Review: Kirby Dick and Amy Ziering expose FDA, $400 billion-dollar medical device industry in wrenching doc ‘The Bleeding Edge

By Robert Abele

July 26, 2018 1:31 PM PT

If body-horror auteur David Cronenberg had dramatized any of the nightmarish stories in Kirby Dick and Amy Ziering’s medical documentary “The Bleeding Edge,” you wouldn’t hesitate to call it a fright film. Such is the grim impact of this investigative, wince-inducing examination of the $400 billion medical device industry, which routinely sends FDA-approved products into the marketplace for use on and in patients without any rigorous clinical safety-testing on humans.

For director Dick and producer Ziering, it’s another effectively enraging, eye-opening look at a systemic case of neglected wrongdoing, one that follows their rape-in-the-military expose “The Invisible War” and campus sexual assault documentary “The Hunting Ground.” That their new film also involves the wanton mistreatment of bodies, and how difficult it often is to find justice for the afflicted, makes “Bleeding Edge” a queasy continuation of the previous films’ concerns.

At the heart of the film’s thesis, and spoken aloud by many of the health care professionals interviewed, is a suspicion about whether innovation and new technologies in medicine should automatically be treated as a better option for patients over standard, proven and research-driven treatments. With our bodies increasingly housing non-biological devices — a previous age’s wonder at the pacemaker giving way to the full-speed-ahead (70 million Americans in the last decade alone) implantation of life-extending technologies — it’s shocking to learn how harmful this revolution has become, especially when medical error was recently declared by a Johns Hopkins study to be the third leading cause of death in the U.S.

The living, though, are the film’s most convincing subjects, offering heartbreaking testimonials to the deleterious effects of a few key devices, starting with a permanent birth control device called Essure that promised 99% effectiveness, yet has often resulted in intense pain, bleeding, and even more severe problems. As with another heavily sold, under-scrutinized gynecological product — vaginal mesh that hardens, causing horrible pelvic damage, and in one couple’s instance, cutting the husband’s penis during intercourse — getting such devices removed (when they were intended to be permanent) can be as undefined and risk-laden a decision as leaving them in.

What the filmmakers reveal is that the FDA approvals process — which hasn’t been updated to meet our technological overwhelm and increasingly powerful corporations — doesn’t require objective testing (score one for industry) and signs off with scant evidence that a product is safe. It leaves doctors assuming heavily pushed devices, because they’ve received FDA’s okay, have been rigorously vetted. But video secured from Essure’s approval hearing shows not only the board’s safety questions barely answered by the company’s advocates but also post-vote laughing from panelists about the very lack of rigor just exhibited.

Combined with the forces of anti-regulation in government and profit-driven companies who know how to market to doctors and cover up their mistakes, the movie lays bare a blueprint for countless suffering. Left behind are people such as Ana, a Southern California woman whose unending medical needs after having Essure implanted wrecked her marriage and job, as well as her ability to take care of her four children.

Aside from the story of an orthopedic doctor who experienced neurological deterioration after getting a metal-on-metal hip replacement, then turned the experience into a heavily researched crusade against the material used, the movie’s tales of debilitating woe come primarily from women. It points to an unspoken but hard-to-miss aspect of Dick and Ziering’s well-argued outrage about the lack of attention given to untested devices. When a group of Essure survivor-activists take their cause to the halls of Congress to demand action against parent company Bayer, longtime patients’-rights advocate, New York Congresswoman Louise Slaughter (who died in March) meets their opprobrium with a pointedly weary, “Women just seem to be expendable, don’t they?”

The good news is that “The Bleeding Edge” can already be called a change agent: Last week, in advance of the movie’s release, Bayer pulled Essure from the U.S. market.

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