The term “FDA approved” has long denoted trust and competency to U.S. medical patients. After all, if the United States Food and Drug Administration (FDA) approves something, then it must be safe and effective. Right? In recent years, FDA approval’s lost some consumers’ trust as drugs and medical devices with the agency’s seal required recalls. And the new Netflix Originals documentary The Bleeding Edge sheds light on why that keeps happening. The filmmakers focus on the FDA’s medical device review process, clearly illustrating how it works — and why it’s failing us. They interview patients, doctors, and even FDA officials for an in-depth look at our current flawed system. The film highlights Essure complication risks for women with the permanent birth control implant. Since then, Essure complication risks infamous for ruining thousands of women’s lives led to a voluntary recall.
Documentary Spotlights Dangerous Essure Complication Issues Affecting Women
The film depicts several problematic devices still sold today, from metal-on-metal hip implants to transvaginal mesh. But the main horror story features Bayer’s Essure complication problems that leave countless women requiring hysterectomies. The device itself looks tiny in person — just two thin, wiry coils. But when a doctor inserts those coils into the fallopian tubes, it can cause all kinds of damage. And the film documents the devastation multiple women suffer after Essure complication issues crop up. In all cases, doctors assured women the procedure was “safe” and minimized Essure complication risks.
The Bleeding Edge highlights two women’s ongoing Essure complication issues. The first is Angie Firmalino, who suffers from an autoimmune disease Essure complication. Despite removing both coils, Firmalino still suffers Essure complication side effects today. The metal fragments left inside Firmalino’s body give her severe, debilitating headaches. Firmalino launched a Facebook page called “Essure problems.” Grassroots efforts like hers to raise awareness about Essure complication risks may have led to the FDA’s 2016 black box warning.
The second woman featured is Ana Fuentes, whose main Essure complication involves chronic bleeding. At first, Fuentes’ doctor blamed this Essure complication on her Latino heritage — but it got increasingly worse. Eventually, excessive surgeries to correct Fuentes’ Essure complication issues forced her to stop working. As a result, Fuentes could no longer pay rent and her children ended up in foster care.
Filmmakers Explain How FDA Loophole Allows Dangerous Medical Devices Onto U.S. Market
The Netflix film explores how the FDA’s 510(k) loophole allows medical devices onto the U.S. market without approval. The FDA’s pre-market approval (PMA) for medical devices, much like drugs, requires long-term clinical trials and safety tests. PMA requires testing each drug or device on humans in order to demonstrate safety and efficacy before gaining FDA approval. But because so many new devices head to market each year, the FDA created its current 510(k) pathway to speed up that process. This lets manufacturers who show a new device is “substantially equivalent” to another approved product already on the market start selling their version almost immediately.
Originally, the FDA implemented the 510(k) process to serve as an exception to the more rigorous PMA approval path. However, it’s become the standard path to market for most medical devices sold in the U.S. today. To compound this problem even further, devices similar to others also approved on the 510(k) pathway are now heading to market. That means the FDA 510(k) program releases medical devices to market that are similar to others recalled later for safety reasons (including killing patients). However, those dangerous device recalls don’t apply to similar products released via the FDA’s 510(k) pathway.
On July 20, 2018, Bayer said that due to extensive Essure complication reports from patients, it would pull the device off the market. And The Bleeding Edge‘s director, Kirby Dick, believes he and his team are, in part, responsible. After Bayer’s announcement, Dick responded, saying: “This is exactly why we do this work. This film has already changed policies and changed history.”
You May Qualify for Financial Compensation After Your Essure Removal
If you or someone you love needed surgery for Essure complication problems, you may qualify for compensation. To check your eligibility for a cash settlement, get your free Essure claim evaluation now. Once you’ve submitted your information, an experienced lawyer will call to discuss your case. This phone call is the first step towards getting the justice and compensation you deserve for Essure complication injuries.
Related: Essure Removal Tips for Women Considering Lawsuits
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.