Essure Lawsuit Filed On Behalf of More Than 100 Plaintiffs

A group of more than 100 individuals have joined in a recent product liability lawsuit filed over complications following Essure procedures, alleging that Bayer Healthcare sold a defective and unreasonably dangerous device for permanent birth control. 

The joint complaint (PDF) was filed in the U.S. District Court for the Eastern District of Pennsylvania on January 8, indicating that women from more than two dozen different states have experienced similar injuries from the Essure device, which has been pulled off of the market across most of the world, but is still marketed in the United States.

Essure is designed to provide permanent sterilization, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, thousands of women have experienced painful and debilitating injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications.

“In short, the device is intended to cause bilateral occlusion (blockage) of the fallopian tube 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 comes about three months after 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., where testimony was heard from large numbers of 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.

The complaint filed on behalf of more than 100 plaintiffs is one of a growing number of  Essure lawsuits filed in recent months, each raising similar allegations that 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.