Hello again everyone:


I contacted the Producer at CBS Evening News in Washington and she would like to know the following (how large would you say the group of people is who found VNS to be unsatisfactory?).

I don’t know the number of people here who have found VNS to be unsatisfactory, do any of you know? If someone knows, I would really appreciate the information so I could tell her.

Also I have sent email to both of my Senator’s, but have not gotten anything back yet.

We are still hanging in there.



Thanks


Keith

Keith, have you tried searching through the forums? You can post follow ups or PMs (private messages) to threads/members who have obviously had bad experiences. For example:

VNS malfunction

Keith, I had left you a reply, but, now I don't see it. I am trying to figure out what to do. I was just told last week, they wouldn't remove the leads in my neck. I am very upset and was thinking of suing. After I saw your message, I got very sad.

Also, could someone help me with posting a message, I can't see the whole screeen the smilies take up more than half the screen??

Thanks!!!

Jennie

edit: I moved/merged this post into the correct thread

Keith the numbers are in the 1000's. Getting people activated can be a problem. Some just want to put it past them, some have given up in fustrastion and some don't KNOW what to do and some are just too lazy.

I know of a several people who believe VNS was the cause of the death of their loved one.

The real question is how to get Cyberonics to give up the actual numbers. They track all this stuff and they know exactly how many are implanted and still activated. I found and interesting statement from a pro-active VNS doctor on epilepsy.com. He stated there were 20,000 active VNS but over 44,000 have been implanted. If this is an accurate account, then it would certainly be reflected in the new % of success that Cyberonics is claiming about VNS even though the original studies are used as a referrance. All the deactivated VNS are excluded, and that would be over HALF!

Apologies - I inadvertantly mangled the original thread title when merging the threads.

MissJennie's original post/thread (in part responding to Keith) is located here:

New Here

My experience with the VNS is one that I'll never forget.
I had my VNS in for 1 year almost to the day. It was "on" for 8 of those 12 months.
The got the VNS into me in a matter of 2 months, it took them 4 months to get it out.
My first experience with Cyberonic was being bought breakfast at the local Friendly's. I was "wined and dined" while the rep. sold me on the idea. Rather tacky now that I look back.
I was handed a sheet that gave all the statics of sucess with the VNS, on people with seizures and a history like mine. I now have to wonder where they got those #'s from.
I was never given a book of all the side effects until after the surgery.

#1 lie- I was told that there was no chance my seizures could get worse. They might stay the same or in the best of all worlds I could become seizure free.

#2 lie - I was told that the one and only side effect people had was a horse voice when the VNS went off.

#3 lie - I would have 2 scars, one on my neck and the other would be in my armpit so it couldn't be seen. I ended up having one scar at my neck the other is on the left side above my breast. i am a very vain women, and am the first to admit it. If I had known I would have a 3 inch scar on my chest I would of said no for that reason only. The scar can be seen with any v-neck or a low scoop neck shirt.

My side effects and reason for removal.
1. seizures got worse not better. My seizures pattern has been changed forever.
I still have more now, then before the VNS was put in.
2. Headaches. (Dibilatateing )
3. facial, ear, neck and throat pain. ( I still have these pains today ever with it being removed.)
4. shortness of breath, had trouble doing anything without being all out of breath.
It felt like somebody was sitting on my chest all the time.
5.Stomach problems, They tried to tell me I had IBS, and put me on medication.
As soon as the VNS was turned off, it went away.
6. Bladder issues. Had to go to the bathroom all the time. They put me on medication for that as well. I ended up on more medications after the VNS was put in. The whole reason for the VNS was to get off some of my medications.

I’m sure there are more things but that’s all I can think of now.

