A provocative new Netflix documentary raises important questions about the safety and efficacy of medical devices in the US.

But separating fact from hyperbole is always tough with any documentary—especially since they almost always have strong prior agendas that the filmmakers need to push (see our reviews of What The Health and Vaxxed). For this episode of Against Medical Advice, I try to tease out the most important takeaway points in The Bleeding Edge while hoping for a balanced understanding of the complexities around medical device use in this country. Because it’s a short video, I obviously won’t be able to dive into the more nuanced discussions that this topic clearly deserves, but stay tuned…we’ll definitely be having those conversations on future shows and your comments on the original Facebook video will help guide that conversation.

The central issue discussed is the regulatory path by which medical devices are approved (two possible paths, actually: the Pre-Market Authorization (PMA) and 510(k) paths). Bottom Line: both pathways are less stringent than drug approval pathways, the 510(k) path being the most permissive. This can lead to devices being approved that are shown to have less efficacy and more adverse events in “real world” use.

The central conflict in the documentary revolves around Bayer’s Essure implantable contraceptive device (now discontinued, presumably as a result of the pressure brought by patient groups lobbying and the documentary itself). Bayer’s response is telling and worth a gander. The stories told by the multitudes of women in the documentary are very compelling and emotionally charged, and in our video I discuss why “ideal” clinical trials may fall short when devices hit the real world and real patients.

Vaginal mesh, the Da Vinci robot for surgery, cobalt alloy metal-on-metal hip replacements, and more are discussed in the documentary. I also discuss the MonaLisa Touch vaginal laser device and the recent FDA warning about this procedure.

Call to Action

  • For patients
    • Understand the risks and benefits of devices by researching and talking with your doctor, and getting a second opinion if necessary.
    • Report adverse experiences to your doctor immediately.
    • Be aware that newer isn’t always better, and often in medicine less is more!
  • For clinicians
    • Understand the FDA pathways for device approval: they are less stringent than you may have thought. Check the quality of the primary trial data when in doubt.
    • Understand our own cognitive biases when it comes to newer interventions and the influence of manufacturer reps.
    • Consider heavy metal poisoning in patients with cardiomyopathy, hypothyroidism, or neurologic problems with metal-metal hip implants.
    • Shared decisionmaking with our patients means understanding the risks and benefits and having the conversation with them, even when we’re pressed for time. We know the best docs already do this.
    • Report adverse events directly to the FDA. This isn’t mandatory, but it is crucial. Here’s the link to do that (it’s buried in the FDA website).
  • For politicians, regulators, and device companies
    • Time to close the revolving door between industry and the FDA
    • The public (and the medical community) needs to understand the conflicts on interest involved in device trials and their funding sources.
    • Time for some public funding of high quality pragmatic device trials? We’ll be talking more about this soon (let us know what you think about this ZPac, what if it were coupled with price restrictions on devices?)

Bottom line: we need your input. Watch the original Facebook video, leave your comments and ideas, and check out the podcast on iTunes or Soundcloud. And below is a LIVE Facebook video I did in response to some of your excellent comments on my take on the documentary!

Okay guys. A bunch of people have asked me to watch the latest Netflix Documentary, “The Bleeding Edge”, and it is about medical devices and how they are killing us. What I wanna do now, is cut through some of the hype. Because, like pretty much every documentary on Netflix, this one has an agenda going in, and it is very, very intense.

It’s basically saying that: Medical devices, such as Bayer’s Essure, to prevent pregnancy, Vaginal Mesh, The da Vinci Robot, Cobalt containing metal-on-metal hip replacements; These have been killing and injuring and maiming scores of people, and the FDA is complicit, and doctors are complicit, and the sky is falling.

Okay, well like anything, there is a lot of truth to these hyperboles, but there’s also a lot of nuance, that I wanna talk about. The Netflix documentary, which you should watch; it’s done very well, it makes you feel very emotional because you connect with the characters in the story. What we wanna do, is look at the actual science and the truth, behind what might be happening, in a bigger picture. And this is for both doctors and patients.

The documentary, really focuses a lot on the Essure device, which is a coil that obstetricians can place into the fallopian tubes of women, to prevent pregnancy. The idea is, it blocks the tubes and prevents sperm from going inside.

Now, this is an alternative to tubal ligation, where you actually make an incision and you tie off the fallopian tubes. That’s the more gold standard, old approach. Well, a lot of women electively were saying, “Well, I don’t want the scar and I don’t want “the incision, let’s try this device”. The way the device was approved, is one of two pathways for medical devices, that the FDA has, and it’s different, than for pharmaceuticals. A lot of people don’t understand this and the documentary tries to explain some of this.

The pathway that this device took, was called the PMA, or Premarket Authorization Pathway. Means that, some studies are done, they tend to be a little smaller, they’re not necessarily long-term, using the device to make sure it’s safe and effective. Now, that’s the more rigorous of the pathways that medical devices use. And the device was approved. It was used for quite a few years, and then a bunch of adverse events started being reported: People having pain, bleeding, inflammation.

