After thousands of complaints were filed with the FDA over Bayer HealthCare’s permanent contraceptive device Essure, 11 lawsuits filed by 14 women have been allowed to progress in California state court. Plaintiffs’ firm Grant & Eisenhofer, one of the firms representing the women in these cases alleging Bayer failed to warn of the risks associated with Essure, recently obtained three favorable rulings from the court. The first and most significant ruling of the three confirmed Bayer’s liability to maintain and update labeling and safety information with the FDA after the initial approval of Essure—updates that hadn’t been communicated even after Bayer received thousands of adverse event reports regarding the device.
Though Essure bears a “black-box” warning, the strongest FDA-mandated caution, it continues to be implanted in women today—often leading to side-effects such as pregnancy, perforation of the uterus or other organs, migration of the device or its components, severe menstrual cramps and even death. “We believe that Bayer concealed from patients and the public the magnitude of risk associated with Essure, and that thousands of women suffered needless pain as a result of being deprived of vital information regarding the safety of this product,” said Grant & Eisenhofer Director Elizabeth Graham.
If you or a loved one suffered complications after receiving an Essure implant, please contact us by submitting the form or by calling us at 888-985-7228 for a confidential evaluation of your potential claim.