Kirby Dick and Amy Ziering, the Academy Award nominated team behind The Hunting Ground and The Invisible War, sit down with Joan Lunden to discuss their new Netflix Original documentary film, The Bleeding Edge. As a journalist, author, TV Host, and breast cancer survivor, Joan brings her own experience with, and knowledge of, the medical device and health industry to the conversation. The Bleeding Edge investigates the medical device industry; from its innovations to its regulation. What you don’t know about the devices doctors use or implant in people every day will shock you, or at least will influence your next doctor’s appointment. It's available to stream on Netflix now.
Kirby Dick and Amy Ziering, the Academy Award nominated team behind The Hunting Ground and The Invisible War, sit down with Joan Lunden to discuss their new Netflix Original documentary film, The Bleeding Edge. As a journalist, author, TV Host, and breast cancer survivor, Joan brings her own experience with, and knowledge of, the medical device and health industry to the conversation.
The Bleeding Edge investigates the medical device industry; from its innovations to its regulation. What you don’t know about the devices doctors use or implant in people every day will shock you, or at least will influence your next doctor’s appointment. It's available to stream on Netflix now.
Rae: Welcome to You Can’t Make This Up, a companion podcast from Netflix.
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Rae: I’m Rae Votta, your host for today’s episode. Every other week on You Can’t Make This Up, we bring a new interviewer discussing a different Netflix series or film with special guests, and all of the stories are surprisingly true. This week, we’re going behind the scenes of the new Netflix original film, The Bleeding Edge. This investigative documentary takes a look at the medical device industry, from its innovations to its pitfalls. What you don’t know about the devices doctors use or implant in people every day will shock you or at least will influence your next doctor’s appointment.
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Rae: And here to talk about The Bleeding Edge are Joan Lunden with the filmmakers themselves, Kirby Dick and Amy Ziering. You may know Joan as a host of Good Morning America for 17 years, but she’s also an author, journalist, and breast cancer survivor. She takes her own experience with the medical device industry and health industry to this conversation. So without further ado, here’s Joan Lunden with director Kirby Dick and producer Amy Ziering.
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Joan: Hi everyone. I’m Joan Lunden, and I am here today to interview Amy Ziering and Kirby Dick, and they are really masters at doing films that expose injustices. It’s great to have the two of you here with me today. I love the work you do.
Amy: Thank you.
Kirby: Thank you. It’s a pleasure.
Joan: You tend to do these films before anyone else has written a book about it or done a big exposé about it, so you do it from kind of ground zero. What brought you to this film?
Amy: We are very interested in doing original investigative reporting and sort of groundbreaking work, so we happened to just be speaking with someone who reported to us that this thing had happened with her device, and not only happened with her, but it happened with like a dozen other women, and she started, you know, wondering and asking questions, and we were like, well, that’s crazy. And then she found out that her device had never tested, clinically tested, so we said, well, is that systemic? Is that just a one-off about the device you were particularly using? And she said, I don’t know. So we started doing our own investigative work and found out not only everything she told us was true, but, you know, true for all devices, and we found that horrific. Like it turns out that all of us are just guinea pigs. Who knew?
Joan: And this is for all kinds of devices, like shoulder replacements, hip, knee replacements, or in the case of women, probably like the woman you’re talking about, that has devices implanted in their Fallopian tubes, so that they’re sterilized. I don’t know if anybody really thinks twice to ask when a doctor says, this is the best thing, and this is the latest thing, and this is what I recommend.
Kirby: Yeah. I mean, people just assume that if it’s new and it’s new technology, it’s got to be great. I mean, we look at not only devices that are implanted but also devices that are used in surgery, devices that are used diagnostically, like CT scanners. I mean, everything has a certain amount of risk.
Joan: Well, I’m going to tell you that as I started watching this, I was I think stunned is the word to use, because I do a lot of work in the health field, and I couldn’t believe that I didn’t know about it. First of all, just the fact that this is a $400 billion a year industry that dwarfs the pharma industry, I didn’t even know that was possible, but then when you start learning about the pervasiveness of these horrible stories about how people’s lives have just been ruined because of a medical device they had implanted in them that they just assumed was safe, is that the general reaction? Are people usually shocked?
Kirby: Oh yeah. People are completely shocked. I mean, people coming out crying. We’ve seen over and over, people in the middle of a screening, texting relatives who have medical devices that the film is covering saying, is everything okay? Should you go to the doctor? In some cases, they should be going to the doctor. It actually turned out that everything was not okay. I will say that the pharmaceutical industry is bigger than the medical device industry, but the medical device industry has loopholes that the big pharma does not, and that gives them a kind of power that even big pharma doesn’t have.
