Medical device the rule of thumb seems to be luck over science

KEY IDEA:  Seventy million Americans have a medical device implanted within their body. “When it comes to medical devices, we built a system that doesn’t work,” David Kessler, the former FDA commissioner, said in The Bleeding Edge.  The disturbing truth is that, despite so many people relying on such implants, the medical device industry is very weakly regulated.

One of the most powerful and rapidly growing participants in this burgeoning economic network is the medical device industry. Generating estimated revenues of more than $ 136 billion in the US in 2014, the implantable-device industry is even more lucrative for many of its component companies than the highly profitable pharmaceutical industry.  Operating-profit margins for the largest companies include 30.0 percent for Zimmer Biomet (artificial joints), 28.6 percent for Medtronic, 25.8 percent for St. Jude Medical, and 23.1 percent for Stryker (orthopedic implants). Johnson & Johnson’s device division squirreled away $ 7.2 billion in profits in 2012, while Medtronic pulled down $ 3.6 billion in profits that year.

In 2015, approximately sixteen thousand deaths associated with medical devices were reported to the FDA . And a Government Accountability Office analysis found that 99 percent of device-related “adverse events” are never reported to the FDA and that the “more serious the event, the less likely it was to be reported.” Based on the GAO analysis, that means medical devices could have been associated with as many as 1.6 million deaths in 2015 . Even if only 1 to 10 percent of those deaths were caused by a device, that means between 16,000 and 160,000 people may have been killed by devices, making medical devices one of the leading causes of death in the US.

Walmart tracks every single head of lettuce it buys and sells and can determine how many heads of lettuce are on its shelves at any given moment, yet no one— not the FDA, not Brookings, not anyone— can say how many people are dying because of implanted medical devices. It’s a black hole.

The Bleeding Edge, a new documentary that premiered at the TriBeCa Film Festival in New York City and is set to be released on Netflix this summer, is all about the $400 billion unregulated medical device industry.

Many doctors have virtually no clue how badly regulated these products are when companies are promoting them. Companies have learned how to exploit a host of loopholes, especially in 510(k) and Premarket Approval routes for FDA approval, for getting medical devices on the market at just a fraction of the stringent rules required.

This isn’t just a problem local to a few devices; rather, it’s a systemic problem. “It’s everyone who is exposed to devices, from birth to death,” producer Amy Ziering told The Daily Beast. “If you’ve ever had an x-ray, or you wear contact lenses to see, this is for you. Devices are us, and our world will continue to use more of these. There’s an issue here that actually puts our lives in peril.”

This is clearly a case of profit driving dangerous practices.  The FDA is supposed to protect consumers, but lobbying by top medical device companies has prevented any new regulation.  So, if you’re getting a medical device the rule of thumb seems to be luck over science.

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