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Medical device safety-research before having surgery
#1
http://www.consumerreports.org/cro/magaz.../index.htm

Most medical devices have never been tested for safety (see above).


Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It’s also worth searching Google. If the results include a lot of law firms looking for clients injured by the device, that’s a sign to ask your doctor some hard questions.

For an optional device like a spinal cord stimulator, look around the Internet for patient forums. Though the information there isn’t validated, you’ll get a sense of whether patients are reporting trouble with the device.

Write down what your doctor wants to implant before you have surgery. If your doctor doesn’t give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, or if there are a large number of adverse events reported on the FDA website you’ll know whether yours is one of the problem models. Also, brand new devices are often pushed by sales reps and have yet to be proven. Be careful.

Stay alert—but don’t panic. If you learn that there are problems with your device that is already implanted, contact your doctor and ask what warning signs to watch for. Also go to the FDA website to read up on official warnings and find out whether it’s safe to keep the device in your body.

POD's (physician owned distributor) be careful. Around 20% of implanted devices used in spinal fusions in US are by a physician owned distributor (POD), where your surgeon has financial interests in the implant he is placing in you. Research where the medical device and biologics used are coming from before agreeing to have them placed into your body. More important than researching buying a car, research the device that will be placed into your body.

http://www.news-medical.net/news/2010012...t-WHO.aspx 8% of medical devices sold in the US are counterfeit.
I am not an attorney.Anything I write should not be considered legal advice.I am writing from my own personal experiences,which is not from any sort of legal background. You should consult with an attorney over legal issues. In California, if you cannot get an attorney you can consult with an I&A officer.
 
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