have ever suspected it was the vns that killed me.

Once the ER doctor and my neurologist realized that the problem was cardiac and not seizures my neurologist had to ran to his office (the next building) to retrieve the equipment to deactivate the device. When the vns was turned off I regained a normal heart beat and have had no cardiac issues in the 6 years since.

The device was implanted in 2000 and I had absolutely no problems until it nearly killed me in 2006.

As of 6/29/2012 there are 1184 "reported" deaths and over 17,000 "reported" adverse events for approx. 70,000 registered vagus nerve simulators. Something is REALLY wrong with that picture.

My story was told in Reader's Digest and The British Medical Journal

Reader's Digest
http://newamerica.net/publications/articles/2010/medical_devices_that_can_kill_35911

BMJ
http://newamerica.net/publications/articles/2011/why_the_fda_can_t_protect_the_public_42817

Some samples from the FDA's adnerse events database (MAUDE

Cardiac Arrest(asystole)
http://www.vnsmessageboard.com/index.php/topic,3832.0.html

Bradycardia / Hypotension
http://www.vnsmessageboard.com/index.php/topic,3850.0.html

Tachycardia / Hypertension
http://www.vnsmessageboard.com/index.php/topic,3862.0.html

Pacemaker/ICD
http://www.vnsmessageboard.com/index.php/topic,4011.0.html

Mental Health
http://www.vnsmessageboard.com/index.php/topic,3837.0.html

Programming Discrepincies
http://www.vnsmessageboard.com/index.php/topic,3975.0.html

Increase/Worsening of seizures
http://www.vnsmessageboard.com/index.php/topic,4117.0.html

SUDEP ?
http://www.vnsmessageboard.com/index.php/topic,3833.0.html

Unexplained deaths
http://www.vnsmessageboard.com/index.php/topic,3840.0.html

1997 FDA CDRH Neurological Devices Panel

DR. PIANTADOSI: Could I just ask the FDA very directly--I'm not confused about what the company thinks, and I really am not interested in the nuances of how SUDEP is defined. Is the FDA satisfied that this device is not associated with an elevated risk of death, all-cause mortality, whatever you want?

DR. COSTELLO:............So, to answer your question, I don't believe it has been shown that the high death rate is directly related to the device. However, we only have 2,000 patient years of experience and a limited number of patients...............I cannot say that I believe that there is an increased risk right now, but I would not want to rule it out either. I think that would require a longer-term study.

Pg. 142
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

The VNS was approved 19 days after this panel met.View Thread

Posted bydennisfegan

24 Replies | Reply | Watch This DiscussionReport This| Share this:Vagus Nerve Stimulator On July 2 2006 I had what I thought was a bad run of atonic seizures. My parents just...

Women's Health Newsletter

Find out what women really need.

For more information, visit the Duke Health Epilepsy Center

Other Epilepsy Information

The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, or blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD. User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. Some of these opinions may contain information about treatments or uses of drug products that have not been approved by the U.S. Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment.

Do not consider WebMD User-generated content as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on WebMD. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. WebMD understands that reading individual, real-life experiences can be a helpful resource, but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately.