This amazing documentary movie is a game changer literally in its effects. It chronicles parts of the lives of some survivors of ineffective medical devices. The show focuses especially on the Food and Drug Administration, which is the US govt organ responsible for monitoring and controlling what pieces of technology can be used on humans.
When I started watching this show I wasn’t all that impressed but if you persevere – it is serious and confronting – the rewards are there. In particular the show deals with a contraceptive device made by Bayer called Essure, a small coil inserted in the fallopian tube. It is designed to create scar tissue so that pregnancy is rendered impossible, but the reactions of the bodies of some women caused pain, incessant bleeding, and associated life problems such as an inability to have intimacy, unemployment, and homelessness.
When I say this movie is a game changer I mean it but I won’t spoil the suspense by revealing now how that happens. Needless to say I was impressed by the efficacy of the filmmakers and equally disappointed by the FDA. The threshold for getting a medical device approved by the FDA is far lower than for drugs and there is an indecent amount of lobbying done. In addition to the money being spent to convince lawmakers to vote a certain way is the revolving door of lobbyists, manufacturing company executives, and the FDA itself, so that an FDA senior official will be later employed by a manufacturer once their time with the administration is over. This cosy relationship between the FDA and industry resembles the situation in Japan where senior bank employees are employed in the ranks of subordinate companies in a process known as “amakudari” (which translates roughly as “sweetness descending”).
‘The Bleeding Edge’ mercifully censors the operations so that you’re not shown all the gory details, but the stories of the women involved are sufficiently difficult to learn about that it indeed becomes easy to switch off. When I came back to finish the program I was enlightened and amazed that this story hadn’t been more fully reported by journalists. I hope many people watch it in order to understand better how Capital can destroy lives when the main purpose of its organs is to make money. In the world of medical devices the primary purpose should be to improve lives.
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