FDA Failing to Monitor Safety of Medical Devices

Discussion in 'Cyberonics' started by Anonymous, Nov 8, 2010 at 5:26 AM.

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  1. Anonymous

    Anonymous Guest

    OMG
     

  2. Anonymous

    Anonymous Guest

    I'ts all over the internet SHIT
     
  3. Anonymous

    Anonymous Guest

    If that BMJ article is not enough to bring CYBX down then something is seriously wrong with our goverment.
     
  4. Anonymous

    Anonymous Guest

    Me thinks the RAPTURE will come early for Cyberonics.

    THE
    END
    IS
    NIGH
     
  5. Anonymous

    Anonymous Guest

    Do you guys really think this article means anything? All devices have problems especially the people that need them. Don't always blame the devices for the outcomes. There are always several factors that include surgeon error, poor patient patient selection, programming and several other factors. This device along with the others have helped millions of patients. If it didn't really work or caused significant harm I think it would be pulled from the market. This device will be around for a long time! Mark my words!
     
  6. Anonymous

    Anonymous Guest

    954 VNS deaths listed in MAUDE (as of 10/20/10)

    102 of those deaths are classified as possible, probable, and definate SUDEP

    Roughly 1 in 100 sufferers of severe epilepsy die of SUDEP. That would mean that you would be 10 times more likely to die of SUDEP with the VNS.

    And let's not forget the 232 VNS deaths in MAUDE that do not mention a cause mentioned.

    Dennis Fegan
     
  7. Anonymous

    Anonymous Guest

    954 VNS deaths listed in MAUDE (as of 10/20/10) are only those that have been REPORTED. Doctors hate to report anything and often they lose money in the process. As lucrative as this product is, I'm sure the current reporting levels at MAUDE are WAY less than usual. If Cyberonics had nothing to hide then they would make public EVERY death of EVERY patient with vns. It would also be interesting in seeing how many units are no longer in service, but they won't publicly give that information either.
     
  8. Anonymous

    Anonymous Guest

    kiss my grits herb
     
  9. Anonymous

    Anonymous Guest

    Correction to post #6

    954 VNS deaths listed in MAUDE (As of 10/20/10)

    102 of those deaths are classified as possible, probable, and definite SUDEP

    *SUDEP is estimated to be 1 per 100 for patients with symptomatic seizures and 1 per 1,000 for patients with idiopathic seizures.

    That shows you are AT LEAST 10 times more likely to die of SUDEP with a VNS than with out it.

    And let's not forget about the 232 reports that do not mention a cause of death. How the hell can the FDA let Cyberonics get away with that? Read the reports for yourself if anyone doesn't believe me. The MAUDE reports are easy enough to find on the FDA site. The FDA's handling of the VNS is a real fine testament as to how they are protecting the welfare of the American public.


    Dennis Fegan



    *eMedicine
     
  10. Anonymous

    Anonymous Guest

    Cool
     
  11. Anonymous

    Anonymous Guest

    Rock on Dennis
     
  12. Anonymous

    Anonymous Guest

    Do you guys really think this article means anything?

    Investigative articles dig for the truth. Cyberonics has been VERY dishonest and deceptive in their marketing, training of physicians, and with the public. The BMJ article is the beginning of the shit storm.

    All devices have problems especially the people that need them.

    Partly true. But the difference is, a surgeon won't replace a hip or knee joint if the patient is over 300 pounds because it will fail. The vns has been implanted in patients who NEVER should have it. Brain injury, COPD, in BABIES! just to name a few.

    Don't always blame the devices for the outcomes.

    You need to pay closer attention.

    There are always several factors that include surgeon error, poor patient patient selection, programming and several other factors.

    This has been stated and has been considered. See previous response.

    This device along with the others have helped millions of patients.

    If you are using the current Cyberonics way of figuring this out then you are quite gullible. The ratio of actual helping vs harming begins with the total number of implants NOT the total number of active units as Cyberonics actually reports and uses as their marketing tool. But then statics are used to confuse and are easily manipulated to say whatever they want.

    If it didn't really work or caused significant harm I think it would be pulled from the market.

    ECT causes irreparable brain damage and does NOT cure depression yet it's still utilized and a moneymaker because it's "grandfatherd in." A failure on FDA's part.
    And when the entire panel at the FDA voted against the vns for depression, I thought it wouldn't pass. Ha-ha! Jokes on us, huh? That's what we get for thinking.
    The FDA has their own problems and sticky fingers. It takes too many DEATHS for the FDA to take notice or a massive expose (http://www.bmj.com/content/341/bmj.c4753.full) of the company and the FDA's failure to keep the public safe. It makes me furious when people think the vns is harmless. If you think it is, just have one implanted for fun.

    This device will be around for a long time! Mark my words!

    Are you insane? It's already obsolete. And when the shit hits the fan, you'll be out of a job and the Class actions suits will kill off what ever is left.
     
  13. Anonymous

    Anonymous Guest

    Cool
     
  14. Anonymous

    Anonymous Guest

    Rock on laura
     
  15. Anonymous

    Anonymous Guest

    Rock on Jeanne
     
  16. Anonymous

    Anonymous Guest

    Rock on Shannon
     
  17. Anonymous

    Anonymous Guest

    No need to dig around for the SUDEP reports. Got em all right here.

    http://www.vnsmessageboard.com/index.php/topic,3840.0.html
     
  18. Anonymous

    Anonymous Guest

    Let's pray the FDA acts quickly. This barbaric device has already taken far too many innocent souls.
     
  19. Anonymous

    Anonymous Guest

    You should go to sharedsymptoms.com. This is a good place to discuss these types of issues and share what you have experienced.