Prior to 1976, the FDA did not regulate medical implants, and so shoddy and even deadly devices proliferated, inserted into Americans' body.
When the FDA finally decided to regulate implants, they were reluctant to subject the devices already in the field to regulation — after all, these were already in peoples' bodies. So they enacted rule 510(k), which grandfathered in any devices in the market, and any devices that were "substantially similar" to those devices.
This is a loophole that eventually grew to consume the rule. Since 1976, medical implant makers like Johnson and Johnson have worked in a stepwise fashion: in 1977, make a device and argue that it's "similar" to a 1976 device. Then in 78, you make another device and argue that it's similar to the device you got approved in 1977. Flash forward to 2018, and practically all medical implants are approved through this process.
Releasing the companies from regulatory oversight did not go well. From "metal on metal" joints that released deadly cobalt into patients' bloodstreams and dissolved their surrounding tissues into metal-studded slurry to vaginal mesh implants that caused incredible, life-threatening harm and could never be removed; to "Essure," a permanent female sterilization tool that also causes life-threatening harm, tens of thousands of Americans have been permanently disabled or killed by their medical implants, their lives turned upside-down, subjected to medical bankruptcy, collapsing marriages, even homelessness and loss of their children.
But the FDA has not stepped up, and the companies routinely refuse to withdraw their products even when confronted with stories from injured and dying implantees. The FDA even approves devices if they're "similar" to devices that had to be withdrawn because they were killing people — the criteria for approval is similarity to an approved device, even if that approval led to disaster.
In a The Bleeding Edge, a 2018 documentary from Kirby Dick (previously) and Amy Ziering, we follow the regulators, the patients and the manufacturers as they enact this awful drama. We see how former FDA officials go into industry, and how industry executives end up running the FDA — Trump's pick for FDA chief is predictably awful — and how the manufacturers game the system, getting away with literal murder.
It's a wrenching, amazing movie. Like Dick's other movies, it's making a difference: less than a week after the film was released, Bayer withdrew its Essure product from the market, despite its staunch assertions that the product was safe for use. It was an important victory, if a small one: Bayer had already withdrawn Essure in every other country in the world, fearing regulatory scrutiny: only in the USA was it possible for this deadly product to be inserted into women's bodies for all these years.
The movie is on Netflix. It's amazing.
From The Guardian's review:
Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all over the walls and ceiling of a hotel room during a medical conference, eventually using soap as ink.
Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. So, Tower studied himself until he found the answer in a blood and urine sample: his levels of cobalt, a metal used in rechargeable batteries, were more than a hundred times higher than normal.
Tower thought it might be related to his metal-on-metal hip replacement and had it redone. On the operating table, his surgeon found metal sludge seeping from the device before it was removed. "Within a month I had an incredible recovery in terms of my psychologic symptoms and ability to think," Tower said.
Tower said he would never have believed neurological problems could come from orthopedic devices, if it wasn't for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson's or dementia-like symptoms.
Hundreds of thousands of people in the world may have been exposed to toxic metals from "metal on metal" hip implants, according to a 2012 joint investigation by the British Medical Journal and BBC Newsnight.
"If we can't change the laws and we can't convince companies to put moral issues above profits, then all of us really have to be vigilant," said The Bleeding Edge's producer, Amy Ziering. "My great hope is you watch this film and then you are really, really, really careful and ask a lot of questions and do a lot of research."