Are Implanted Medical Devices Creating A 'Danger Within Us'?

Jan 17, 2018
Originally published on January 19, 2018 12:25 pm
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DAVE DAVIES, HOST:

This is FRESH AIR. I'm Dave Davies in for Terry Gross who's off this week. Our guest Jeanne Lenzer is a former physician's associate who worked for years in emergency rooms until medical studies showed a treatment she and others used for chest pain was actually causing deadly heart rhythms. Her search to understand what went wrong led her to a new career as an investigative medical journalist. Her new book is about the potential dangers of the millions of medical devices implanted in our bodies - artificial joints, cardiac stents, surgical mesh and pacemakers, among many others.

Lenzer says medical devices are approved with far less scrutiny than drugs, and many high-risk devices go to market without clinical trials. Lenzer writes about several devices that have proved problematic. And her book focuses in some detail on a treatment for patients with drug-resistant epilepsy. An electrical device is implanted in the patient's body that sends regular impulses to the vagus nerve, which runs from the brain down through the neck, chest and abdomen.

A review of clinical studies by the Cochrane collaborative found the vagus nerve stimulator effective in reducing seizures for people whose epilepsy does not respond well to drugs or for whom surgery is not a good option. The Cochrane review also found that more studies needed on the effectiveness and side effects of VNS therapy. Lenzer says there's reason to believe the VNS device can cause deadly cardiac symptoms, and that it's been approved with virtually no research on how many patients implanted with VNS die.

Jeanne Lenzer is a longtime contributor to The BMJ, formerly the British Medical Journal, and her writing has appeared in The New York Times Magazine, The Atlantic and other publications. Her new book is "The Danger Within Us."

Well, Jeanne Lenzer, welcome to FRESH AIR. Do we know how often medical treatments cause problems and harm people - essentially, the cure becoming the cause of injury?

JEANNE LENZER: We don't. There are people with the Lown Institute and other places that are trying to get some numbers on this, but it's very hard to estimate how often drugs and devices are unnecessary and how many people they're harming. One of the problems with devices is that nobody's really tracking the numbers of harm - or the rates of harm, I should say.

So the FDA has a database where doctors and hospitals can report deaths and serious adverse events, but they don't know how many people are implanted with a particular device. So if you have 100 deaths in a database from a particular device - I mean, if there are only 200 of those devices implanted in people, that's really scary. If there are 2 million people implanted, that's another story. And that's exactly what we don't know because the FDA doesn't require manufacturers to report how many people are implanted.

DAVIES: And it's not that hard. We plant chips in our cats to keep track of them, right?

LENZER: Right, yes. And Walmart tracks how many heads of lettuce they have on a shelf at any given time, and they know exactly how many heads of lettuce they have to replace. They can track those a lot better than we're tracking medical devices implanted in people.

DAVIES: You know, we're aware of some awful stories about medications - drugs that prove to be problematic, like Vioxx. But you say we're a lot less skeptical about devices that get implanted in our bodies. There are a lot of them. Just give us some examples of things that we're carrying around in our bodies - medical devices.

LENZER: So there's everything from what seem like very low-risk devices like surgical mesh that's put in women to prevent stress incontinence - urinary incontinence, used in men for hernias, all the way up to implanted cardiac defibrillators and pacemakers all the way to deep-brain stimulators, Wi-Fi-enabled, computer-chipped devices, as well as combination devices that actually have drugs embedded in the device. So there's drug-eluting stents. There's spine implants that have biologic products implanted with it that have caused serious drug reactions and death.

And the problem with devices is - you know, there's several problems that are actually unique to devices compared to drugs that are actually far more concerning. One is that you often can't remove the leads from drugs. So there's wire leads going from many devices - into the brain, into the heart, on the vagus nerve. And these often become embedded in scar tissue, and you can't remove them. They can also interfere with CAT scans. And turning them off electrically, sometimes only the specialists know how to do that. And there's some horrific cases of patients being - where the electrical impulses are affecting them in a way that's very painful, and it takes quite a while for them to turn off the device.

