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karenben
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« on: October 03, 2014, 05:18:02 AM »

Hi,

I am a new member but have been reading here for awhile. My son, now age 10, had a VNS put in last May. He has had intractable seizures for 5 years ( sz. started at age 5) and we have tried nearly everything ( keto diet, steroids, neurofeedback, many supplements, 15 meds, etc.) and so VNS was a last resort.

Unfortunately, it has not helped, and when we turned it off to see if it was worsening things, it appeared to be making things worse. I am ready to take it out but our docs want us to try again, more slowly, turning it up every 3-4 weeks instead of every 1 weeks. I am still on the fence about this. I realize that sometimes improvements can take awhile to see, but what if you are seeing worsening…might it not continue to get worse?

Anyway, I have read enough of the horror stories that I am inclined to get it taken out. However, our neurosurgeon recommends only taking out the generator. Apparently, the FDA is now saying one can do an MRI with the leads in. I wonder if we do want all of it out, if anyone has recommendations for which surgeons have experience taking out the generator and leads. I cannot seem to find any names of peds surgeons who do this. Or am I being too anxious about leaving in the leads. In our world, in which electromagnetic frequencies are more and more ubiquitous, I am worried about the longer term effects of leaving the coils in.  Any thoughts? Thanks for reading this!
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dennis100
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« Reply #1 on: October 03, 2014, 06:51:35 AM »

Keep it turned off, karenben. For some reason doctors encourage their patients to give the VNS a little more time to work. After years of seeing no improvement I asked my neurologist to disable to device. He suggested  I give it more time to work. Being a good patient I took his advise. It didn't make sense to me but I trusted my doctor. About a year later I developed what I thought were atonic seizures. Turns out what I thought were atonic seizures actually were 30 second heart stoppages (asystole) that occurred during the 30 second stimulation cycles. I've had no further cardiac problems since the device was turned off in the emergency room 8 years ago. My story was told in Reader's Digest and the British Medical Journal.

Reader's Digest
http://www.vnsmessageboard.com/index.php/topic,4490.0.html

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

I certainly wouldn't trust anything the FDA says regarding the MRI issue. How can it be dangerous one day and safe the next? My personal opinion, the whole point of the VNS is to create nerve damage in hopes of killing us via vagal inhibition. The FDA doesn't care if the damage was created by the VNS or MRI. They just want it created.

It's been a little slow on the board lately. I hope other members chime in on this one.
« Last Edit: November 19, 2014, 02:18:57 PM by dennis100 » Logged
karenben
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« Reply #2 on: October 03, 2014, 03:11:42 PM »

Yes I would like to hear from others, too. Did you have your removed?
Do you know of docs who do the full removal ? Why do you think the Feds are trying to kill epileptic people ( or depressed ) people?
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dennis100
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« Reply #3 on: October 03, 2014, 11:35:51 PM »

As stupid as my theory sounds, it's the conclusion I came to as for why the FDA is not protecting us from that deadly device. I had the generator and leads explanted. All that remain are the electrodes which are encased in scar tissue and would be too dangerous to remove.

We have some members who had the device completely removed. You will have to wait for their feedback on that one.  

BTW- What happened to me has happened to many others.
http://www.vnsmessageboard.com/index.php/topic,3832.0.html

You need to ask yourself: Why is VNS indicated for treatment resistant stuff and disorders in the elderly?

Alzheimer's Disease
http://www.ncbi.nlm.nih.gov/pubmed/12444809

Autism
http://www.ncbi.nlm.nih.gov/pubmed/20515333

Burn-induced organ dysfunction
http://www.ncbi.nlm.nih.gov/pubmed/19482432

Chronic heart failure
http://www.ncbi.nlm.nih.gov/pubmed/23229137

Gut injury and lung permeability in trauma-hemorrhagic shock
http://www.ncbi.nlm.nih.gov/pubmed/22846937

Medication-refractory mental illness
http://www.ncbi.nlm.nih.gov/pubmed/12059125

Mood disorders in elderly population
http://www.ncbi.nlm.nih.gov/pubmed/19519563

Postoperative cognitive dysfunction in elderly patients
http://www.ncbi.nlm.nih.gov/pubmed/19631475

Severe mental diseases
http://www.ncbi.nlm.nih.gov/pubmed/23266132

Traumatic brain injury
http://www.ncbi.nlm.nih.gov/pubmed/22695423

Others
http://www.vnsmessageboard.com/index.php/topic,3933.0.html

I had never even heard of the VNS until after I was told I wasn't a candidate for brain surgery. Seems like my doctor should have at least mentioned the VNS before he sent me out of town to be evaluated for brain surgery.

