Mirena is a birth control device known as an intrauterine device (IUD). The device, which is manufactured by Bayer, was approved by the U.S. Food and Drug Administration (FDA) in 2000. The Mirena device is placed in the uterus where it releases hormones intended to prevent pregnancy for up to five years. 

Though it’s advertised as “one of the most effective forms of birth control” on the Mirena website, it is associated with a number of concerning health side effects, including pseudotumor cerebri (PTC). Those who use the Mirena IUD should be aware of symptoms of pseudotumor cerebri in adults. 

About Mirena

Long-term birth control option Mirena is a small t-shaped device that is made from biologically safe plastic, which is directly implanted into the uterus of the patient. A hormone called levonorgestrel is released from the device, which stops the patient from ovulating and prevents sperm-to-egg fertilization. Ideally, this device would be a hassle-free birth control method that would last up to five years.

Rewire says that Bayer estimates that Mirena is the most-prescribed IUD in the United States. Reportedly, two million people use it worldwide. A large number of them reportedly complain of Mirena side effects.

Mirena and Organ Perforation

More than 70,000 adverse events reports have been filed with the FDA since the Mirena IUD’s release in 2000, with a significant portion of them indicating device perforation and migration.

In a surprising development in Mirena IUD side effects, 1.4 out of every 1,000 women who have used the Mirena IUD at some point in their lives may be at risk for organ perforation, but new research suggests breastfeeding may be a contributing factor due to how the device compromises the mother’s pelvic region.

In a past issue of the medical journal Contraception, German researchers had observed the side effects women endured in Europe while using the Mirena IUD. 

The study was conducted at the ZEG-Berlin Center for Epidemiology and Health Research, and observed over 60,000 women from six different European countries that had completed surveys after using either a levonorgestrel-releasing intrauterine systems (LNG-IUSs) like the Mirena, or a copper IUD like the ParaGard, for a year.

The results showed that approximately 1.4 per 1,000 women who were implanted with LNG-IUDs like the Mirena had suffered organ perforation, while 1.1 per 1,000 women implanted with the copper IUD experienced organ perforation.

But in an interesting twist, the researchers observed that breastfeeding significantly increased the risk of organ perforation. A total of 81 perforations were observed during the study, and 63 of those women confirmed to be breastfeeding.

“Breastfeeding at time of insertion was associated with a sixfold increase, with no differences between LNG and copper IUD users,” the researchers determined.

After the study was published, Bayer Pharmaceuticals sent out a press release addressing the study. The company stated that they condone the research, as it was an important part of the European Active Surveillance Study for Intrauterine Devices, which was meant to confirm that the safety profile for the IUD systems.

This study was conducted due to the immense concern of device perforation and migration of the patient’s uterus, after numerous women complained of suffering this occurrence and its lasting side effects after using the Mirena IUD.

Mirena Organ Perforation Lawsuits

Currently, Bayer Pharmaceuticals is facing thousands of Mirena IUD lawsuits from women across the United States, each alleging that they suffered various Mirena side effects from the birth control device. Thousands of women claim that the device had perforated and migrated away from their uterus soon after it was implanted, resulting in varying degrees of internal injuries.

In many of these cases, the women started suffering Mirena IUD side effects years after the device was first implanted, with minor cases of cramping to severe events like ectopic pregnancies. Bayer has tried to argue against these Mirena lawsuits, stating that device migration would only be seen soon after the device was implanted and that medical error by a physician was to blame, rather than the product itself.

Multidistrict litigation (MDL) has been established under U.S. District Judge Cathy Seibel in the Southern District of New York, to centralize the similar lawsuits. The Mirena MDL was established to avoid conflicting rulings from different judges, to reduce the chances of duplicate discovery, and to further serve the convenience of the parties.

Mirena and Pseudotumor Cerebri

Unfortunately, organ perforation is not the only concerning side effect possibly associated with Mirena.

Hormonal birth control pills and implants like the Mirena IUD have been linked, according to at least one lawsuit, to an increased risk of pseudotumor cerebri, a medical condition that mimics the effects of a brain tumor and can cause severe headaches, migraines, vision loss, and permanent blindness.