And these things were actually listed in the potential complications for the device, but a lot of times these weren’t explained to patients, or it wasn’t made clear, or honestly, patients come, expecting great things from our newest technology, and they don’t listen to the complication, they don’t hear it and that’s normal human, sort of functioning. So then, stories started coming out about the devices being placed inappropriately, a lot of failures, people getting pregnant.

Facebook Groups were formed with women who have had complications from the device and it became a very, very big deal because these patients collectively have a big voice. At that point, Bayer, the producer of the Essure Device sort of pushed back, and said, “No, it’s safe, “we did the trials” et cetera. But let’s dig into this.

The documentary will make it seem like there’s no benefit, and it’s terrible across the board and devices are poorly regulated, et cetera. But there’s more truth to it. For many people, the device did work but, as David Magnus, the Director for the Center of Biomedical Ethics at Stanford, told me: “The trials that are done to approve these devices, “are often funded by the companies”. So, Bayer, so there’s already a kind of a financial conflict of interest. Bayer wants to show a positive result, that the thing works.

So what do they do is they design a trial that is idealized. In other words, doctors who are well-trained to place the device, are used. The patients are recruited very carefully. The device is placed under perfect circumstances. There’s good follow-up with a Hysterosalpingogram to make sure the device is placed right and that it is blocking the fallopian tube. They use alternative contraception for three months, which is recommended and they follow up. And guess what? The results are very positive. 99% effective in preventing pregnancy, Well that’s pretty good. Compared to a tube ligation that’s great.

So, what happened in the real world? In the real world, many patients didn’t get the follow-up Hysterosalpingogram. In the real world, many physicians maybe didn’t place the device right. Or, there’s a sales rep from Bayer, sitting in the room going, “Well, you know what, “the first device didn’t go in, put in another one”, and they’re putting in multiple devices. Now remember, these reps aren’t doctors, but doctors have to rely on them for information from the manufacturer and that’s another tricky piece. The doctors also feel like, ‘Well, the FDA studied this, ‘so it’s probably safe and effective, so I can place it’. But they don’t realize the limitations of the original trials. So, in the real world, over periods of longer follow-up in trials that were not sponsored by Bayer, up to maybe a 10% failure rate. Tubal ligation, the gold standard is much better than that.

So, this is how we can actually fail to predict what a device is actually gonna do when it’s in circulation. Now, does this mean the sky is falling and everything is terrible?

No, it means we need to do a better job of understanding, as clinicians, what the primary data actually shows and then explaining to our patients carefully, and this may be a multi-step process especially for elective procedures, what are the risks?

And as patients, we need to be asking, “How many of these procedures have you done?” “Are you good at this?” “What are the complications you’ve seen?” “Is there any resources I can read, that are vetted online “to actually understand what this is?”

And as docs, we need to look at the primary data. So, the Essure Device, is a great cautionary tale of how idealized trials, really aren’t the best. We ought to be doing pragmatic trials; Trials that simulate what would happen in the real world.

Now, the second thing that the documentary kind of, really points out, is that, we’re not really good at reporting adverse events when they happen, out in the world. So, the device is approved through the PMA pathway and it turns out, that things are happening but they’re maybe under-reported. And they use a term in– they use a number in the documentary, a 5% of all adverse events are reported. Now, I haven’t confirmed that number, but we know that it is low.

So, one thing doctors can do– they’re not mandatorily required to report adverse events they see. Either they should be, or we should do it voluntarily. We should go directly to the FDA Site, and report. Because, although the manufacturers are technically required to report severe adverse events, are you gonna really put all your trust in that? I would go directly to the FDA.

So, that’s another piece of this, is the post-marketing surveillance; Are we seeing what’s happening in our patients?

One of the examples in the movie was, a doctor, who had a metal-on-metal– he was an orthopod. Had metal-on-metal hip implanted in himself. He’s done these to patients, the metal includes cobalt, he started having neurologic symptoms months later, getting really weird signs of dementia; had a imaging of his hip, had the hip removed. It had disintegrated, the metal had dissolved, and his blood levels of cobalt were sky-high. Well, it turns out this had been reported increasingly. The product was removed, that particular product and now, actually rheumatologists are taught in certain settings, ‘Look for high blood cobalt levels ‘in people who’ve had these devices placed ‘because they can mimic dementia, and we could be ‘institutionalizing people, for a reversible cause’. When you take the hip out, it gets better. Well, this is how post-marketing surveillance should work.

Now, here’s a question: Why did that metal-on-metal hip device get implanted in the first place? Why did the FDA think that was okay?

The second pathway that the FDA uses to approve devices, is something called the 510pathway. Medical device manufacturers, and by the way this is a multi-billion dollar industry, on par with pharmaceuticals, right? but less heavily regulated by FDA. They went to FDA in the early days and said, ‘You know what, if we make revisions to a device ‘and it’s substantially similar to previous devices ‘that are used for similar applications, ‘we shouldn’t have to go through a full clinical ‘trial process to prove that it works, ‘we should be allowed to innovate, ‘without having to go through all this time and expense, ‘and get these things in front of patients quicker’.