« Last Edit: November 19, 2014, 06:15:02 AM by dennis100 » Logged
dennis100
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« Reply #4 on: October 06, 2014, 04:50:27 AM »

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164

More
http://www.vnsmessageboard.com/index.php/topic,4142.0.html
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dennis100
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« Reply #5 on: October 06, 2014, 11:08:35 AM »

When death results from vagal inhibition, there are no characteristic postmortem appearances. The cause of death can be inferred only by exclusion of other pathological conditions, and from the accurate observations by reliable witnesses, concerning the circumstance of death.

http://healthdrip.com/vagal-inhibition/
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dennis100
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« Reply #6 on: October 06, 2014, 12:03:14 PM »

1997 FDA CDHR Neurological Devices Panel

Okay; finally, does vagus nerve stimulation work? Does it reduce seizure frequency in patients with medically-refractory partial seizures? And here is a summary of the results from the E05 study. I'll start up here on the upper right. The primary efficacy endpoint of this study was a comparison of the average change in seizure frequency between the high and low stimulation groups. And the decrease was 28 percent for the high stimulation group; 15 percent for the low stimulation group; and the difference between the two groups was statistically significant, confirming the study hypothesis.

pg. 60
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

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

The next issue which I would like to address is the long-term data. As can be seen in the extension phase of the XE5 study, here are the results of the randomized, controlled trial and then followup at 4, 6 and 9 months. Both the mean percent change and the median percent change during the extension phase showed approximately a 30 percent seizure reduction for these patients. However, this data is confounded by the fact that the patients were changing their medications during this period.

Similarly, despite optimal antiepileptic drug therapy, only 20 percent of the patients in the extension phase, using a last visit carried forward analysis, had 50 percent or greater reduction in seizures. One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.

pg. 130
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf
« Last Edit: October 08, 2014, 05:39:05 AM by dennis100 » Logged
dennis100
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« Reply #7 on: October 06, 2014, 12:15:25 PM »

It's possible the VNS is an open secret in the medical community. Keep quite and don't screw it up or we take your license away.

Model Number 102
Event Date 04/01/2005
Event Type Injury Patient Outcome Required Intervention
Event Description
It was noted in (b)(6) 2005 that the patient was going to undergo repositioning surgery to have it moved closer to the skin surface so the generator could be communicated with. No additional relevant information has been received to date. It was noted that the patient's neurologist and surgeon are no longer in practice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3759661

My VNS doc is no longer in practice. Just a funny coincidence I guess.

Model Number 102
Event Date 01/01/2014
Event Type Malfunction
Event Description
The patient's husband reported that the patient's depression has returned and they are unsure if the device is working. The patient's physician went out of business and the patient and husband are looking for a new physician to check the vns. The patient's husband reported that the device was last checked about six months ago. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800731
« Last Edit: October 08, 2014, 07:14:04 AM by dennis100 » Logged
dennis100
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« Reply #8 on: October 06, 2014, 12:45:51 PM »

Once a medical device has FDA approval it then becomes part of the protocol for the condition it was approved. Doctors are free though to prescribe a FDA approved device for just about anything they wish. The term is off-label use.

« Last Edit: November 11, 2014, 02:17:51 PM by dennis100 » Logged
dennis100
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« Reply #9 on: October 06, 2014, 01:39:02 PM »

Event Date 03/25/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. It was reported that the patient was walking into a room and simply dropped dead. Treating neurologist indicted that the death may be cardiac-related, but is not sure as autopsy results are pending. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043
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dennis100
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« Reply #10 on: October 08, 2014, 08:18:30 AM »

Event Date 03/03/2008
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that during surgery to replace a pt's generator, the pt experienced five episodes of asystole. The events resolved spontaneously without intervention. The events corresponded to the generator on time. The generator was programmed off and the events resolved. The pt at their postop visit had the generator programmed onto a lower setting and did not have a reoccurrence of the asystole event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1021157
More
http://www.vnsmessageboard.com/index.php/topic,3842.0.html