Though pseudotumor cerebri is not a tumor, it can still have serious health effects. This condition produces effects that are similar to a growing brain tumor due to increased pressure on the brain caused by excessive levels of cerebrospinal fluid inside the skull.

“Just because pseudotumor cerebri isn’t an actual brain tumor doesn’t mean that it isn’t a potentially serious health condition. Seeing a doctor to promptly diagnose symptoms and begin treatment can help to prevent complications,” the Columbia University Department of Neurology notes. 

Pseudotumor cerebri is also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. Pseudotumor cerebri, which literally means “false brain tumor,” is characterized by high intracranial pressure caused by the accumulation or poor absorption of cerebrospinal fluid. The disorder, which is also referred to as idiopathic intracranial hypertension or benign intracranial hypertension, is mostly common reported in women between the ages of 20 and 50.

This neurological disorder that occurs when high pressure in the brain results in symptoms resembling those of a brain tumor. High intracranial pressure is usually caused by an abnormal accumulation of cerebrospinal fluid, the fluid that surrounds the spinal cord and brain. 

Pseudotumor Cerebri Symptoms

Pseudotumor cerebri is often tied to hormones, according to another lawsuit, and symptoms may include:

• Frequent headaches or migraines that may originate behind your eyes and worsen with eye movement
• Ringing in the ears that pulses in time with your heartbeat, creating a “whooshing” sound (pulsatile tinnitus)
• Feeling dizzy or nauseated
• Vomiting
• Blurred vision, double vision, blind spots
• Vision loss affecting one or both eyes
• Difficulty seeing to the side
• Seeing light flashes (photopsia)
• Neck stiffness
• Neck, shoulder or back pain
• Problems walking
• Forgetfulness
• Depression

Some women notice an increase in pseudotumor cerebri symptoms while exerting energy because exercise tends to raise the pressure in the skull.

Mirena and Pseudotumor Cerebri Lawsuit

In 1995, the New England Journal of Medicine published a study linking pseudotumor cerebri with birth control pills and contraceptive implants containing the hormone levonorgestrel, such as Mirena. In light of this information, pseudotumor cerebri birth control lawsuits have accused drug makers of failing to warn women about the risks of developing pseudotumor cerebri from the effects of birth control.

Now, these kinds of lawsuits have been filed against Bayer, the maker of Mirena.

Rewire reports that a set of similar Mirena lawsuits were consolidated in the Southern District of New York. Rewire says that 856 cases are combined into the lawsuit against Bayer. 

In one such lawsuit, plaintiff Montresha R. says she had the Mirena IUD inserted in April 2007 by her healthcare provider. After the device was placed, Montresha allegedly began to experience symptoms of pseudotumor cerebri in adults including “continual headaches, nausea, pressure behind eyes, blurred vision, tunnel vision, blind spots, and [a] pulsating sensation in her ears.” 

Due to these symptoms, Montresha reportedly sought medical attention in April 2010 and underwent diagnostic testing including MRI imaging. In May 2010, she was diagnosed with pseudotumor cerebri.

Montresha claimed that her pseudotumor cerebri was a direct result of the Mirena IUD’s hormone, levonorgestrel. The hormone allegedly causes the body to produce too much cerebrospinal fluid which in turn reportedly causes the condition. Like many other PTC lawsuit claims, her pseudotumor cerebri is allegedly permanent and she claims that past and future pain and suffering can be attributed to the birth control device.

“As a result of the injuries she suffered as a result of the defective and unreasonably dangerous Mirena IUD, she has been permanently injured and has incurred or will incur past and future medical expenses, has experienced or will experience past and future pain and suffering, has incurred or will incur lost wages, and is subject to an increased risk of future harm.”

In light of these lawsuits and growing patient concern over Mirena’s side effects, experts note that there is not much medical literature supporting claims of Mirena’s connection to pseudotumor cerebri. 

The Mirena PTC Lawsuit is Case No. 1:19-cv-00860-UA and is part of the Mirena MDL, In re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), Case No. 17-MD-2767-PAE, in the U.S. District Court for the Southern District of New York.