A New Netflix Doc Exposes Huge Problems With the Way Certain Medical Treatments Are Approved

'The Bleeding Edge' shows how the FDA doesn’t hold medical devices to the same standards of safety and effectiveness as it does prescription drugs, even though some devices will presumably remain in the body for the rest of people's lives.

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Aug 3 2018, 5:32pm

Over the past two decades, documentarians Kirby Dick and Amy Ziering have explored subjects their peers wouldn’t go near. This Film Is Not Yet Rated tackled the absurdity of the Motion Picture Association of America (MPAA), The Invisible War unveiled the epidemic of rape within the military, and The Hunting Ground examined sexual assault on college campuses.

Their latest project, titled The Bleeding Edge, targets the $400 billion medical device industry and its cult of innovation—pitting promising new devices against older, more proven treatments. More specifically, Dick and Ziering aim to expose the corporate carelessness around FDA-approved medical devices like Essure, a permanent birth control implant that blocks the fallopian tubes so women can’t get pregnant.

Since Essure arrived on the market in 2002, the product that was billed as a nonsurgical alternative to a woman getting her tubes tied has been plagued by controversy. More than 16,000 lawsuits have been filed against its manufacturer, Bayer, claiming the product has led to unintended pregnancies, severe pain, and injuries including the implant perforating the uterus and the fallopian tubes. The Bleeding Edge seeks justice for these women, and other Americans harmed by devices like metal-on-metal replacement hips, robotic surgery devices, and vaginal mesh.

Through interviews with doctors and journalists, The Bleeding Edge shows how the Food and Drug Administration (FDA) doesn’t hold medical devices to the same standards of safety and effectiveness as it does prescription drugs, even though some devices will presumably remain in the body for the rest of people’s lives. A device can get approved without any human trials if it’s “substantially equivalent” to a device that’s already approved; this is what’s known as the 510(K) pathway. “That provision, which was meant as an exception, in essence [is] a loophole,” David Kessler, a former FDA commissioner, says in the film. “[It] became the rule, so that the vast majority of devices today regrettably are regulated under this framework.”

For devices that require what’s known as pre-market approval, manufacturers have to submit clinical trials; Essure was tested in clinical trials, but the trials only followed women for 12 to 18 months. The film also explains how doctors aren’t required to report complications from medical devices to the FDA, so the information it receives is very likely incomplete. Still, there were nearly 12,000 reports of adverse events linked to Essure in 2017 alone.

One week before the film’s release on Netflix, Bayer announced it would no longer sell Essure in the US—the only country where it was still available—because of declining sales. The news is now mentioned at the end of the film.

I talked to Dick and Ziering about the film's message and impact.

In a statement on July 27, Bayer said your film “presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the [FDA’s] determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device.” How do you two feel about Bayer’s perspective at this point?

Amy Ziering: The first thing I’ll say is their comments come five days before the release—

Kirby Dick: Seven days.

AZ: Seven days before the film started streaming globally, and subsequent to the film’s incredible premiere at Tribeca to great critical acclaim, Bayer elected to pull Essure off the US market. After seven years of intense lobbying, lawsuits being filed, intense pressure by advocates, the product is selling just fine, and coincidentally right before [the film] starts streaming globally, they realize that they need to pull it. Let that speak for itself.

KD: The facts in The Bleeding Edge are accurate, and they’ve been rigorously vetted by extensive research and by multiple experts. Rather than attacking the messenger, we think Bayer should be addressing the harms its products have caused in tens of thousands of women. As we show in our film, there’s this Facebook group of more than 37,000 people, and many if not most of those people are women who’ve been harmed by Essure. And that’s probably just the tip of the iceberg, because most people are not going to join a Facebook group. Most people are just going to suffer in silence.

AZ: I also want to say it’s right out of big business’s playbook to start a white noise campaign and discredit the message, right? And the messengers. But you know, our record is unimpeachable. We have no dog in this race. I’d be very happy to make a film saying that product is great. So it’s also strange, like what’s our motivation to put out false information, you know? What is that? Please don’t be deceived by the typical corporate obfuscation.

Part of that obfuscation is Bayer’s description of the negative publicity around Essure, calling it “inaccurate and misleading.” Do you think they mean “factual and inconvenient”?

