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Speaker 1

00:00

-♪ ♪ -♪ ♪ 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.

Speaker 1

00:14

Specifically, we're gonna talk about medical devices. The modern-day miracles 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.

Speaker 2

00:27

I was very frightened to do a hip replacement. I really didn't want to do a hip replacement.

Speaker 3

00:32

And, she got the hip replacement, and she's better than new. I can't believe, I'm resistant for that. Fascinating to see her.

Speaker 3

00:38

She's dancing as if she never got a hip replacement, you know?

Speaker 1

00:42

Admit it, you didn't see that story ending with a breakdancing group of 50-year-olds called, and this is true, Moms in Da Hood. And you're gonna be even more surprised when I tell you they're actually here tonight. Please welcome Moms in Da Hood!

Speaker 1

00:56

-♪ -♪ -♪ They're not here. They're not here. They're not here. Of course they're not here.

Speaker 1

01:04

Of course. You think they're coming to a post-Game of Thrones HBO? Their mom's in Da Hoos. They got better places to be.

Speaker 1

01:12

It would be a waste of their valuable time. The medical device industry is huge. They constitute a $156 billion market in the U.S. And more people have 1 than you might think.

Speaker 1

01:24

About 32 million Americans, that's 1 in 10, have at least 1 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 while medical devices can undeniably do tremendous good and save lives, they can also cause real problems.

Speaker 1

01:46

And you're probably aware of some of them thanks to personal injury lawyer ads like these.

Speaker 4

01:51

Have you or a loved 1 had complications after a knee replacement or revision surgery?

Speaker 2

01:56

Have you or a loved 1 had hernia mesh implanted specifically for hernia repair?

Speaker 4

02:00

Have you or a loved 1 had an IVC filter implanted to prevent blood clots from reaching the lungs? Have you or a loved 1 had an IVC filter implanted to prevent blood clots from reaching the lungs?

Speaker 2

02:04

Have you or a loved 1 developed a drug-resistant bacterial infection or superbug after undergoing an ERCP procedure using a duodenoscope?

Speaker 1

02:13

Yes, actually. Yes. I do have a loved 1 who's developed a drug-resistant bacterial infection or superbug after undergoing an ERC procedure using a Tuho Dynascope.

Speaker 1

02:22

And may I say, I thank God, the card categories at Hallmark have gotten so specific, I had options on that 1. Now look, while it's easy to roll your eyes at 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.

Speaker 1

02:47

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 trial.

Speaker 1

03:13

And don't feel bad if you're suddenly surprised by that. 1 researcher found that many doctors aren't aware of this either.

Speaker 5

03:20

We were surprised to see how little surgeons knew in our study about the approval process for devices. That some of the surgeons seemed to think that while the FDA had taken care of this, that of course these devices had been tested in humans.

Speaker 1

03:35

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.

Speaker 1

03:50

So tonight, let's talk about how medical devices get approved. And before we start, the nature of this story means there are 2 clips that you're gonna see that are a little gross. So before each 1, I'm gonna say a safe word, a possum, and flash it on screen with a sound effect like this. Basically, whenever you see that, if you are squeamish, you will know to look away.

Speaker 1

04:10

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.

Speaker 6

04:21

Today's doctors, drugs, and medical devices truly work medical miracles for young and old alike. But there are some as phony as a 3 dollar bill. Like this Xerod applicator, for example, which has claimed to cure arthritis with Z-rays.

Speaker 6

04:37

There are no Z-rays. -♪ Z-rays

Speaker 1

04:39

♪ -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. Feel the Zs.

Speaker 1

04:49

Feel the Zs 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.

Speaker 1

05:09

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.

Speaker 1

05:24

Watch their response when someone pitched them an acupressure band and tried to pull the whole FDA cleared card.

Speaker 4

05:30

Hey, Romy, is there any... Proof that this actually works?

Speaker 7

05:34

It's an FDA-cleared medical device.

