The Netflix documentary The Bleeding Edge, directed by Kirby Dick, casts a dim light on the $400 billion-dollar medical device industry and the regulatory agency charged with protecting consumers against dangerous drugs and medical devices.
The documentary focuses on several people who received or were treated with a medical device – from vital devices like hip implants and blood clot catchers to elective ones like breasts implants and contraceptive devices. These patients trusted their devices were safe, but later found the products were never tested for safety and efficacy, learning they were essentially guinea pigs.
One patient is an orthopedic surgeon who was implanted with a metal-on-metal hip implant. His device disintegrated inside his body and released metal ions in his bloodstream, causing him to suffer neurological problems.
Another is a woman in her 40s who received transvaginal mesh to treat urinary incontinence. The mesh eroded into her internal organs and could not be fully removed. She lives with abdominal bleeding and excruciating pain, and can no longer have sexual intercourse with her husband.
One patient is a woman who was implanted with Bayer’s permanent birth control device Essure. The device fractured and migrated inside her reproductive organs, causing pain and requiring surgery. She now suffers from a debilitating device-related autoimmune disease.
Almost all medical devices are approved through the Food and Drug Administration (FDA)’s 510(k) process, an accelerated program designed to bring medical devices to the market faster. But under this system, the only requirement is that the device must be “substantially equivalent” to one that is already on the market. That means medical devices are being approved and marketed without first being tested for safety and efficiency.
The overuse of this process means that the first users of these devices are often the ones who discover the side effects, and in many cases, live with the consequences. They’re also the ones who have to push for change, like victims of the contraceptive Essure.
The Essure movement began with a Facebook page that ultimately united 40,000 women who claimed they suffered Essure side effects. The women took their fight to Washington, and lawmakers pressured the FDA to investigate their claims. In October 2016, the agency fell short of banning the device, instead ordered Bayer to place a black box warning on the device’s label.
The Essure victims continued to fight, ultimately resulting in a stiff restrictions of Essure’s use. Following the documentary’s release, in July 2018, Bayer announced that effective Dec. 31, 2018, it would no longer sell or distribute the Essure birth control device.
Netflix – The Bleeding Edge
FDA Statement ht