Medical Devices: Last Week Tonight with John Oliver (HBO)

we're going to talk about medicine you know the thing that Doogie Howser pretended to be able to practice leading to 92 deaths and life in prison yeah that's how the show ended you didn't watch long enough specifically we're going to talk about medical devices the modern-day miracles so that range from contact lenses to pacemakers that keep hearts beating to hip replacements that can transform lives as this woman will tell you in a solemn testimonial I was very frightened to don't do a hip replacement I really didn't want to do a hip replacement and she got to hit replacement she's better than no I can't be a loser for that fascinating Maceo she's dancing as if she never got a hip replacement you know admit it you didn't see that story ending with a breakdancing group of 50 year olds called and this is true moms into hood and you're gonna be even more surprised when I tell you they're actually here tonight please welcome moms into her [Applause] we're not here you think they're coming to a post game of thrones HBO got better places to be it would be a waste of their valuable time the medical device industry is huge they constitute a 156 billion dollar market in the US and more people have one than you might think about 32 million Americans that's one in 10 have at least one medical device implanted in their bodies that's right all these years we've been waiting anxiously for the robot apocalypse and it turns out the robot apocalypse was inside us the whole time and what medical devices can undeniably do tremendous good and save lives they can also cause real problems and you're probably aware of some of them thanks to personal injury lawyer ads like these have you or a loved one had complications after a knee replacement or revision surgery have you or a loved one had hernia mesh implanted specifically for hernia repair have you or a loved one had an IVC filter implanted to prevent blood clots from reaching the lungs have you or a loved one developed a drug resistant bacterial infection or superbug after undergoing an ERCP procedure using a duodenum scope yes actually yes I do have a loved one who's developed a drug resistant bacterial infection or superbugs after undergoing an ELC procedure using a tuhoe Dina scope the card categories at hallmark have gotten so specific I had options on that one now what well it's easy to roll your eyes and ads like those the problems that they are citing are very real medical devices can malfunction sometimes in horrifying fashion just imagine a defective defibrillator painfully shocking you multiple times or a malfunctioning insulin pump giving you the wrong dose well both of those things have happened in fact a massive recent investigation found that 80,000 more than 80,000 deaths and 1.7 million injuries possibly linked to medical devices were reported to the FDA in the past decade and while you'd naturally assume that medical devices are extensively tested before they're put on the market that is not necessarily the case even devices that go inside you may never have been subjected to a clinical and don't feel bad if you're suddenly surprised by that one research have found that many doctors aren't aware of this either we were surprised to see how little surgeons knew in our study about the approval process for devices that some of the surgeons seem to think that well the FDA at taking care of this that of course these devices had been tested in humans that's terrifying even your doctor may not know that you're essentially being treated like a guinea pig and nobody wants to be treated like a guinea pig unless it means you get your own hanging water bottle that you can suck on from your bed which actually sounds completely delightful to me so tonight let's talk about how medical devices get approved and before we start that the nature of this story means that there are two clips that you gonna see that are a little gross so before each one I'm gonna say a safeword opossum and flashing on screen with a sound effect like this basically whenever you see that if you are squeamish you will know to look away and now that you have been fairly warned let's begin for many years medical devices were hardly regulated at all instead the FDA produced sternly worded public information messages like this today's doctor's drugs and medical devices truly work medical miracles for young and old alike but there are some as phony as a $3 bill like this Zehra applicator for example which has claim to cure arthritis with z rays there are no Z rays he was right of course Z rays wouldn't be discovered until 2011 when they were identified as the powerful sexual radiation emanating from Zayn Malik who your disease feel disease right now burrow into your soul but in the 1970s Congress passed a law giving the FDA the authority to approve medical devices and you might assume that on the basis of that every single device you see is FDA approved but in fact far more of them are instead something called FDA cleared and that is a distinction with a big difference because FDA cleared is a much lower bar to clear you've probably seen the phrase FDA cleared on products like this anti aging laser treatment but it can mean very little even the Sharks on Shark Tank know this watch their response when someone pitch them an acupressure band and tried to pull the whole fda-cleared card Iran is there any proof that this actually works it's an FDA cleared medical device that's not on that cubes is right I mean when is he not but my man cubes nailed it again there but you saying something is fda-cleared is in no way proof that the device actually works it's a phrase that can promise way more than it delivers like when a serial describes itself as part of a complete breakfast that doesn't really mean anything anything can technically be part of a complete breakfast if you adjust it alongside oatmeal yogurt granola fruit salad and a glass of orange juice heroin is part of the complete breakfast and the way most products get cleared is through a loophole in a system called the 510 K pathway it wasn't actually