My theory of all the problems created my the VNS is that the most important nerve in the body can only withstand so much punishment. So whatever newer and approved model Cyberonics comes up is never going to solve the problems..
Say for instance the device is programmed to stimulate the nerve for 30 seconds every three minutes, like mine was, that amounts to the Vagus nerve being zapped 300,000 times annually. I don't believe the Vagus nerve, or any nerve for that matter should be subjected to that kind of punishment. My vns was implanted for 6 years when disaster struck, after one million eight hundred thousand zaps to the nerve.
Event Date 05/29/2001 Event Type Injury Patient Outcome Other; Required Intervention Event Description An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.
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
Candi, I read the 1997 CDRH Neurological Devices Panel and Dr. Piantadosi seemed to be the only person there with a brain on his shoulder. His statement below has stuck with me ever since I read it. I 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.
It is highly recommended to visit a healthcare specialist as soon as possible if a person is found to be suffering from the symptoms mentioned above. The healthcare specialist will advise many tests which would be essential for detecting the exact area of the damage and proceed with relevant treatment. The vagus nerve is one of the essential nerves of the body which performs multiple yet essential functions! The treatment also depends upon the severity of the condition. At times, the pressure on the vagus nerve releases with time, so not much of a treatment is required. However, checking with a medical professional would be able to determine the actual cause and treatment that should follow. By Shalu Bhatti Last Updated: 10/12/2011
The symptoms of vagus nerve damage vary from the area of damage to the severity of the damage that has taken place. Below mentioned are the most well known symptoms of vagus nerve damage.
Vocal Changes: As mentioned earlier, the vagus nerve meanders all the way from the brain stem to the tongue, neck, heart etc. Therefore, damage to this nerve can also result in difficulty in speaking as the movement of tongue becomes troublesome. The voice of the person may also become hoarse.
Gag Reflex: As mentioned earlier, the vagus nerve is responsible for governing the responses of the reflex range. A damage may result in loss of reflex or gag reflex which can result in choking!
Dysphagia: Dysphagia is a condition wherein a person experiences difficulty while swallowing! As the vagus nerve controls the movement of the tongue as well, its damage can also lead to dysphagia.
Digestive Problems: Another symptom of vagus nerve damage would be suffering from digestive problems like constipation, indigestion, etc.
Deafness: A branch of the vagus nerve also passes through the ear, a damage to which may result in hearing loss resulting to deafness!
Cardiovascular Problems: As the vagus nerve also extends to the heart as well as the cardiovascular regions, the damage may result in symptoms like irregular heartbeat and other cardiovascular diseases like arrhythmia. If this is the case then the patient may suffer from symptoms like chest pain, breathing problems and also dizziness.
Urinary Incontinence: Urinary incontinence is another symptom which can result from a vagus nerve damage as this nerve also innervates the bladder muscles.
As ya'll know what I thought were drop attacks actually were 30 seconds of cardiac arrest during the stimulation cycles. If you or a loved one with the device develops a sudden increase or new onset of atonic seizures get yourself to the doctor ASAP and asked to have the vns turned off before it kills you.
Examples from the FDA's adverse database _____________________________________________
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.
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.
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.
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
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.