#NetGalley

An excellent exposure work is made by Jeanne. This is a complete and well-documented research work about the dark side of the Medical Device Industry in America. I recommend this book for University libraries in particular for law and medical students.

This book is a must-read before having any serious medical issue! And, of course, you cannot know when a medical issue might happen, so read this book now.... It seems astonishing that things can be as unsafe as they are, but greed and ignorance have created a terrible situation for the average human (without a medical degree) needing medical help. I will be asking MANY questions and doing my own research if my family or friends need any sort of medical device! It makes me worry about the elderly ones who already have replacement knees, hips, etc., too.

Pretty intense book. As a recipient of several medical devises, it gave me plenty of food for thought. I never realized the implants I have were never tested. I always assume the medical profession looks out for us, to some degree. I figured the implants were tested before use in humans. Scary. Oddly, I have wondered for years about the drugs we're given by our doctors.... Well researched and riveting read.

Wow -- this book was terrifying but it's probably one of the most important books out there in the market right now. The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It has been on my radar since I saw a review on NPR and I'm so glad I was able to get an early reviewer copy. This book is well researched, insightful, and the most horrifying book I've read about the dysfunction in the United States' healthcare system.

Having worked in the healthcare industry and suffering from a chronic illness, I've had more than my fair share of run-ins with the medical device industry. Even then, I had no idea just how corrupt the system really was. Learning that many medical devices are implanted with little or no testing is awful -- especially when I consider the fact that I was thinking about having an off-label device implanted myself!

The United States is at a pivotal moment. There is a lot of upheaval happening. Perhaps this book could stir the pot and lead to change in the current healthcare system. I know one thing: Everyone should read this book before considering medical device implants. Do your research. Know your risks. Be your own advocate. The healthcare industry won't help you there.

A bit tedious of a read at times but a worthy read. The lack of oversight in the medical industry is a daunting problem that has gone unaddressed for far to long.

This book is well-researched and addresses a major concern in the US healthcare system—the safety of medical devices and the lack of oversight and regulation about how they are approved and used. It doesn’t surprise me how often research is manipulated to show a desired outcome. This is a problem in most research, unfortunately. Of course I the field of medicine, there are real lives at stake and the consequences can be deadly Fegan’s story and those of the numerous other patients are heartbreaking and challenging to read.

As one might expect, there were some passages that were quite technical, so that could be a barrier for the casual reader. There is also a significant amount of repetition (some phrases were repeated almost word for word multiple times) that I found frustrating. There were also some structural issues that interrupted the flow of the book.

Overall a compelling read with just a few flaws. 3.5 stars

Eye opening look at the implanted medical devices industry. Well researched and written. I knew the medical industry was problem ridden but this book made me realize just how bad it is. Recommended reading for all.

Wow! That a riveting read! The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It is written by a Physician Assistant, turned investigative journalist who worked in the medical field for over a decade. This book is deeply insightful and credible. Much has been written about the harm certain popular classes of pharmaceuticals may be causing, but rarely does one get a glimpse into the underbelly of the medical device industry in the USA. This book should not be confused with a suspicious all-encompassing disdain for the medical device industry. Quite the contrary! It offers an eye opening historical and objective view of what can and does go wrong, all the while maintaining that, of course much of it is lifesaving as well. Author Jeanne Lenzer does a formidable job at keeping the reader entirely engaged in what could have come off as rather dry content.

License to kill

Stephen King must be envious. Nothing he has written is nearly as frightening or as suspenseful as what the medical-industrial complex does to its customers, us. In Jeanne Lenzer’s The Danger Within Us, the implants we now consider to be everyday miracles (hips, knees, stents, pacemakers, etc.) have caused conditions worthy of banning by international treaties against torture. The greed, selfishness, self-dealing and corruption is unending, and nothing ever seems to stop it.

The book is structured around a single interminable case, Dennis Fegen, who was implanted with a device called a Vagus Nerve Stimulator (VNS) which is meant to lessen epileptic seizures, among a dozen other things, all unproven. It dug its way into his jugular vein (from which it cannot be removed) and nearly killed him countless times, stopping his heart every three minutes. The company bullied the Food and Drug Administration (FDA), leveraged congressmen and withheld failure stats to win approval for this device, which studies say is essentially useless, when not dangerous. At least as many do worse with it as do better. The US military is now considering it for vets with PTSD.

Medical devices are not tracked like prescription drugs. Lenzer estimates 70 million Americans have had implants in the last ten years alone. The number of people who died because of them is not collected either, and the FDA itself says less than 1% have been reported by the device makers. Since the number of reported deaths is 16,000, possibly two million have actually died. Annually. (Overall, the health care system is the number three cause of death in the USA.) Lenzer cites several experts who estimate that a good 50% of devices get implanted unnecessarily. Standard medical treatment would be just as effective, if not more so. And safer.

Lenzer provides plenty of other examples, including drugs like Genentech’s blockbuster tPA, which has been proven to be no better than its old fashioned competition, and in some ways worse. Though far more expensive, of course. And as we head into the great future of the internet of things, more and more devices report data. They are hackable targets, able to kill the patient remotely, via cellphone.

There are numerous books like this in various sub-fields within medicine, as well as chemicals, nutrition and agriculture. The evidence is stark. The effects often fatal. And nothing ever comes of it. (Just ask Dennis Fegen, who has been contacting anyone and everyone for years with zero results.) No congressional hearings, no permit revocations, no criminal prosecutions. Not even libel suits. Maybe the occasional fine. And to top it off, the Supreme Court has ended liability suits by victims if the device operated properly. Industry bribes doctors to sell each other. Industry finances politicians. Industry dangles fat jobs in front of FDA types. Doctors live in a state of suspension of disbelief when it’s not simple gullibility. The bogus VNS gizmo sits front and center on the company’s website. At $40,000 (installation not included), it is key to their success, and to hell with the (over a thousand) bodies piling up. The Danger Within Us in infuriating.

David Wineberg