Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word "complications" means on a device's warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.
The film traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that's inserted into the fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led her to nearly bleed to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did.
The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which -- even according to a former head of the department -- is a broken system. The medical device industry is the least understood and regulated in the FDA umbrella. Dick exposes so much that I yelled "Oh my God!" multiple times while watching.