Joan: And it’s so rapidly expanding because of rapid innovation in technology, right? That’s really kind of going faster than the science itself.
Amy: It’s also rapidly expanding because of the profits you can make. It’s not necessarily—I mean, I heard doctors describe technology they were given as technology in search of patients as opposed to patients in search of technology. You know, if you can come out with a new hip implant, that’s just slightly different, but you can charge a whole lot more for it, it might not be better, but you can say it’s a new product, and people will gravitate towards that, and you can make greater profits. So it is a huge industry that is growing and growing and growing, and that’s fine, but it’s growing without the proper oversight and the proper checks and balances, and that’s what’s scary and dangerous.
Joan: Yeah, that’s really the problem. I mean, you want innovation, and everybody's looking for a better product. The problem seems to be in the way these things come to market so untested. Let’s just listen to Dr. Michael Carome, I believe his name is. He is the Director of the Public Citizen Health Research Group, talking about the FDA’s testing and approval process.
[Clip plays]
Michael: Most people probably believe when they get a medical device, they implant it, be it a pacemaker or a joint, that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case.
[Clip ends]
Joan: How is that not the case? Everyone assumes—I mean, the FDA is there to protect people. How do we have such a broken system?
Amy: The FDA is only as strong as the laws we pass, right? The FDA is at the behest of Congress, so if Congress is persuaded by lobbyists to pass laws that deregulate and don’t hold corporations accountable to certain standards, then the FDA only can uphold and put into practice those very laws. And the problem is that the device lobby is very, very powerful, and it really has defanged the FDA. So there aren’t these regulations anymore in place that make sure that devices are properly tested. In fact, 98 percent of all devices that are brought to market have never been clinically tested in humans, and that’s staggering.
Joan: It’s unthinkable. It’s mind-blowing.
Amy: It’s unthinkable. And I also want to say, when people are listening to this, they’re like, what’s a medical device? Because that also seems arcane and strange, right? But devices, we’re talking about anything from stethoscopes to X-rays to CAT scans, ultrasounds, hip implants, breast implants, defibrillators, anything that’s technology based that sort of interacts with your body, that’s a medical device, and that’s what you now need as a consumer to be aware of and informed that it’s actually never been rigorously tested. Yeah, hopefully it’s great and will help you, but you don’t know there’s risks involved that you really need to be informed about.
Joan: A stethoscope is one thing, but when you start talking about medical devices, knee, hip, shoulder replacements, vaginal inserts that go up into the Fallopian tubes that keep you from getting pregnant, these are things that are implanted into people, and the idea that studies were not conducted on humans, and doctors just start using these?
Kirby: No, it’s absurd. I mean, it is—just to slightly tweak the statistics here, 98 percent of devices, the FDA does not require human clinical testing on. Occasionally, there is clinical testing done, but the fact is really on the vast majority of higher risk devices, the FDA does not require clinical testing, so it just doesn’t make any sense. What happens is they get implanted in people, and then the people, the patients themselves, are part of a test, and they don’t even know it. And so it gets implanted in sometimes tens, hundreds of thousands of people, and then it might be 5, 10, 15 years later before this collective group says, we’re harmed. And by then, of course, the medical device companies have made an incredible amount of profit. Oftentimes, to just take hip implants, they made a profit putting in the first one. Then when they found out that those hip implants were bad, it had to be removed, and then they made another profit replacing it with a hip implant. So it’s a system that the medical device companies come out ahead on almost every time.
Joan: But as the complaints start coming into the FDA, I mean, we learn in the film that there were some members of the FDA that did speak up and did voice their concerns about safety, and they lost their jobs! Was it hard for you guys, for that reason, just to get experts to talk to you?
Kirby: Oh yeah, no, we’ve made a lot of films about subjects that, you know, people are very afraid to talk about it, you know, talk in our films, but we’ve never experienced it quite like this, where people were incredibly paranoid. I mean, we talked to people who’d worked in the medical device industry, and they would tell us horror stories, but they would say, absolutely not going to appear in the film. There is a real retaliation throughout the medical device industry for people who speak up and tell the truth about these, because there’s so much money being made throughout the industry.