We were also wined and dined- a "Cyberonic's pizza information party". Had all the pizza and drinks you can eat and drink (even asking if anyone wanted the leftovers afterwards), all the cute little cyberonics pens, pencils, notepads, magnets, etc. in a cute little goodie bag and a speech that had every one of us parents (at least 90% of us had kids under the age of 12 with a few teens and adults thrown in for good measure) wanting to have the VNS implanted into our child as soon as we could get it scheduled. There were at least 20 to 30 people there with several Cyberonics reps and adults that had the VNS implanted that we could ask questions to. We were told the only side effects were: 1. an infection (we ruled this one as ok since Scott had already developed an infection once before after surgery and antibiotics cleared it up). 2. die during the surgery (we ruled this out as a problem too because Scott has had several surgeries and he did great during every one of them 3. it might make his asthma worse (this was the only side effect that worried us but after talking to several adults and even a parent of another child that had the VNS who had no problems we discussed it with our Neuiro and was told if Scott's asthma got worse then it would be turned off and removed- eased our mind greatly). and last but no least 4. it could change his voice when the VNS came on (after hearing the adults talk while theirs was going off we didn't see there would be much of a problem- gladly trade a funny voice every few minutes for the seizures). Those were the only side effects we were told about. They (Cyberonics Reps) really hyped up the fact that the VNS could completely stop the seizures- give us a miracle! We weren't handed the patient manual until the day after it was implanted and after I signed Scott's discharge papers. I honestly thought I had researched the VNS throughly so didn't even bother reading the manual until Scott started having problems. I was completely shocked when i read all the side effects then I got extremely angry when my posts started getting deleted on Cyberonics message board and not being posted at all and every time I called Cyberonics, I was told someone would call me back but of course no return phone calls from Cyberonics. Even our Neuro and Neuro-Optic, Neurosurgeon and Cardialogist tried calling them many times and they wouldn't even call them back either.

Scott had his VNS implanted in Feb. 2000. Had the generator changed out (used the same leads and coils) in April 2003. Had it completely turned off in Oct. 2003 and then had the generator and leads removed (coils remain implanted still wrapped around his vagus nerve) in Nov.2006.

Heres Scott's long list of medical problems that the VNS caused: completely stopped his growth and weight (grew less than 1/4 inch in height and gained only 6 ounces of weight the entire almost 7 years it was implanted), caused such severe GI problems that he is now fed by a feeding tube and a feeding pump 24 hours a day, prevented him from going into puberty (he grew 3 inches in height and gained 6 pounds within 3 months of having it removed plus started puberty too), it caused Intracranial Hypertension and Papilledema, low blood pressure that required 24 hour monitoring and oxygen as needed, Cerebral Hypoxia attacks that also required oxygen as needed, severe headaches that sometimes lasted for hours and caused thousands of seizures, neck and shoulder pain, jaw pain, severe constipation even with medications (has to be cleaned out every 2 weeks or he gets impacted), slow stomach and intestines, stomach aches, bloating, ear infections (never had one in his life until the vns was removed and now has them pretty regularly), low body tempature (another "gift" of having the vns removed- doesn't run a temp even when he has a severe infection), made his already severe asthma much worse, changed his voice completely, swallowing problems, and not sure if this is the whole list or not!

The majority of these problems will affect him for the rest of his life and could even kill him. I think that the FDA should FULLY explain what "FDA approved for people over 12 years of age" really means. Allowing the VNS to be implanted into Scott was by far the worst mistake I ever made in my life. I will regret it till the day I die.

HI Fay!

:FYI: I read in the Physicians Manual that VNS is "Unapproved Use" in a person with respiratory disease/disorder. Have you read that? You may want to bring that up to your doctors. It is in the "Warnings" section of the Physicians Manual. Hang in there, and give a hug to Scott from me....you guys are troopers!

Dispatch

should we write our story here???

Thanks Dispatch.
Back in 2000 most people didn't have a computer- including me. I became a stay at home Mom after Scott's birth due to his medical problems (in the hospital too much) so we simply didn't have the extra money to buy one. I thought I had researched the VNS very well having gone to the library several times to use their computers (I googled it and visited Cyberonics website- which was the only source of information about the vns back then), called Cyberonics several times, talked to a couple of Cyberonics reps and even talked to several adults that had the vns. I also talked to 2 to 3 parents that had kids that had the vns implanted. I wasn't ever told by anyone- not even Scott's Neurologist- that there was a vns manual at all. i was lead to believe the vns was safe and had very few side effects. If I had been told about the manuals (both the docs and the patients manuals) I would asked to read them before I agreed to allow it to be implanted into Scott. If I had read the other possible side effects of the vns I NEVER would have allowed it to be implanted into him. But we weren't told- we were scammed into thinking it was pretty safe. The patients manual wasn't handed to me until after I had signed the hospital discharge papers the day after it was implanted into Scott. And even then it was tucked into the box the vns had came in along with the two magnets. Nobody ever told me about it. I found it- and read it from front to back- when Scott started refusing to eat and drink, started experiencing severe stomach aches and starting losing weight. After Scott lost 21 pounds he didn't have to lose (and the GI found several deep ulcers in his stomach) he had to have a feeding tube placed. A very close friend gave us her "old" computer when she bought herself a new one (she got tired of babysitting my other kids while I went to the library to use their computer) so I started surfing the net to see if anyone else was having the same problems. I ended up on the Cyberonics message board (the only website available about the vns back then) where I met Donna (Birdbomb). We were going back and forth with posting our problems (including a few other people) who were also having problems. Within a couple of my posts I noticed a lot of my postings to the board weren't being posted. I started reposting my posts but they would never get posted. The few replies that did get posted got a canned answer to my questions and it wouldn't let anyone else post their answers to my questions. A week later Cyberonics permanently shut down their message board. Thank God Donna started this message board almost immediately after Cyberonics shut down theirs. NOTHING is hidden on this board about the VNS. It is ALL TRUE and includes the links to where the source of the information came from.

