Mirena is an intrauterine contraceptive (IUD) that has been linked to a rare brain disorder. Hundreds of lawsuits have been filed by women who were diagnosed with Pseudotumor Cerebri (PTC) or Intracranial Hypertension.
What is Mirena?
Mirena is an intrauterine contraceptive device (IUD) manufactured by Bayer. It was approved by the FDA in 2000 to reduce the risk of pregnancy for up to five years. Mirena is also approved to reduce menstrual bleeding. Approximately 2 million women use Mirena in the United States.
Mirena Brain Injuries
- Idiopathic Intracranial Hypertension (IIH)
- Pseudotumor Cerebri (PTC)
- Benign Intracranial Hypertension (BIH)
FDA Warning Letters
The first warning letter was sent on March 29, 2009. The FDA was concerned that online advertisements were misleading because they “fail to communicate any risk information.”
The FDA sent Bayer another warning letter on December 30, 2009. The FDA was concerned about promotional materials Bayer created with Mom Central, an online social networking website. According to the FDA:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act. ”
In May 2014, lawyers for nine women with PTC or IH asked federal judges to consolidate their cases in a Multi-District Litigation (MDL) in one federal court. The judges refused because there were not enough lawsuits. Over the next two years, more than 100 additional lawsuits were filed. By December 2016, with 116 Mirena brain injury lawsuits pending in 17 district courts, lawyers asked judges again to create a MDL.