Bayer Healthcare introduced the Mirena IUD in 2000, with U.S. Food and Drug Administration (FDA) approval. The Mirena IUD was marketed as a stress-free form of birth control with a five-year life span.

An IUD is a small, T-shaped device inserted into the uterus by a healthcare professional. Once inserted, it releases a synthetic hormone (levonorgestrel, a progestin) into a woman’s system. IUDs have traditionally been known as a safe, effective, and long lasting method of birth control. However, they can have some severe side effects.

Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena complications. Regular side effects can include pelvic or abdominal pain and heavier bleeding for a few weeks after insertion. These reports traditionally include migration and perforation, going far beyond the realm of expected side effects, and now another side effect has joined the ranks – Mirena brain injury.

Recently, reports have been filed connecting Mirena to Idiopathic Intracranial Hypertension (IIH), also known as pseudotumor cerebri (PTC) as the condition’s symptoms can mimic an actual tumor. The link is presumed to be the hormone Mirena uses, as the FDA has controlled other products containing levonorgestrel, like the birth control implant Norplant. That packaging includes warnings of IIH risks, but Mirena’s does not.

IIH is a new area of litigation for Bayer Pharmaceuticals, the drug’s manufacturer. Mirena has over 2 million users in the United States, and currently around 2,000 product liability lawsuits pertaining to migration and perforation injuries. Now, as “Plaintiffs speculate that it is this hormone that results in a build-up of spinal fluid and puts pressure on the brain and optic nerve, resulting in IIH,” a new wave of Mirena IUD lawsuits may be on the horizon.

Pseudotumor cerebri (PTC) is a neurological disorder characterized by increased pressure around the brain unrelated to a tumor. The pressure, caused by elevated levels of spinal fluid, can mimic side effects an actual tumor may cause, like headaches, nausea, tinnitus and issues with vision.

Symptoms may appear as follows:

• The most common symptom of PTC is a “throbbing” headache, which can be associated with nausea. Generally, they are at their worst in the morning hours.
• Tinnitus, often classified as a ringing in the ears. Sufferers will often hear and feel a “whooshing” that coincides with their pulse.
• Vision issues, like double vision or blurred vision, can occur from fluid pressure on the optic nerves. If the pressure is not relieved, victims can experience temporary blindness, and if not treated, the risk of permanent blindness.

All symptoms, if not treated, can worsen and may cause permanent damage, so it is important for any Mirena user with these symptoms to contact her doctor. A brain scan is often called for to rule out any other potential ailments, like a tumor or blood clot. If diagnosed as PTC, treatment options range from medication to surgery to help alleviate pressure.

The cause of PTC is unknown. It can only be diagnosed “if there is no alternative explanation for the symptoms.” It can happen in all age groups, but is most often found in women from 20-40 years of age. Women who suffer from obesity are at higher risk for the condition. A number of other elements may increase the risks as well, including levonorgestrel, the progestin used in the Mirena IUD.

In the case of women who allege developing pseudotumor cerebri while using the Mirena IUD, levonorgestrel appears to be the only shared risk factor present.