a bad idea when they initially came up with it basically the FDA wouldn't make companies go through a strenuous testing process if their device was substantially similar to one that had come before that way they wouldn't stifle innovation but it was only supposed to apply narrowly the problem is nowadays more than 80% of medical devices are cleared through the 510 K loophole including around 400 implanted medical devices every year those the ones that go inside your body and that whole idea of being substantially equivalent to devices that came before has some real problems with it because it can essentially become a high-stakes game of telephone let me show you in 2008 a company called de PUE received FDA clearance for a hip replacement based on its substantial equivalence to six previous devices all of which were cleared because of their similarity to devices before that and if I sit before that and before that all the way back to hips that were on the market in 1975 now incredibly some of those devices have since been taken off the market by their manufacturers because of their high failure rates but under FDA rules de PUE could still use them as a basis for getting their hips cleared and the thing is depew's hip really would have benefited from clinical testing in human beings because there was a big problem while it may have looked similar to his predecessors it was crucially different in the both its ball and socket were made out of metal and it turns out that when metal rubs are going metal bad things can happen which sounds like the tagline for a movie about a masturbating robot yep you'll notice that we didn't actually come up with a funny fake name for that movie because the perfect name for a movie about a masturbating robot already exists and it's chappie those metal hips began to degrade with wear and tear and the consequences were grim orthopedic surgeon dr. Herbert Huddleston of Tarzana testified at trial he's taken out dozens of metal on metal hips that failed in the worst cases own and the soft tissues around the hip started look like pieces of cheese except pitch-black pieces of cheese sometimes we get in there and it looks like it's filled with old oil that you've drained from your car before the clip sorry that wasn't a possum that was one of them I won't I won't miss the next one that's on me anyway depew's parent company has since spent more than three billion dollars to settle thousands of lawsuits over their metal hip implants and you feel that this could have been avoided if an outside agency had just had a closer eye on what Depew was doing because the company being you know a company was excitedly trying to put as many of its hips in people as possible just watch the pew sales force celebrates the early success of its metal hips taking shares of business was the theme of a Mardi Gras style parade and a de PUE sales conference in 2008 this video shown to the jury stars deep used then top marketing guru alongside costumed alligators a bloody man with a hatchet and a giant metal hip implant you probably have a lot of questions there and if you like me the first one is I include an axe murderer in your parade about medical implants I can only assume it's a Mardi Gras themed reference to the Axman of New Orleans a mostly forgotten serial killer who stalk the streets of the Big Easy in 1918 apparently threatening anyone and this is true who wasn't enjoying jazz at Huff that is an admirably deep cut although if I'm honest I would have preferred them to have put in at least as much research into metal poisoning as they did into early 20th century jazz loving serial killers and it's not just the sales force who were amped about the success of depew's hips one of the people who helped design it dr. Thomas schmaltz Reid was excited too although not entirely for the reason that you would hope a doctor would be excited about a new medical device because he even made an appearance to pump up to pew sales force at that meeting with his special Smoltz Reid's charm did you know that the first billion is the hardest billion here billion there pretty soon it adds up to some real money anyone here want to go for two I'm gonna say that again is anyone here want to go for two now I know that sounds bad but I'm sure if some of the patients who had used his product were there they too would have stood up and cheered and then you know collapsed in their heat because their hips are now pitch black cheese and if you wonder why a doctor should be so excited about sales deployed him 20 million dollars in royalties for his role in helping to design their hips including a cut of every sale and if I may paraphrase a deeply smarmy man 20 million here 20 million there pretty soon that adds up to some real money but but but I will say this for metal on metal hips at least they can be removed it's not easy and it's sometimes dangerous but it can be done it is much harder to do that with certain types of surgical mesh another FDA cleared device very basically mesh is implanted in the tissue which then heals around it sealing it in which can make it risky to take out without damaging the surrounding tissue and organs meshes were initially cleared by the FDA for hernias but a few years back they were also cleared for use on vaginal tissue in many cases without having had to undergo any clinical trials and things did not go well and ahead of the next clip I am going to say a person not not because you're about to see anything gross but because of what you're about to hear it felt like a cheese grater inside of me it felt like the material was pulling on the muscles and I'd get shooting pains you almost felt like there was something inside of you that was like sandpaper back and forth every time you'd walk that is obviously horrifying there is absolutely no circumstance in which you should feel like there is sandpaper in your groin apart of course from when a cat is going down on you that's the only time that's the only time and even then even then there are real problems involved even there they're good to take it down take it down the good news is the good news