A Watchdog group called Public Citizen has asked the FDA to recall the Cyberonics Inc. implantable depression treatment device known as the Vagus Nerve Stimulator (VNS), claiming that Cyberonics has not proved that the electronic stimulator device is effective.
In a July press release, Public Citizen called the FDA’s approval of an electronic medical device to treat depression “One of the Most Questionable FDA Decisions in Recent Memory“.
According to the Reuters News Agency, controversy over the VNS is not the only problem Cyberonics is dealing with, as they face delisting fo their stock from the Nasdaq market in a US Securities probe over stock options.
It would be a huge mistake to recall the VNS units at this point! Let the company workout the problems. If you asked the people who have the VNS installed, I’m willing to bet they would not want a recall. Depression kills!
I have a Cyberonic’s VNS Implant which has been shut off for about 2 years now,due to device malfunction.At that time the device had remained continuously on and could not be shut off with the magnet.After remaining on roughly an hour the ER Doctors had ordered x-rays and realized the device had migrated from it’s original location.They were able to move it around enough to allow the magnet to disable it. I returned to my doctor who shut it off. A few weeks later he tried to turn it back on,but I developed severe headaches as soon as it cycled.Device was again shut off,and remains off at this time.Have contacted Cyberonics about it,but have never heard from them.For some reason they have a habit of contacting my physician instead of me,when I make attempts to contact them?
The VNS implant was a HUGE mistake for me. I wish I had never had the device. It didn’t work for me to help control my seizures. I had severe sore throat and infections.I finally asked my doc to turn it off. And I had it removed and had the scar repaired. I still have the wire attached to my VN
I have a scar and medical bills. ..for nothing. I think the success rate is highly exaggerated
Recently my son died of heart failure after he had a tonic/Clonic seizure on October 18th, 2018…He had a VNS installed on December 4th, 2017. The VNS his neurosurgeon installed was supposed to be a Cyberonic 2220..That is what the box said when she gave it to me after the surgery. I had the VNS removed after my son died. It was not what the neurosurgeon had told me was installed. Instead it was by Sentiva Model number 1000. My son had an MRI on October 4th and I was contacted by the medical staff at Swedish Medical about the model and make of the VNS. I gave them the information on the box. After my son had the MRI he complained that the VNS was going off too frequently and that he was tired of being a guinea pig and wanted to have the VNS removed. I agreed !! His seizures seemed to be more severe after the VNS was installed and turned up by his Neurologist. I had to call the EMTs and have my son taken to the ER every month. We were never briefed on any complications of this VNS before it was installed. I was not told how to turn off the VNS by placing and taping the magnet over the implant and keeping it there. The autopsy and the toxicology report came back normal…His heart was healthy as was all of his other organs. I am devastated and my heart is broken into pieces. I began researching online a day after my son died…..That is when I found out that these Implants could malfunction and stop the heart instead of stopping the seizure. The medics worked on my son for three hours and put him on life support. I told them that he had a VNS implant but they said that they did not know anything about that device. His seizure was a 8:00 am and they pronounced him dead at 11.10 am. Right now I am just in a state of shock knowing that I might have been able to save my son’s life if I knew how to turn the VNS off…!! The day before my son died he was in the car with his older brother and bent forward in pain. My older son asked him what was wrong and my youngest son said it felt like heartburn. My youngest son also told his brother that he wanted the VNS out. My dead son had an appointment with the Neurologist on October 21, 2018 and I said that we would have it turned off and see about having it removed. However, it was already too late….I am angry, my grief is enormous…It was hard to even write this comment. But this device should be recalled…!! Death is not an option…It did not ease my son’s depression nor lessen his seizures. My son said it only seem to make everything worse !!!