Joan: That was a very sad interview with that FDA person. It really shook me up, because here was a guy who like was really idealistic. He was a fabulous doctor, and he said, you know what? I think I can use my mind and my talents to help even more people if I work at this regulatory agency. He was excited, you know, and went in with this incredible idealism and this incredible fervor and deep believe in wanting to help others and then saw that there were problems with CAT scans and reported it. And rather than them going oh, that’s interesting, let’s do more investigations, let’s call the companies, you know, he was rebuked, he was challenged, he was admonished, and it just sort of startled him. That’s his job, that’s what he thought his job was, and he didn’t realize that actually, no, you know, unfortunately, not everyone in the FDA but to some degree the FDA, as we also heard over and over again, is a captive agency.
Amy: Well, there’s almost an incestuous affair going on seemingly between manufacturers of devices and anything else, that they go back and forth between the FDA. They can be at a company and write up a report, and the next month or two, they’re over at the FDA and they’re approving their own report. I mean, it’s really incestuous.
Kirby: Well, there is. There’s a real revolving door. It’s so many people who’ve been the FDA commissioner, the head of the FDA, have worked in industry before, and then after they’re the FDA commissioner, then they go back to work in industry, so repeatedly, we heard the phrase, it’s a captive agency. And the reality is, there are a lot of really great scientists at the FDA who are really doing the right thing, but there’s so much pressure from the industry, and Congress is really, I think, unaware that in many ways, this is a problem. I mean, I think just like you were surprised, I’m willing to bet that the majority of members of Congress who oversee the FDA aren’t aware that most implanted devices are not first tested in humans.
Joan: Can we schedule a viewing in Congress one day?
Amy: We would love that.
Kirby: We are going to do that, yes, yes.
Joan: Okay.
Amy: No, because it’s not a partisan issue. I mean, Republicans and Democrats both buy the ideology that they have told that innovation is better, and we got to deregulate, and we got to free the system, so that more products can go on the market and help people. And it’s just not true. Again, let’s go back to hip implants. Sometimes, you know, there’s no need to improve it. Like, if it isn’t broke, don’t fix it. Honestly, the implants they did in the ‘70s work great, very little problems, but you can’t make a lot of money on a product that’s been sold since the ‘70s. How do you raise the prices? You’ve got to tweak it. You’ve got to say it’s better and bigger and different, and that’s what the issue is. So this rush for newer, better, is not exactly in the patient’s best interest, but like I said, people in Congress believe the marketing. Oh, it’s new. It’s got to be even better, and we’re helping more people. It just isn’t true.
Joan: And it’s not only in Congress, but it’s also the same with I think a lot of doctors. You know, they’re really sold on a lot of these things. We hear from one doctor in the film, who’s doing a lot of implants himself, hip implants, and he’s using some of the new cobalt implants, and then—he’s a human, too. He get a bad hip, he gets an implant, and his health just spirals downward. Let’s listen to what his wife says is the end of this downward spiral.
[Clip plays]
Wife: He was attending a conference, and I got a call. He had trashed a hotel room. He wrote all over the walls. He took pens, Sharpies. He wrote on the ceiling, he wrote all over, and when that was done, he took soap, and he wrote on the mirrors. It was the full on breakdown. You could see it in his eyes and just in turmoil, knowing full well that he’d lost it. All the while, he’s still thinking, he’s still connecting the dots.
[Clip ends]
Joan: That was a highly respected orthopedic surgeon who experienced that, Dr. Stephen Tower, and I guess shortly after that, he said, test me for cobalt poisoning, saw the high levels, and that taken out, and within like a month, he was completely well. So there is no mystery there of what caused his problem. So even a doctor who’s using these is just unaware of the implications of what can happen to those patients.
Amy: Because often what the symptom that you’re having I isn’t necessarily obviously correlative to the device itself, right? He was having a hip implant, but he was experiencing symptoms of dementia. So an ordinary person wouldn’t necessarily then go oh, it must be the hip implant. They’d think, oh, do I have Alzheimer’s? You know, is something else going on with me? But thankfully because he was an orthopedic surgeon and he kind of started thinking creatively, he thought, well maybe there’s some other reason for this, and he, as his wife said, connected the dots and said, oh, maybe it’s some kind of poisoning, metal poisoning that’s sort of causing my brain dysfunction. So that’s a big issue with these devices. We saw over and over again that people often don’t associate their illness with the device itself because it can manifest in very, very different ways, and that’s another thing we want people taking away from watching the film is be aware of all the different ways you can have problems with these devices. It’s not necessarily a one-to-one correlation or obvious.
