"When it comes to medical devices, we created a system that doesn’t work," says former FDA commissioner Dr. David Kessler in Kirby Dick and Amy Ziering's Netflix documentary The Bleeding Edge. That's a bold statement to make about a $400 billion healthcare industry, particularly coming from its former gatekeeper. But to the patients whose lives have been irrevocably—and often traumatically—harmed due to complications from devices that were not tested on humans, it's an understatement.

Following the game-changing success of their controversial documentaries about sexual assault—The Hunting Ground and The Invisible War— Dick and Ziering have created a searing exposé filled with testimonies from top experts in the field and well-researched facts from dozens medical studies and legal documents. This investigative research yields systematic corporate cover-ups, profit-driven incentives, and insufficient regulations that jeopardize doctors' ability to uphold the Hippocratic Oath.

The film zeroes in on an FDA loophole called the 501(k) exemption, which operates by the transitive property, allowing device manufacturers to sell their products without testing or trials as long as they are similar to other devices on the market—even if those devices were ultimately recalled for safety concerns. The case studies here are the Essure birth control device, transvaginal mesh implants, cobalt metal-on-metal hip replacements, and the DaVinci surgical robot.

These devices caused nightmarish complications in hundreds to thousands of patients, ranging from a doctor who had a psychotic breakdown due to cobalt poisoning from his hip replacement, to one woman whose organs fell out after being operated on by a robot. 

The worst part? Most doctors don't even know this is happening.

No Film School sat down with Dick and Ziering to discuss the complex and arduous art of investigative filmmaking. The film is already making waves; just 12 days before its premiere at Tribeca, the FDA imposed strict regulations on the sale and distribution of Essure. According to the filmmakers, the FDA was well aware of the existence of The Bleeding Edge

"We usually first get intrigued, then outraged, and then we decide to make a movie."

No Film School: How did you first hear about the issue of underregulated and under-tested medical devices?

Amy Ziering: One of the producers we're working with, Amy Herdy, came to us and said, “I have this neighbor with this crazy story. Will you meet them when they come down to LA?” We met them, and we heard their crazy story, and then thought, “Wow. How is this possible?” Something bad had happened to them. We had no idea.

Kirby Dick: The idea that medical devices were as unregulated as they are... it's absurd.

Ziering: Right? We were like, “What?” We thought that it couldn't be true. It's kind of similar to The Invisible War.

Dick: [We had] almost the same reaction.

Ziering: Yeah: “What? How is this fucking possible? [Soldiers] have no recourse to a system of justice? They can just get raped and that's it?”

It was the same thing here. We were like, “Wait, that makes no sense. [Medical devices] have gotta be tested.” And [the patient] was like, “No. Honestly, they're not.”

We usually first get intrigued, then outraged, and then we decide to make a movie.

NFS: That's a great three-step process. What was the first step in approaching this from an investigative angle?

Dick: It was learning the breadth of the medical device industry. We got a crash course—kind of a medical school education. We're all affected by medical devices all the time. We don't even realize it. We go in for X-rays, CT scans. And as we get older, of course, it becomes much more a part of our lives. So we started looking at the range of medical devices. I think we looked into between 25 and 50. The majority of them had real problems. Obviously, there are some wonderful medical devices that save lives.

We worked with Amy Herdy to start contacting patients and doctors who were in the field. This was one of the things that really struck us—people were so afraid to talk. Especially people in the medical industry. We've made a lot of films where people are afraid to talk. Here, the fear was the greatest. It's a huge industry, and there's so much money flowing through it. 

Ziering: They're very brutal. They really do ostracize—

Dick: And retaliate. 

Ziering: And retaliate. 

Dick: You see Dr. Tower in the film. There are only a few people who are whistleblowers, even though it's a huge field, because everyone else knows to keep their mouth shut. We were in contact with whistleblowers and a lot of them were really afraid. They had [leaked information] legally but they didn't want to come out publicly. But they did give us a lot of information. 

Ziering: Coupled with that, what’s interesting is that the majority [of physicians] had no idea. It's not even their fault. They're like, “We don't know that there's a problem.” 

Dick: Like Dr. Tower, who was implanting hips. He had one implanted himself and it was hugely problematic. And it was only then that he really started digging into it. He realized these hips that he was implanting in other people were not even tested in humans. This is one of the most shocking things about this film. Most doctors don't know this. 

V1_0'The Bleeding Edge'Credit: Netflix

Ziering: We do these test screenings to see how the films playing. Pretty late in the game, we wanted to bring the experts in. "Did we get anything wrong?" We wanted to make sure everything was solid, so we had a bunch of medical people at the screening. About a month later, I was just out and about in LA, and I happened to run into [someone from the test screening]. He's like, “Oh my god, I have to talk to you.” I was like, “What?” He goes, “I saw your movie a month ago. Remember I gave you notes?” This person will remain anonymous, but is super high up in a major medical institution in LA, let's just put it that way. And he says, “I just want you to know, your film completely changed the way I work.”

