'We can no longer rely on the FDA': The Bleeding Edge mirrors the disturbing reality of a corporatized America
The documentary highlights the devices which have nearly destroyed people’s lives and the shocking corner-cutting regulations of the federal agencies
If you thought America's federal medical agencies were pulling out all the stops to ensure your health safety, you should probably think again. Kirby Dick’s new searing exposé on the medical device industry in the country shows how the United States has become so business-driven that it no longer cares for its citizens.
You may think that watching a documentary about the inhumanity of a mechanized industry will not be a shocker anymore, but 'The Bleeding Edge' renders you speechless when you realize no one's really got your back. Not even the government you entrusted your health with. The documentary, in the end, emerges as a real-life, sci-fi horror film.
The Netflix Original documentary is about the medical device industry in the US which generates revenues of $300 billion a year by producing highly-sophisticated apparatus which are either used to assist operation procedures on people or implanted in their bodies.
"Medical devices are a way of life in America' — Jim Spencer/ Journalist- Minneapolis Star Tribune
Nearly 70 million people in America have been outfitted with internal medical devices over the last decade.
There is, no doubt, that several of these devices assist patients by improving their quality of life. The film doesn’t deny that. It, instead, highlights the devices which have nearly destroyed people’s lives and the shocking corner-cutting regulations of the federal agencies before certain contraptions are permitted to be used on people.
The filmmakers, in the documentary, have primarily focused on the guardian group of the medical device industry — the US Food and Drugs Administration (FDA), along with a few medical device producing firms like Bayer and Johnson & Johnson.
The documentary focuses on four main contraptions used in America which have caused significant harm to a large number of patients: Essure — a female sterilization device; cobalt-based joint replacements; vaginal mesh; and Da Vinci — a robotic surgical system.
The film details the lives of multiple women and men who are living with the aftermath of implant surgeries.
Essure gave women autoimmune diseases with broken fragments of the device still lodged in their uterus even after extraction. A surgeon’s personal account of how a cobalt-hip replacement cost him his mental sanity and resulted in elevated levels of cobalt in his blood. Vaginal mesh implants resulted in bleeding and acute pain and the lack of knowledge amongst doctors to take the device out.
And finally, the use of the Da Vinci robotic surgical system, which resulted in botched surgeries — in one case a woman’s colon falling out of her vagina — as doctors in the documentary admitted they were not comfortable using the system until their 200th operation with the device.
All these devices were cleared through the FDA’s regulation system and still continue to be in the US market.*
The film, through a former FDA commissioner Dr. David Kessler, points out existing loopholes in the agency’s archaic regulation system which continues to give clearance to medical devices with a disturbing lack of research and testing: the Pre Market Approval (PMA) and the 510(k) Clearance process.
The 510(k) is a loophole which allows the industry to argue that their gadget is safe considering that it is “substantially equivalent” to the ones previously released, even if the prior device was recalled due to malfunction. While the PMA follows a stricter set of regulations, it is still rendered regressive in the documentary through multiple examples.
The 'Bleeding Edge' screams to be seen as it manages to do what no one has done before — take the FDA to task to an extent that it declined to give an on-camera interview for the film, similar to other big medical device companies like Bayer. The film shows that there is nearly no difference between the regulator and the industry it is assigned to regulate.
*Bayer called off Essure from the US market a week before the release of the documentary. Thousands of women have filed lawsuits against the firm with the birth control device as their subject, claiming it has caused them injury.
Kirby Dick, while talking to Variety‘s PopPolitics, said:
"We don’t think it’s coincidental that they did it just a week before the release of the film on Netflix. I think they knew that the public would be outraged at the fact that they still had this product on the market.”