Wednesday, August 15, 2018

You Must See The Bleeding Edge

Americans value innovation, and we built a health care system that rewards it, but at what cost? Few people understand that medical devices are not regulated as well as pharmaceuticals and patients can have untested objects implanted in their bodies. 

Prescription drugs must be tested in humans, and the FDA reviews the data before they're approved to go to market. The process has its shortcomings, but nothing like what goes on with medical devices. Through a what is essentially a loophole, the 510(k) pathway, medical devices can be approved if the manufacturer demonstrates that their device is "substantially equivalent" to a device that's already on the market. Manufacturers can get approval even if the device they're using for the comparison has been recalled because it caused problems. The new device might be made from entirely different material like using cobalt in a hip replacement or used in a completely different way like mesh that was used for hernia repairs being used for gynecological repairs. Under the current administration, what little control the FDA had is eroding. 

As frightening as the situation is and as horrifying as the stories you'll hear in The Bleeding Edge are, you'll be buoyed by how you see patients fighting back. Right before this film was released, Bayer announced that it would stop selling Essure, a permanent birth control implant, in the U.S. It had already been banned in other countries, but despite women suffering from persistent pain and bleeding, organ perforation, dangerous unintended pregnancies and more, it continued to be available in the U.S. 100,000 women are suing the manufacturers of gynecological mesh implants in the largest multi-district litigation since asbestos. (A story that was also covered by 60 Minutes.) 

Kirby Dick, the director, sheds light on a topic we all need to know more about if we want to protect ourselves and the people we love. The film concludes with some good advice:
  1. Research any device that will be used on or in you. New is not necessarily better.
  2. Get a second opinion for any risky or expensive procedure.
  3. Ask your surgeon how many procedures he or she has performed.
  4. Have a friend or family member be your advocate while you're in the hospital.
  5. To see if a medical device company has paid your doctor, go to 
You can watch the documentary on Netflix and you'll find more resources on The Bleeding Edge website. 

Many thanks to Terry Harris for pointing out this documentary to me.


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