He said, “Well I was sent a device to use, and typically I would take it at face value. 'This is great, please use it in infants.' Because of your film, it stuck in my mind and I wrote them back and I said, 'Can I see the studies that shows that it can be used in newborns?' And they wrote back and said, 'There are no studies. It tests fine 12 years and up.'" He's like, “I'm not doing it.” And he said he never would have done that otherwise. 

NFS: So there isn't a culture of thinking critically about what the reps or device companies are sending to doctors?

Ziering: At least with this guy, there was an assumption that the homework's been done. That "FDA-approved" means something. 

Dick: One of the things we want people to walk away with [after seeing this film] is when they hear the word "innovation," to just stop right there. And instead of rushing toward it, which doctors and patients do, just stop. That ties into the title, The Bleeding Edge. Make sure that your device... if it hasn't been tested, it's at least been used for ten or 20 years. 

Ziering: New isn't better. It's better to have something that's been around and there aren't a million lawsuits against it. 

NFS: Tried and true. 

Ziering: Yes. That's also what's crazy. If it's not broken, it doesn't need to be fixed. Those are working just fine, the ones put in in the ‘70s. It's just about profit, because they can't sell more unless they say it's better. Or they can't compete, so you have to come up with a new design. But maybe it doesn't need a new design. Same with the robots. With hysterectomies, Surgeons can do them just fine, and even better [than robots]. And experienced surgeons have an amazing low complication rate.

"We've made a lot of films where people are afraid to talk. Here, the fear was the greatest."

NFS: What were some instances of pushback that you experienced when you were talking to patients or whistleblowers? And how did you navigate those?

Dick: Fear was through the roof. Some doctors were like, “I know this happens, but I can't talk to you on the record about it.” There's a long history of companies and doctor's associations ostracizing a surgeon. Blaming them. For example, if [a surgeon] says, “Look, I'm seeing a problem with this,” then the pushback is, "Well, you must not be a very good surgeon." And that can really destroy a career.

Ziering: So there was pushback in terms of people's readiness to speak. Because there is such a lack of transparency, it's like pulling teeth to try to get the right numbers and figure out if our research is solid. That was a phenomenal amount of work. 

NFS: Can you talk a little bit more about the research process? I know that was probably the heaviest lift here. 

Ziering: Mammoth. Absolutely mammoth. And Kirby and Amy Herdy deserve a truckload of credit. There's not a study this guy has not read, pored through, called up the experts and harassed them at length. Kirby's remarkable, like a national hero, honestly. And I'm not saying that 'cause I work with him. There's no one like him. And there's no one that does what he does. And no one understands it, so I'm glad you asked that question.

Amy Herdy, as well. She's a phenomenal researcher. We also have a really good staff of amazing fact checkers and a great legal staff. It's very collaborative. But it's exhausting and really, really hard.

Dick: I read 1,000 studies in the process of doing this. 

Ziering: A lot of documentaries take a book and put it [onscreen]. Or they [make a film about] a thing that happened in the past. The thing that's a little bit different about us is we do the hard, heavy lifts of original research. We don't rely on someone else who's already found the experts and told the story. 

130221-invisible-war-rape-clift-tease_kh7ohy'The Invisible War,' directed by Kirby Dick and produced by Amy Ziering.

NFS: How does the research start to take narrative shape? 

Ziering: It's evolving throughout. There's not one moment where you decide. Usually, there's research, we do an interview, that informs the research, and that informs the next step. We go out in a lot of different directions and then you just see what's yielding the most information—the most solid story, the most compelling character. 

Dick: Since there are no books out on the subject, it's sort of up to us to present the big picture. The whole filmmaking process is building that picture. It's one of the great creative challenges of documentary filmmaking.

There are other [kinds of documentaries], and that's great. But certainly, to go out and to tackle an entire industry where there is no collective perspective on it, and to use this art form to do it—that is a creative challenge. 

Ziering: There's a weird misperception that [investigative documentaries] are self-evident. That's there no art to it. There's no sort of creative force to it. It's like, "Excuse me!"

Dick: It's self-evident because of all the work! But oftentimes viewers, and even critics, think, “Oh! Okay, so I'm just getting this information.”

No. Actually, this is a huge creative undertaking to get you to that point. And not only just to get you to that point, but to get an entire culture to the point of reacting and addressing this issue. It's a massive creative undertaking.

There's a perspective that art films are the highest forms of documentary. There are wonderful art documentaries, but the hierarchy is what I find problematic. I think the one thing about documentaries is it's a wide-open field. For people to say there's a hierarchy and the art film is at the top—that's such an anti-art perspective. The whole idea of art is that you go in all directions. You look for everything. 

"We look for subject matter that no one else has covered, certainly in film....We like to break these major stories through documentary."

