Essure is a permanent birth control device approved by the FDA in 2002 that is implanted into the fallopian tubes to prevent pregnancy.
The FDA has received reports of more than 9,000 removals of the device since 2009 due to complications including bleeding, pain, miscarriages, hysterectomies, fetal deaths and unwanted pregnancies.
About 39,000 claims have been filed against the device, and Bayer’s $1.6 billion settlement resolves roughly 90 percent of them, the company said. Bayer is in discussions to resolve the remaining claims, and other terms of the settlement are confidential.
The settlement includes no admission of wrongdoing or liability by Bayer, and the company said it still stands by the device.
“Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure,” Bayer said.
In 2016, the FDA placed a box warning on the device, and in 2017 patient advocacy groups called on the FDA to take action against the device as more women reported being harmed by it. In 2018, the FDA restricted the sale of the device to only healthcare providers that would offer information about the device’s risks and benefits to patients.
Bayer pulled the device from the U.S. market in 2018, but said its decision was because of a decline in sales rather than due to adverse event reports from women with the device.
Read Bayer’s full news release here.
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