Speaker 4

05:36

That's not an answer to the question.

Speaker 1

05:39

Cubes is right. I mean, when is he not? But my man Cubes nailed it again there.

Speaker 1

05:44

Because saying something is FDA-cleared is in no way proof that a device actually works. It's a phrase that can promise way more than it delivers. Like when a cereal describes itself as part of a complete breakfast. That doesn't really mean anything.

Speaker 1

05:57

Anything can technically be part of a complete breakfast. If you ingest it alongside oatmeal, yogurt, granola, fruit salad, and a glass of orange juice, heroin is part of a complete breakfast. And the way most products get cleared is through a loophole in the system called the 510K pathway. It wasn't actually a bad idea when they initially came up with it.

Speaker 1

06:17

Basically, the FDA wouldn't make companies go through a strenuous testing process if their device was substantially similar to 1 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 percent of medical devices are cleared through the 510K loophole, including around 400 implanted medical devices every year.

Speaker 1

06:41

Those are 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.

Speaker 1

06:53

In 2008, a company called Depew received FDA clearance for a hip replacement based on its substantial equivalence to 6 previous devices, all of which were cleared because of their similarity to devices before that, and devices 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, DePuy could still use them as a basis for getting their hips cleared. And the thing is, DePuy's hip really would have benefited from clinical testing in human beings, because there was a big problem.

Speaker 1

07:31

While it may have looked similar to its predecessors, it was crucially different in that both its ball and socket were made out of metal. And it turns out that when metal rubs against metal, bad things can happen. Which sounds like the tagline for a movie about a masturbating robot. You'll...

Speaker 1

07:47

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 Chappy. But... But those... Those metal-on-metal hips began to degrade with wear and tear, and the consequences were grim.

Speaker 2

08:06

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...

Speaker 8

08:16

The bone and the soft tissues around the hip starter 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.

Speaker 1

08:27

A possum! A possum! Shit!

Speaker 1

08:29

Shit! I meant to say that before the clip. Sorry, that was an opossum. That was 1 of them.

Speaker 9

08:34

I won't miss the next 1. That's on me. -♪ Ooh...

Speaker 1

08:36

♪ -$3.5 BILLION Anyway, DePue's parent company has since spent more than $3 billion 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 Depew Salesforce celebrate the early success of its metal hips.

Speaker 2

09:03

Taking shares of business was the theme of a Mardi Gras-style parade at a DePuy sales conference in 2008. This video, shown to the jury, stars DePuy's then-top marketing guru alongside costumed alligators, a bloody man with a hatchet, and a giant metal hip implant.

Speaker 1

09:23

Now, you probably have a lot of questions there, and if you're like me, the first 1 is, why include an axe murderer in your parade about medical implants? I can only assume it's a Mardi Gras-themed reference to the Axeman of New Orleans, a mostly forgotten serial killer who stalked the streets of the Big Easy in 1918, apparently threatening anyone, and this is true, who wasn't enjoying jazz enough. And that is an admirably deep cut.

Speaker 1

09:48

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 Dupuis Hips. 1 of the people who helped design it, Dr. Thomas Schmalzried, was excited too.

Speaker 1

10:06

Although not entirely for the reasons that you would hope a doctor would be excited about a new medical device. Because he even made an appearance to pump up Dupuis Salesforce at that meeting with his special Schmaltz-Reed charm.

Speaker 9

10:19

Did you know that the first billion is the hardest? Billion here, billion there. Pretty soon it adds up to some real money.

Speaker 9

10:33

-...anyone here want to go for 2?

Speaker 1

10:35

-...Yeah! I'm gonna say

Speaker 4

10:37

that again. Does Anyone here want to go for 2? I'm going to

Speaker 9

10:37

say that again. Does anyone here want to go for 2?

Speaker 1

10:42

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 a heap, because their hips are now pitch black cheese. And if you're wondering why a doctor should be so excited about sales, DePuy paid him 20 million dollars in royalties for his role in helping to design their hips, including a cut of every sail. And if I may paraphrase a deeply smarmy man, 20 million here, 20 million there.

