In line with their focus on injustices committed against women in their previous features “The Invisible War” and “The Hunting Ground,” Dick and Ziering duo hone in on female-specific implements that have resulted in adverse side effects for users. Their collective horror stories don’t lack in grisly details: organs spilling out of their bodies through orifices, genitals being mutilated during intercourse, and violent mental breakdowns caused by metal poisoning. Part of what gives “The Bleeding Edge” such powerful impact is that many of its subjects are medical professionals who were affected by the very devices or procedures they would recommend to patients - had they not experienced the consequences themselves. As you might imagine, most manufactures opt-out of the more tedious and ethical choice, thus unleashing improperly vetted products prone to ravage the lives of those who wear them.Īlso Read: 'The Hunting Ground' Filmmakers: Betsy DeVos Title IX Decision 'Should Scare the Hell' Out of Parentsįinding an enthralling equilibrium between hard numerical data and heartrending testimonials, Dick masterfully weaves together both the expert statements you’d expect in a documentary like this and first-hand accounts from victims the results are alarming and essential for anyone even remotely invested in their own physical and psychological wellness. PMA follows a stricter set of parameters that ensure each contraption is tested more rigorously, if ever so slightly. The 510 (k) refers to a loophole by which the industry can argue their new gadget is safe given that it’s “substantially equivalent” to one previously released, even if that preceding example malfunctioned and was recalled. Concepts like the 510 (k) Premarket Notification and the Premarket Approval process (PMA) are thoroughly demystified in simple descriptions that allow the general viewer to grasp the magnitude of this state-sponsored nightmare. The film brings the FDA to task by unmasking the archaic regulatory practices that have enabled companies in the medical field to get easy approval for untested and often unsafe new technologies. Such is the sinister reality that audacious documentarian Kirby Dick, alongside his creative producing partner Amy Ziering, strives to denounce in “The Bleeding Edge,” their exposé of the Food and Drug Administration, an institution they say fails to prioritize public health above financial gain. The medical industry - operating under the pretense that innovation for the sake of humanity’s wellbeing is their primary objective - bargains with patients’ bodies to maximize billionaire profits.
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