Essure Injury Lawyers

Bayer Will Discontinue Sales of Essure Birth Control Implant, 16,000 Essure Lawsuits Pending

July 20, 2018—Bayer announced that it finally is pulling its controversial Essure birth control implant from the United States market, a device that is subject to lawsuits or claims by more than 16,000 women who allege injuries as a result of the device. Many of the women sustained perforations of the uterus or fallopian tubes which they attribute to the device.

Women impacted by the device have campaigned for the FDA to recall and ban Essure, but the agency instead responded with a black box warning. A black box warning is the most serious warning available to the FDA and is reserved for medical devices with side effects that may cause serious injury or death. When the FDA announced the black box warning for Essure in 2016, it warned that Essure could travel into the abdomen and pelvic cavity, requiring surgical removal.

The FDA also required Bayer to limit sales of Essure to doctors and medical practices that agreed to fully inform women of the serious side effects and risks associated with Essure.

About Essure Birth Control

Essure is a metal implant that consists of two small coils comprised of a nickel alloy and fiber that is placed into the fallopian tubes and designed to create an inflammatory response that causes scar tissue to form, blocking the tubes. It was approved by the FDA in 2002 and since that time has been the subject of nearly 27,000 reports of adverse events.

When Bayer finally announced that it would suspend sales of Essure in the United States, it already had been pulled from England, Brazil, Canada, France and several other countries. In fact, the United States was the last market where Essure continued to be sold and implanted.