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Dozens of Australian women are expected to file a class action lawsuit over Essure birth control complications, alleging that Bayer failed to adequately warn about the risk of painful and debilitating complications associated with the device, which has now been removed from the market in multiple countries.
Several news organizations in Australia report that the Essure class action lawsuit will be filed against Bayer before the end of the year, joining thousands of similar claims pending against the manufacturer of the birth control implant in the United States and other countries. The claims all raise similar allegations, indicating that women who had the device implanted to provide permanent protection against pregnancy were left with devastating injuries, after the device migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.
Essure was introduced as a form of permanent sterilization that can be accomplished through an outpatient procedure, where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, lawsuits allege that the design was not adequately tested or researched, and thousands of women indicate that they have experienced complications.
Women in Australia indicate they suffered allergic reactions to nickel used in the Essure coils, which was exacerbated when the devices corroded, broke, or migrated out of position, puncturing organs and causing other damage.
Australia was the first country to recall Essure from the market, with Australian health officials announcing that the implant would no longer be sold in that country in August 2017. A month later, Bayer announced it was removing Essure from the market in every country except the United States.
Bayer finally announced it would remove Essure from U.S. markets last month, just days before a scathing documentary, called “The Bleeding Edge began”, began streaming on Netflix. The documentary highlights the Essure risks and problems with a number of new medical devices, and raising questions about whether adequate testing and research was conducted before they were aggressively marketed to patients.
In the U.S., Bayer currently faces several thousand Essure lawsuits brought on behalf of women who have been left with devastating injuries, each raising similar allegations that the company manufactured and sold an unreasonably dangerous and defective sterilization product, withholding information about the risks associated with the procedure.
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.