DAVIES: You know, drugs are regulated and devices are by the Food and Drug Administration. And you note that for a new drug the FDA typically requires at least two randomized trials, so there's some sense of whether it's safe and effective. What's required of manufacturers of new medical implants?

LENZER: Well, to explain that, I have to go back to 1976 which is the year that devices came under the regulatory authority of the FDA. Prior to that, there were lots of implanted devices. There were pacemakers. There were artificial hips. And what the FDA did in 1976, when they took control of approving devices, is they said, OK, you guys are already all on the market. You can stay on the market. We'll divide you up into three classes - low-risk, medium-risk and high-risk. That's Class I, II and III. And the high-risk devices, you're going to have to prove that you're safe after you're on the market. Well, the problem is most companies never submitted any safety studies afterwards. And in fact, a study showed that five years after a device was on the market, and they required a post-approval study, 40 percent had never been conducted.

DAVIES: I just want to make sure I understand this. You had to show the studies after it was already on the market - after thousands of people have the devices implanted.

LENZER: Sure. And even now, when a new device comes on the market, like the vagus nerve stimulator, the company - it's not uncommon for companies to be required to prove safety after it's on the market. And the tragedy with the vagus nerve stimulator is they actually gave just conditional approval to the device. And the reason for that was they were concerned - and this is a direct quote from the FDA transcripts. During the scientific review, one of the scientists said, I'm concerned about the high rate of deaths among these patients in test studies and who were implanted prior to approval. So the FDA panel decided that they would just give conditional approval - meaning that, OK, we don't know if it's safe, but you'll have to prove it's safe after it's on the market.

DAVIES: I want to talk about one very specific case that you discuss at length. But first, you know, you describe how we got to this situation where there are so many devices that seem to be relatively loosely regulated. And you're right. There are three major developments - one, an explosion of medical technology starting in the '60s. A second development was the passage of Medicare in 1965 and the growth of private insurance. How did that affect this?

LENZER: Well, until the 1950s, medical care was very cheap. I mean, in fact, a study in the early 1900s showed that the biggest loss when people were hospitalized wasn't medical costs. It was simply the loss of pay from work. There wasn't much that people did in hospitals other than have a nurse maybe to cater to them, so they could stay in bed or some cheap antibiotics for pneumonia. That was about it. The problem with the explosion of medical technology in the '70s when the first CAT scans and MRIs came on the market is that they were so expensive that the average person couldn't afford it. And that meant there was a very limited market for those kinds of tests.

But with Medicare - and at the time, Medicare was enacted. It was opposed as socialized medicine, but it was actually the exact opposite of socialized medicine. It was actually fee for service. Doctors could charge anything they wanted to charge - whatever they considered customary and usual costs, which meant that their prices exploded. And they would charge that to the government. And there was no cap on the government payments.

So we then had a whole group of older people who are insured essentially through taxes by the government. But doctors were charging on fee for service. Then what that meant was that regular care for people had really transformed. I mean, now we had ways of treating people that were very different than before. But all the people who weren't covered by Medicare certainly couldn't afford it. So then we got private insurance to cover those people.

DAVIES: Right, so there was, in a sense, a huge market and a lot of money to be made if you could figure out a device that physicians and hospitals wanted to implant.

LENZER: Absolutely.

DAVIES: You also - another develop you said was an act of Congress in 1980. Explain this and why it mattered.

LENZER: So that was the Bayh-Dole Act. And with that act, what they did was encourage what they call technology transfer so that universities, for the first time, could actually patent rights. And academics were encouraged to partner with industry. And the whole point of a university, theoretically, was to have an independent place of inquiry where they didn't have to have fear or favor regarding what they found. And if they found that certain chemicals were dangerous - environmental toxins, whatever - they were supposed to be able to do that without - again, without fear or favor.

But by partnering with industry, that all began to change. And we began to see research that was basically entirely controlled by industry. And that's what we have today. Most research is actually either conducted solely by industry, or it's partnered with academia and with the national institutes of health.

DAVIES: And so - and if industry is funding a lot of research and funding chairs and positions and faculty, there's a financial interest to, you know, to do things that gets the industry where it wants to be with a particular drug or device.

