Public Citizen Watchdog Urges FDA to Recall VNS
September 6, 2006
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.
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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?