French Women File Lawsuit Against Bayer for Damages Associated with Essure Contraceptive Device
Medical device manufacturers make products that are sold all around the world. Although most of the lawsuits we read about regarding medical devices involve American plaintiffs, there are some instances in which foreign individuals sue U.S. manufacturers abroad for damages they sustained as a result of the defendant’s products. Recently, two French women filed a lawsuit against Bayer, alleging that they sustained damages as a result of using the company’s Essure contraceptive implant device.
The Essure device is comprised of a small metal coil that a doctor inserts in the fallopian tubes by using a catheter. According to the U.S. Food and Drug Administration (FDA), during the 13 years since the Essure device was approved, the FDA has received over 5,000 complaints regarding the device. These complaints describe a wide variety of side effects, including breakages of the device, severe pain, and menstrual irregularities. Other complications include intra-abdominal or pelvic migration of the device, irregular bleeding, and complications requiring the women to undergo surgical procedures to have the device removed. There were also some reports indicating that the patient experienced an unintended pregnancy, depression, uterine perforation, and dizziness. Sources indicate that some 120,000 women in France obtained the device during the last 14 years.
In their complaint, the plaintiffs are requesting an expert to determine the relationship between the damages that they are experiencing and the device. In response to the women’s lawsuit, the French Health ministry stated that the problems that the women experienced may have been a result of the methods that the physicians used to insert the device rather than an issue with the device itself. Still, this could result from the manufacturer’s failure to provide appropriate instructions on how to implant the device, or it could be the result of malpractice on the physicians’ part.