is that the FDA recently ordered vaginal mesh manufacturers to stop selling their product and as for metal on metal hips going forward they won't be FDA cleared instead they'll have to go through the much more rigorous process that gets you FDA approved it requires that a high risk device be tested on humans which is great but even the approval system has its problems for one thing the FDA relies on manufacturers to do their own clinical testing and those tests can be very limited and for just one example of the approval system shortcomings look at ashore metal coils that were marketed as permanently implanted birth control devices for women assures manufacturer in his application for FDA approval claimed that 99% of women in their clinical study he's rated their comfort with the device as good - excellent and the FDA approved it and yet 15 years later the FDA had received over 32,000 reports of problems with ashore including pain dislocation of the device genital hemorrhage and perforated organs none of which really sound particularly good or excellent - Mickey and if you're having trouble squaring that with the sky high satisfaction rating is yours clinical studies some of the participants in it say there may be a reason for that the first time I saw the questioned rates your comfort of wearing the device I said what does this mean I'm not wearing anything this is something that's implanted inside of my body the nurse said can you feel it and I said I can feel pain in my abdomen where that pain is coming from I don't know and she said then you need a raid it is excellent they would say are you happy with the product I would say no and they would say but you're not pregnant I don't see correct well then then it's doing its job so you have to be happy with that okay but just because something is technically fulfilling its job does not mean you have to be happy with it Pennywise technically fulfills all the requirements of a birthday clown but when you book him for your kid's fifth birthday party and it doesn't go well you should not be obliged to rate him as excellence so I guess that the big question here is how can you know if a device is potentially harmful and unfortunately good information is actually very difficult to find for start one estimate suggested less than half of 1% of medical device failures are even reported to the FDA which when you think about it is genuinely remarkable a hundred percent of rude waiters are reported to Yelp and those aren't killing anybody in fact public reporting of issues with devices is so bad many patients have been forced to learn about problems in less than ideal ways like from that alarmingly alert woman in a law firm commercial or often even Facebook a couple of months ago the FDA held hearings to alert women to potential issues with breast implants but for years and years and yes before that women were finding out simply by warning one another about it online the private group is called breast implant illness and healing by Nicole and today it has more than 79 thousand members I was like this is unbelievable that this can happen with so many people page after page that's my story that's my story everyone has the same symptoms yeah they found out through Facebook groups traditionally the least reliable source of information right below horoscopes Infowars and a mole person screaming in the subway tunnels but this system clearly needs reform and don't just take that from me eight years ago the Institute of Medicine actually called for an end to the 510k loophole you know the one that hips and mesh went through saying it should be replaced by a regulatory framework based on sound science and that framework does not need to be so strict that innovation is stifled just not so lacks that people are getting needlessly hurt at the very least you would hope that implanted devices would undergo clinical testing before being put inside of you but but any any time that meaningful reforms have been suggested device manufacturers have lobbied hard and helped defeat them because of course they have any changes would mean they would have to work harder and nobody wants to work harder you think we like doing these heavily research stories you think this was fun for us HBO makes us do this if it was actually up to us we'd work one day a week and every segment would be two minutes long and have a title like pillows and how they are soft bye bye but look that would be fun but until our current system is improved unfortunately patients have to be their own advocates and experts advise researching any implanted device and asking questions like is there an alternative can the device be removed if something goes wrong and how long has the device been on the market because just because something is new does not necessarily mean it is better or even that it's been tested the point here is our medical device system needs serious attention and until it is fixed it would be nice if people were alerted to the flaws with our process with the same urgency with which they're alerted to the flaws with our devices attention if you or a loved one are thinking about getting an implanted medical device you may want to listen the up because it turns out the FDA is so far up medical device manufacturers asses you can only locate them with a duo D no scope and thanks to that manufacturers are getting rich doctors are getting rich and patients are getting their insights turned into oil and cheese sorry opossum you and your loved ones need to know it can take years before the public finds out about problems with a new device and in the meantime your best source of information may be Facebook and the only thing you should ever learn from Facebook is which of your friends has the ugliest baby its grace so act now to protect yourself before it's too late basically treat medical devices like guys who have played Batman 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 and if hearing about duodenal scopes and sandpaper vaginas has made you uncomfortable as long as it hasn't made you pregnant I'm afraid you have to rate your experience as excellent you