NFS: I think part of the problem is people don't understand what the process is that gets them to your end goal, which is dialogue—cultural and societal dialogue. 

Dick: Exactly. Precisely. 

NFS: So let’s bring people into the process more. How did the narrative begin to take shape?

Dick: Well, it's continual. 

Ziering: We don't storyboard. We edit as we go. Everything's at once. Research, production, and post are all the same time. Everything's contemporaneous.

Dick: Because everything's informing everything. 

Ziering: We'll do a heavy set of interviews and transcribe them—

Dick: And vérité.

Ziering: And then get some things cut. So it's not like this moment four months in when we're like, “Okay, we have these five devices and these five characters.” It changes. 

Dick: It's constantly shifting. 

Ziering: We cut a lead character in The Hunting Ground. The cut we sent Sundance with the lead in was a 90-minute film, so you can imagine how much she was in. We pivot. That's hard, too, because you always have to warn subjects. 

NFS: Are there certain ways in which you can manage your own sense of risk in terms of how many resources you're putting in?

Dick: Well, that's one of the most complex things about making documentaries. We view production and post as an exploratory process from start to finish. 

Ziering: So you just factor that in. You know you're going to be doing some futile things. You budget that in.

Dick: You know you're going to be striking out all the time.

Ziering: And you don't beat yourself up. 

Dick: Well, you do. 

Ziering: Sometimes you do.

Dick: Sometimes you don't make the right decision to follow somebody. And then you're scrambling and you really beat yourself up. That's where documentary is very close to art. It's unpredictable and the process is so important. You have to immerse yourself before you know where it's going to go. 

Thg_3'The Hunting Ground,' directed by Kirby Dick and produced by Amy Ziering.

NFS: There's enough information and research packed into The Bleeding Edge to qualify it as a cinematic exposé. Would you call it that?

Dick: Absolutely. Dr. Tower's story could be [something] that people are talking about 30 years from now. A practicing orthopedic surgeon up in Alaska is coming across this information [about dangerous hip replacements]! Obviously, the studies have to be confirmed by larger studies, but that is pretty amazing. I can't even think of a parallel story of this stature, particularly in science, that was actually broken by a documentary. We feel very proud of that. 

Ziering: I think we're a little ahead of the curve here. We were a little ahead of the curve, obviously, with [our previous two films about] sexual assault. We made those movies long before it was trending. I think this is another issue that's groundbreaking. This is an issue no one knows about.

"Just getting this information out will start to change things."

Dick: That's what we try to do. We are very particular about how we select subject matter. We look for subject matter that no one else has covered, certainly in film. We like to break these major stories through documentary.

We also pick stories where we feel that the information in the documentary will be so powerful that it will affect change. And that's happened with the last two films. We think this film [also has that] potential. We're getting this film out to medical schools and the whole range of the medical industry, because the reality is that most doctors want to do the right thing. So just getting this information out will start to change things. 

It's the same thing with members of Congress. Just like [consumers], they bought the fact that medical technology should embrace innovation. That we should have less regulation to get to this innovation. I think once they see this film, a lot of them, Republican or Democrat, are gonna say, “Hey, wait a minute. I've got a hip in!” 

NFS: What can a documentary do that a New York Times exposé based on a medical journal article, for example, could not? 

Ziering: I think it gives you a longer, more meditative space to really do a deep dive. And I think it's also different to hear a testimony firsthand from a person as opposed to reading it. We're humans and we empathize by visual cues that exceed the print. I think that's what the power of documentary can be. 

Dick: I think because it's an immersive experience, it's more impactful. As Amy's saying, there's so much impact because you have 90 or 100 minutes. You hear the testimony. The argument is completely laid out. And you walk away with a really complete understanding of it—the personal experience and the science. 

Ziering: We're in this incredibly ADD culture. Everyone's distracted. Everything's a Tweet, 140 characters. It's overwhelming. We're seeing this hunger and this desire to have to be forced to sit and contemplate for 90 minutes. 

And the other third part of it is the shutting down of all of the investigative bureaus. There aren't a lot of places doing original investigation anymore. Those places are aggregators. Even the New York Times now is covering the late shows. We're out there doing, as Kirby said, original work. I think people are hungry for that. 

Dick: And I think you can tell you have success by the way it impacts people. 12 days before this premiered at Tribeca, the FDA commissioner announced this very significant change around Essure

Ziering: The women had been pressuring the FDA with no results for years and years and years. [The FDA] knew The Bleeding Edge was coming out because we obviously had to reach out to them for comments. 

Dick: Right. They knew we were focusing on Essure. They knew we were following these women [who were Essure patients]. 

Ziering: Yeah. After decades of not doing anything on this...the timing is not a coincidence.

For more, see our complete coverage of the 2018 Tribeca Film Festival.

For more information on 'The Bleeding Edge,' click here