LENZER: Yeah. And that's not just conjecture. There are multiple studies that look at behavior and outcomes and interpretations of medical studies when they're conducted by industry versus by truly independent sources. And invariably, what we find is that industry accentuates the positive and eliminates the negative. I mean, they have repeatedly been found guilty of suppressing bad outcomes, and they get fines for this regularly. In my book, I list numerous fines that companies have paid over and over again for concealing deaths and bad outcomes. And they just consider that part of the cost of doing business.

DAVIES: You know, this collaboration between medical research and academic research and private industry, I mean, obviously, presents at least the potential for conflicts of interest. The argument on the other side is, you know, we want these brilliant minds in academic institutions to be producing stuff that helps us - that actually improves our lives. That was the idea behind the act, wasn't it?

LENZER: Maybe. I mean, I think we have to question how much we're being flooded with dangerous things when we do that. I mean, there's upsides and downsides to every course of action. And certainly, we want to be able to transfer the knowledge that is obtained independently to people who will market these products. But I think that what we need is a clear dividing line in these roles so that we don't have industry telling us what's safe and what's not safe. They should produce the products. And we need to have independent assessments of those products.

I mean, think of it like cars. Would you go to Toyota to ask which car is the best car on the road or the most fuel-efficient car or the safest car? I mean, most of us would want to go to consumer reports or some independent entity. And that's what most of us want for medical research. We shouldn't have to go to Medtronic to ask what's the best way to treat back pain.

DAVIES: Our guest is Jeanne Lenzer. She is a medical journalist and has a new book about problems with implanted medical devices. It's called "The Danger Within Us." We'll continue our conversation in just a moment. This is FRESH AIR.

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DAVIES: Our guest is Jeanne Lenzer. She is a medical journalist who has a new book about problems with implanted medical devices. It's called "The Danger Within Us."

There's a guy whose story runs through the book that illustrates one of these cases. He's a man named Dennis Fagan, who was a firefighter and paramedic in Corpus Christi, Texas. First of all, just explain what was the medical condition that he faced.

LENZER: So he had epilepsy. And he was managed with medicines for many years.

DAVIES: And they - the seizures became more and more troubling, and he needed something different. And so he turned to this - his neurologists, I guess, suggested this medical device. Tell us what it was and what it - what it is and what it does.

LENZER: So he recommended a vagus nerve stimulator. He wasn't all that enthusiastic about recommending it, but it was sort of a last-choice option. And Dennis was ready to try anything, so he had this vagus nerve stimulator implanted. And it's like a little matchbox-sized generator that's put under the collar bone a lot like a pacemaker. And then lead wires - these wires are tunneled under his collarbone up to the neck where the vagus nerve is. That was the idea - that it would stimulate the vagus nerve and, therefore, stop his seizures.

DAVIES: And explain...

LENZER: Or at least reduce them.

DAVIES: And explain what the vagus nerve is.

LENZER: So the vagus nerve is a long nerve that runs from the brain all the way down to the anus. And it basically sends branches out to every organ of the body, regulating virtually every function in our body from heart rate to digestion to orgasm and elimination.

DAVIES: All right. So this was marketed by a company called Cyberonics, right?

LENZER: Yes.

DAVIES: Just tell us a little bit about what this company is and what made them think that stimulating the vagus nerve would have a positive impact on epileptic seizures.

LENZER: It's not really clear. I mean, there was a fellow who first got involved in patenting it for seizures and - Jacob Zabara. And he tells a story about watching his wife do Lamaze breathing during childbirth. And he says that that made him wonder if the vagus nerve could somehow mediate what was going on, that she was moderating her pain with this breathing which is mediated through the vagus nerve. And he wondered if that could somehow affect seizures. And then they ran a couple studies. The first study the FDA did not approve.

And the second study that they demanded was the basis for approval, even though there are some questions about whether it really showed any significant difference in seizures. It depended on the way you looked at the study and the way you divided up the numbers. The bigger problem was that how many people died. And that was the rationale for FDA, when it considered the device, only gave conditional approval for the device. The problem is that the basis of that approval, the conditional approval based on the concern about a high number of deaths, high rate of deaths, is that they weren't required to tell patients this.

DAVIES: So the FDA gave it conditional approval because there was concern about deaths. What happened next? Did it go on the market?

LENZER: Well, the idea - yeah, it went on the market in 1997. And the idea of conditional approval is that once the company proves it's safe after it's on the market, then its approval is complete. When Dennis Fegan contacted me, one of the first things I did was go to the company - and this is a dozen years after it was on the market - and asked them for the evidence that the device was safe. Had they ever proved it was safe? And they sent me five studies. And I read all five studies very carefully, and not one of them reported any deaths. It's not that they reported there were no deaths, it's that they had no report about deaths.

So I called the FDA and asked them for what evidence they had the device was safe. And they said, oh, it's safe. We'll send you our evidence. And they sent me the exact same five studies that the company had sent me. So I thought I must be missing some unpublished data here. I went back to the company and said, do you have unpublished data about deaths? I need to know about deaths. That's why this device was approved conditionally. And they said, we never collected data on deaths.

So for the five studies that they submitted, they never recorded how many people died, if they died, when they died. And then when I pressed them, they said, well, we did collect mortality data from the Social Security Death Index. And I said, well - you know, at the time, I was writing for the British Medical Journal. And I asked to release those data on behalf of the British Medical Journal. And they refused to release the death data.

So I went back to the FDA certain the company was going to get slammed. I mean, here it is. Here's a device on the market over a decade after it was approved, and yet, they'd never done a study looking at deaths, nor would they release the death data. And when I brought all this to the FDA, the FDA said, it's safe. And I said, how can you say it's safe when we don't have death data? And their answer - and I have it in writing - is we never asked the company to count the number of deaths. We only asked them to characterize death.

DAVIES: Meaning what?

LENZER: (Laughter) Well, how you can characterize deaths without knowing if anybody died is anybody's guess. I mean, theoretically, you can say, well, the idea is, did they die of pneumonia? Or did they die of sudden heart death? You know, those might give you clues into the problem. But how do you report the nature of a death if you're not collecting any death data?

And what I really think is important here is not just about the VNS device. VNS is just an example of many devices like this. Again, like I said, 40 percent of conditional approvals haven't had a post-approval study five years after it's on the market. So people are being subjected to devices that scientists may have had serious concerns about, and yet, they don't even know if they're safe or not.

DAVIES: Jeanne Lenzer is a medical journalist. Her new book about medical devices is called "The Danger Within Us." After a break, she'll tell us about Dennis Fegan's near-death experience in an emergency room. Also, David Bianculli reviews "Electric Dreams," a new Amazon series based on the works of Philip K. Dick and the new season of "Black Mirror" on Netflix. I'm Dave Davies, and this is FRESH AIR.

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DAVIES: This is FRESH AIR. I'm Dave Davies in for Terry Gross, who's off this week. We're speaking with medical journalist Jeanne Lenzer, who's written a new book about the risks and implanted medical devices such as artificial joints, cardiac stents and pacemakers. She says they're approved with far less scrutiny than new drugs, and some can cause serious harm. Her book is called "The Danger Within Us."

I want to return to the story of Dennis Fegan. Dennis Fegan, this firefighter and paramedic who suffered from epileptic seizures, and out of some desperation, got this vagus nerve stimulator planted in him, this little box with wires that would stimulate the vagus nerve that runs down his body and hopefully ease his epileptic seizures. He ended up in a life-threatening situation in - when was this - 2009, I guess.

LENZER: 2006.

DAVIES: 2006. Tell us what happened.

LENZER: So one night, he was awakened about a - with a pain in his throat. About 2 in the morning, he woke up. And he knew that the pain in his throat was associated with a seizure, so he got up, and he put a vertical mark on his calendar on that date. And he used that calendar for his neurosurgeon and his neurologist so that they could manage his medications.

DAVIES: So he could count...

LENZER: Well, by the...

