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LoreD

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I just finished watching this documentary about the medical device industry:

 

The Bleeding Edge: behind the terrifying new Netflix documentary.

 

The $400bn medical device industry is exposed in a horrifying look at a string of products that have wreaked havoc on patients

 

 

A terrifying new documentary carries a stark warning that a nightmare has been lurking in the medical industry for decades and it might be in your body.

 

The Bleeding Edge, which premieres on Netflix, examines the $400bn medical device industry responsible for products such as hip implants and robotic surgeons, through the lens of five products that have wreaked havoc on the lives of thousands.

 

“A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals,” director Kirby Dick told the Guardian. “We felt it was very important that the public, doctors and policymakers know about this because right now medical device companies can get away with just about anything.”

 

Dozens of people speak about issues that followed procedures involving medical devices, including women whose intestines fell out of their bodies after robotic surgery.

 

Doctors, too, come forward afflicted by the unknown effects of some of these devices. Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all over the walls and ceiling of a hotel room during a medical conference, eventually using soap as ink.

 

Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. So, Tower studied himself until he found the answer in a blood and urine sample: his levels of cobalt, a metal used in rechargeable batteries, were more than a hundred times higher than normal. Tower thought it might be related to his metal-on-metal hip replacement and had it redone. On the operating table, his surgeon found metal sludge seeping from the device before it was removed. “Within a month I had an incredible recovery in terms of my psychologic symptoms and ability to think,” Tower said.

 

Tower said he would never have believed neurological problems could come from orthopedic devices, if it wasn’t for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms.

 

Hundreds of thousands of people in the world may have been exposed to toxic metals from “metal on metal” hip implants, according to a 2012 joint investigation by the British Medical Journal and BBC Newsnight.

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I think a lot of devices are designed for good reasons and to also make money. The problem is that the manufactures of devices do not spend a lot of time nor money making sure their products will not end up causing more harm than good. This is true for devices of any kind. The computer software designer doesn't spend a lot of time  or money making sure their software cannot be hacked. The automobile manufacturer didn't spend a lot of time making sure you'll be safe in an accident just like the maker of the toaster didn't spend any time or money making sure their toaster wouldn't cause a fire in your home, etc... 

Without regulation that is. Regulations make these manufactures go back and make their products safe up front - that is the purpose of regulation. It saves lives as well as a lot more.

It would be grand if all food companies thought twice before over packaging their products in plastic. 

And regarding implant devices - we need to kill the patent rights for these things, possibly spend more at the NIH so that we can embed safety into the devices up front - and yes, share the  knowledge with the world, the soul idea being one of improving peoples lives.

 

Peace!

 

 

 

 

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I think the improvements are passed as long as the device does not exceed 10% alterations

 

 so covering the prosthetic with a new cover does not meet the guidelines for testing. The item has not be altered by more than 10%

 

 no R&D in improvements for devices that go inside me ?   again not a doctors fault, they count on the FDA to give them the tools they use/need  

 

 

I do not think giving America better access to life saving drugs still in testing was ever the the point of big pharma 

 

 I will be sure to watch it 

 

 

 

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16 minutes ago, rrober49 said:

 

I think the improvements are passed as long as the device does not exceed 10% alterations

 

 so covering the prosthetic with a new cover does not meet the guidelines for testing. The item has not be altered by more than 10%

 

 no R&D in improvements for devices that go inside me ?   again not a doctors fault, they count on the FDA to give them the tools they use/need  

 

 

I do not think giving America better access to life saving drugs still in testing was ever the the point of big pharma 

 

 I will be sure to watch it 

 

 

 

this is part of the point in sharing the knowledge and putting more money into the NIH so that we all pay upfront for the R&D. Then, let the market work, but also protect the market from monopoly - utilize anti-trust leverage over monopoly so that nobody gets too big.

 

 

 

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11 hours ago, TheOldBarn said:

this is part of the point in sharing the knowledge and putting more money into the NIH so that we all pay upfront for the R&D. Then, let the market work, but also protect the market from monopoly - utilize anti-trust leverage over monopoly so that nobody gets too big.

 

 

American population is beta testing medical devices for free  and insurance is paying for it  that's our R&D and our families are the lab rat

I try to not hate on the FDA for this  after all it is what they said could happen 

the knowledge was there and the wisdom,  let's go back to the old hard ass FDA until we can better micro manage the system ? 

 

 More to the point of cobalt

Human toxicity of cobalt-containing dust and experimental studies on the mechanism of interstitial lung disease (hard metal disease)

D Lison - Critical reviews in toxicology, 1996 - Taylor & Francis
In the industry, the potential for exposure to cobalt metal dust is particularly important during 
the production of cobalt powder and the processing and use of hard metals and other cobalt-
containing alloys. The different adverse health effects reported in these workers are …

 

 I kinda think we knew even longer that" long term exposure  or overexposure" to cobalt was a problem  and the drunken side effects are not new to man at this point

 

 

 

 

 

 

 

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