Model Number 103
Event Date 07/10/2013
Event Type Death Patient Outcome Death
Event Description
It was reported that the patient's settings were increased from an output current of 1. 5ma to 1. 75ma, and that the patient passed away the next day. Per the initial reporter, the patient passed away from cardiac arrest/seizure related. This physician believes that it was sudep, but this was not confirmed. The physician did not specify if there was a relationship between the death to vns and did not provide any additional information. Follow up with the patient's treating neurologist found that he was unaware of the circumstances surrounding the patient's death and did not know the cause or relation to vns. He stated that it occurred the day after the patient's settings were changed; however, could not comment on if there was a relationship or not. The patient's body was cremated and no autopsy was performed. Follow up with the funeral home found that they could not confirm if they still had the patient's vns device and would not be able to return it to the manufacturer. No other information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3298903
More
http://www.vnsmessageboard.com/index.php/topic,4155.0.html

Model Number 101
Event Date 05/02/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that after increasing programmed parameters, the pt experienced a choking sensation. During the episode, the pt's eyes became dilated and pt passed out. Treating neurologist was unable to get a pulse for a short period of time, but reported that the pt regained consciousness after prgrammed settings were reduced to original parameters. The pt was sent home in good condition after resting in the doctor's office. It was reported that programmed parameters were increased due to an increase in seizures activity; however, investigation to date has been unable to determine whether the increase was above pre-vns baseline frequency. At follow-up office visit two days later, device diagnostic testing with within normal limits, indicating proper device function. Normal mode output current was reduced from 1. 25ma to 1. 0ma.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=613869
More
http://www.vnsmessageboard.com/index.php/topic,4261.0.html

I reviewed all the reported VNS adverse events (25,000+) in FDA's databank. They are categorized and posted here:
http://www.vnsmessageboard.com/index.php/board,79.0.html
« Last Edit: November 17, 2014, 08:20:20 AM by dennis100 » Logged
karenben
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« Reply #11 on: October 10, 2014, 01:14:36 AM »

 I appreciate all the data and have read much of it. We have it turned off and now I am trying to get names of VERY good doctors who will explant the whole thing. Can anyone help me with that?
And Dennis, I do know of many people that have been helped a lot by the VNS ( sz. reduction). Why does it work well for some and not for others?
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dennis100
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« Reply #12 on: October 10, 2014, 02:13:35 AM »

Placebo effect: Also called the placebo response. A remarkable phenomenon in which a placebo -- a fake treatment, an inactive substance like sugar, distilled water, or saline solution -- can sometimes improve a patient's condition simply because the person has the expectation that it will be helpful. Expectation to plays a potent role in the placebo effect. The more a person believes they are going to benefit from a treatment, the more likely it is that they will experience a benefit.
http://www.medicinenet.com/script/main/art.asp?articlekey=31481

<a href="http://www.youtube.com/watch?v=udJ31KKXBKk" target="_blank">http://www.youtube.com/watch?v=udJ31KKXBKk</a>
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dennis100
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« Reply #13 on: November 17, 2014, 04:11:40 AM »

Let's face it, our medical condition is disgusting to the general public. There is an instant reaction when the word "epilepsy" is mentioned. If you haven't noticed, try it. Tell someone you have epilepsy and watch what happens. They will try to get as far away from you as possible.

People avoid you. Maybe it's because they fear actually witnessing a seizure or possibly catching epilepsy if they get too close. Who knows? When was the last time you saw a television ad seeking funds to cure epilepsy? I'll answer that one. You never did. I see ads for breast cancer, muscular dystrophy and multiple sclerosis all the time but never epilepsy. If 1 in 100 actually suffer from epilepsy then we deserve a little air time ourselves. Whenever seizures or epilepsy is mentioned on television it is always done in a mocking way. Why is that?