DAVIES: ...He - it was a way for him counting them, right? Yeah.

LENZER: Yes. Yeah. And when his parents found him the next morning, they saw him stumble out of his room and fall unconscious onto the floor. And when he came to, he got up, sat down on a dining room chair and immediately fell face-first into the floor again. This time, you know, he's afraid of falling again, so he wiggles across the room with his back against the wall. His legs are splayed in front of him. His jeans are soaked with urine. He looks half dead. His parents frantically call for an ambulance. By the time the ambulance gets there, he's already passed out eight more times.

The paramedics, figuring he's having seizures - as Dennis thought he was having seizures - gave him seizure medication that they injected in his arm. But it didn't stop the seizures. So they rush him to the hospital, where the ER doctor also gives him more seizure medicine seeing his seizures. And again, he can't stop the seizures. And the ER doctor is frantic. He, you know, thumps Fegan on the chest trying to bring him back to life. And that's when he notices something very curious.

Fegan's heart is stopping at precisely three-minute intervals. This makes no sense to the ER doctor. He calls in a cardiologist. The cardiologist rushes downstairs, looks at him. They both see the same thing. And it's only when the neurologist arrives - Fegan's neurologist - who says, oh, Fegan has a VNS device, and it's set to fire at exactly three-minute intervals. So the device, instead of stopping his seizures, was stopping his heart. So they rushed to turn off the device. And when they finally get it turned off, the seizures stop immediately and Fegan doesn't have anymore. They send him up to the ICU to recover. And the next day, Fegan learns that his heart has been stopped by the device. And that launches him into a decade-long battle with FDA, regulatory authorities and the device manufacturer.

DAVIES: So to be clear, there was this unanswered question about how many deaths might be associated with the vagus nerve stimulator. And in this one specific case, we find that every three minutes, as the stimulator fires its electronic pulse, this man's heart stops. And that ends when the device is disabled, right?

LENZER: Right. And Fegan gets concerned about other people implanted with the device and wants to know whether it's happening to other people, so he finds out about the FDA's MAUDE database. It's a database where all device adverse events are kept. And when he looks into the database, he sees that many people have actually had very similar experiences to his own, but also, many have died. And he's wondering, you know, if I'd been found dead, he told me, everybody would have said I died of epilepsy rather than the device. And it's only because he lived and there's a recording in the ER of what happened to him that anyone knows it wasn't because of epilepsy. It was because of the device.

DAVIES: This raises one of the interesting issues about these devices and their regulation. The FDA has this database at which physicians and hospitals are expected to report problems - adverse events with medical devices. Sounds like it would be a smart way - and the FDA says it is the way - we look for red flags. Why doesn't it work better?

LENZER: Well, first of all, there's a study showing that only about 1 percent of all serious adverse events make it into the FDA's adverse event database. And something that really surprised me was, it turns out that the more serious the event was, the less likely it was to be reported. Manufacturers are supposed to report these adverse events. And there is some leeway granted to them about determining whether the device event was related or not to the device.

So, you know, sometimes people cough and sneeze when they have a device. It doesn't mean the device caused it. The problem is is that there's no independent party assessing whether these problems are related to the device or not. So leaving that decision to the company presents a real conflict of interest.

DAVIES: Yeah. So, for example, if someone died because this stimulator had actually stopped his heart, it could appear to be epilepsy and therefore would not appear as an adverse event associated with the device.

LENZER: Absolutely.

DAVIES: Right, right.

LENZER: That's a big problem. And that's something that I refer to as cure as cause, where - doctors assume that when a patient dies - and I did too when I was in practice - that a patient has a heart attack, they died of a heart attack and the bad heart rhythm that went with it. We don't assume that it's the drug or the device that we prescribed for the patient. And that's a real problem because it turns out that the kind of studies we need - there really shouldn't even be a decision about whether a side effect is due to the device or not.

We should just count up all the adverse events, all the deaths that occur in the patients who are implanted and in the control group. And that would give us a far better picture because it turns out that the kind of studies we need - there really shouldn't even be a decision about whether a side effect is due to the device or not. We should just count up all the adverse events, all the deaths that occur in the patients who were implanted and in the control group. And that would give us a far better picture of what's going on.

