USA – FDA provides updates on postmarket safety review of Bayer’s Essure

Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday provided an update on the ongoing postmarketing safety review of the device.

“Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.

Background

In February 2016, FDA announced it would require a new Section 522 postmarketing study and a boxed warning for Essure following thousands of complaints from patients that the device caused abdominal pain, menstrual irregularities, headache and fatigue, and in some cases unplanned pregnancies and miscarriages.

In July 2018, Bayer announced it would discontinue sales and distribution of Essure in the US at the end of the year, following the company’s decision to pull the device from international markets in 2017. In its announcement, Bayer cited declining sales as the reason for discontinuing sales of the device and said it stood by the product’s safety and efficacy.

In response to the company’s decision to end sales of the device, FDA announced changes to the ongoing postmarketing safety study as Bayer struggled to reach the study’s sample size.

FDA also said that the study will follow women for five years rather than the three years the study initially called for, and will feature additional blood testing in an effort to better understand patients’ immune reactions to the device…