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John Oliver - medical devices in the US (California) (Califo

PostPosted: Mon Jun 03, 2019 6:11 am
by 4anewusers ... d=tcoshare

On Sunday night’s episode of Last Week Tonight, John Oliver turned his spotlight on the $156 billion medical device market. About 32 million Americans, or one in 10, have some medical device in their bodies, he said.

“Turns out the robot apocalypse was inside us the whole time,” Oliver joked. While medical devices are common, according to Oliver, they aren’t all safe—leading, he says, to 80,000 deaths and 1.7 million injuries related to medical devices each year.

The FDA classifies medical devices. While some are “FDA Approved” meaning they are tested in clinical trials, according to Oliver, the majority of such devices merely meet the lower bar of being “FDA cleared” for distribution. (There are other classifications, such as “FDA registered” and “FDA listed.”)

According to Oliver, the phrase “FDA cleared” doesn’t really mean anything. “Like when a cereal says it’s part of a complete breakfast,” he said. “Anything can technically be part of a complete breakfast. If you ingest it alongside oatmeal, granola, yogurt, and a glass of orange juice, heroin can be part of a complete breakfast.”

Finding good information about medical devices can also be difficult. According to Oliver, very few medical device failures are reported to the FDA, which he finds stunning, because “100% of rude waiters are reported to Yelp and those aren’t killing anybody.” Oliver suggests that patients have to be their own advocates and ask questions, such as how long a device has been on the market and whether it can be removed once implanted.

To help spread the word about the risks of medical devices, Oliver conscripted 30 Rock and Unbreakable Kimmy Schmidt star Jane Krakowski to remind people to beware. “Treat medical devices like guys who have played Batman,” joked Krakowski. “Some are great, but new ones aren’t necessarily better, and there are a few you definitely don’t want to let inside your body.”

See the segment above.

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Re: John Oliver - medical devices in the US (California)

PostPosted: Mon Jun 03, 2019 7:34 am
by injured7825
I've had a few doctors suggest a spinal cord stimulator and I always say no way because I cannot get Murphy’s Law out of my head, " whatever can go wrong will go wrong"

Re: John Oliver - medical devices in the US (California) (Califo

PostPosted: Sun Jun 09, 2019 2:18 pm
by 4anewusers
I would like to see patients FULLY informed before having a spinal cord stimulator implanted. Many are not told what the implantation entails and instead are told it is a very minor procedure. Provide them the same packet of directions that the doctor receives to follow to implant it and they will have a better idea.

Warning for video OPOSSUM!

Re: John Oliver - medical devices in the US (California) (Califo

PostPosted: Mon Jun 10, 2019 7:49 am
by 4anewusers
Spinal cord stimulators ranked number one with most reported adverse events from a medical device reported to the FDA recently.

If you watch the video above they describe the patients condition as 6 month post lumbar fusion when they implanted the stimulator and stated spinal cord stimulators should NOT be used as a last resort? WTF!

Even reviewing one of the top manufacturers websites on their product....they list SOME of the possible complications, but leave out one important one, death. Spinal cord stimulators fall just under heart pace makers for reported deaths. Oh Medtronic, you are so lucky the FDA website only lists adverse events for a device up to 500, then a special code is needed to view more. All manufacturers are so lucky that less than 1% of adverse events are reported to the FDA. This will hopefully change if current proposed legislation passes that makes reporting mandatory for doctors. Patient advocates are leading the fight with this legislation. ... nings.html

I am not advising against these devices as they do provide pain relief to many patients, but I would like to see patients given complete informed consent. This means letting them know part of the procedure is a laminectomy, for example. Also let them know the risks, including death.