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. “Blood exploded out of me,” the woman on screen was saying (until I made her stop). “It looked like a horror scene. There were large splats all over the floor.”
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. Fellow Cut staffer Emily Sundberg tells me she actually did faint during this scene. 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. Consider:
• 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 doctor who recalls losing his mind in a hotel room, grabbing a ball point pen and scribbling all over the walls and ceiling. It was a symptom, he now believes, of metal poisoning from his hip replacement. (When his surgeon went in to remove the device, he discovered that it had been leaking toxic “sludge” into his bloodstream.)
• 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. “I had three feet of my colon fall out.”
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. 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.
Currently, 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: “[B]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. 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. Even if that “equivalent” device was itself not tested thoroughly. Even if that device was later deemed dangerous. Even if that device was later recalled.
And 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. 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. 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. This proposal, as a Reuters reporter noted at the time, would “[shift] safety monitoring from the pre-approval to the post-market setting, [and] would essentially turn patients into guinea pigs.”
It’s all so bleak. The documentary ends, and you feel helpless. Hopeless. And then, at the last possible moment, a bit of optimism appears. 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. I thought about that at the end of The Bleeding Edge, which gets an alternate ending, too, kind of. 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. at the end of 2018.”