Bayer has permanently withdrawn its Essure permanent contraceptive device from the European Union, the Federal Agency for Medicines and Health Products reported. The company said the decision to withdraw the product was not related to health or safety issues.
Separate European states began to withdraw the device from the market last year. Some patients implanted with the device reported adverse events such as perforation of the uterus and fallopian tubes, persistent pain or hypersensitivity or allergic reactions. In addition, some reported hair loss, depression and mood changes, among other side effects.
Women implanted with the device may continue to use the device, and preventive removal is not necessary for women not presenting any symptoms, FAMHP said.