The FDA has sent a Warning Letter stating that Bayer "overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risk of using Mirena, and includes false or misleading presentations regarding Mirena."Request More Information
Mirena is an IUD (intrauterine device) manufactured by Bayer Corporation. The device is T-shaped contraceptive device that inserts into the uterus to prevent fertilization. Bayer’s website states “there’s no single explanation for how Mirena may work”. but that it “most likely” works in one of several ways: thickening cervical mucus to prevent sperm from entering the uterus; inhibiting sperm from reaching or fertilizing the egg; thinning the lining of the uterus.
Mirena also releases small amounts of releases small amounts of levonorgestrel, a progestin hormone found in many birth control pills, locally into the uterus at a slow and steady rate. According to Bayer, some combination of these likely accounts for the product’s efficacy in birth control.
Mirena was approved by the FDA in 2000 for contraception and in 2009 for heavy menstrual bleeding. Bayer markets Mirena as a safe and long-term reversible form of birth control. However, Bayer may have sold the device without fully and properly warning women about its risks, which include:
- Perforation of the uterine wall
- Migration of the IUD to organs outside of the uterus
- Pelvic Inflammatory Disease
- Expulsion of the IUD
On January 14, 2012, the FDA sent a Warning Letter to Bayer concerning its live consumer directed program. The letter explains that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risk of using Mirena, and includes false or misleading presentations regarding Mirena.” Mirena’s product information warns about the migration or perforation of the IUD during the insertion time period but does not warn that these risks can occur throughout the entirety of the product’s 5-year life span.
If you or a loved one has suffered complications as a result of a Mirena IUD, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal.