Essure Organ Perforation Experienced By One Out of Every 50 Women Receiving Sterilization Device, FDA Interim Analysis Finds

The analysis comes from postmarketing surveillance data on Essure recipients, which was required by the FDA after Bayer pulled the birth control implant from the market in 2018.

Federal regulators have issued an update regarding the ongoing analysis of long-term complications with Essure birth control implants, indicating that one out of every 50 women who received the permanent sterilization device suffered unintentional perforation of internal organs.

The U.S. Food and Drug Administration (FDA) issued interim results from its second analysis of the recalled Essure birth control implants, finding that 1.9% of patients experienced perforation of the uterus, fallopian tubes or cervix.

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.

Bayer issued a final analysis report of Essure adverse event data in September 2021, indicating it was aware of nearly 60,000 reports involving serious injuries, nearly 600 reports of Essure malfunctions and at least 115 deaths.

The FDA has continued to analyze that data, with the most recent results involving an analysis of all patients who completed one year of follow up in the postmarket surveillance study.

“As of the 2021 interim analysis, the overall adjusted incidence of patients with unintentional perforation of the uterus, fallopian tubes or cervix by any surgical instrument or sterilization device remains 1.9% (5/264) in the Essure group,” the FDA analysis found. That compares to only 1.1% among patients who underwent laparoscopic tubal sterilization (LTS).

The FDA indicates the perforation incidents occurred either due to migration of the Essure implant, or due to surgical instruments used during its implantation or removal.

The agency also found that about 0.4% of Essure recipients experienced implant expulsion, which was not experienced by any in the LTS group.

The next interim analysis will come when patients have completed three years of follow-up, according to the agency.

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.