Dozens File Essure Lawsuit Over Birth Control Implant Complications

A group of 60 plaintiffs from 21 different states have joined in a lawsuit against Bayer Healthcare, alleging that complications from Essure birth control implants caused a variety of severe injuries and health problems. 

The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Pennsylvania on September 5, indicating that the manufacturer withheld information from consumers, doctors and regulators, failing to disclose serious risks associated with their permanent birth control device.

Most of the plaintiffs were women who received the implant, but a number of husbands with loss of consortium claims were included as well.

Essure procedures involve the placement of coils in the fallopian tubes, which cause scar tissue to form and prevent pregnancy. However, thousands of women have suffered painful injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications.

“(T)he device is intended to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage,” the lawsuit states. “However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.”

The lawsuit points out that the FDA repeatedly warned and sanctioned Bayer over the manufacturing of the Essure implants and for failing to report injuries and adverse events to the agency. The lawsuit notes that on May 30, 2013, the FDA found an internal spreadsheet containing 16,047 entries of complaints that Bayer failed to properly report.

Bayer defended its actions by alleging that all of the complains involved patients who were not experiencing pain at last contact, calling their injuries “mere trivial damage.”

The lawsuit came right about when Bayer announced it was halting sales of the Essure implant all over the world…except in the United States. The company claimed that the decision to stop selling Essure was a marketing decision and not related to the numerous complaints of adverse events.

In November 2016, following controversial hearings in the U.S. involving testimony from women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry. The agency also required that women be provided with a checklist to make sure they are aware of the risks before undergoing an Essure coils procedure, and many medical experts suggest that no woman should elect to undergo the sterilization.

Bayer currently faces Essure lawsuits brought on behalf of about 3,700 women in the United States, alleging the manufacturer has known about the serious risks and failed to adequately warn women and the medical community.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.