The Mirena IUD, a contraceptive device manufactured by Bayer Healthcare, has been implicated in neurological disorders among women who use it. Law firms across the country are now investigating claims from women who have experienced these Mirena IUD side effects, which include a condition known as pseudotumor cerebri.

Since December of 2016, over 850 lawsuits have been filed and consolidated into multidistrict litigation (MDL) before the U.S. District Court for the Southern District of New York.

What is the Mirena IUD?

The Mirena Intrauterine Device was first granted FDA approval in 2000. Part of a class of of medical devices known as “hormonal IUDs,” they are indicated primarily for the prevention of pregnancy. They may also be prescribed for women who experience abnormally heavy menstrual flow or are undergoing estrogen replacement therapy.

Generally regarded as being among the most effective forms of contraception, according to the Global Library on Women’s Medicine, hormonal IUDs are effective for between three and seven years, and have a failure rate of approximately 0.2 percent.

The Mirena product releases a hormonal medication known as levonorgestrel , which is also used in the “morning after” pill as an emergency contraceptive. Levonorgestrel is a synthetic form of progesterone, a hormone involved in the reproduction cycle of mammals; administered artificially, it essentially “tricks” a woman’s body into reacting as if she were already pregnant, thus preventing the sperm from attaching itself to the egg.

What Are Mirena IUD Side Effects?

Common side effects of levonorgestrel itself include breast discomfort, abnormal or painful menstruation, diahrrea, fatigue, headaches and nausea. In the case of the Mirena IUD however, some women have experienced more serious symptoms that affect the brain, according to the Columbia University Department of Neurology.

Also known as idiopathic intracranial hypertension, pseudotumor cerebri (PTC) is a condition that causes the pressure inside the skull to increase, mimicking symptoms of a brain tumor when no malignancy is present. While medical science is unclear as to why or how this happens, available evidence suggests that it is caused by a buildup of cerebrospinal fluid (CSF) in the bloodstream. Normally, risk factors include obesity, certain medications such as tetracycline and growth hormones, excess vitamin A, and co-morbidities such as anemia, kidney disease and sleep apnea.

Normally, CSF acts as a cushion for the brain, cushioning it from shocks; it also plays a significant role in the healthy nervous system function. However, excess amounts built up in the skull can lead to vision problems (including temporary blindness), tinnitus (ringing in the ears), dizziness, nausea and vomiting and pain in the neck, shoulder and back.

How Common are Mirena IUD Side Effects?

Since the Mirena IUD came on the market nearly two decades ago, the FDA has received over 95,000 adverse event reports related to the device; of all IUD currently approved for sale, the Mirena has generated the highest number of complaints. Approximately one-third of those reports involve pseudotumor cerebri; other women have reported the device falling out of place and heavy bleeding.

Has The FDA Taken Action?

Neither the FDA nor Bayer Healthcare have addressed the issue of Mirena IUD side effects; adverse event reports are reviewed however. Women who suffer from Mirena IUD side effects can report the problems directly to the manufacturer or to the FDA via the MedWatch web page.