Kirby: Exactly. And also, Dr. Tower assumed, like everyone else, that the hip implant that he had put in him had been tested in humans first, and that if there was this kind of problem, he assumed it would have been discovered. He was as shocked as anybody else to learn that the very hip implant that was put in him, the FDA had not required clinical testing. So what we learned from making this film is that doctors who are implanting these devices do not know that the FDA has not required clinical testing on them first, and that doctors, when they see the film, are just extremely grateful and actually even change their practice. We’ve heard that on—Amy you have a good story about that.
Amy: Yeah. You know, we do test screenings before we release a film for experts, and we test screen for many doctors obviously in high positions of authority, and a couple weeks after one screening, I ran into someone in the supermarket, and I didn’t recognize him. He turned around and said, oh my God, I got to talk to you. I changed the way I practice medicine. I was like, what are talking about? He said, well, you know, I was sent a device recently, and he’s head of a major institution in Los Angeles, and they told me I could implant it from infants to adults, and so I wrote back. I said, I never would have before, but I wrote back and said, please show me the study, and didn’t hear from them. He said, wrote back again, show me the study. They sent back a study. He looked at the study. He says, this is 12-year-olds and up. Where’s the study for infants? Gets back an email. There is no study for infants. And he was like, how could you have told me to put this in a tiny body? Like, it horrified him. And he said, before our film, never would have occurred to him that this was—he would have taken at face value, okay, I’ll start ordering these up and doing these operations.
Joan: You know, it begs the question, how much responsibility can we really put on doctors who are busy, practicing medicine? How much should they have to be researching? They assume the FDA is doing that.
Amy: Yeah. The responsibility really is the corporations first, right? I mean, and then the FDA to make sure the corporations are putting out safe products. It’s really not the doctor’s fault. This isn’t an anti-doctor film. It’s extremely pro-doctor. Doctors watch it and thank us. We are hoping this will get shown at medical schools, because doctors need to understand the regulatory process, so they can ask the right questions just like consumers do.
Joan: But weren’t you shocked to learn that doctors kind of get sold on these? In the right way, I mean, the manufacturers come, and they tell them all about it, and that the doctors were unaware that the testing wasn’t going on properly, vigorous testing?
Kirby: Completely shocked, completely shocked. And the studies that are done, the vast majority of them are actually funded by the medical device industry, so obviously, the results they find are in favor of the produce working very well. And that’s the information that doctors have. I mean, as you said, they’re very busy. They get a study. It’s very complex. They read over it, they go to the conclusion, it works, they say great, and they move forward. We had to be so careful when doing this film. We had to read over a thousand studies because there were so many out there that were obviously biased because of medical device funding.
Joan: And the doctors, of course, have people coming into their offices and showing them, and there’s this sense that there are so many patients suffering, and they want the latest, greatest, whatever it is that’s going help solve their problem, so I guess there’s a rush to action.
Amy: Yeah, no, you’re right. I mean, it’s a good point. I mean, obviously, when you’re injured or ill, you’re vulnerable, right? And you don’t really want to ask questions, and you want to trust your doctor, and you want to believe something’s going to make you better, so it’s sort of a perfect storm of conditions, where a patient, you know, is going to be really trusting, and they’re going to naïvely believe that newer is better. And what we really want to raise the red flag is newer is not necessarily better. I mean now, after making this film, I want a product that’s been in people for 20 years and hasn’t caused issues, you know? I don’t want the newest, latest, greatest.
Joan: Let me ask a question. As issues start coming up, though, with a product, and the FDA starts getting complaints, are doctors notified?
Kirby: Well, oftentimes it takes a long time, because only about—what is it? Three to four percent of complaints ever get to the FDA, and then the FDA has a system that’s actually very hard to navigate. So it can take years and years and years before this sort of mass of complaints builds up, and by then, of course, there’s much harm. I mean, we do want to say that there’s a lot of great medical devices out there, you know. And we’re all for a robust medical device industry, but we want to make sure that the medical devices that are out there have been proven to work first. That’s the key point, and then let’s move forward with them. But without that step, I don’t think anybody wants to be a guinea pig for a new medical device.
Amy: Often you hear, well, you know, there’s risk with everything. Everything has complications. Even in our film, we have a doctor saying that, and yes, there’s risk, and there’s risk, right? I mean, yes, you know, there’s risk, there’s human error. You obviously have a system that’s not going to be perfect, but how high is the risk? That’s what we’re asking. When the risk gets too high, if you tell me, you know, here’s a device, and you know, it works in 30 percent of the people, it doesn’t work in 30 percent of the people and it causes more harm, and 30 percent of people, it’s indifferent, I might make a different calculation. And consumers just don’t have that information, and device companies aren’t tracking the efficacy of that, and FDA doesn’t have the bandwidth to do that, so it’s really, as we heard over and over again, the device industry was characterized over and over again as the Wild West. Now that’s terrifying.
