It honestly came across as though the documentary was “crediting” the medtech industry with “inventing” lobbying and this tactic was somehow unique in government to this example. Frankly, this aspect somewhat confused me. Later, the documentary describes the medtech industry’s nefarious work behind the scenes, using lobbyists to dupe members of Congress into passing supporting legislation that protects the industry.

Again, I’m not completely against the idea that this does seem somewhat flawed when one examines the big picture.Īnother item presented (almost as a throwaway line at the very beginning of the film) was the statement that for as much power as we believe the pharma industry has, the medical device industry has even more.

If this is entirely accurate in how it’s presented, I agree that it’s a problem and should be reviewed.Īlso, when you consider the chain of potential technologies that are cleared based on predicate devices, you could conceivably have a very long line of incremental advancements that results in the “first” device not at all resembling the most recent product that’s been cleared. It states that even if a predicate device is later recalled, it can still be used for the 510(k) process. It highlights problems with the FDA’s 510(k) process in regard to how predicate devices are used for clearances of new technologies. Sure, some actual data is presented, and in the case of the Essure device, the patient testimonials are overwhelming in number, but the data is sprinkled between the many patient stories.Īnother issue I have with the documentary is that it spends so much time sharing the patient stories for a limited number of truly problematic devices, it doesn’t thoroughly explore some of the other issues it mentions almost in passing. Unfortunately, this is done too much for emotional impact and is not sufficiently complemented by hard facts. We are overwhelmingly provided with anecdotal evidence of failed products, whether the Essure device from Bayer, metal-on-metal hip implants from DePuy, or vaginal mesh from J&J, and hear of the suffering these patients endured. This disclaimer, however, is made necessary due to just how much we are shown those patients and hear their stories in the documentary. That clearly happened and, without question, is a tragedy. No patient should lose trust in the healthcare system, their doctors, or the companies developing technologies that are supposed to help them. For many, no lawsuit will preserve what they’ve lost or make up for the suffering they’ve endured. The medical industry has utterly and obviously failed them and that is truly a catastrophe. Let me start with my disclaimer: My intention is not to come across as uncaring or cold-hearted to the suffering of the many patients featured in the documentary. I would also encourage you to listen to the Mike on Medtech podcasts where we discuss a number of issues brought up in the film. For those who have not had the opportunity to view it, I would certainly encourage you to do so.

Recently, I watched the controversial medical device industry documentary, “The Bleeding Edge,” featured on Netflix.

The bleeding edge hip replacement