MY BIRTH CONTROL WRECKED MY BODY
A new film takes on the $400 billion medical device industry
IN 2009, Angie Firmalino was steadfast in her decision: If the birth of her second child required a Caesarean section, she’d have her tubes tied as part of the procedure. But there was an emergency complication with the C-section, and the on-call surgeon didn’t end up doing the tubal ligation.
Firmalino, a 46-year-old mail carrier from Tannersville, NY, didn’t want another surgery right away, so her OB-GYN suggested what sounded like a great solution: Essure, a metal coil that’s inserted into each of the fallopian tubes as permanent birth control. A few weeks later, Firmalino had the devices — which were approved by the FDA in 2002 — implanted.
“I immediately started having problems,” she tells The Post. “[There was] a lot of bleeding, I was running fevers, but mostly dealing with this sharp, stabbing pain on my lower left side.”
An ultrasound revealed that the coils had expelled from her tubes and embedded in her uterus. She had a procedure to remove the coils, but polyethylene terephthalate fiber fragments from the devices remained — leading to a hysterectomy and, because of complications, two surgical repairs.
Firmalino believes that those fragments set off an autoimmune condition that’s attacking her connective tissue. She says that she now suffers from chronic headaches — “every day, 24/7” — and joint pain, resulting in surgeries on her left shoulder and both elbows.
Firmalino’s story is among those highlighted in a new documentary, “The Bleeding Edge,” which begins streaming on Netflix this Friday. In the movie, Oscar-nominated filmmakers Kirby Dick and Amy Ziering expose issues with the $400 billion global medical device industry, including the shocking ease with which devices — including Essure — are approved by the Food and Drug Administration. Personal narratives show the devastating effects this has allegedly had on many lives.
“The public and policy makers and even doctors are unaware of the issues around medical devices,” says Dick, the director. “[For] the vast majority of risky devices . . . the FDA does not require testing in humans before it allows doctors to implant them in people. When I tell people that, [they] are just astonished.” (Although Essure did undergo human clinical trials, a citizen petition alleging trial misconduct prompted a re-evaluation by the FDA. In 2016, the agency found no evidence of “systematic or intentional” misconduct.)
Essure is just one of the potentially problematic devices examined in the film, but Dick says it’s a major focus of the film because of the way women who say they were harmed are fighting back.
After Firmalino’s medical issues began, she created a Facebook group in 2011 called “Essure Problems” to warn other women about the device. The group has now amassed more than 36,000 members, some of whom met with FDA Commissioner Scott Gottlieb earlier this year, leading the FDA to mandate that doctors must tell potential patients about the risks of Essure. By April, about 16,800 people — including Firmalino — had filed legal claims regarding Essure, according to Steven Immergut, a spokesman for Bayer Corporation, the company that makes it. Immergut told the New York Times that “we believe we have meritorious defenses and intend to continue to vigorously defend Essure.”
Then, last Friday — with the documentary’s release looming — Bayer announced that it was discontinuing sales of the device by the end of the year.
“The safety and efficacy of Essure have not changed,” Bayer says in a statement, adding that, “This decision is based on a decline in US sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.”
Upon hearing the news that Essure was leaving the market, Firmalino was overwhelmed.
“It’s been seven years of my life working up to this moment,” she says. “I’m just relieved and grateful that soon . . . no more women will be implanted with this device and face potential harm.”