Speaker 1

11:10

Pretty soon, that adds up to some real money. -...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.

Speaker 1

11:24

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.

Speaker 1

11:47

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 possum. Not because you're about to see anything gross, but because of what you're about to hear.

Speaker 10

12:03

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.

Speaker 1

12:22

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!

Speaker 1

12:33

That's the only time! And even then, even then, there are real problems involved. Even then. The good...

Speaker 1

12:40

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.

Speaker 1

12:49

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.

Speaker 1

13:06

For 1 thing, the FDA relies on manufacturers to do their own clinical testing, and those tests can be very limited. And for just 1 example of the approval system's shortcomings, look at Assure. Metal coils that were marketed as permanently implanted birth control devices for women. Assure's manufacturer, in its application for FDA approval, claimed that 99 percent of women in their clinical studies rated their comfort with the device as good to excellent.

Speaker 1

13:31

And the FDA approved it. And yet, 15 years later, the FDA had received over 32,000 reports of problems with Assure, including pain, dislocation of the device, genital hemorrhage, and perforated organs. None of which really sound particularly good or excellent to me. And if you're having trouble squaring that with the sky-high satisfaction rating that's yours clinical studies, some of the participants in it say there may be a reason for that.

Speaker 11

13:58

The first time I saw the question, rate your comfort of wearing the device. I said, what does this mean? I'm not wearing anything.

Speaker 11

14:06

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.

Speaker 11

14:19

And she said, then you need to rate it as excellent.

Speaker 7

14:22

They would say, are you happy with the product? I would say no. And they would say, but you're not pregnant.

Speaker 7

14:29

I would say, Correct. Well, then it's doing its job. So you have to be happy with that.

Speaker 1

14:35

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 excellent.

Speaker 1

14:54

So I guess 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 a start, 1 estimate suggested less than half of 1 percent 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.

Speaker 1

15:19

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 years before that, women were finding out simply by warning 1 another about it online.

Speaker 12

15:45

The private group is called Breast Implant Illness and Healing by Nicole. And today it has more than 79,000 members.

Speaker 5

15:52

I was like, this is unbelievable that this can happen to so many people.

Speaker 11

15:56

Page after page, that's my story, that's my story. Everyone has the same symptoms.

Speaker 1

16:01

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. Look, this system clearly needs reform, And don't just take that from me.

Speaker 1

16:17

8 years ago, the Institute of Medicine actually called for an end to the 510K loophole. You know, the 1 that HIPPS 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 lax 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.

Speaker 1

16:43

But 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 researched stories? You think this was fun for us?

Speaker 1

17:01

HBO makes us do this. If it was actually up to us, we'd work 1 day a week, and every segment would be 2 minutes long and have a title like, Pillows and How They Are Soft, Bye-Bye! -♪ Bye-Bye! -♪ AUDIENCE LAUGHS AND CLAPS But look, that would be fun.

Speaker 1

17:15

But... 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?

Speaker 1

17:29

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 floors with our devices.

Speaker 12

17:50

Attention! If you or a loved 1 are thinking about getting an implanted medical device, you may want to listen the fuck up. Because it turns out, the FDA is so far up medical device manufacturers' asses, you can only locate them with a duodenoscope. And thanks to that, manufacturers are getting rich, doctors are getting rich, and patients are getting their insides turned into oil and cheese.

Speaker 12

18:11

Sorry, a possum. 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 fucking Facebook. And the only thing you should ever learn from Facebook is, which of your friends has the ugliest baby?

Speaker 12

18:29

It's Greg's. 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.

Speaker 12

18:41

And there are a few you definitely don't want to let inside your body. And if hearing about duodenoscopes and sandpaper vaginas has made you uncomfortable, as long as it hasn't made you pregnant, I'm afraid

Speaker 4

19:00

you