Hi Momofky! I'm wondering the same thing. Not sure if this is where we post it or not to be honest with you. I posted ours here after Petunia posted hers. Am hoping that either Donna or Bernard will answer your question soon. Hugs, Fay

If you have already posted your your story in Your Story no need to do it here, just create a link back to it.

If you haven't, first create a thread there, then link back here. That forum is for member views only, guests cannot see it and personal stories such as ours really need to be in a more secure forum.

If reporters come investigate, they must first contact me .

hello fay!! it's so nice to see you here again!! :bigarmhug: :) i was thinking bout you!!!! :) hope all is well..
donna, i want to write another story about kyle b/c the one that i wrote was when ky first had his vns implanted.. before he started to do poorly with it and ending in removing it!!
can i rewrite a new one in the my story forum and post it here???
i want to help in any way i can~

I would prefer it to be in the above mentioned forem for security measures. Too may trolls : Sign043 :

:huh: Oops! Did I screw up?!

Nope! :rolleyes:

Kay!

Hello! My heart goes out to you and your family. It seems it is common practice for us patients to not be fully informed. I, like most of you all, never received the Patients Manual until after I was inplanted. I did read my Patients Manual, but I was still very drugged up, and missed the very important information in it. If I woul;d have had it prior to inplant, I would have never been inplanted. I recently got my hands on the Physicians Manual. None of the websites CYBX referred me to gave me any information that I wasn't an appropriate candidate, not even their DVD I got, the book "Out Of The Black Hole" by Charles Donovan, or any literature. I, like you and many others, counted on my doctors and CYBX, and believed in the information they provided. After all, CYBX was in constant contact with me until shortly after my inplant. And I was told they were in this for the long haul with me. This is all a gross injustice to all of us who have endured horrible experiences with the VNS whether it was for TRD or Epilepsy.

Have a wonderful day! :D

Dear Keith & others,

If you can bring Cyberonics under a subpoena, and ask them how many people have been implanted etc. they should HAVE to give that information to a lawyer. I support anyone who has had a bad experience from the VNS to attack Cyberonics!

Again, it is wrong of any agency to not reveal problems with this device that other patients have had as a result of the VNS!! It's just like a drug that has a bad side effect; that the FDA/drug company doesn't want to to list, as that would makes sales drop! It's all about money.

Keith, you could write an article to your local paper, and you could write to the FDA as well.

What else can we do, or can I do anything to help you? Have you told your physical problems to your insurance company, I certainly would tell them of your difficulties with this device. You also print out the stories that people have written here on the VNS, that are life threatening.

I support you. If you take this to the courts, you can subpoena(Cyperonics) someone, and they HAVE to show up as part the subpoena, or they can get in more legal trouble. I had to do this with a doctor in the past. He wouldn't call me on the phone, so I went to court and subpeoned him to court. He was there. If the person that has been issued a subpoena doesn't come, your case is favorable to you. In other words you win your case.

Again, please tell me what I can do.

Sincerely,
Bonnie

ok i don't know if i'm writing this in the right area,but here goes..


kyle was a 14 yr. old teenager with epilepsy he would have many grand maul seziures anywhere from 2-3 weekly.. we had tried so may meds. with all of them resulting in failure over a period of time. we had decided to do the VNS after hearing how wonderful it was and how we owed it to him to try, seeing as it works GREAT in patients with MJE (juvenial myocolic epilepsy) and that he was a great canidate.. they would tell us how children just like kyle after having it implanted would be near SEZIURE free and the only few side affects they had to deal with was a little tickle in the throt and maybe some coughing, a voice change ONLY when it's going off,but those go away over a period of time... we did alot of research on the vns and of corse the "nurse" and dr gave us all of the pretty purple pens,paper,and info. even videos to watch on how the vns has IMPROVED these peoples lives .... ..we were so EXCITED for kyle and he could not wait to have this Life changing device that would let him have a new lease on life..so after careful considerations and lots of reading we as parents and as a family decided to have kyle's dr.ordered the surgery we couldn't wait for this for him...everything moved so FAST we met with them in march by june kyle had the vns implanted!!

