Kirby Dick and Amy Ziering make investigative documentaries that tackle hypocrisy. These Oscar-nominated truth tellers exposed closeted politicians voting against gay rights in “Outrage,” the U.S. military cover up of the rape of soldiers in “The Invisible War” and how college campuses cover up rape crimes in “The Hunting Ground.”
In their latest effort, “The Bleeding Edge,” Dick and Ziering explore the ramifications of medical devices that cause harm rather than do good. They investigate women who say they were harmed by Essure, a device that is used to provide permanent birth control. (It sterilizes women by blocking the fallopian tube). Angie became an activist, seeking out other women who suffered medical problems, such as Ana, a Latina mother of four, who began bleeding profusely after the Essure device was inserted.
UPDATE: Bayer announced on July 20 that it would stop the sale of Essure at the end of 2018. According to a statement provided by the company:
Since its approval, Essure has been an important option for women seeking permanent birth control, offering a less invasive alternative to tubal ligation. In recent years, however, the demand for Essure has decreased due to a number of factors, including decreased use of permanent contraception overall, the increasing popularity of long-acting, reversible birth control options, and inaccurate or misleading publicity about the device. Our decision was not based on concerns about the safety and efficacy of Essure. Essure has been on the market for more than 15 years and has been successfully used by hundreds of thousands of women.
Any effort to protect and promote women’s health must be rooted in science. More than 40 studies, involving more than 200,000 women, have been conducted to evaluate the safety and efficacy of Essure. The data demonstrates Essure’s positive safety profile as confirmed by highly respected medical organizations such as the American College of Obstetricians and Gynecologists. FDA also has maintained that Essure’s benefits outweigh any potential risks.
Like all medical products, Essure use is associated with certain potential risks, which have been appropriately communicated in the label to doctors and patients. There is no reliable scientific evidence of any new safety issues related to Essure.
Over the last few years, Essure has been the subject of conversation on both social and mainstream media platforms. The concerns raised about Essure are based primarily on anecdotal reports from individual patients. Bayer takes all such reports seriously. It is important to understand, however, that anecdotal reports have limitations. While such reports can raise questions about potential issues with a product, they do not provide answers. Such questions can only be answered through evidence-based medicine, including clinical trials and observational studies.
In 2015, the FDA conducted a thorough review of the reports related to Essure and held an Advisory Committee meeting to discuss those reports. After completing its review, FDA confirmed that the benefits outweigh the risks associated with the device, but did request a new study to evaluate the comparative risks of Essure and tubal ligation. Since that time, a number of large-scale studies have generated new data addressing many of FDA’s questions and provided further reassurance about the safety and efficacy of Essure.
Bayer responds to "The Bleeding Edge":
As a leader in women’s healthcare, Bayer believes strongly that women and their physicians should make reproductive health decisions based on sound science. In contrast, the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film. The 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 Food and Drug Administration’s (FDA) determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device. The film also relies on many conflicted sources without disclosing their potential biases. This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device.
"The Bleeding Edge" filmmakers respond to Bayer:
We are not surprised that Bayer has attacked our film, which reveals the serious complications caused by its flawed implantable birth control device Essure. Bayer has a long history of maligning critics of Essure rather than addressing the harms it has caused to tens of thousands of women.Everything in "The Bleeding Edge" is accurate and has been rigorously vetted by extensive research and multiple experts.Essure was approved under an “expedited review” based only upon studies that weren't randomized or non-blinded and lacked comparator groups. These studies only followed most participants for 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime.We were glad to hear Bayer’s July 20 announcement that it would stop selling Essure after 2018. Until then, we urge any woman who is contemplating Essure to be fully informed of its risks.
“The Bleeding Edge” also considers products such as cobalt hip replacements that caused toxicity in the bloodstream that led patients to experience dementia; women who have had vaginal mesh procedures that had serious medical side effects; and women who had vaginal cuff surgeries performed by a doctor operating the da Vinci Robot, only to suffer calamitous pain and problems.
Dick and Ziering shrewdly explore how bad products get on the market (it’s easier than you might think), and they follow the money, holding inexperienced doctors and greedy companies accountable as patients feel guilt and lose their quality of life. What is more, the filmmakers ask viewers to take action, research products and ask doctors questions.
The filmmakers sat down to discuss their work during the film's world premiere at the Tribeca Film Festival.
While I was watching your film, it terrified me so much I actually had to stop and call my mom who had hip surgery last year. I needed to know if she had a cobalt hip because I feared all of the issues your film raised about that device.
Amy Ziering: That’s what we want! People were texting relatives during the premiere.
What was it about the medical device industry that made you explore this topic?
