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Watch enough documentaries, and you’ll find yourself having trouble getting out of bed in the morning. You’ll certainly think twice before undergoing a medical procedure, especially on the heels of Kirby Dick’s documentary about the hazards of so-called “innovative” medical devices. Chronicling the unnecessary pain and suffering of patients caused by complications of devices and procedures that received little or no testing, The Bleeding Edge is a terrifying eye-opener. The Netflix-produced documentary recently received its world premiere at the Tribeca Film Festival.
“When it comes to medical devices, we built a system that doesn’t work,” says David Kessler, a former FDA commissioner. The agency’s mission goes back many years, as demonstrated by a vintage PSA featuring actor Raymond Massey that proclaims, “Help stamp out quackery!”
Dick (The Invisible War, The Hunting Ground) and producers Amy Ziering and Amy Herdy concentrate on just a few examples of the $400 billion medical device industry. The first involves Essure, a permanent birth-control device that is claimed to be 99% effective at preventing pregnancy. Unfortunately, it often produces such complications as cramps, bleeding and worse. The documentary includes an excerpt from a video of an Essure approval meeting in which doctors’ questions go unanswered and several of the participants joke openly about the lack of rigor in the process.
Then there’s vaginal mesh, commonly used in gynecological surgeries even though the FDA didn’t require human studies before approving it. The mesh, purposely designed to inflame scar tissue to hold it in place, becomes rigid and almost impossible to remove. One female patient says that, not long after mesh was inserted, her husband suffered a cut penis when they attempted intercourse. The members of a support group talk about sex lives destroyed and marriages ruined. Onscreen graphics inform us that mesh lawsuits have cost its manufacturer Johnson & Johnson $300 million in the last decade. But that’s a drop in the bucket compared to its revenues of $683 billion during the same period.
Another problem is robotic surgery, performed remotely by doctors who are too often insufficiently trained in the procedure. “The story of how the robot came into healthcare is the story of what’s wrong with healthcare today,” says a Johns Hopkins University professor. Several women describe undergoing hysterectomies performed by doctors using the “da Vinci robot” that went disastrously wrong. One of them suffered pain and bleeding for weeks before three feet of her colon literally fell out of her body.
Hip replacements composed of such metals as cobalt often produce horrific aftereffects. An orthopedic surgeon who received one himself began experiencing tremors, cognitive issues and serious psychological problems. It was determined that the metal had seeped into his tissue and bloodstream. Amazingly, the product is still commonly being used.
It all boils down, naturally, to lax oversight and insufficient regulatory practices. The FDA’s “Premarket Notification” system stipulates that a new medical device can be approved without testing if it is equivalent to an existing device — even if the prior device has been recalled.
Nine FDA scientists who expressed safety concerns about the agency’s lax regulatory process were spied on and eventually let go. Meanwhile, the medical device industry employs an army of lobbyists and many FDA commissioners and other employees go to work in that industry after leaving the agency. Needless to say, things are only getting worse in the Trump era and under current FDA head Scott Gottlieb. Frighteningly, Gottlieb gained confirmation only after promising to recuse himself for one year from any decisions involving the no less than 20 healthcare companies for which he’s worked.
The Bleeding Edge occasionally suffers from its overemphasis on individual cases. It doesn’t add much to our understanding of the problem, for instance, to watch a homeless Hispanic woman desperately struggling financially after her health was ruined by Essure, although it obviously adds a human face to the problem.
The film concludes by informing us that no one from the FDA or any of the companies involved agreed to be interviewed. Their silence is both telling and infuriating.
Production companies: Netflix, Chain Camera Pictures, Shark Camera Productions
Director-screenwriter: Kirby Dick
Producers: Amy Ziering, Amy Herdy
Executive producers: Jason Spingarn-Koff, Ben Cotner, Lisa Nishimura, Ian Darling, M S Johnson, Debra L. McLeod
Director of photography: Thaddeus Wadleigh
Editors: Derek Boonstra, Andrew McAllister
Composer: Jeff Beal
Venue: Tribeca Film Festival (Spotlight Documentary)
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