Film Review: The Bleeding Edge

The latest in Kirby Dick’s powerful series of seething-fury documentaries takes on the medical-device industry with typically devastating results.
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One thing you know going into a Kirby Dick documentary: It’s never going to be a fair fight. He and his producer and writing partner Amy Ziering have been focusing their ire on secretive institutions that breed corruption at best and violence at worst, from the endemic of unreported rape in the U.S. military (The Invisible War) to the farcical abuses and inanities of Hollywood’s film-ratings system (This Film Is Not Yet Rated). This time out, Dick has taken on the medical-device industry, which as a shibboleth of careless greed has few equals in modern America.

Composed mainly of the stories of patients who have suffered the effects of that greed,The Bleeding Edge is firmly in the camp of the modern skeptics who hear all the buzzwords about disruption and innovation and wonder: Is all this new tech worth it? Whether it is or isn’t, the movie notes that some 70 million Americans have had a medical device implanted in the last 10 years. If all these devices were being studied and tested before their approval for sale by the Food and Drug Administration, then this statistic might not be an issue. But when it appears onscreen, it’s meant to frighten. That’s because Dick makes the credible argument, through the testimony of industry experts and one voice-disguised whistleblower, that not only does the device industry routinely put profit before patient safety or even medical necessity, the FDA itself does a miserable job of screening new devices for safety.

The bulk of the movie delivers gut-churning first-person testimony to the effects of that laissez-faire approach. While various stylistic clichés are in full effect during these scenes, particularly the sentimental soundtrack, the impact of what these women and men have gone through is nothing less than tragic. Seeking a permanent birth-control device, several of the women here were implanted with the Essure, a little metal coil meant to block the Fallopian tube. Many later started having complications that ranged from bleeding to stabbing pain and losing the ability to have sex. The results were lost jobs, partners, lives. One woman had a doctor tell her that Latinas just bled a lot more; another says she has “had a headache since 2011.”

Further horror stories abound. There is the doctor who decided to get a hip replacement and was talked into getting the metal-on-metal version. One and a half years later, he was having medical and mental issues that culminated in a full-blown mental breakdown; he later found out that not only had his blood’s cobalt level spiked, the implant was spinning off metal guck. A company hawks its remote surgical machine Da Vinci at a TED Talk but fails to require much training of doctors in how to use it or even prove that it has any positive impact besides seeming cool.

The filmmakers don’t just fill The Bleeding Edge with firsthand testimony of wrongs committed, a common error with issue documentaries. They also chart a stark argument for the FDA being captured by the industry it is supposed to regulate. Experts and a former commissioner explain that standards for medical-device testing are lower than those for food and drugs. In normal cases, new devices require an already-low standard of evidence. Making matters worse, a Congressional loophole allows devices to avoid testing if they’re seen as similar to a device (approved or not) already on the market. “There’s nobody paying attention,” says Angie Firmalino, one of the organizers of online forums for sufferers of complications from the Essure.

Some mention is made of the place of doctors in the problem of pushing potentially dangerous devices on patients who may not need them—a nauseating moment at a medical convention protest shows a doctor sneering to a woman protesting Essure that patients suffering from it are simply “in the category of people who have complications.” But primarily this is a movie aimed right at the citizens and patients it wants to fight the well-funded industry groups lobbying Washington. Sharply argued, indignantly one-sided and stylistically monotonous The Bleeding Edge sometimes seems closer to angry PSA than documentary. But that may not be a distinction that matters.