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A joint lawsuit has been filed on behalf of a group of 70 women, indicating that they all suffered painful and debilitating injuries from Essure birth control coils, including organ punctures and other problems that occurred when the sterilization device shattered or migrated out of position.
The complaint (PDF) was filed late last month in the U.S. District Court for the Eastern District of Pennsylvania, pursuing damages against Bayer for selling an allegedly defective and unreasonably dangerous product.
Essure is designed to provide permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, thousands of women have experienced serious complications when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.
The lawsuit comes amid renewed regulatory concerns over the device, as the FDA recently confirmed that it received at least 12,000 adverse event reports last year involving the Essure, with many of those involving migration injuries, punctured organs and problems removing the device, which is a potentially new problem that the agency is now investigating.
It also comes after Bayer announced it was halting sales of the Essure implant all over the world last year, 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.
Last month, a group of women met with FDA Commissioner Scott Gottlieb, calling for an Essure recall in the U.S. as well.
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.
This latest lawsuit indicates that those prior efforts to warn about the Essure risks came too late for many women.
“Had the Defendants complied with their federal regulatory duties and their duties under state law by reporting the known risks and complications in a timely fashion, the Plaintiffs and their physicians would have had this relevant, critical information available to them prior to the implant of the Essure device,” according to the lawsuit.
The case 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.