Joan: Yeah, because these things are being put into people. I mean, the thing that comes to my mind is of course the Essure, which is a main focus of the film, and it’s the little medical device, the little metal and plastic coil that’s inserted up through the vagina into the Fallopian tubes with the idea of causing inflammation and then scarring, so that you basically instead of having a hysterectomy, just come into your doctor’s office, and this’ll just take a short little time, and it will cause permanent sterilization. Now, you know, I think about gynecologists, and I know a lot of them, and I’m thinking, how can they be putting these into women all the time if over the last 15 years, because I think it was 2002 that that thing originally got approved, and were not 15, 16 years later, and there have been tens of thousands of women who have been so injured by this, perforation of the Fallopian tubes, has gone into the abdomen. I mean, it’s caused so many problems. Some women’s lives have been totally devastated. At what point do you say, wait a minute. At what point, as a group of physicians, do you just say, no more? And yet in all the other countries around the world, they pulled this thing off the market, and it is continued to be sold here in the United States, until, I should just say, coincidentally, perhaps, but until this film debuted, they had pulled the thing off the market a few days later. Do you find that kind of an interesting coincidence?
Kirby: Interesting would be the right word, yes. You know, in our film, we follow this amazing group of women who have been harmed by Essure and get together, and they go up against the FDA, and they go up against Bayer, the manufacturer of Essure, and they were able to accomplish a great deal, but they weren’t able to get it off the market until now.
Amy: It was actually after the premier, as you said Joan, but one week before its global release on Netflix, so I don’t think the timing is coincidental. I think they saw a storm coming, and so they miraculously removed it from the market, which we’re super happy about, but their public statements are saying they stand by the product, and they’re just removing it for poor sales, has nothing to do with anything else.
Joan: Well, poor sales because the FDA at least made them, about a year or so ago, start informing women of all the complaints and all the things that were going wrong in women. I would imagine that accounted for the 70 percent drop in sales. But they have to stand by the product right now, because they have, I don’t know, 20-some thousand lawsuits against them.
Kirby: I think they have like 16,000, yeah, lawsuits against them.
Joan: And they unfortunately have won some of them because they seem to—instead of falling on the sword, they’re falling on the FDA saying, hey, not our bad. We sent it over to the FDA, and the FDA put it on the market, so we’re not responsible. So they kind of have to take that stance. Otherwise, it could affect how they do in all these lawsuits.
Kirby: Yes. Bayer bought Essure from another company, Conceptus, that invested it and marketed it for a long time, and then Bayer came on and did so. Conceptus was involved in hiding 32,000 adverse events from the FDA. Bayer had that information once they bought it. That was there. Bayer knew that this was a problem long ago. They could have acted a long time ago. It wasn’t until these women, and it wasn’t until the film that they actually finally acted. And that says a lot about Bayer’s sort of moral and ethical stance toward this whole thing.
Joan: And by the way, as you say, kudos to this group of women. One woman—you know the idea that one person can’t make a difference—one woman, she goes on Facebook, starts this, other women hear, like oh my gosh, she’s having those problems? So am I, and I don’t know, one of these groups has like 33,000 members.
Kirby: Yeah, over 36,000.
Joan: Over 36,000, which kind of tells you how big this problem is out there, but it really goes to show when you get together in a group, and you are dogged about something, that they finally can make a difference.
Kirby: Yeah, we’ve made films about activists before. Our last film, The Hunting Ground, about sexual assault on college campuses, looked at women, college women, who are going up against their schools and changing policy and trying to protect women from getting raped on the campus, but I have to say, I think that this group of women, it’s kind of a model for the future patient advocacy movement, because what they’ve done is before, 10 years ago, 20 years ago, when people were harmed, they were isolated. They had no way of connecting. They were probably so ill that they couldn’t even travel. Now with social media, that’s changed all this. And I think—we know that millions of people have been harmed by medical over the past decades. I think you’re going to see a lot of people, people who have been harmed by hips, people who have been harmed by the da Vinci robot, more and more getting together and becoming, I hope, powerful advocacy groups that if they collectively come together could be a very powerful constituency that could start pressuring Congress to actually change the laws to protect people.
Joan: And you just bring up, you know, the training. We’ll get to the da Vinci robot in a minute. Even the training in the Essure, they train the doctors to put them in, but they didn’t train the doctors to take them out, so as women started having all these difficulties, and they said, get this thing out of me, many times, as they pulled these things out, they fragmented and broke and traveled through the body and actually ended up causing more problems. At what point in time are we going to learn from all of this? Will there be the political will found to put some safeguards into place to protect patients? I think we all expect that of our government.