The day of surgery we were so excited for him. kyle went in had the implant and woke up talking a little funny, nothing big. we knew that was going to happen and it would go away over a period of time? while he was in recovery the "nurse" met with us and handed us the users manual..going over it with us, all along my family and i are thinking "oh wow why are we getting this NOW"??? that night he had a seziure.. still nothing big he has epilepsy so we expected that he just went thru surgery.. ??
well as time went on and kyle was adjusted ,adjusted and adjusted almost weekly.. like we were told to do so the vns would work GREAT for him and he would find his 'sweet spot" it worked VERY well and we were so happy.. only for about month or so. and then the vns slowly showed it's UGLY NASTY, VICIOUS SIDE . over a period of time.


by mid november kyle was having a HUGE increase in seziures!!! he could hardly breath he was chocking,gagging,his ear was hurting he had jaw pain he coughed ALL the time.. i even took him to the dentist b/c he comlpained of his jaw hurting so bad.. of corse the dentist said all was good..HUMM. he had a hard time eating and drinking it was getting pretty bad... we were asking the dr all along what should we do??? she sent us to the "nurse" ( i say "nurse' b/c i know he was a cyberonices rep. ) to adjust and the DR.increased his meds. 3 times the amount kyle is on adavin and zongran, she put him on 12 mgs of adavin (that is insane) he was so stoned and could hardly function.. :(
well by the end of november kyle was having GRAND maul seziures almost daily!! he was having them at any time of the day,
he developed a pattern at night it was always at 4 am. and that set the day, after that it was 6:50 am,then again at 11 am ,noon,3 -6 and so on..we were told by the "nurse" (cyberonices troll) "oh mrs holmes kyle would be having these with or without the vns.. he has epilepsy,and it very complacted.. we have to adjust,adjust and adjust again!! we'll figure it out!!! (really i didn't know that ) so we did EVERYTHING the "nurse" said to do UNTILL
the first of december kyle was a MESS he was living on the sofa,recovering from a seziure or having one! it was all day and night!! before the vns he had a life. he had seziures,but still was able to function and have somewhat of a teenager's life
this was so sad to see him like this !! he was gagging,turning a grayish green color and not being able to breath! he could not eat right b/c he would cough so bad it would prevent him from being able to swallow!! his voice sounded BAD all the time!!! he would have to stop in a sentence till it was eaiser for him to talk.... and the worst of all of the side affects were ,THE seziures were so much different then the ones he had before the vns they were VILOENT! the ones in his sleep scared me to death i would hear him and run to his room sometimes sleeping in his room he would bury his face in the pillow and almost smother! thank god we ALAWAYS heard him.. god knows... ?? :angel:
by 12-04 i DEMANDED the VNS to be shut off! i called over 30 times that day NEVER HEARD A WORD from them i was crying and begging them on the voice mail to shut it off!!! NO ONE ever called back! they left us out there on our own with my son having non stop seziures ,gagging and turning gray/green

on 12- 04 kyle's aunt and i took poor kyle in the car traveled almost an hour (that's how far we live from the dr) all along he 's having seziures in the car.
we MARCHED in i told them SHUT this thing off NOW!! they told me "you do understand mrs holmes we do not know what will happen he may go into a seziure and not come out!! but that's on you it's your son and your decision"...
i knew as his mother and something was telling me "no it won't turn it off otherwise he's going to get worse or it's going to kill him"..so on 12-04 -07 at around 2pm kyles VNS was SHUT OFF, kyle stopped having seziures,his color came back and he was ok.. at that instant in the hospital looking at my poor helpless son while his head was hanging lifeless in the wheel chair i knew the VNS was DONE and we were getting it taken out... i HATED it at that point i HATED them MORE for all the lies they fed us. preying on our despration and our poor helpless son. they fed him a life that he will never have and they PLAIN out lied so much it makes me ILL... he was 14 at the time looking forward to a new life and it was all based on lies. In the am of 12-04 he was the sickest he has ever been in his ENTIRE life, and after it was shut off slowly he regained some normalcy.the seziures stopped with the exception of a few,but NOTHING like it was when it was on..
so now we decided to have this thing removed..
the dr and "nurse" DROP us and we are no longer a patient of there's so there goes the surgeon that put it in ,we needed her to take it out..our calls were NEVER returned...we called and called asking them to take it out.. NOTHING !! that was the end of the "nurse" and dr. and surgeon.. GONE!! just like that!!

