85% of Bayer Essure Adverse Event Reports Submitted Last Year Linked to Device Removal: FDA

Abdominal pain and bleeding were the two most frequently reported Essure adverse events, according to the FDA.

More than 3,700 Essure adverse event reports were received by federal regulators last year, even though the Bayer birth control implants were removed from the market in 2018, with the majority of the problems involving women who required removal of the sterilization device.

The FDA issued an update on Essure adverse event and product problem reports on March 14, as part of an ongoing program designed to evaluate the long-term risks and problems linked to the implant.

Essure was marketed by Bayer for years as a safe and effective form of permanent birth control, involving flexible coils inserted into the Fallopian tubes during an outpatient procedure, which is intended to cause scar tissue to develop that blocks the tubes and prevents insemination. However, the device was removed from the market in 2018, following thousands of reports involving painful and debilitating Essure complications.

Following Essure’s removal from the market, the FDA required Bayer to conduct extensive postmarketing surveillance of women who had received the implant, to get a better sense of the likely adverse health effects of the birth control device.

In this latest update, the FDA indicates it has received a total of 67,643 medical device reports linked to the Essure implant. While most reports received between 2013 and 2015 were voluntary submissions from women who received Essure implants, last year 98% of the 3,701 reports received by the FDA were submitted by Bayer. Of those, 85% were related to device removal, the FDA noted, and most were linked to litigation.

“The nature and severity of the reports in 2021 remain consistent with prior years,” The FDA update states. “In 2021, 63% of all submitted reports cited litigation.”

The FDA notes that some of those reports may be duplicates from previous years.

In February, the FDA issued the interim results of its second analysis of recalled Essure birth control implants, indicating that 1.9% of patients experienced perforation of the uterus, fallopian tubes or cervix.

According to the newly updated data, the most commonly reported problems from 2002 through 2021 were linked to abdominal pain, followed by reports of hemorrhage or menstrual irregularities. The next most common reports were of fragments of the Essure left in patients’ bodies and reports of perforation, respectively.

Bayer faced tens of thousands of Essure lawsuits filed by women who experienced adverse health effects while implanted with the birth control device.

After several years of litigation, the company announced in 2020 that it would pay $1.6 billion to settle about 90% of all Essure cases pending at that time. However, with approximately 750,000 women worldwide implanted with the device, and 70% of those Essure procedures occurring in the United States, it is expected that additional lawsuits will be filed in the coming years as women continue to experience complications.