Kirby: We do, but of course, if nobody in the country knows, if the public doesn’t know, if doctors don’t know, if legislatures don’t know, it’s hard to. I mean, I think that’s one of the things about the power of documentaries is that can change the way—they can change history. I mean, we had that experience with a film we made called The Invisible War about rape in the military. Very few people were aware of it, and then the film came out, and about a year later, Senator Gillibrand of New York saw the film. She took it up as her sort of cause, and she fought through Congress, and she got 35 reforms passed through Congress and signed into law about this issue. And sure, there are still problems with rape in the military, but there have been improvements, and that all happened with a documentary. So we’re hopeful the same thing happens here.
Amy: Yeah, and you raised a really good point, Joan. I mean, yeah, they can put them in, but make sure your surgeon can tell you all about the ways to take them out. And we heard that over and over from doctors. Oh, it just doesn’t even occur to them. I don’t—I don’t know how to take it out. And then you’re stuck, you know? So if you’ve got a faulty device in your body, that’s a scary thing.
Joan: And some women, I mean, I remember from the film that there was one woman who I think had eight of them in her, because the doctor didn’t realize that the first one, he thought, didn’t shoot it up in to the Fallopian tubes, so try it again, and try again. Of course, if the doctors going into this don’t have a sense that there are going to be problems, they probably aren’t even thinking about the need to take it out.
Kirby: Exactly. Again, I mean, there were studies done. Actually, this is one of the few devices that there were actually studies done, but we found in our research that some of those studies, that the patients reported their—what was happening and the harms that were happening, and they were altered by the researchers, who again, were paid by the company. So, you know, we’ve seen this kind of really nefarious activity going on, and people can get away with it because again, nobody knows it’s really an issue.
Joan: But the risk is so unbelievably high. You brought up da Vinci. I mean, these are these high-tech surgical robots, and everybody's probably seen a little video of them on the news somewhere along the way, but as these things were discovered and developed, all with good intentions and all for good reasons and can really help when operated properly, but they started being brought into any doctor’s office who could afford to bring it into, and these doctors are doing surgery on people without the proper training. Let’s just listen to one doctor, Dr. Robert Poston. Let’s just take a listen.
[Clip plays]
Robert: I was told that it takes 10 cases to get good at robotics, but I know now in retrospect that I didn’t really start to feel comfortable until I was about 200 or 300 cases.
[Clip ends]
Joan: So I can’t even imagine a doctor going into a surgical suite and putting his hands in and operating on a person with a very high-tech robotic machine with practically no training. It’s almost unthinkable!
Kirby: Yeah. No, I mean, I have to say that, you know, Intuitive Surgical, that manufactures the da Vinci robot, really had a very cynical and aggressive marketing campaign to get this out into the public. And one thing they did not want to do is have doctors feel like it was going to take a month, two, three, four months of training before they could actually operate using a robot. So what they told them is you can go out, you can take two days of training, you’ll do two surgeries that are proctored with another doctor there to oversee it, and then you’re good to go.
Joan: Wait. Seriously?
Kirby: Oh yeah. Oh yeah. That was over and over. This information came out in trial. And so, again, they know that these things are causing harm, right? But they’re the only people that know, really. Nobody else does. The doctor—and by the way, if the surgeon who’s been told that he or she can operate makes a mistake, they just say oh, you’re a bad surgeon.
Amy: Yeah, doctors over and over again told us that there was a huge disparity between the information they were given about what they needed to be sufficiently trained and what they found in reality, and over and over again, they said in reality, they found it was at least 300 surgeries for them to become proficient, so what happens to that first 300 patients? And the other thing about robots, Joan, is that you said, yes, in some cases, but it’s really small, there’s advantages to using a robot. In most, there aren’t. The advantage is you can charge a lot more because it sounds a lot sexier, right? A big, fancy robot, and you’re getting the state of the art, and it’s longer recovery time, and actually, you know, someone was pointing out the other day to me that you know, a lot of things, there’s a value to someone knowing how to tactically go in, hands on, and fix things, right?
I mean, what happens if the robot malfunctions? What happens if the power goes down? What happens if there’s a huge problem the robot causes, and you need to then go in there yourself? What if you’re not a physician that’s worked for four years only on a robot? You’re in the room. You don’t know what to do. You don’t have those years of experience now actually manually working on a patient. And that’s the sad and scary thing. Hysterectomies, again, it’s just like the hips I was referring to, do it the old fashioned way. Works great. You don’t need to have these fancy robot doing it, and yet they can charge more, so the fancy robots started taking over this, and as we see in the film, to horrific, horrific consequences in women, unnecessarily.
