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November 25, 2018 12:34 PM   Subscribe

The Inplant Files In 2017, one in five of all medical device adverse event reports in the U.S. was linked to a Medtronic device.
From garage startup to global dominance, Medtronic bent and broke rules in its relentless pursuit of success and denies all wrongdoing.
A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry.
posted by adamvasco (18 comments total) 30 users marked this as a favorite
 
This morning, I came across this AP article on Hacker News: Medical device that treats pain shocks, burns patients in whose comments was included a link to this Guardian story: Revealed: faulty medical implants harm patients around world.
posted by bz at 1:24 PM on November 25, 2018 [3 favorites]


So in the Star Trek future where medical devices are commonplace and safe- I think the key is that in that wonderous imaginary future we have luxury gay space communism and so without the profit margin, safety is the highest goal.

We do not have luxury gay space communism here on earth and therefore these wonderous devices... not so wonderous.

Capitalism ruins everything.
posted by Homo neanderthalensis at 2:19 PM on November 25, 2018 [8 favorites]


In 2017, one in five of all medical device adverse event reports in the U.S. was linked to a Medtronic device.

A quick look at the industry spread shows that Medtronic has between 30 and 50 percent of the market for its flagship products. So .... with only twenty percent of the reported adverse events it's actually doing better than average for the industry.
posted by Tell Me No Lies at 2:43 PM on November 25, 2018 [24 favorites]


If you have Netflix, I just watched The Bleeding Edge, a documentary by Kirby Dick and Amy Ziering that I thought did a great job of explaining the extremely weak standards for demonstrating the safety of medical devices and the consequences of that.
posted by Horace Rumpole at 2:50 PM on November 25, 2018 [3 favorites]


Ugh, this is terrifying. I know someone with debilitating chronic pain who was referred to a pain management specialist, after their primary care physician's office could no longer prescribe most opioids due to all the red tape it now requires, and immediately started getting pushed toward these devices. I'm so glad I told them that didn't seem like a good option. More surgery plus attaching a device to the spine seemed like a bad idea all around, a good way to get backed into a corner where there weren't any more options and they'd have even more pain if it didn't go well, and to find out they're not even really testing a lot of these things, which end up shocking and burning people... Just no way.
posted by limeonaire at 2:51 PM on November 25, 2018 [7 favorites]


My wife has the new Medtronic 670g insulin pump. She had already had one warranty replacement. And currently they have a serious shortage of supplies for the pump, and there are no alternative suppliers because Medtronic is very aggressive about patent lawsuits. My wife probably spends 4 hours a month on the phone with them trying to sort out screwed up shipments or defective supplies. The company is a disaster.
posted by COD at 4:18 PM on November 25, 2018 [10 favorites]


One more thing. The retail cost of using the 670g is $40,000 USD a year. That does not include the cost of the pump, which is about $9,000.
posted by COD at 4:20 PM on November 25, 2018 [7 favorites]


So in the Star Trek future where medical devices are commonplace and safe- I think the key is that in that wonderous imaginary future we have luxury gay space communism and so without the profit margin, safety is the highest goal.

In the most popular iteration of that franchise, the villains force their brand of body implants on people.
posted by Halloween Jack at 5:31 PM on November 25, 2018 [5 favorites]


I know- I'm a Trekkie. But you forget Picard's artificial heart and Nog's artificial leg. Medical devices in the Star Trek universe are commonplace and helpful.
posted by Homo neanderthalensis at 5:51 PM on November 25, 2018 [1 favorite]


I worked for Medtronic for a short while, after they bought the company I was working for. I was out sick following oral surgery when I got the call to come in and clean out my stuff because my job was gone. No, come in today.
posted by Kirth Gerson at 3:09 AM on November 26, 2018 [3 favorites]


I had a Medtronic device for the better part of a year. It worked great until it got infected, and then I had to have a third procedure to get it out (I had to have two procedures to put it in). I believe that I had to have this due to an illegal kickback with the insurance company, BCBS of Maine, because there was an outpatient procedure that worked just fine. My doctor and I challenged it and the company refused to let me continue with outpatient, insisting that it was an implant or over $1,000 per month out of pocket.

I have a bunch of other feelings about this, including that it was irresponsible to push me to do this as someone who has a compromised immune system and gets infections regularly and easily, but - the device itself was great.
posted by bile and syntax at 11:10 AM on November 26, 2018 [2 favorites]


More of this investigation is now coming out.
Breast implants study reveals serious safety concerns
Global investigation finds lack of clinical oversight and failure to track long-term outcomes.
Figures suggest at least 615 cases worldwide of lymphoma related to textured implants.
In Brazil Essure/Bayer had implants banned but this was overturned after lobbying by the company. About 1 million had been sold worldwide.
Bayer was being sued in France and will stop selling its birth control implant in USA at the end of 2018.
posted by adamvasco at 11:58 AM on November 26, 2018 [2 favorites]


My wife had a Medtronic neurostimulator implanted in 2011 to treat chronic back/sciatic pain. It was basically the only option left after many injections, physical therapy, acupuncture, several other surgeries including a spinal fusion. She'd already climbed the ladder of narcotic pain pills and was at the point where she was using Fentanyl for the worst of the pain. The device has worked to the point that she no longer takes narcotics and just needs gabapentin for occasional nerve pain, and has improved her quality of life beyond what we'd anticipated.

Neither of us doubts for a second that there can be serious complications, however, and of course the usual big pharma grifting / kickbacks / etc. would be conspicuous if absent. Ultimately, with the choices being "shady company selling habit-forming narcotics to mask the pain" and "shady company selling potentially life-changing (in a good way) device that can also lead to harmful/fatal complications", we chose the latter, but it was not an easy choice.
posted by tonycpsu at 12:21 PM on November 26, 2018 [3 favorites]


I know- I'm a Trekkie. But you forget Picard's artificial heart and Nog's artificial leg. Medical devices in the Star Trek universe are commonplace and helpful.

Don't forget Worf's 3D-printed spine.
posted by Kitty Stardust at 2:20 PM on November 26, 2018


Worf's 3D-printed spine

Premium username material right there.
posted by wires at 6:02 AM on November 28, 2018 [2 favorites]


My wife had a Medtronic neurostimulator implanted in 2011 to treat chronic back/sciatic pain.

My husband had one of these implanted last year and it has been a godsend. Its really unfortunate that it is used as a last resort instead of before something more permanent (like a fusion).
posted by LizBoBiz at 7:12 AM on November 28, 2018 [1 favorite]


I work for a medical device company (not Medtronic), and though I'm by no means glad to read about these device failures, and the continuing/increased suffering by folks with faulty implantable devices, reading the articles + thread does provide a more nuanced view to the narrative I'm fed by Corporation of, "everything we do is incredible always."
posted by yunhua at 10:06 AM on November 28, 2018


Overview all you need to know about the implant files.
posted by adamvasco at 5:10 AM on December 1, 2018


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