Ziering: Our investigative producer, Amy Herdy, came to us with a story and said you have to talk to these neighbors of mine. They had had an experience and had done their research. They said here’s what we learned and here’s what happened to us. Kirby and I had no idea. That’s batshit crazy, that can’t be possible! We started investigating. That’s what we do. We hear about something, we’re intrigued, we do some research and we’re outraged, and we go, “Oh, my God! We have to make a film about this!” We get compassionate and feel compelled to do this. Because no one else is.
Kirby Dick: We look at major issues that haven’t been covered in documentary and oftentimes in general audience books on the subject. That’s true with “Invisible War” and “Hunting Ground” and with this film. That’s our creative challenge. We look for where no one has gone before in film, certainly in documentary. We want these films to create the awareness that not only protects patients, students or people in the military but also creates the awareness among policymakers to address this issue.
Ziering: And viewers. We use the leverage of cinema to have you call your mother, which you might not do if you read an article in passing. It’s different when you have people for 90 minutes and you can say, “Focus, this is important. Here’s the analysis.” And as a human being, you respond empathically.
Dick: We’ve made all different kind of films — art films, vérité kinds — but at this point in our career, this is the greatest creative challenge: to use the art of documentary to open up an entire issue and do it in such a way that the culture reacts to it — positively — that the culture actually changes.
What was your criteria for the patient stories you told?
Dick: One, obviously, is veracity, but more importantly, corroboration, which was a real challenge in the medical field, because sometimes people can be harmed because it was a bad surgery. There can be a lot of different reasons, so we had to be certain it related to our subject matter. We look for stories that had potential, but we looked for people who told their stories very, very well, and I think we had incredible subjects.
Angie goes from victim to advocate; Ana does too. They become empowered. Their stories provide the film with its humanity. What decisions did you make on how you told these stories?
Dick: There has been good reporting on these issues, but we wanted to take it a step further and say there’s a problem with the entire industry and the way that it’s regulated. We had to show the breadth of the problem. Also, we’re dealing with a science here, so it’s incredibly complex. We had to make sure we got it right, and we had to make sure to explain very complicated devices and procedures in a way that audiences could understand and still be involved in the film.
Ziering: Unfortunately, the way we receive news now, everything is seen as an aberrant one-off. Breast implants — there’s a problem! Then people think, they fixed that, it’s all OK. No! It’s a systemic problem. No device is impervious to these conflicts of interest. You need to pay attention.
You tell viewers to follow the money and provide them with a call to action.
Dick: It’s a dark, dark world, the medical industry. Actually, it’s much darker than our film in a lot of ways.
Ziering: Our film is pretty dark.
Dick: I’m saying there’s more than this.
Ziering: Our film is the tip of the iceberg.
Dick: Exactly. It’s what we could corroborate.
Ziering: Can I say more about our filmmaking? Kirby is from art school, and I’m from a philosophical background. He comes from a conceptual art space where a film does something. “This Film Is Not Yet Rated” not only told the story of the problems with the ratings board, but it was itself submitted to be rated. There’s a performative aspect. The film is part and parcel to the problem it was examining. We’ve taken it to the next level. These issues explode like little bombs, and you’re calling your mother.
You create awareness and that helps foment change. Your visuals are graphic at times and yet very necessary. Can you talk about that aspect of “The Bleeding Edge”?
Dick: Film is a very immersive experience, so you want to use every tool that you have. Print doesn’t have that opportunity in the same way. A photo won’t be the same as a film. We are dealing with the body here. This is not some sort of imaginary world — this is your world, literally. We were judicious where we used [vivid images], but they do bring it home. These are life and death issues.
Ziering: You have someone in a room for 90 minutes. How do you move them? What’s the most powerful experience they can have in this moment. How many movies do you call someone after or remember five years later? They stick. That’s not an accident.
There’s this dismissal of films that are just reporting, as if it’s not an art in itself. There’s as much artistic and creative energy and gravitas as we brought to our films “Derrida” and “Sick,” which are art films. For us, it’s all on the same spectrum. The arguments and the work don’t just appear. We shepherd you on this journey in an artful and thoughtful way, even if they are difficult.
The most shocking fact in the film may be that the worse the efficacy, the less it’s reported. That may be pro-active in getting people to talk about it, so hopefully it will make more people come forward. I was surprised by the fear and shame these people had to talk about the important issues that need to be aired.
