One of the best books in medicine I have read. A splendid, savage story about the failings of modern device regulation that reads like a mystery, not a work of medical non-fiction: It turns out to be both.
— VINAY PRASAD, Assistant Professor of Medicine, Oregon Health and Science University, and author of Ending Medical Reversal

Americans live shorter, sicker lives than citizens of peer nations, at far greater expense.

In The Danger within Us, award-winning journalist Jeanne Lenzer explores how we got to this point, taking as her lens the wildly profitable, powerful, and unaccountable medical device industry. Vividly illustrating the costs and consequences of this industry in the lives of ordinary Americans, Lenzer tells the story of one working class man who ends up in a David and Goliath fight for justice after a medical device in his body nearly kills him. His crusade leads to shocking revelations: Corporate greed, shameless profiteering, corrupt doctors and regulators, and a terrifying lack of oversight, all of which is leading to dangerous devices going to market and into our bodies.

Did you know...

  • Medical interventions have become the third leading cause of death in America, killing more Americans each year than diabetes, murders, car accidents and AIDS combined.
  • You might think medical devices—like pacemakers, artificial hips, cardiac stents, etc.—don’t have side effects like drugs do. Nothing could be further from the truth.
  • The FDA does not require clinical testing for most high-risk implanted devices, and only 5% of the highest risk cardiac devices undergo the equivalent of the standard requirement for drug testing: two randomized, blinded clinical trials. Patients serve as unwitting test subjects to determine whether devices are safe.
  • Tens of millions of Americans have an implanted medical device, and yet the death rate caused by these devices is unknown, because no one is keeping track. Not the FDA. Not the manufacturers. Not hospitals. Not doctors.
  • The FDA habitually defends the interests of industry over the public interest, in part due to the “revolving door” between the businesses being regulated and the FDA.
  • The average annual compensation package for CEOs of the 18 publicly traded medical device companies in the U.S. was $15.4 million in 2015.

cardiac pacemakers and stents • artificial hips, knees, shoulders, etc. • cochlear implants • vagus nerve stimulators • deep brain stimulators • breast implants • surgical mesh • skull plates • intrauterine devices