Essure Lawsuits Filed By Women in France Mirror U.S. Complaints

As Bayer continues to face a growing number of Essure lawsuits in the United States, each involving allegations that women suffered severe and painful complications from the permanent form of birth control, the manufacturer is now also being targeted by women in France.

Essure is a medical device marketed and sold by Bayer Healthcare, which is designed to provide permanent birth control. It involves an out-patient procedure to implant coils in the fallopian tubes, which cause scar tissue to form and prevent pregnancy.

Two new lawsuits over the device were filed late last week in France, which is the second largest market for the Essure birth control implant, after the United States.

Growing questions have emerged in France over the risk of Essure procedure complications in recent months, mirroring concerns in the United States. In response, the French health ministry issued a statement recently suggesting that investigations indicate problems may be related to the way the device was implanted, as opposed to the design of the product itself.

According to a report published by Reuter’s Business Insider, the French ministry began investigating the Essure in July 2015, and had Bayer issue more specific instructions on how the devices should be implanted as a result.

The statement and recent lawsuits in France come after the FDA announced new Essure warning label changes last month in the United States, which include a “black box” warning, as well as patient checklist that must be given to women considering the permanent birth control, to ensure they understand the potential risk of complications.

The FDA warnings here do not indicate that the problem lies with implantation procedures, and the women who have filed lawsuits in France, like the growing number of claims in the U.S., say the problems lie with the design of the Essure itself.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer estimates that 70% of those have been implanted in women in the U.S. Women in France are the next largest population of Essure users, according to Bayer.

Bayer faces about 3,000 product liability lawsuits in the United States, and as Essure injury lawyers continue to review and file claims for women nationwide, it is expected that the size of the litigation will continue to grow over the coming months and years.

Each of the lawsuits raise similar allegations that an unreasonably dangerous and defective device was sold to women nationwide, indicating that Bayer failed to adequately report problems with the device to the FDA, doctors or consumers.