Ziering: People don’t even know how to analyze what’s going wrong with them, and companies can exploit that. If you’re having these bizarre autoimmune reactions, and you are getting diagnosed with Parkinson’s, as in the case with the hip implants, or hysteria, as with most of the Essure women, or told you are Latina so you bleed a lot. You don’t know. You haven’t gone to med school. You don’t connect it to the device. You don’t have the comprehensive wherewithal to know, "it’s my device." Also, there’s a temporal issue. You can get the hip implant, and 10 years later you get dementia. How on earth are you as a consumer supposed to connect the dots?
Dick: Or even a doctor? How’s your GP supposed to connect those dots? The other thing, in terms of the shame, particularly with the women who were harmed with the DaVinci robot procedure, several of them compared it to being raped. So there is this tendency to blame yourself for making a stupid mistake. There is no way you could know. In the case of the hips, these doctors don’t know how things are being regulated. The doctors here are victims, too. That’s really an important part of this story.
How much is the doctor’s fault? They don’t want to be seen as an authority that doesn’t know. You encourage patients to question their doctors. Your film encourages transparency.
Ziering: And more analytical about complications, too. You blame yourself, but you just don’t know, so you think it’s just my bad health. If you die, you don’t know if you died because you were really ill, or you died and you really didn’t have to. You would internalize it.
One of the women we first spoke to and were shocked said she called the hospital to get her records, and they wouldn’t send them to her. Then they were redacted. Then, when she finally got them — because she hired a lawyer — it all didn’t add up. Then the lightbulb that went off was, I thought it was just illness and it was my thing, but when I learned it happened to five other [people] and no one had to die, I realized . . . all those women thought the same thing!
You discuss that kind of dismissal in the film, that women are seen as “disposable.” It’s stunning. Why would anyone not treat a patient who is suffering?
Dick: These medical companies sell these products to these doctors and don’t let them know of the risk — especially if they’ve not been practicing a long time. In the case of Essure, they implant them, and then they aren’t aware, and there are no studies to make them aware, that there are all these risks at play. This is why I think the Essure women are really an incredible example of how patients and patient advocacy can change things. They are the future of patient advocacy. There are hundreds of devices that are harming people, and if all those groups would form around all those devices, then collectively come together, you have a constituency of well over a million, and that can become a real force. One of the great hopes for the protection of the entire population is patient advocacy like what the Essure women are doing.
Ziering: Yeah, that’s good, but also the FDA didn’t change anything, and these women have been screaming for years, unheard, until we made a film. So, I think it’s a combination of things.
Can legal cases change things?
Ziering: Not exactly, because of Tort Reform. It’s a $683 billion industry and they paid off $200 million in settlements. They can factor that in. That’s the collateral damage: We might have to settle because it’s a bad product. We might have to pay $500 million, but we made $683 billion. We’re good.
Dick: That’s a calculation done all the time. These companies in many cases know their devices have problems even before they put the on the market. Certainly, during its time on the market. The tradeoff is they don’t want to lose market share, so they will fight it on the back end. And they’ve been successful. That’s what’s really sad about this whole thing. It’s been a good marketing and financial decision — even though it’s been horrific for patients.
Ziering: That’s why it has to not only be more than patient advocacy. Corporations have to grow a conscience. We’re in a corporate oligarchy, and money rules. I hope we get this to the executive who decides they are going to do the right thing.
The lobbyist and the FDA have to be delinked . . .
Dick: Everyone — the public, the medical industry and the legislators — have all bought this idea that innovative medical technology is going to save us. In fact, it is innovative technology that very often is really harming us.
Ziering: But it shouldn’t be on us. All our rhetoric and thinking on this has to shift. Stop f**king people over, institutions. Stop it!
How did you track the money?
Dick: We worked with Amy Herdy, who does the lion’s share of investigating. It took two years of work to get to the bottom of this. It’s very covered up. The retaliation against anyone speaking up in the medical industry is phenomenal. No one wants to speak up. Doctors know if they speak up, not only the medical device but also the medical industry will come down on them and they can lose their livelihood.
Ziering: There’s no transparency. These studies don’t exist or, if they do exist, they are hard to get a hold of. The industry doesn’t want to be held accountable, so it does everything it can, not to have the research made accessible to the public.
These companies also will put out a bad product but rely on the 10 years it’s going to take you to figure out you to have a problem and the five years you need to get a lawyer, so in 15 years, they’ve already made so much money that by the time the injured population wins $100 million, they are fine and they take it off the market.
Dick: Then they put on another innovative product.
That’s the most disturbing fact, in a film that is full of disturbing facts — that an inferior product can get on the market because it’s similar to a bad one that has been approved! The pyramid is staggering.
Ziering: That bad product can get recalled, but as long as a device is similar, it can get approved.
Dick: That is the most absurd regulatory process I’ve ever heard of!
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