The medical device industry has the power to make or break us, literally.
The Bleeding Edge (2018), a Netflix documentary created by Amy Ziering and Kirby Dick, opens a previously hidden wound in an influential industry that has caused more damage than most people are aware of.
Jeanne Lenzer, author of The Danger Within Us, claims that nearly 70 million Americans have been implanted with medical devices over the past 10 years. But the $300-billion-dollar-a-year industry is not very well-understood by the general public.
The Bleeding Edge focuses on a permanent birth control method called Essure, marketed to women as an alternative to tubal ligation. A quick, easy procedure. 45-minutes in the office, no incisions, no anesthesia, and back to work the next day. But for many women, the journey did not end there.
Angie Firmalino, a mail carrier from Tannersville, New York had her last child at 37 years old, in 2009. Then, she and her husband decided they didn’t want to have any more kids, so Angie sought medical guidance. Her OBGYN recommended Essure, a small, coiled metal device inserted into the fallopian tube. The device would cause an inflammatory response, closing the fallopian tube and preventing pregnancy.
After Angie had her procedure, she had frequent fevers, bleeding, and stabbing pain in her left side. The doctor determined the device had migrated to her uterus. Even after the doctor removed it, she continued having problems. In a horrific event, she began bleeding profusely in a hospital room, large clots covering the floor. In a moving scene, Angie wonders about the fate of her children if she doesn’t survive this health complication.
Since getting her Essure implant, Angie has had to undergo a lumbar puncture and spinal tap, as well as surgery to remove the devices, a tubal ligation, a hysterectomy, two surgeries to repair her vaginal cuff, and three joint surgeries. Because doctors have gone back and forth so much on proper removal protocols, many doctors often break or stretch the devices, causing them to fragment. These leftover pieces can trigger immune responses and cause a connective tissue disorder that deteriorates joints.
To warn family and friends, Angie started the Facebook group “Essure Problems.” Soon after, strangers began joining and sharing their stories with complications from Essure.
Essure Problems became an irreplaceable source of support. Members raised money to unearth a video of the meeting at which the FDA approved Essure. The lead man presenting the device to the FDA panel admitted he owns stock in Bayer, the company that manufactures Essure. Presenters were often unable to answer panelists’ questions with hard data, and the panel laughed while speculating, “What are we going to do if we see problems with this in 10 years?” They joked that private investigators would find them and ask them why they approved Essure. In a darkly ironic twist, a little over ten years later, this documentary was released.
Producer Amy Herdy brought the Essure issue to the eyes of filmmakers Amy Ziering and Kirby Dick. In an interview with Make Muse, Ziering said that after hearing people’s stories, the pair were “very intrigued and shocked because we consider ourselves well-informed but we had no idea that the industry was this unregulated, no idea, in these staggering ways.”
In an interview with Make Muse, Amanda Dykeman, Vice President of ASHES non-profit and head research coordinator for Essure Problems, described her experiences as an E-Sister (a woman who has suffered complications from Essure). Dykeman is a single mother of three boys ages 8, 10, and 12. After asking her doctor about a tubal ligation after the delivery of her middle son, the doctor refused, suggesting she was too young, and recommended Essure because it was reversible. After the birth of her third son, Dykeman opted to have the Essure implant.
After her procedure, Dykeman experienced “extreme fatigue, severe abdominal pain and bloating, debilitating migraines, constant chronic infections, tooth loss and decay, excessive bleeding and clotting, widespread abdominal adhesions, and depression with suicidal ideations,” she wrote in an email to Make Muse.
“It was a struggle just to find a physician that would listen, and none of them could correlate what I was experiencing with Essure. In fact, many of the ER physicians I encountered had never even heard of it. I was alone and afraid and made to feel crazy,” Dykeman wrote.
Dykeman first connected with the E-Sisters after googling Essure Problems, worried about the possibility of becoming pregnant even with her Essure implant. Sure enough, she discovered other women who had become pregnant despite their Essure implants. Babies born from mothers with Essure implants have shown health problems, and sometimes the device punctures the amniotic sac, causing preterm labor. Too many women have had to bury their premature babies as a result. E-Sisters have recorded over 800 failed pregnancies associated with Essure.
Ana Fuentes, mother of four daughters from Santa Ana, California, had a similar story. After a doctor performed the procedure to implant Essure, Fuentes experienced severe cramping and bleeding. When she called her doctor, he assured her it was all in her head, a common refrain that women hear far too often in doctor’s offices across the country and the world.
Fuentes had to visit the hospital frequently, even passing out at work from the pain and then driving herself to the hospital. She had to start wearing diapers to deal with the constant bleeding. Because she couldn’t perform sexually, her husband left her. A doctor attempted to explain these problems by saying that most Latinas have menstrual problems. Because she was Latina, he explained, she would bleed a lot. But Fuentes was astounded, responding that she has been Latina her whole life and has never experienced this much bleeding.
Fuentes had a hysterectomy, but the severe pain she still experiences cost her her job. Because she couldn’t afford her rent, she had to move out of her house. She was terrified she would be separated from her four daughters if she couldn’t find a job and other accommodations.
In 2017, at the largest annual gynecological convention in the United States, the E-Sisters organized a rally. They chanted, “Bayer has no data, do you have malpractice?” Doctors approached them to ask questions, but many didn’t take them seriously. One man said that, “If you do a good job, then you don’t have any problems.” Despite the accounts of experiences from over 30,000 women in the Facebook group, the doctor said they were “talking nonsense.”
In an even more disturbing turn, the documentary dives into the lack of regulation in the medical device industry. Devices don’t have to be proven safe or effective before they are put on the market. Instead, to gain FDA approval, a device must simply be proven “substantially equivalent” to a pre-existing device. However, this 1976 rule grandfathered in existing devices. So the benchmark for approval of the vast majority of devices today can be based on ineffective devices that have since been recalled!
In the last 20-25 years, the medical device industry has funded about 70% of biomedical research. Since they pay for the research, they’ll get the results they want to share, potentially causing death and injuries for years to come.
AdvaMed, the lobbying group which represents the device industry, spent over $64 million on lobbying in 2017. They influence vulnerable politicians who don’t have science backgrounds with their impressive language, and they fund campaigns with dark money contributions. Additionally, many former FDA officials went on to work in the medical device industry.
President Trump’s pick to run the FDA, Dr. Scott Gottlieb, is well-known in the pharmaceutical and medical device industries. Gottlieb was a partner at New Enterprise Associates, a venture capital firm that funded the development of Essure.
But despite all that, following the release of The Bleeding Edge, Bayer recalled Essure from the market. Ziering says the team was elated. “Obviously they did this in response to what they felt would be backlash once the film got traction globally, and we’re relieved because, you know, how many women’s lives are now going to be prevented from being horribly derailed by a faulty device.”
The Bleeding Edge tells a story of struggle, a story of disbelief, a story of the tragic consequences of the skepticism women face about their own pain. And even though the incredible activism of the E-Sisters should be celebrated, it’s important to remember the terrible impact that Essure has had on so many women’s lives: sterilization, devastation, health precarity. Ana Fuentes’s four daughters now live with a church-affiliated foster family as she continues to struggle with her health.
Dykeman encourages other women who have been impacted by Essure: “It’s not all in your head. Never convince yourself otherwise and keep fighting for your own health and happiness because you are worth much more than the price tag the device manufacturer has labeled you with.”