DAVIES: Coming back to Dennis Fegan, he was obviously deeply troubled by what happened in the emergency room and started gathering information about this. He also decided he wanted the vagus nerve stimulator removed, and he consulted a surgeon about that. What did he learn?

LENZER: Well, he was told that he could have the generator taken out but not the lead wires, the lead wires that tunneled up to his neck and were wrapped around the vagus nerve because many surgeons have found that the wires become enmeshed in scar tissue. And it just becomes too dangerous to try to tease those wires out of the scar tissue. They can tear and destroy the very nerves that are next to them and even the jugular vein and the carotid artery that are right adjacent to the vagus nerve. So it's too dangerous a surgery, and they left the lead wires in but took the generator out.

DAVIES: Dennis Fegan was frustrated by what happened to him, and one of the things he considers is a lawsuit. It turns out he is unable to sue and he learns why. What's going on here?

LENZER: Well, it turns out there was a Supreme Court ruling in 2008 called Riegel v. Medtronic, and it's also called the pre-emption ruling. And what it means is that patients who are implanted with high-risk devices that went through the premarket approval process called PMA are not allowed to sue. And the basis for that is - is that supposedly they underwent rigorous testing proving the device was safe.

DAVIES: So patients can sue in the case of a drug that they think has harmed them but not in devices that have gone through this process.

LENZER: Not in certain devices - that's right - certain high-risk devices.

DAVIES: Jeanne Lenzer is our guest. She's a medical journalist, and she has a new book about problems with implanted medical devices. It's called the danger within us. We'll talk some more after a short break. This is FRESH AIR.

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DAVIES: This is FRESH AIR, and we're speaking with Jeanne Lenzer. She is a medical journalist. She has a new book called "The Danger Within Us: America's Untested, Unregulated Medical Device Industry And One Man's Battle To Survive It."

You argue in this book that the FDA does a bad job of regulating these devices because they've become heavily influenced, maybe even captured by the industries they regulate. This is a big subject, but briefly, what's the evidence of that? What's happened here, do you think?

LENZER: Well, part of the problem is - is that the FDA commissioner, the lead legal counsel used to be civil servants who came up from within without having to fear political interference. There's a former FDA scientist who told me that decades ago - yeah, they might get a call from a politician now and again and say, hey, what's going on that you're holding up this device approval or that problem? And he said, you know, we'd explain it, and that would be the end of it.

That's no longer the case. We've had a number of instances now, including an episode dubbed Devicegate in which all of the scientists agreed that certain devices should not be approved because they were unsafe and ineffective. And yet the devices were put on the market over the unanimous opinion of their own scientists when politicians made phone calls to FDA superiors. This is really stunning that politics is trumping science. And it's getting worse now with 21st Century Cures Act that was passed in late 2016, which essentially is deregulating even further.

DAVIES: You know, most of us ordinary patients in the world aren't going to do research about medical devices, right? We're going to trust doctors to know what works and what is safe. Broadly speaking, should we?

LENZER: This is a terrific problem. I mean, I have a medical device implanted. I'm very happy with it, but I got to confess. I didn't research it because the truth is we are dependent on the research that comes out of these companies. And that's where I wanted to alert the public that we need to make some structural changes so that we can trust these devices. As you said, we can't individually research them because we don't have the capability to do it. Even if we read the studies that are released, we don't know that we can trust them.

And I'll give you two examples of just how difficult the situation is. One of the people I talk about in the book is a man who was harmed by a hip implant. Well, it turns out that man is also an orthopedic surgeon who specializes in hip replacements, and yet he landed up being poisoned by his hip implant from cobalt that leaked out of the hip and destroyed his muscles and tissues and even caused some degree of heart damage.

Another example is a Medtronic executive that I report on who had a Medtronic device implanted in her spine and suffered just terribly disabling and painful effects from that device. So even people who are insiders and who should know don't really know.

DAVIES: So how do we protect ourselves? What should we do?

