Mirena and Brain Injury

Each time we are prescribed a new medication, we expect it to not only address the underlying medical issue or condition, but to work safely and effectively without causing unexpected, debilitating side effects. Unfortunately for tens of thousands of women across the United States, the inter-uterine device known as Mirena has not lived up to these expectations, and is wreaking havoc in an immeasurable number of patients relying upon the drug as a safe and effective method of preventing pregnancy.

In addition to the well-documented instances of uterine perforation associated with this device, women are now reporting frightening brain injuries linked to the use of Mirena – and its manufacturer, along with the Food and Drug Administration, has so far failed to adequately and fairly address these claims.

Mirena’s slogan – ‘Keep life simple’ – stands as an ironic reminder that this drug can potentially deprive women of just that: simplicity. Those who have used the Mirena IUD in the past and are currently struggling with the unexpected onset of a painful and debilitating brain injury, may be encouraged that new lawsuits are emerging on a regular basis, allowing injured patients the opportunity to recover some of what they lost by trusting in this dangerous and risk-laden contraceptive.

Brain injuries linked to the Mirena IUD

The brain condition most commonly associated with the Mirena IUD is known as Idiopathic Intracranial Hypertension (IIH). This disorder is sometimes also referred to as a “pseudotumorcerebri,” as its symptoms closely mimic that of an actual brain tumor.

The condition is characterized by the onset of elevated spinal fluid surrounding the brain – and can lead to a host of terrifying symptoms.

Some of the most commonly-reported effects of IIH include any of the following:

• Headaches of varying severity, particularly concentrated at the back of the head. Headaches often occur first thing in the morning or late at night;
• Temporary visual blurriness;
• Temporary blindness;
• Difficulty controlling eye muscles;
• Double vision;
• Permanent deterioration of the ability to see

Upon the onset of these symptoms, patients are encouraged to immediately seek assistance from a medical professional in order to rule out the possibility of an actual brain tumor. From there, an eye examination will likely be performed, revealing optic nerve swelling at the back of the eye. A subsequent CT scan or MRI will also be ordered, which could reveal smaller than normal spinal fluid ventricles. Like actual brain tumor patients, the results of these scans will reveal elevated pressure in the skull, and the extent of the excess spinal fluid will be measured in order to determine an appropriate course of treatment. Patients with IIH often must undergo a spinal tap and drainage of the fluid, followed by continual monitoring of the patient’s vision and eye health.

Understanding the link between IIH and the Mirena IUD

Mirena IUD lawsuits relating to brain injuries are still relatively new, however there is increasing support for the correlation between the use of the hormone levonorgestrel (found in Mirena) and the development of IIH. Other risk factors for IIH include sudden weight gain (including weight gain due to pregnancy), genetic predisposition to increased spinal fluid, or the use of certain medications including the antibiotic tetracycline, steroids, or vitamin A.

The Food and Drug Administration, which is an entity responsible for protecting Americans from unsafe and risky drugs, has yet to issue an official statement on the alleged link between Mirena IUD and IIH. However, physicians have revealed that in the number of Mirena patients facing the effects of IIH, the presence of other known risk factors is virtually nonexistent.

Mirena IUD complications and issues

Brain injury is just one of several life-threatening complications associated with the Mirena IUD. In addition to causing pseudotumors, the FDA has identified the following potential hazards associated with Mirena and recently required the manufacturer of Mirena (Bayer Pharmaceuticals) to list the following potential Mirena side effects on the label:

• Ectopic pregnancy – Nearly 50 percent of all pregnancies occurring during the use of the Mirena IUD are ectopic – meaning, the fertilized egg implants dangerously high in the fallopian tubes, causing certain miscarriage and possible infertility;
• Sepsis;
• Uterine perforation;
• Ovarian cysts;
• Pelvic infection;
• Vomiting

In several other cases involving allegations against Mirena, the above-listed side effects have caused pain, discomfort and the need for invasive revision surgery. Many women enduring uterine perforation caused by Mirena have contemporaneously experienced the loss of fertility.

Ongoing Mirena IUD litigation

Currently, over 1,600 lawsuits are pending with regard to uterine perforation caused by the Mirena IUD. These lawsuits are organized according to a concept known as multidistrict litigation – which allows plaintiffs from several jurisdictions the opportunity to combine their cases for pretrial matters and advance a strong cause of action together.

With regard to Mirena and IIH, nine plaintiffs commenced their lawsuits outside of the ongoing multi-district litigation and plan to organize a separate MDL pertaining solely to the Mirena-IIH correlation. It is speculated that as many as 60 separate brain injury lawsuits could come together alleging that Bayer knew or should have known of the risks of IIH with its Mirena product, and failed to warn consumers nonetheless.

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