Why Am I Hearing About a New Study on Essure When It’s No Longer In Use?
I heard there's a new study about the Essure birth control device. I thought it was no longer being used. What's up?
You’re right. Essure is no longer available in the U.S. — but many women still have the device in place, and a study of the device, mandated by the Food and Drug Administration (FDA), is still going on. First, a little background. Essure is a permanent non-hormonal, non-surgical birth control method designed to be an alternative to tubal ligation. The device consists of two pieces of coiled metal that are inserted into the fallopian tubes through the cervix. Once implanted, scar tissue grows around the coils and, eventually, this tissue permanently blocks the fallopian tubes, which prevents sperm from connecting with an egg—and ultimately prevents pregnancy.
Essure was approved by the FDA in 2002. In fact, the NWHN testified at an FDA panel meeting, supporting its approval, in order to give women an alternative to surgical sterilization. But, in our testimony, we also cautioned that extensive follow-up studies were needed to determine exactly how effective Essure is, and whether its use creates any unexpected risks. The FDA agreed, and required the manufacturer to follow clinical trial participants for five years, among other conditions. Sadly, the company’s follow-up wasn’t adequate and no useful results were reported, leaving women who used Essure in the dark about what to expect.
A grassroots movement of women who believed that they had been harmed by Essure eventually forced the FDA to re-consider the device’s safety and effectiveness. Thousands of Essure users described experiencing serious problems, including pelvic pain, autoimmune and neurological disorders, and even uterine rupture. In response, in 2016, the FDA required the device manufacturer to undertake a long-term study comparing the experience of women who received Essure with that of women who choose to be sterilized through surgery.
Bayer, Essure’s manufacturer, began the study as required, but stopped distributing the Essure device in December 2018, after facing mounting pressure from lawsuits, proposed legislation, and the continued activism of women who were unhappy with their device.
On July 6, 2020, almost 20 years after its approval, the first interim results of the long-term study were released by the FDA. The results confirmed what women who received Essure had been saying all along: the device is far more likely to cause pelvic pain and bleeding than surgical sterilization. According to the FDA, nearly 20% of the women who received an Essure device either had it removed within the first 3 years of use, or underwent an invasive procedure to treat heavy bleeding (endometrial ablation). The FDA also calculated that twice as many women with Essure implants had pelvic pain compared to women who underwent surgical sterilization (9% vs. 4.5%, respectively). Early data indicate that reports of autoimmune conditions are also more common in women using Essure, although those reports have not yet been fully analyzed.
The FDA-mandated Essure study confirms the critical importance of doctors respecting women's knowledge of their own bodies. Thousands of women — many of whom were treated dismissively by their doctors — experienced chronic and severe pain after receiving an Essure implant. We hope that the study’s interim results will help women get respectful and appropriate treatment from their doctors if they experience Essure-related complications.
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Evita Almassi, MSW, served as the Communications and Digital Marketing Manager for the NWHN. Her 10+ years in nonprofit communications – especially with social media advocacy campaigns – enabled the NWHN to reach and empower more women in their health education and advocacy journeys.
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