LENZER: I don't really think there's any individual way to find out which devices are really safe, except I'll say this. You can go and check the FDA's database and look up the device and see if there are warnings about it. But beyond that, if it's a device that's recommended, many of them do work great. I mean, lives are being saved and transformed in many positive ways. And that's part of what troubles me. I mean, I wouldn't have bothered with this if I didn't feel that there was some merit in the field. Medical devices can be wonderful. What we need is to be able to tell the difference between the ones that don't work and the ones that do work.

DAVIES: You know, we focused a lot on this one case - the vagus nerve stimulator. You write about several others in the book. Are there other devices that are particularly problematic?

LENZER: Yes. The Sprint Fidelis leads that go to defibrillators pacemakers were found to have fractured and cause serious injury and death. And these were implanted in hundreds of thousands of people. And this is one of the problems with devices - is that, you know, what do you do once you're implanted with something that may be dangerous? Having them removed in 15 to 18 percent of people, nearly 1 in 5 people suffered serious adverse events or death when they tried to remove the leads.

Hip implants have leaked chromium and cobalt, and there are other problems. Pelvic mesh - again, a seemingly simple device. It's just mesh after all - surgical mesh. And yet it has grated through tissues like a cheese grater through cheese and caused what's called fistulas - holes between the rectum and the vagina and causing serious pain, infections, hemorrhage. There are all kinds of problems with medical devices that people might want to think about first.

And one of the common things I hear from patients is, you know, now that I think of it, my problem wasn't that serious. So a woman who has a little bit of urinary dribbling when she sneezes or gets excited goes and gets this pelvic mesh put in because a doctor recommends it and then has a lifetime of pain, infections and suffering. So I guess my best advice would be, if you're not certain you really need something, it might be best to wait.

DAVIES: Right. If you take a medication, you can always stop. When you...

LENZER: Yes.

DAVIES: And when you put something inside your body, as you say, the leads may sometimes fuse onto other - create scar tissue and - yeah.

LENZER: And ask if your ER doctors know how to take care of you. I mean, there was one tragic case of a woman with a vagus nerve stimulator who called her sister saying, oh, my God, my VNS is shocking me. I can feel it. It's so painful. I dropped to my knees. And her sister told her, go. Go straight to the ER.

And the young woman who was about 39 years old, a young mother, said, I can't because they don't have the tools to turn this off. I have to wait until my doctor comes in on Monday morning. She didn't get to see her doctor on Monday morning because her 9-year-old daughter found her dead in the bathroom on Sunday night.

DAVIES: You know, this book is powerful. And I could imagine some looking at it and saying, you know, this is too dark a portrait, that there's always risk in treatment and that, you know, people do suffer from conditions that these devices can - are intended to treat and that, you know, you focused on all the problems and maybe given too little attention to people who, you know, are happy with devices that have changed their lives. How would you respond to that?

LENZER: Well, fair enough in terms of my book - not so fair in terms of the total literature out there. And that's why I did focus on the problems because there's a lot of rah-rah information about devices. Everybody's tech-happy and thinks that the newest cutting-edge device must be better than the older device and - when in fact that's not always the case. In fact, when you look at the Sprint Fidelis leads, they were a slight tweak to older leads where they made them somewhat thinner to be more flexible. The problem is, is they were thinner and therefore broke.

So newer isn't always better, and all the excitement about high-tech stuff needs to be moderated with an understanding that these things sometimes cause serious harms. And all I want is for patients to be able to learn the truth so they can make their own assessment about whether they want a device. I want people who have epilepsy to be told the truth about the side effects and downsides as well as the upsides. And that's true for all devices.

DAVIES: Jeanne Lenzer, thank you so much for speaking with us.

LENZER: Thank you. Thank you for having me.

DAVIES: Jeanne Lenzer is an investigative medical journalist. Her new book about implanted medical devices is called "The Danger Within Us." Coming up, David Bianculli reviews the new Amazon series "Electric Dreams" based on the works of Philip K. Dick and the new season of "Black Mirror" on Netflix. This is FRESH AIR.

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