FDA Warning on Mirena IUD
FDA Warns of Dangerous Side Effects
Mirena FDA warning was issued to the drug’s manufacturer, Bayer HeathCare Pharmaceuticals. The Mirena FDA warning documented the health complications associated with Mirena. The Mirena FDA warning also addressed the overstatement of efficacy, unsubstantiated claims, and misleading statements used in Mirena advertising. The Mirena FDA warning also requested that Bayer immediately cease to disseminate the promotional materials that violated FDA regulations.
The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.
The Mirena FDA warning cites a direct contradiction regarding Mirena compliance routines. According to the Mirena FDA warning, the program script specifically noted that Mirena “has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.” However, the Mirena FDA warning cites that it is recommended for Mirena patients to receive an examination 4 to 12 weeks after Mirena insertion, as well as once a year afterwards. Additionally, Mirena users are advised to check that the device’s threads are in place following each menstrual cycle, which equates to a monthly basis.