Medical devices

Since this group is entrenched in medical intervention issues, I wanted to share a link to a movie that I saw with the Utah Film Center last night.

"The Bleeding Edge" is an exposé into the medical device industry. I know people here have mentioned getting devices for afib, and there are so many other reasons people get medical devices, I thought this would be of interest here...

Honestly, it should be of interest to everyone, as it turns out the FDA approval process for medical devices is probably not what we all think it is.... and not as good as we think it is.

[www.netflix.com]

This clip doesn't give any cases as to what happened and with what device, mostly just a scare tactic. If certain devices have done harm lets hear about it, I have a device, a pacemaker, I have read that some patients with pacers do have problems. I believe that my pacemaker, which for some ungodly reason was set to pace me at 80 bmp, and I also am quite sure that this setting caused me to have AF episodes. I met with my EP a couple of weeks ago and asked him about this, he said lets not talk about this, very shocking to me. I am looking for a new EP.

Liz

That was just the trailer... You'd need to watch the movie. I would call the movie more educational than scare tactic, but once you are educated you might be scared!

That said... the devices they chose to chronicle in the movie were the Essure birth control device, the Da Vinci surgery robot and hip replacement part ... the later was a the story of a doctor who had his fail and ended up with a severe case of cobalt poisoning.

A few other things were mentioned as well... including a mention of pacemaker or implantable defibrillator (I forgot which) that had some sort of faulty wiring that lead to numerous deaths.

The point of the movie was not so much to point out specific bad products, or to convince people that medical devices are somehow inherently bad, but to point out how flawed the approval process is, how powerful the device industry is, and how 'FDA approved' is not really the stamp of approval and safety that we'd like to think it's. Very sadly eye opening. It's worth a watch.

I spent many years in the medical device industry. I can tell you that once a device has made it to FDA approval it's ready.

You would not believe the number of requirements for a device to make it that far. This is also the reason they cost so much.



Edited 1 time(s). Last edit at 08/22/2018 05:05PM by rocketritch.

I work for a company that makes medical devices and lab instruments used by the pharmaceuticals industry, so naturally we're FDA regulated. Rocketritch is right. It typically takes years to get a medical device from first prototype to FDA approval, and a lot of drugs and devices never get approved at all. In fact, we just underwent an FDA audit. The company prepared for it for weeks, and everyone was nervous as hell about it. Not because we do anything shady but because FDA audits are rigorous, and the consequences of failing one can be severe. I watched enough of that movie to know it's a bunch of lies, half truths and distortions combined with a huge dose of sensationalism and fear mongering.

And just for full disclosure, I participated in a clinical trial for the Watchman FLX three weeks ago and had one implanted. On September 17th I'll be undergoing a TEE to confirm the device remains properly placed and leak free. If so, I'll be able to stop anticoagulants for life because I'll have the same stroke risk as someone who's never had afib. My CHADS score just won't matter anymore. I had no qualms about receiving the device.

The movie did not have issue so much with approval for new, novel devices, I'm sure, as you say, the approval process is difficult. The big issue it had was that modifying an existing device fast tracked the approval, (It seems there was name for this that I've forgotten) and that the testing of these newly modified devices was very limited, and the system of reporting for adverse outcomes nearly non-existent.

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Carey
I work for a company that makes medical devices and lab instruments used by the pharmaceuticals industry, so naturally we're FDA regulated. Rocketritch is right. It typically takes years to get a medical device from first prototype to FDA approval, and a lot of drugs and devices never get approved at all. In fact, we just underwent an FDA audit. The company prepared for it for weeks, and everyone was nervous as hell about it. Not because we do anything shady but because FDA audits are rigorous, and the consequences of failing one can be severe. I watched enough of that movie to know it's a bunch of lies, half truths and distortions combined with a huge dose of sensationalism and fear mongering.

And just for full disclosure, I participated in a clinical trial for the Watchman FLX three weeks ago and had one implanted. On September 17th I'll be undergoing a TEE to confirm the device remains properly placed and leak free. If so, I'll be able to stop anticoagulants for life because I'll have the same stroke risk as someone who's never had afib. My CHADS score just won't matter anymore. I had no qualms about receiving the device.

FDA audits are a real hassle but necessary. The company I worked for did allot of prototype work so we also got audited by potential customers as well as ongoing ones. And I would say in some cases those audits were worse than the FDA.

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bolimasa
The movie did not have issue so much with approval for new, novel devices, I'm sure, as you say, the approval process is difficult. The big issue it had was that modifying an existing device fast tracked the approval, (It seems there was name for this that I've forgotten) and that the testing of these newly modified devices was very limited, and the system of reporting for adverse outcomes nearly non-existent.

The Watchman FLX trial I'm enrolled in is an example of a modified device. If you look at pictures of the original Watchman and the Watchman FLX side by side, you can see that the changes were fairly minimal. (A description and photos of both devices can be found here.) The FLX has been approved in Europe since 2015, but nevertheless it's being required to undergo clinical trials in the US that won't be complete until 2021. Patients in the study are followed for two full years, so adverse events are being tracked and reported. I believe this is a fairly typical approval process for a modification to a previously approved device. It's still rigorous.

Fast tracking does occur, but it's the exception, not the rule, and the purpose is to get crucial drugs and devices to market faster that people will otherwise die without. It's somewhat controversial and not everyone agrees it should be allowed, but tell that to someone who's been given six months to live and the drug they need to survive won't be approved for another year. As I said, I think that movie engaged in a lot of distortions and fear mongering.

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bolimasa
That was just the trailer... You'd need to watch the movie. I would call the movie more educational than scare tactic, but once you are educated you might be scared!

That said... the devices they chose to chronicle in the movie were the Essure birth control device, the Da Vinci surgery robot and hip replacement part ...

I had a surgery with the Da Vinci robot about four years ago. I flew to New York City to have it done by someone who had thousands under his belt. I was back to work in two days. I saw my urologist that week, and he thought I was joking when I told him I had already had the procedure.