Additional Injuries And Deaths Related To Essure Reported

Additional Injuries And Deaths Related To Essure Reported

Introduction

On March 15, the U. S. Food and Drug Administration (FDA) issued an update on the ongoing analysis of serious injuries and problems linked to Bayer’s birth control device Essure, indicating that around 12,000 injury reports and at least nine deaths were recorded as of November 2020.

The analysis is based on the summarized data of the reports identified between September 2020 through November 2020 by the manufacturer. The report included a total of 11,884 reportable events out of which 11,830 were serious injury reports, 45 were malfunction reports, and 9 were death reports.

The most common patient problems reported were pain, perforation, foreign body/device fragment in the patient, pregnancy (including ectopic), heavier periods (menses/hemorrhage), and hypersensitivity.

Essure was developed by Conceptus Inc., a subsidiary of Bayer AG, and was used for permanent surgical sterilization in women. The device was suspended from the market in most countries since 2017, after receiving thousands of adverse event reports, which included perforation of the fallopian tube, neurological damage, severe pain, and even deaths.

The manufacturer continued to sell the device in the U.S. until the end of 2018, and in July 2018, it announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and report problems associated with the device.

Since 2002, it is estimated by Bayer that 750,000 women have received the birth control device, and 70% of those procedures happened in the U.S.

Last year, in August, Bayer officials had announced that the company reached an agreement with plaintiff law firms to pay approximately $1.6 billion to settle nearly 90% of all the lawsuits, including the cases filed in the state of California Joint Council Coordinated Proceedings (JCCP) and the cases pending in the Federal District Court for the Eastern District of Pennsylvania (EDPA).