Now there’s some truth to that, but what ends up happening? ‘Well, if metal on polyethylene hips are good, ‘metal-on-metal hips are substantially similar, ‘why don’t we go ahead and get a 510 exemption?’ Which means, they’re substantially similar to previous devices. Expedite it though, start using them, ‘Oops, there are adverse events ‘that we didn’t predict, because we didn’t do ‘a long enough, extensive, pragmatic trial.’ On top of that, a lot of the trials that are done, again, are sponsored by the companies that are making the device, and there is always gonna be conflict of interest and bias, in that.

The third piece that the documentary focuses on is FDA Conflict of Interest. Many of the high levels of FDA, have worked in industry and when they leave FDA, they go back to industry. Now, you need to understand the industry you’re regulating in order to be a regulator, this is true. But this revolving door could be a serious problem. Maybe we need to allow it to revolve only once and you can’t just keep going back to industry. That would kind of change behavior. So there is definitely truth to that.

There’s also truth that the 510 pathway for medical devices, that many doctors don’t even understand exists, is not a very rigorous way to prove safety and efficacy.

I’m gonna give you one example: I have a friend who is a physician and she was suffering with some incontinence and prolapse that came, with getting older, having multiple children, that sort of thing. And she had an obstetrician who she trusted to take care of her. This obstetrician had a brand new device that was approved through the 510process, called the– they “marketed” as MonaLisa Touch, creepy.

It’s an intravaginal laser, that is supposed to remodel the vaginal wall, create better tension so that there’s less prolapse, less incontinence, less painful intercourse, those kind of things. Well, it’s marketed heavily and the doctors believe it probably works because there’s very small case-study trials that are not really sufficient at all, and they’re not compared to placebo, right? And the device was approved because it was very similar to a laser that burns off warts. And as a result they’re marketing it to women, and they’re doing it. Well, this person got the thing done, maybe had a placebo response, felt a little better. The doctor said, “Well, you need to come back “every six months to have a revision, “it’s $2,000 every time”. And she was happy to do it.

 

Until the FDA just released a letter saying, ‘Hey, guess what? ‘There’s no evidence that this actually works ‘and we’ve had reports of harm, from people reporting ‘bleeding, pain, those kind of– ‘burns from the laser malfunctioning’ that kind of thing. ‘So, guess what, maybe not the best idea’. Hey, it would’ve been nice, to understand that before. It would’ve nice, to look at science before we aggressively market to patients whatever’s the newest, best thing.

 

And you know what? Even as a doctor, she felt trust. It’s almost a Shamanic relationship we have with our doctors, with her obstetrician, who she loved and trusted and she didn’t question, and she said, “Well, if she thinks this is a good idea, I’m gonna do it”. And even after the FDA letter came out, she still wanted to go and get the repeat procedure because she was like, “Well, I don’t wanna make “my doctor mad”.

 

This is the heart of many of our problems. As clinicians, we can’t accept, that innovation by itself may not be a good thing. Because we’re conditioned to believe that, ‘You know what, if we can do it, we probably should do it, ‘it’s probably better, and we trust the FDA, ‘and we trust authority’. We shouldn’t, we should question everything, we should look at the primary data. If we’re doing this as a marketing thing, and you’re trying to make money to support your practice, think hard about how we really need to understand what we’re doing to people, instead of, for people.

As patients, we need to question everything. But we also need to do it in the context of a deep relationship with our healthcare practitioner, cause that is the heart of it; being able to have an honest, open discussion and say, “How many of these have you done?” “Have you seen complications?” “What’s the primary data?” those kind of questions are important.

Now, it’s so easy, because clinicians need so little data to put a device in, and so much data to take it out. They need to be proven to them, that they didn’t cause this harm, right? That’s how it is, we’re conditioned to feel like, ‘I couldn’t have caused this complication’. We need to do better.

So here are my calls to action. If you’re a patient: Question things. Do some research. Ask questions of your doctor, let them curate your experience. And if you feel like you’re being marketed it to or pushed, walk away and get a second opinion.

If you’re a clinician: You need to look at the primary data. Understand how the FDA works through the PMA and the 510process, they’re not very rigorous. Question everything, look at the primary trials and see if you’re convinced, that this is safe and effective and if you are seeing adverse events, please report them directly to the FDA and the manufacturer. We’re gonna leave links in the blog post.

And if we can do this, and we can address our own biases, then there will be no need to make, pretty inflammatory documentaries, like “The Bleeding Edge”, that are then gonna present to the public a very one-sided and emotionally charged argument. If we got our stuff together, both as patients and doctors, we could do so much better to reduce medical errors, reduce complications, and make our medical devices what they’re intended to be, which is life-changing, beneficial things that can improve suffering.

And that’s what they can do, that’s what they often do, and that documentary doesn’t show and we can do better, to make this happen. Please hit Share, tell your friends. And by the way, I did convince that friend not to get more of that procedure. And if you are involved in MonaLisa Touch, look at the primary data. Alright guys, we out. Hit Share.