The women who advocated against Essure initially organized on social media, partnering with… [+] attorneys and a group of physicians who supported their concerns.
Courtesy Amanda Dykeman
It’s the end of an era for Amanda Dykeman, one of the many women who has campaigned against the permanent contraceptive device Essure. Bayer, the device’s manufacturer, announced earlier this week that they will no longer sell or distribute the device in the US after Dec. 31 this year. The move comes after years of debate — both in court rooms and in the court of public opinion — about the safety of the device.
Essure is a permanent form of birth control approved by the FDA in 2002 for women ages 21-45. It consists of a pair of soft, nickel-titanium coils that providers insert into each of the Fallopian tubes. The coils cause scar tissue to grow around them, thereby blocking the Fallopian tubes so that eggs cannot reach the uterus.
Bayer continues to stand by the safety of the device, and many OBGYNS feel confident about the safety profile of the device based on the research Bayer has conducted. But complaints from women about the device have continued to pile up.
One of the leaders of those women was Dykeman, whom I profiled in an NPR article about Essure almost exactly three years ago. At the time, she was gratified that the US Food and Drug Administration had decided to take another look at the safety of the device after thousands of women complained of chronic pain and a range of other problems they said the device caused.
“I no longer feel like I chose Essure. Essure chose me,” Dykeman said this week. “This path to justice I’ve been on has taught me so much and I can’t wait to share it with others. I’ve learned a lot about researching medical devices over the years, and I am making it my life’s mission to share that knowledge in the hopes that next time it won’t take as long for the next generation of advocates to get a dangerous medical device pulled from the market.”
That path led the FDA to require a post-market study on Essure’s safety in February 2016, along with the addition of a black box warning on the device and a Patient Decision Checklist to be sure women understood the device’s risks and benefits.
For Dykeman and her fellow “E-sisters,” more than 37,000 women in a Facebook group who supported one another and shared the problems they experienced, that wasn’t enough. They continued to push for stronger regulatory action against Bayer, and in April 2018, the FDA restricted the sale and distribution of the device “to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions.”
“The device has been associated with serious risks including persistent pain,
