The Bleeding Edge: a terrifying, enraging look at the corrupt, deadly world of medical implants

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 501(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. Read the rest