Mirena is an intrauterine device (IUD) that has been linked to a rare brain disease that can cause chronic headaches and blindness. Over 100 lawsuits have been filed by women who accuse Bayer of failing to warn about these risks.
Overview
Mirena is a type of birth control known as an intrauterine device (IUD). Mirena is sold by Bayer HealthCare and it was approved by the FDA in 2000. Since then, more than 2 million woman have used Mirena. It is more than 99% effective at preventing pregnancy for up to five years.
How Does Mirena Work?
Mirena is inserted into a woman’s uterus (womb), where it slowly releases levonorgestrel (a synthetic version of the hormone progestin). It thickens cervical mucous, which helps prevent sperm from entering the uterus. It also makes the lining of the uterus thinner, which reduces the chances that a fertilized egg will implant and grow.
Brain Injuries Linked to Mirena
In early 2014, Bayer was hit with nine lawsuits accusing them of downplaying risk information about brain injuries from Mirena, including:
- Idiopathic Intracranial Hypertension (IIH)
- Pseudotumor Cerebri (PTC)
- Benign Intracranial Hypertension (BIH)
Over 100 Mirena Brain Injury Lawsuits
Attorneys petitioned a panel of federal judges to centralize the litigation in May 2014. However, in August, the judges denied the petition because there were only 9 lawsuits. The number of lawsuit has grown substantially since then. In December 2016, with at least 116 lawsuits in 17 district courts nationwide, lawyers filed another request to centralize the lawsuits in one court.
FDA Warning Letters for Mirena
In December 2009, the FDA sent a Warning Letter (PDF) to Bayer due to a promotional program for Mirena. The marketing program featured parties hosted by experts who claimed that Mirena could help a woman “look and feel great,” improve a woman’s sexual relationships, and quality of life. 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.”
The FDA also pointed out that many women do not “feel better.” In fact, about 5% of women who use Mirena actually reported a decrease in libido, which could potentially harm sexual relationships.
Failure to Warn About Side Effects
The FDA also sent Bayer a Warning Letter (PDF) in March 2009. This time, the FDA was concerned that Bayer’s sponsored links on internet search engines are misleading because they make representations and/or suggestions about the efficacy of Mirena, but fail to communicate any risk information.
By law, advertisements for drugs and medical devices must include risk information. By omitting important risk information, including the most frequently occurring risks and side effects, the ads misleadingly suggest that Mirena is safer than it really is. By August 2013, the FDA had received over 70,000 reports of adverse events associated with Mirena.
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