If government found a sneaky way to make us disappear wouldn't they do it?
« Last Edit: November 19, 2014, 09:44:53 AM by dennis100 » Logged
dennis100
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« Reply #14 on: November 17, 2014, 07:59:23 AM »

Vagus Nerve Stimulation for Rheumatoid Arthritis: Interview with Anthony Arnold, CEO of SetPoint Medical
by Janelle Chang on Nov 16, 2012 • 11:14 am

SetPoint Medical based out of Valencia, CA presented at the ACR annual meeting this past weekend and highlighted positive first-in-human results from an open label pilot study focused on RA. The study results suggested that by stimulating the vagus nerve using a commercially available neuromodulation device, the inflammatory reflex can be regulated to improve “clinical manifestations of rheumatoid arthritis (RA)”. Although the study used a commercially available device, SetPoint is developing a proprietary neuromodulation device which is smaller and more compact, allowing it to be implanted directly on the vagus nerve. The device is also designed to be programmed using an iPad, eliminating the need for a custom programmer like other neuromodulators on the market. It is also projected to be more cost-effective over currently approved drugs to treat RA. Medgadget interviewed Anthony Arnold, CEO of SetPoint Medical (via phone) to discuss this new product, treatment, and the company’s focus for 2013.

http://www.medgadget.com/2012/11/vagus-nerve-stimulation-for-rheumatoid-arthritis-interview-with-anthony-arnold-ceo-of-setpoint-medical.html
« Last Edit: November 17, 2014, 08:11:51 AM by dennis100 » Logged
dennis100
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« Reply #15 on: November 17, 2014, 08:10:15 AM »

Comorbid Personality Disorders
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01119053

Obesity
http://www.ncbi.nlm.nih.gov/pubmed/20600417

Severe anxiety disorders
http://www.ncbi.nlm.nih.gov/pubmed/23245749
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dennis100
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« Reply #16 on: November 17, 2014, 08:11:31 AM »

Neurosci Lett. 2011 Apr 20;494(1):70-4. doi: 10.1016/j.neulet.2011.02.059. Epub 2011 Mar 6.

Vagus nerve stimulation inhibits heroin-seeking behavior induced by heroin priming or heroin-associated cues in rats.
Liu H1, Liu Y, Yu J, Lai M, Zhu H, Sun A, Chen W, Zhou W.
Author information
Abstract
Vagus nerve stimulation has been used for the treatment of neuropsychiatric disorders, such as epilepsy. However, little is known whether it is also effective for the treatment of heroin dependence, in particular for relapse to heroin seeking. In the present study, we investigated the effects of vagus nerve stimulation on reinstatement (relapse) of heroin-seeking behavior induced by heroin priming or heroin-associated cues. The rats were trained for heroin self-administration for 14days and followed by extinction training in which heroin was replaced by saline and heroin-associated cues were turned off. In addition, animals were also received daily electric stimulation of vagus nerve (30Hz, pulse width of 0.5ms, 0.5mA (low-intensity) or 1mA (high-intensity); 30s on, 5min off; 10 continuous cycle per day) or false stimulation during extinction training. We found that such vagus nerve stimulation significantly inhibited heroin priming (0.25mg/kg, s.c.) - or heroin-associated conditioned cue-induced reinstatement of drug-seeking behavior, when compared to false stimulation control. Further, such a behavioral inhibition was correlated to a reduction in the expression of FosB and an increase in the expression of phosphorylation of cAMP response element binding protein (p-CREB) in nucleus accumbens. The data suggest that vagus nerve stimulation may inhibit heroin- or heroin cue-induced relapse, possibly by regulation of the expression of Fos and CREB in nucleus accumbens.
http://www.ncbi.nlm.nih.gov/pubmed/21362452
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dennis100
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« Reply #17 on: November 19, 2014, 02:09:55 PM »

How can damage to the vagus nerve cause immediate death?
Cardiovascular Health Questions
Answers.com>Wiki Answers>Categories>Health>Cardiovascular Health

Best Answer

Nervus vagus belongs to parasympathetic nervous system which inhibits the contraction of heart, decreases its excitability and frequency of generated nerve impulses in heart. By overstimulating n.vagus these effects on heart are more intense - it could lead to total inhibiton of heart contractions, which would eventually lead to death within a little while.

Very intense slap behind ear or intensive pressure on neck area could lead to death as n.vagus is overstimulated. It is very rare though.

http://wiki.answers.com/Q/How_can_damage_to_the_vagus_nerve_cause_immediate_death

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