Edited By Kevin Connolly
Published: January 23, 2018
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For many Americans, medical devices such as hip implants and pacemakers can improve and save lives.

The United States is the largest medical device market in the world, valued at $140 billion in 2015, according to the most recent estimates from the U.S. Department of Commerce.

But, the reality is that medical device manufacturers may not have adequately tested the products they sell. Even when they do tests, they may obscure results from the public or bury important safety information.

My guest on this episode of Drugwatch Podcast is award-winning investigative journalist Jeanne Lenzer. She has appeared in and written for media outlets and journals, including The New York Times, The Atlantic and the British Medical Journal (BMJ).

A former physician assistant, Lenzer questioned how much the public actually knew about the drugs and devices they received from doctors.

“What triggered my career into investigative journalism was finding out that some drugs were killing people and yet many doctors were unaware of those deaths,” she said. “And I was puzzled by this.”

In her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, Lenzer discusses corruption in the medical-device industry and how it affects patients.

The U.S. Food and Drug Administration did not begin regulating medical devices until the 1970s, long after it began approving drugs. The 510(k) premarket clearance process and the premarket approval (PMA) process are two methods the FDA uses to allow devices on the market.

According to Lenzer, both pathways have problems.

“The problem is that in many — if not most instances — the manufacturers of those devices, have never submitted safety and efficacy studies for those devices,” she said.

In the case of premarket approval (PMA) devices such as the vagus nerve stimulator or Essure birth control, a court ruling prevents patients from filing lawsuits against manufacturers, leaving them with no recourse.

In addition to shedding light on the problems with the industry, Lenzer provides consumers with some tips to take action and protect themselves.

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