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.
In November 2016, the FDA issued a new labeling requirement for Essure and other permanent birth control implant devices. The guidelines require a patient checklist to prevent some of the listed side effects from occurring. They also require a boxed warning on the label to ensure that consumers read the side effects and instructions for the device. The FDA has also mandated a new study to investigate the apparent problems associated with permanent birth control implant devices.
Although many have alleged that Bayer engaged in clinical trial misconduct associated with the Essure device, the FDA indicated that it conducted a review and concluded that Bayer did not engage in any manipulation of the testing or test results.
If you or a loved one has suffered injuries as a result of a permanent birth control device, you may be entitled to compensation. At Moll Law Group, our Essure lawyers have assisted many women and their families across the United States with investigating their potential claims, including clients in Texas, New York, and California. Understanding your rights, whom you should name in your lawsuit, and whether you have gathered the appropriate evidence to support your claim may be daunting. We can assist you with every step of the process and ensure that your rights are protected along the way. To set up your free consultation, call us now at 312-462-1700 or contact us online.