Joan: When we hear that woman say that her colon—is that was it was?—was falling out after this, it’s just—
Amy: Yeah.
Kirby: And we were—I mean, the shocking thing is we were able to find seven ourselves.
Amy: Seven survivors of that.
Kirby: Seven cases, and before the da Vinci, it was considered extremely rare.
Amy: To ever have that happen. It’s be like infinitesimally small that you’d have your colon fall out as a result of an operation, and now, meh, it’s a possibility.
Joan: And what does the patient do? The question, as you say, is going to be, who’s fault is it? Is it the doctor? Is it the machine?
Amy: Well, you raise a great point also, because of Tort reforms, people can only sue for so much, so A, as I said, there’s a delay in trying to figure out that the device hurt you. B, once you do figure it out, because now they’ve also rigged the system, so that you can only sue for so much, once you complain, you can’t make that much—it doesn’t sort of offset the irreparable harm your life has now been caused by being disfigured and severely ill the rest of your life. But it still is good for the companies because all they have to do is then pull the product off the market, pay you a minimal fee, and keep all the rest of their profits. So again, it’s scary, right? They’re not necessarily incentivized to improve the product. They just pull it and pay off a settlement fee, and in one device, one of the experts told me, there was a device that was 2.8 billion in sales around the world. Fifteen years later, they settled lawsuits worth 200 million, and they still came up 2.6 billion ahead.
Kirby: And you know, it’s interesting, because if you’re a patient, and your doctor comes to you and says, look, we have this great new machine. It’s a robot. It’s state of the art. It’s the most innovative thing we have. You know, your natural impulse is to say, great, use it. But one of the things we want to convey to people is when they hear the word innovative, rather than running toward that, to stop, to do the research and find out. And the other thing we found out is—because a lot of doctors have now seen the film—there’s a lot of doctors out there that are very suspicious about the da Vinci robot. They feel that it’s been thrown out on the market too fast, that as Amy says, there are some particular uses where it’s definitely better, but it’s a very expensive, complicated machine that is dangerous if it’s not handled properly.
Amy: And what we heard over and over again is that the marketing was so effective that it sucked the hospitals in, believing they had to buy this fancy, new machine. Then they were stick with paying these bills, so there was a lot of pressure for them to simply book surgeries even when the doctors were undertrained. That’s what’s scary, too, is these poor people, over and over, they were like, we wish we never heard the name da Vinci. Like, why? It’s sad, because some of these were elective surgeries. Some of these were surgeries that could have been done the old fashioned way just as fine.
Joan: Has there been any reaction at all from anybody at the FDA? I mean, they’re the ones that approved it and let it go on the market.
Kirby: Sadly, I mean, we asked them about—I mean, we obviously look at a lot of devices in our film, and we ask them to respond to all of them and the issues and problems we saw with the approval process, and they just, you know, just basically deferred. They had a few kind of very basic statements, but they didn’t address the specific questions. Certainly, they wouldn’t sit for an interview. No one from the FDA who’s still working there—we had former employees—and certainly no one from any of the companies sat for an interview.
Joan: Which is scary, because right there, they’re an agency that should be wanting to. Like come on, public, like ask me questions.
Amy: Yeah, I mean, it’s hard to defend the indefensible, right? That makes it very difficult.
Kirby: Well, yes, but they’re a public agency, right? They’re paid by our taxes. I think when a film that is this rigorous and this extensive and is making this powerful of a critique, they have a responsibility to the public to answer these questions and not duck them.
Joan: Go on camera.
Kirby: Commissioner Gottlieb, he should stand up. He shouldn’t just run away from these questions. It’s a form of—I don’t know. In a way, it’s a form of cowardice not to step up. I mean, if he really believes what he’s doing is right, then he should stand up and defend it.
Joan: Yeah. What does this agency have to hide? I mean, that’s what’s strange. I mean, why not talk to documentary people on camera? It’s just—it doesn’t—
Amy: It’s a little bit bizarre.
Joan: It doesn’t make any sense.
Kirby: I mean, when we made The Invisible War, we went into the Pentagon. We had nine generals and admirals speaking to us, but we couldn’t get one person from the FDA. And believe me, we tried.
