A new Netflix Original documentary titled The Bleeding Edge takes a look at the $400 billion medical device industry in America, and the dangers that come with manufacturing products like hip implants, vaginal mesh, Essure birth control, and robotic surgery devices in a corrupted system.
According to the Guardian, “dozens of people speak about issues that followed procedures involving medical devices, including women whose intestines fell out of their bodies after robotic surgery. Doctors, too, come forward afflicted by the unknown effects of some of these devices.”
“A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals,” stated The Bleeding Edge director, Kirby Dick. “We felt it was very important that the public, doctors and policymakers know about this because right now medical device companies can get away with just about anything.”
Filmmakers interviewed doctors and patients who have been personally harmed by these dangerous and defective medical devices. “It’s normal for medical devices to come with risks for adverse reactions, and it’s a physician’s responsibility to discuss those risks with their patients. However, medical devices often escape scrutiny on their path to the American market, the filmmakers say, and demand more research and testing than they currently have,” reports TIME.
The FDA created the 510(k) pathway a provision that allows manufacturers to obtain approval if there is proof that their device is “substantially equivalent” to other devices already on the market. However, the documentary notes that it has become commonplace for devices akin to existing units to be approved for sale and open to the public without more recent testing or scrutiny of modified features.
“That provision, which was meant as an exception, in essence [is] a loophole,” explained Dr. David Kessler, a former FDA commissioner, in The Bleeding Edge. “[It] became the rule, so that the vast majority of devices today regrettably are regulated under this framework.”
“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 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.”
The Bleeding Edge became available on Netflix on July 27, 2018.