31 July 2018

Netflix Documentary Targets Essure and other High-Risk Medical Devices

essure protests lawsuit

The Bleeding Edge is a new Netflix documentary focusing on how medical devices like Essure have harmed patients with serious side effects. The documentary features personal stories from patients who’ve suffered serious effects caused by the permanent birth control implant. Many of the women featured in the documentary believe Essure was rushed through the FDA approval process to turn a profit.

Putting a Spotlight on Essure

April Hicks, one of the women featured in the documentary is a mother of three who suffered through Essure’s side effects for five years. Hicks says she suffered from chronic back pain, hair loss in clumps and fatigue, emotional pain and physical pain. According to Hicks, one of the most frightening things was feeling like the doctors wouldn’t listen. Doctors hadn’t found the cause yet, but Hicks already knew her pain was caused by Essure.

The Essure device is comprised of metallic coils bound in synthetic fibers that are implanted in fallopian tubes to spur scar tissue growth, creating a barrier that prevents pregnancy. Hicks maintains that no one should have to endure the pain that she had to from her Essure implant. She soon learned that she was one of tens of thousands of women who’ve been hurt by the serious side effects associated with Essure.

Women Speaking Out Against Essure

A number of women featured in the documentary actually spoke out against Essure. They described their own experiences with Essure as involving crippling pain, persistent heart palpitations, crippling pain, fatigue, migraines and multiple trips to the ER. One of the women featured on the documentary works as an administrator for the Essure Problems Facebook group of nearly 30,000 members. The group has been leading a grassroots movement to get Essure off the market.

The FDA Gets Involved with Restricting Essure

In February 2016, the FDA began requiring Bayer to add box warning and patient checklist in order to sell Essure. Bayer was also ordered to continue conducting postmarket studies on the safety profile and effectiveness of Essure in real-world environments. The manufacturer says they sympathize with the patients who’ve had problems and will continue cooperating with the FDA.

Bayer told a local FOX syndicate that they recognized the FDA actions as an opportunity and path forward to gather more data and provide doctors with the tools for patient counseling. The manufacturer maintains that the FDA’s position is that the product is safe and effective for many patients, and eliminating it from the market would limit women’s options for birth control.

More Women Taking on Bayer and Essure

Many of the women in the documentary struggle to understand why the FDA was not more aggressive with Bayer over the serious side effects associated with Essure. A number of them felt let down by the agency and that they are being put at risk with dangerous devices like Essure available in US markets. The women on The Bleeding Edge were only able to relieve their pain by having their uterus removed.

These women say they will continue to fight to help prevent others from suffering unnecessary pain, stress, and additional surgeries. Ultimately, the women featured on the series strive to return to a state of normalcy after having the implant removed. In June, a judge ruled that a number of federal lawsuits against Bayer can move forward. The Bleeding Edge Netflix documentary premiered on July 27.


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