The Mirena intrauterine device (IUD) has been linked to development of pseudotumor cerebri (PTC), a debilitating condition caused by an accumulation of cerebrospinal fluid in the skill. The fluid causes increased pressure on the optic nerve and results in symptoms such as:
- Migraine-like headaches
- Vision problems such as blurred or double vision
- Temporary blackouts
If pseudotumor cerebri goes untreated or is not treated promptly, the pressure and damage to the optic nerve can be irreversible and can even cause permanent blindness. The Mirena IUD contains the synthetic hormone levonorgestrel, which is released daily to prevent pregnancy. This hormone has been linked to PTC and papilledema for many years.
What is Mirena?
Mirena is a type of long-lasting, reversible birth control known as a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. The Food and Drug Administration approved Mirena, one of only two hormonal IUDs approved for use in the U.S., in 2000. In 2009, the FDA expanded Mirena’s use to include the treatment of heavy menstrual bleeding in women already using IUDs.
Globally, the IUD is the most popular form of reversible birth control, with an estimated 150 million users. In the U.S., the popularity of IUDs is growing, and in 2011, the devices made up about 10.4 percent of the contraceptives issued by doctors, up from 1.4 percent in 2002. The reasons for Mirena’s growth in popularity are simple:
- Mirena can protect against pregnancy for up to five years and is more than 99 percent effective in controlling pregnancy
- Mirena is more convenient than most oral contraceptives because once implanted, there is no need to take a daily pill
- Mirena has a failure rate of less than one percent, while oral contraceptives can have a failure rate as high as 30 percent if they are not taken properly
Plaintiffs pursuing Mirena Lawsuits against the device’s maker, Bayer, allege that Bayer failed to warn of the increased chance of developing papilledema and PTC. The lawsuits also charge that Bayer failed to test Mirena properly to learn of the potential risk and the company failed to notify doctors that patients who have PTC and use levonorgestrel-releasing implants like Mirena should consult with their doctors and have the IUDs removed as soon as possible to avoid further injury.