Halloween is just around the corner and Kirby Dick’s documentary The Bleeding Edge (2018) is appropriate for the season in that it is most definitely not for the faint of heart. This column chronicles all of the must-watch documentary films available for streaming. If you like what you see, grab the magazine for less than ten dollars, or subscribe and get all future magazines for half price.Įvery week, Megan Condis and a group of friends get together for Documentary Sunday, a chance to dive into the weird, the wacky, the hilarious and the heartbreaking corners of our culture. at the end of 2018.This column is reprinted from Unwinnable Monthly #108. In a late addition to the film, a title card was added just before the credits, and it tells us this: “Shortly after the premiere of this film, Bayer announced it would stop selling Essure in the U.S. I thought about that at the end of The Bleeding Edge, which gets an alternate ending, too, kind of. Did you ever hear about Get Out’s alternate ending? The original was deemed a “downer,” so they decided to change it to something slightly more hopeful. And then, at the last possible moment, a bit of optimism appears. The documentary ends, and you feel helpless. This proposal, as a Reuters reporter noted at the time, would “ safety monitoring from the pre-approval to the post-market setting, would essentially turn patients into guinea pigs.” The current copy-of-a-copy system is seriously flawed, but at least it requires some pre-market testing of some version of the device. The proposed plan would be a way to fast-track approval of medical devices without requiring manufacturers to name an “equivalent,” also called a “predicate,” product. Even if that device was later recalled.Īnd then there’s this: I missed the reports about it last fall - “Cat Person” had just been published, you see, and I was distracted - but in November, the FDA proposed a loophole for the existing loophole. Even if that device was later deemed dangerous. Even if that “equivalent” device was itself not tested thoroughly. Enter said loophole, called the 510(k) pathway, through which a medical-device manufacturer only has to prove that their product is “substantially equivalent” to a device already on the market. As it is now, this process is often already irresponsible - and, as the filmmakers point out, it is likely to get so much worse under the Trump administration.Ĭurrently, many devices - even high-risk ones - aren’t thoroughly tested before they go on the market, due to a kind of loophole in the system: “ecause so many new devices are brought to market, including new iterations of already approved devices, some medical companies argue that it’s too expensive to send each device through massive amounts of clinical testing,” explains Time health reporter Alexandra Sifferlin. So much gore and so much trauma, and yet the detail I can’t stop thinking about is sort of boring by comparison: It seems I am now obsessed with the flimsy process by which the FDA approves medical devices. The woman who describes the aftermath of a hysterectomy performed via robotic surgery: “I go to the restroom and I felt something emerge from my vagina,” she says.(When his surgeon went in to remove the device, he discovered that it had been leaking toxic “sludge” into his bloodstream.) It was a symptom, he now believes, of metal poisoning from his hip replacement. The doctor who recalls losing his mind in a hotel room, grabbing a ball point pen and scribbling all over the walls and ceiling.The man who tells the filmmakers about the time his wife’s recently inserted vaginal mesh cut his penis, while the two were having sex.The documentary is rough on those of us prone to vasovagal reactions, as it feels like a horror film pretty much all the way through. Fellow Cut staffer Emily Sundberg tells me she actually did faint during this scene. She was describing the gruesome side effects she suffered as a result of Essure, a surgically implanted permanent birth-control device, and she was making me feel a little faint as she did so. There were large splats all over the floor.” “Blood exploded out of me,” the woman on screen was saying (until I made her stop). I only made it 11 minutes into The Bleeding Edge, Netflix’s terrifying new documentary about the medical-device industry, until I had to hit pause to compose myself.
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