In an interview with The Guardian, the film's director talks about how the medical device industry and their lobby has been flying under the radar. “No, no, no, the device industry has much more power.” “People think pharma’s got power,” says Spencer. When you think of medical lobbying, the pharmaceutical industry probably comes to mind, but in the film, journalist Jim Spencer talks about how much bigger the medical device lobby is. The Bleeding Edge reveals how under regulated the $400 billion dollar medical device industry really is, and how it is able to thrive not only through FDA loopholes, but also through political lobbying efforts. was the only country that still had Essure on the market.
Essure has face nearly 16,000 lawsuits, noted the New York Times, and was already banned in several countries. But in some cases, the device has been found to break off and travel to other parts of the body, causing internal injuries and neurological disorders, as highlighted in The Bleeding Edge.
The Essure device is a coil which is implanted into the Fallopian tubes, which helps create a barrier, blocking sperm from fertilizing an egg. Just a a week before the documentary is set to air, CNN reported that Bayer pulled it’s Essure birth control device from the market after the FDA ordered its sales to be restricted back in April. Drug Watch indicated that this has led to an increase in device recalls, with over 180 million medical devices being recalled in just the second half of 2016. So, without much testing or regulation, some devices are able to come to consumers, but many are then recalled after issues arise. To qualify for a 510(k) exemption, all a device manufacturer needs to do is claim that their device is “substantially equivalent” to one that is already on the market. One of the most controversial loopholes is the 1976 FDA 510(k) Clearance Process, which allows certain medical devices to gain FDA approval without any clinical studies to back up their safety or effectiveness. While all of these devices were approved by the U.S Food and Drug Administration (FDA), the documentary highlights the loopholes that allow some devices to hit the market without sufficient testing. The Bleeding Edge takes a deep look at the medical device industry and highlights the dangers of certain devices, including the Davinci Surgical Robot, cobalt hip replacements, transvaginal mesh implants, and most notably, the Essure birth control coil. But what are the risks of medical devices really, and what should you know before you opt for one? After watching some of the horror stories in the documentary, you may be a little hesitant about certain medical tech. In Netflix’s new documentary film, The Bleeding Edge, writer/producer Amy Ziering and director Kirby Dick dive into the world of medical technologies and the terrifying, - and sometimes deadly - consequences they bear.
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