Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today.
The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial hips, and women whose surgeons used Intuitive Surgical’s da Vinci robotic arm to perform hysterectomies. It focuses on the efforts of women who had Essure implants to get the device off the market through Facebook groups, picketing of medtech conferences, and one-on-one conversations with physicians and lobbying members of Congress.
Facebook group founder Angie Firmalino recounts her experience following removal of Essure. “Blood exploded out of me,” she says. “It looked like a horror scene.”
Award-winning filmmakers Kirby Dick and Amy Ziering, of “The Invisible War” and “The Hunting Ground” also followed Ana Fuentes, a mother of four who says that she started wearing diapers to contain her excessive bleeding following implantation with Essure. Her doctor told her that Latinas bleed more than other women. Fuentes’ husband left and she eventually lost her job due to excessive medical appointments. After she and the girls became homeless, Fuentes placed them in foster care.
Orthopedic surgeon Stephen Tower blames high cobalt levels from his metal artificial hip for neurological problems and a mental breakdown. Tower, who had revision surgery with a plastic-and-ceramic hip, now speaks to groups of physicians on the hazards of metal hips.
The film also includes criticism of the industry and the FDA by watchdog groups, doctors and former FDA officials. It dissects the 510(k) approval process, pointing out that predicate devices that have been recalled still count toward approvals.
“FDA does a credible job with the vast majority of products,” former FDA commissioner David Kessler says in the film. “The problem we have is, when it comes to medical devices, we built a system that doesn’t work.”
Introduced in 1976 at the request of the medtech industry seeking speedier, less expensive approvals than required for a premarket approval or PMA, the 510(k) process allows for FDA clearance of “substantially equivalent” devices with less research.
“That provision, which was meant as an exception — in essence, a little loophole —
that exception became the rule,” Kessler says. “So, the vast majority of devices today, regrettably, are regulated under this framework.”
“There’s a lot of problems with that 510(k) system,” adds Rita Redberg, MD, a cardiologist and editor of JAMA Internal Medicine. “That’s how metal-on-metal hips got on the market.”
The filmmakers also slam the industry for its focus on innovation. “They wheel out patients and they say, ‘This person wouldn’t be alive today if it wasn’t for this innovative product,’” says Deborah Cohen, associate editor of the British Medical Journal. “It’s all very glossy. It’s a slick machine.”
“Just because you have a new technology doesn’t mean it’s innovation,” adds Redberg.
“Too often you hear people say, ‘Oh, you’re going to stifle innovation. They’re not talking about stifling innovation. They’re talking about … putting untested devices on the market. That’s not innovative.”
When the filmmakers take aim at medtech lobbyists, AdvaMed president Scott Whitaker counters, “We want to make sure that new medical innovations get to patients and help save lives, improve the human condition, eliminate suffering and make this world a better place. That’s what we all agree on, right?”
The FDA, Bayer, Johnson & Johnson, and Intuitive Surgical declined to be interviewed for the film. AdvaMed and the companies did not immediately respond to MassDevice’s request for further comment.
J&J issued a statement to the filmmakers saying, “Your assertion that our ‘vaginal mesh and hip products have had a negative impact on the health of patients’ is untrue.” In a lengthy email to MassDevice, an FDA spokeswoman said no one at the agency had seen the film, although the agency did provide “extensive responses to the filmmakers’ questions.”
“Regardless of which process is followed, FDA strives to permit marketing of only those devices with a favorable benefit-risk profile,” the email response says. “However, not all information regarding benefits and risks for a given device are generally known before the device reaches the market… This is why the FDA uses a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices, including analyzing reports of problems that are submitted to our public database, reviewing results from Post-Approval Studies, and evaluating the available clinical literature.”
The statement also pointed to the FDA’s efforts at building its collaborative National Evaluation System for Health Technology (NEST) to “link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims. Full implementation of NEST will improve surveillance, signal management and mandated postmarket studies, and has the potential to support studies designed to answer specific device safety questions,” the statement said.
Bayer removed Essure from markets outside the U.S. in 2017. In March 2018, the FDA said it was evaluating the nearly 12,000 adverse event reports it received in 2017 about Essure, a 136% increase over the number of reports logged in 2016. Since its U.S. approval in 2002, the FDA has received a total of 26,773 adverse event reports on Essure.
In April 2018, the FDA required Bayer to add a boxed warning to the Essure label and advised physicians to explain the potential risks of the device to women. Bayer pulled Essure from the U.S. market July 20, 2018, one week before today’s documentary debut.
“Evaluating the postmarket safety of Essure continues to be a top priority for the FDA, and we expect Bayer to meet its postmarket obligations concerning this device,” the agency’s statement continued. “Ensuring the safety and effectiveness of medical products is a core part of our consumer protection role.”
Near the end of the film, Firmalino and other women visit members of Congress to explain how Essure affected them and thousands of other women.
“Women just seem to be expendable, don’t they,” says U.S. Rep. Louise Slaughter (D-NY). Slaughter died in March 2018.
“That’s how we’re starting to feel,” responds one member of the group. “We’re disposable.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.