so we took him back to his old dr. at the Cleveland clinic..there we met with the nurosurgeon and was told kyle should have never been activated at the time of surgery.??? humm more BULLSHIT.. so all was moving along we were having this thing removed!
2 weeks before the removal a CYBERONICS rep calls my house telling me to give it one more chance and the seziures he was having was a NOT to blame on the VNS!!
i told her :Censored: i'm sorry but that thing ROBBED him of his life and shattered his hopes and dreams and she can go :Censored: :Tantrum: anyways..
that day kyle started having more seziures.. and a few VERY weird symptoms his tounge and throut was BURNING!!!!!!
OMG i was so worried his nerve was being FRIED! and he was going to have permant damange! so here we go again back to the hosptial to have test's done he had a CT and EVERYTHING came back normal.. the symptoms started a seziure pattern, again at 4 am..
well it only lasted a few days i took him to his nuro, and he did a test i SWORE that damn thing turned itself back on.. they tested it. it wasn't on ,but the seziures stopped and the "weired symptoms" went away too???

hummm i don't know ,but call me crazy for thinking they have more control over that thing than we will EVER know!!!
everything stopped and kyle's symptoms went away..
on 03-20-08 kyles VNS was removed! ALL of it ,the coils and all!!!!! we are thanking god and all the angels that it's over and and that DAMN thing is out of him!!
i hope and pray no child and parents have to suffer and go thur anything like what some of these patients go thru... living with epilepsy is ENOUGH,but when bad gets worse.. it's a LIVING hell and in my opinion cyberonics are very evil people and will stop at noone and money is there motive..
and something has to stop this before more innocent people and children suffer!
btw kyle has gone almost 6 weeks seziure free.. and is only on 2 mg.s of adavin and his zonagran...we hope and pray everyday he continues to do so well....
god be with you all!! :angel:

Hi Keith,

You have my support. My daughter had the vagus nerve stimulator implanted in 2004. There was no improvement in Laura’s seizures; they actually worsened. In June of 2006 my daughter, Laura, died suddenly. I requested an autopsy. The medical examination stated she was dead before she hit the ground. Other than a seizure disorder, Laura was in good health. The medical examiner has listed the cause of death as “undetermined”. We submitted the vagus nerve stimulator to the FDA to determine if the device had malfunctioned. After repeated requests of getting the VNS read for its vital data, our efforts were to no avail. I have seen my daughter have many seizures; I know the after effects and the signs of seizures. On the night Laura died, there were no typical signs of her seizures. It is now April, 2008 and I still have no answer as to my daughter’s death. I believe there have been many deaths and/or injuries attributed to the VNS device. For everyone that has had a problem with the VNS, please help us.

Hello Laura's Mom. My whole heart goes out to you. I am so sorry about Laura's death. I cannot even begin to imagine the pain you have experienced (and always will).
Laura's death is much like Scott's (my son) best friend, who died in March 99 in her sleep at the age of 11. Her death was ruled as sudden unexpected death of epilespy. Her vns is still implanted in her chest. Her parents refused to allow it to be removed because they knew it's what caused her death and they didn't want Cyberonics to get it back to test it then deny it caused her death. Like Laura, Jo-Jo was healthy and had no other medical problems besides "a seizure disorder". Within a few months of having her vns implanted her parents noticed that when she was sleeping she'd sometimes stopped breathing. Every time they brought it up to the Neuro her vns was adjusted. It wasn't long before she'd stop breathing for longer periods of time and her skin started turning bluish gray during these episodes. The docs (and Cyberonics when she called them about it several times) blamed it as seizures in spite of both her parents knowing that she had never stopped breathing or turned blue during seizures before the vns was implanted. In fact her tonic clonics had never lasted more than 2 minutes each and she'd never had a nonstop seizure or had a cluster of nonstop seizures either. They finally got an appt to have a sleep study done but Jo-Jo died a few days before the test was to be done.
How old was Laura when she had the VNS implanted? I hate to say this but there might not have been anything wrong with her vns but her death being from vagus nerve damage caused by her vns or a side effect of the vns instead. Everything falls on deaf ears at Cyberonics and the FDA. The FDA will make a report, but that's all they do. They seem to pretend that all these problems (including deaths) aren't happening while Cyberonics simply denies all of it and blames it on something else. Have you checked the FDA MAUDE reports to make sure Laura's death was reported? Hugs, Fay