Amy: Oh, but I did want to say that the FDA actually did respond, right? Because right before Tribeca—so again, we put out this request. We told them what was in the film. We wanted to do an interview. We wanted to discuss these issues with them. No, they refused the request for the interview, but lo and behold, right before Tribeca’s release—
Joan: The premier.
Amy: The premier, they did change a policy vis a vis Essure. So again, the pressure and power of advocacy combined with documentary filmmaking did force a change in the FDA, a slight change, but a change nonetheless.
Joan: Does the FDA, though, hold the power to make these changes in what is obviously a broken system, or is this a political—does this take Congress? And are they the ones that can make these changes and change the system, so that patients are ultimately protected?
Kirby: Yeah. The FDA has to abide by the laws that Congress pass. I do think the FDA can be much more rigorous in what it does and not fold when faced by the political pressure of the medical device industry, which they have done. But I think ultimately, it’s up to Congress.
Amy: But we also hope that it’s not just Congress. This is something that Congress only does the behest of its constituents, allegedly, so I mean, pressure has to come from the public, because we know that lobbying dollars also can buy and persuade politicians. So you know, I think that everyone needs to see this film and everyone needs to become informed and outraged and sort of put the political pressure on their congresspeople to do the right thing and pass the right laws that regulate the FDA that make a safer industry for everyone.
Joan: So in closing the really bottom-line takeaway here is innovation, breakthrough, leading edge can sometimes be the bleeding edge.
Kirby: Yes, exactly.
Joan: And that we all have to become aware of this and be better consumers and become informed patients, which is difficult when you don’t have all this information that we learn in the film. And that’s why you guys do your work, and that’s why you do it so well. Amy and Kirby, we thank you. I just hope we can—I’d like to have it be mandatory viewing of everyone in the country. And thank you so much for your good work.
Kirby: Thank you. Thank you.
Amy: Thank you.
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Rae: That was Joan Lunden with Kirby Dick and Amy Ziering. And now let’s hear from you. It’s time for a dramatic reading of your dramatic social media reactions to The Bleeding Edge.
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Man: @katielewis writes, if anyone wants an intriguing documentary to watch, go watch The Bleeding Edge on Netflix. There is some draw-dropping, [Beep]-ed up things happening in the FDA and medical instrument industry.
Woman: @mrscharlottex says, I love Netflix documentaries, but man, does The Bleeding Edge have me all fired up. Medical devices are no joke.
Man: @ellieclutterangel says, The Bleeding Edge on Netflix blows open the potential dangers of medical devices implanted in the body. If you’re having any kind of replacement surgery, you should watch this to be more informed.
Rae: You can share your thoughts and feelings on an upcoming episode, too. Find us on Twitter @cantmakethisup, on Instagram @youcantmakethisup, and on Facebook @youcantmakethisupnetflix, or just search for us. I promise you’ll find us. Before we leave you, we’re bringing back The Bleeding Edge filmmakers for one more segment. That’s right. It’s time for Whatcha Watching, where we find out what the people on the podcast are watching on Netflix. Let’s find out what Joan, Kirby, and Amy are watching now.
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Joan: I have a favorite author, Harlan Coben. He’s just done two shows for them. One’s called The Five. The other’s called Safe, and these are like episodic. It’s like reading one of his books, except it’s in 10 episodes, and when it comes to documentaries, they are so incredibly well done that I am always kind of—it’s mind-blowing how well the documentaries are done, certainly the case of your film, The Bleeding Edge being one of those.
Kirby: Well thank you. I mean, I think we’re in the golden age of documentaries right now, so it’s a wonderful time to be making documentaries.
Amy: Because we do such grim work, I usually binge the comedy specials on Netflix, and of course, Ali Wong is amazing, and Chris Rock and of course, Nanette.
Kirby: I always love watching Black Mirror. I guess I always go for the dark side. So yes, and that’s actually—this is sort of real-life Black Mirror material. [Laughter]
Joan: I would have guessed you would have been a Black Mirror watcher.
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Rae: That’s it for this week’s episode. We’ll be back in two weeks to talk about another documentary film, Jim & Andy, or by its full title, Jim & Andy: The Great Beyond - Featuring a Very Special Contractually Obligated Mention of Tony Clifton.
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Rae: You can find this show on Apple Podcasts, Stitcher, Google Play, Spotify, and wherever else you get your podcasts. Make sure to subscribe, rate, and review this show. It helps other people find it, and it’s extremely validating to me personally. You Can’t Make This Up is a production of Pineapple Street Media and Netflix. Our music is by Hansdale Hsu. I’m Rae Votta, and thanks for listening.
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