Hundreds lawsuits have been filed by women who used the Mirena IUD and developed brain injuries, such as Pseudotumor Cerebri (PTC) or Intracranial Hypertension (IH). These side effects can cause severe headaches or blindness.
What is Mirena?
Mirena is a type of contraceptive that is implanted in a woman’s uterus. It is a T-shaped piece of plastic that slowly releases levonorgestrel, a synthetic version of the hormone progestin that is used in many birth control pills. Mirena is more than 99% effective at preventing pregnancy, and it works by thickening the cervical mucous, preventing sperm from entering the uterus, and decreasing the thickness of the uterine wall. It works for up to five years.
Mirena Brain Injury Lawsuits
Bayer HealthCare is facing hundreds of lawsuits from women who developed severe brain injuries after taking Mirena. These women accuse Bayer of downplaying decades of evidence linking levonorgestrel, the hormone in Mirena, with the following side effects:
These conditions elevate levels of cerebrospinal fluid, which puts pressure on the brain. The most common symptom is a headache that worsens. Over time, it can also damage the optic nerve and cause vision problems, double-vision, papilledema, and blindness.
Mirena Lawsuits Centralized in Federal Court
In May 2014, attorneys asked federal judges to centralize the growing litigation. In 2017, the lawsuits were centralized in one federal court. The Mirena Multi-District Litigation (MDL) is overseen by U.S. District Judge Paul A. Engelmayer in the U.S. District Court for the Southern District of New York.
FDA Warning Letters for Mirena
In 2009, the FDA sent Bayer two warning letters due to misleading and incomplete information in their advertisements. The first warning letter was sent in March 2009. The FDA found that Bayer’s sponsored linked on internet search engines were misleading because they failed to communicate any risk information.
By law, advertisements for medical devices must include information about side effects. If they omit risk information (especially the most common side effects), they misleadingly suggest that the product is safer than has been demonstrated.
The second warning letter came in December 2009. This time, the FDA was concerned about a promotional video for Mirena. This program featured hosts who read from a script, and claimed that Mirena could improve their sex life, help them “look and feel great,” and improve quality of life. The FDA warned:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
Although the video made explicit claims that Mirena could help busy women have a more spontaneous sex life, the FDA warned that about 5% of women actually have decreased libido. Other Mirena side effects that could decrease quality of life include weight increase, acne, breast pain, bleeding, and more.