Channel: LastWeekTonight

Views: 7,190,843

Keywords:

Id: -tIdzNlExrw

Length: 19min 5sec (1145 seconds)

Published: Sun Jun 02 2019

Reddit Comments

[u/stonecats]

wow, this main report really hit home for me.

i had a hip replacement 10 years ago just when they were hyping metal on metal socketed implants. at the time i specifically asked my surgeon about them, and he explained at my age having an implant with a plastic liner was better because it had a bit more "give" - that body joints are not meant to have the precision of machine parts, and how plastic mimicked the cartilage and fluid layer evolution designed into our joints naturally. what was shocking to me now in retrospect is; at the time all the online hype had been manipulated to favor metal on metal, so clearly that company was paying someone to do a social media managed campaign.

one of the arguments they used was metal on metal would last longer because there was no plastic liner to wear out - again my surgeon talked me down by pointing out two things; i was not a very active person nor had plans to become one, thus the plastic liner wearing out prematurely would be less likely, and second that plastic liners were a known commodity (with materials used improving over the years) that had been applied over the past 30 years, so it would be better that i had another hip replacement 30 years from now (it's a far less invasive procedure with faster recovery time - than it was a few decades ago), then take a chance on a new metal on metal design with no long term track record.

yeah, i know... boy was i lucky i had this surgeon at that hospital, instead of some hack who made his fortune in medical device kick backs. i was long aware of the fda cleared versus approved distinction, because since college i had known to avoid penny stocks that had "invented" and marketing fda cleared gimmicks and ignore late night cabletv commercials advocating fda cleared well-being and exercise devices, many that were based on fda approved inventions from over 50 years ago. however it truly never had even occurred to me that any such products were also being used internally.

[u/Jedi-El1823]

OPOSSUM!

[u/mdb_la]

Anyone else notice when they are talking about the terrible survey results that the answer choices are out of order?. Not sure if that's another intentional way to skew the data but no survey should have answers ordered:

Excellent --> Good --> Fair --> Very Good --> Poor

[u/Moritani]

Guess I have to rate all my past boyfriends as excellent now.

[u/leafwater]

I'm a doctor with a board exam coming up and I'm going to go ahead and count this as studying. Thanks, John Oliver.

[u/-Kite-Man-]

hey something like this just happened to me. watching the millionaires cheer over it made me tear up and have to stop watching, but on the bright side at least i probably wont be around to think about it too long

also i take a lot of painkillers now

[u/AoE_Mobius_One]

I used to intern at DePuy in their Hip segment group. I can at least say that they have since transitioned away from Metal on Metal hip replacements since I had last worked there a few years ago. Hip implants from them are now either ceramic on metal, plastic on metal, or ceramic on ceramic. Of the four components of a hip replacement, this critical junction occurs between the “ball” and the acetabulum liner, as those are the two parts of the component that move on each other, like a normal joint.

[u/gambit700]

AS someone with an implanted medical device all I have to say is....OPOSSUM!

[u/HBB360]

Again, how is this up on YouTube multiple hours before going on HBO GO?! I get the one day delay but if they have it up on Youtube that means it's ready to go out to HBO GO as well, why wait?