KD: These are women who’ve definitely been harmed. There’s no question. These are women who are really trying to get the truth out and trying to help other women, and to go after patients who’ve been harmed by your device seems to me just unbelievably aggressive.

Damage after the fact.

KD: Bayer is a multinational corporation. I mean, if they made a mistake on this one, own up to it, right? There’s tens of thousands of adverse event reports on the FDA website. Again, we know that only a small percentage of adverse events are reported. Bayer has known this is a problem for a long, long time, and they have really, as far as we know, done very little to own up to this problem caused by their device.

For Bayer, what would “owning up to it” look like in 2018?

KD: Most importantly, if the device needs to be taken out, they should properly remove this device [from people's bodies]. One of the huge problems is many doctors do not know how to remove this device, and they’re removing it in the wrong way, creating much worse problems because fragments of the device then get distributed throughout a woman’s abdomen. That’s exactly what happened to Angie Firmalino [one of the film's main subjects]. That would be the first step, I think. To just intervene at this point and act in a way that prevents more harm from happening.

AZ: And then to be morally and ethically responsible. Own the problems with your product and do whatever it takes to make amends. Given that you have women who have lost their jobs, suffered incredible financial impacts in addition to having to deal with health issues for the rest of their lives, financial renumeration. Support. This was an elective surgery. This was not something they had to do, and they were not given enough information about the risks in making this choice, and they’re suffering horrific consequences.

You both interviewed dozens of women for this project. A through-line in most of the conversations is how people’s sex lives have been drastically affected by the faulty contraceptive. How do they move forward given their situation?

AZ: I know from having sat in rooms with them that it’s totally heartbreaking. I would sit there and young women, anywhere from their 20s on up…to have that part of their lives needlessly taken away when they were, ironically, just doing something to enhance their sexual enjoyment, to take contraception off the map. That’s the cruel irony. I don’t personally know how you recover from that. Part of our empathy for that kind of trauma motivated our desire to do this film and get it right and get it out there so that no one else has to be needlessly hurt this way.


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And yet both of you had to dive into that trauma, and begin to piece together a collective story. Did you feel the responsibility of making sure these women were understood?

KD: You know, they’re not only physically hurt, they’re psychologically traumatized by this. We’ve heard women say they felt like they were raped by a device, and they have PTSD symptoms around this whole issue, oftentimes, for the rest of their life. We try to really be very caring of them, of their story.

Amy did the interviews and she sets up a safe environment. One of the things we’ve seen with the interviews we’ve done with patients is that this is very validating for them. For so long in so many cases, the medical device company, the industry itself, sometimes even doctors, have denied what happened. To have someone come in and really listen to them and listen to their story is very meaningful. And also for them to participate in a project that is hopefully going to help change things so that other patients aren’t harmed. It really gives some meaning to the profound suffering that they’ve experienced.

AZ: You’re right...ask[ing] these questions comes with extreme responsibility, and we take that responsibility very, very seriously. That’s why we craft our films with the passion, integrity, thoroughness, and rigor that we do. Someone put their trust in you with their life story. That relationship is not something we do or take lightly.

What was it like to sit across from Scott Whittaker, the CEO of AdvaMed, the trade organization for the medical device industry? What is that dynamic like—is he trying to understand where you guys are coming from, are you guys trying to understand where he’s coming from?

KD: I did the interview. It was a very open, transparent conversation. He knew in particular that we wanted to talk about some of the problems of medical devices and regulations. But it’s not really about an individual. It’s really about a system, you know? It’s an industry that has been able to, unfortunately, put out many products that are dangerous, and it’s about our regulatory system, the FDA, which is not doing the oversight that it should. That’s really where we want the focus of this film to be put, and where we see changes need to be made. This is not a film about Scott and AdvaMed; whatever problems there were, he did not create the problems. He could be a part of the solution, absolutely, and we hope he will be. But this is really much more of an indictment of the industry and the FDA.

AZ: We hope [the film] leads to other companies heeding the message, and the public pressuring the FDA to have more oversight of an industry that was too often described to us as the lawless West. Which is not how you want an industry described that is in care of your body.

This interview has been edited for length and clarity.

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