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Mirena Brain Injury

mirena brain injuryThe Mirena intrauterine device (IUD) was designed and marketed to provide safe and effective birth control for women. Unfortunately, several serious side effects have been reported as a result using this IUD; most recently there have been reports of Mirena brain injury, including Idiopathic Intracranial Hypertension (or IIH) or pseudotumor cerebri (PTC). These conditions can include headaches and vision problems that can be permanent if not treated.

Although the FDA has not issued an official warning about a Mirena IIH link, they have regulated other products with the same hormone that come with warnings about an IIH risk. The Mirena IUD is a hormonal form of birth control that works by releasing a small amount of the hormone levonorgestrel into a woman’s body over time. 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.

The manufacturers of the Mirena IUD, Bayer Pharmaceuticals, are already contending with hundreds of lawsuits regarding IUD migration and organ perforation. Now, legal pressure regarding a Mirena link to IIH is mounting as a small group of woman have banded together to create a separate category of litigation concerning this troubling Mirena brain injury side effect.

What is IIH/PTC?: symptoms, treatment, prognosis

Idiopathic Intracranial Hypertension (IIH) is a serious condition involving elevated levels of spinal fluid in the brain that build up and cause pressure. IIH is sometimes called pseudotumor cerebri (or PTC) because the condition comes with symptoms that mimic the side effects of an actual tumor.

IIH is progressive and includes the following side effects:

  • Headaches, which are at first somewhat dull. At the beginning, they may be confined to the back of the head. Women may experience them, or experience them in their most intense state, late at night or early in the morning. Headaches will become more painful and frequent if the condition is not treated.
  • “Whooshing” noises. As spinal fluid continues to build, some women report hearing strange noises.
  • Blurred vision. As the condition worsens, and the spinal fluid begins to put pressure on the optic nerve, women may experience episodes of blurred vision.
  • Double vision is also a result of optic nerve pressure.
  • Temporary blindness. As time goes on, women may experience episodes of temporary blindness or “blackouts.”
  • Permanent blindness. If the condition is not treated, it may result in permanent blindness.

It is important that any woman who develops such symptoms should consult with a medical expert as soon as possible. A doctor will first rule out alternative conditions, such as a blood clot or actual tumor, which have similar symptoms.

If IIH is diagnosed, some treatment options are available. Medications may dampen the symptoms and, in more serious cases, surgery to install various kinds of shunts may help to drain the excess spinal fluid and reduce the vision or pain problems. Patients respond in different degrees to these measures; however, the treatment is often focused on preventing further harm rather than repairing the damage done through the brain injury. Vision problems, including blindness, can be permanent.

Can the Mirena IUD cause IIH?

It is not always clear what causes IIH. The following are some possible risk factors or causes:

  • Patients who have recently gained weight (including pregnancy weight) are at risk for the conditions.
  • Medications/supplements, including some antibiotics, steroids, and vitamin A, may elevate the risk of IIH for some patients.
  • Patients who were born with narrow veins that direct blood flow from the brain may develop IIH.

However, in some cases where women have developed IIH while using the Mirena IUD, none of these risk factors were present.

Some medical experts believe that the hormone levonorgestrel, an active ingredient in the Mirena IUD, can also cause IIH. No warning about potential Mirena-caused IIH is included on the label, despite a number of reported instances to the FDA, and the FDA has issued no warning statements regarding the matter. However, IIH is listed as one of the potential side effects of the levonorgestrel-containing birth control implant Norplant.

Other Mirena side effects

There are also a number of better known Mirena IUD side effects, including:

  • IUD expulsion
  • IUD migration
  • Pelvic Inflammatory Disease (PID)
  • Ectopic pregnancy
  • Perforation of the uterine wall

These conditions may result in damage, pain, and discomfort that require extensive rounds of surgery. In some cases, unwanted pregnancies can also result. These conditions appear to be unrelated to IIH/PTC and have thus involved a separate process of litigation for women who claim to have suffered Mirena IUD uterine perforation or IUD migration.

Mirena IIH litigation

At this point, over 1600 lawsuits concerning IUD migration and perforation have been consolidated as part of two distinct litigation processes: approximately half are part of a federal Mirena multidistrict litigation (MDL) in the Southern District of New York, with the second half centralized in Bergen County, New Jersey as part of a state-wide multicounty litigation (MCL).

In both litigation processes, the lawsuits filed by the plaintiffs have been consolidated because their cases involve very similar contentions regarding migration and perforation side effects.

However, hundreds of other women who have experienced alternative Mirena IUD side effects have also filed lawsuits that do not adhere to the criteria of the MDL and MCL. Recently, nine plaintiffs petitioned for their own MDL regarding Mirena brain injury (IIH/PTC) in the Middle District of Tennessee. In a response to their petition filed on June 17, 2014, Bayer objected that the number and quality of the complaints was not sufficient to warrant a separate MDL.

However, the response revealed that the number of complaints had already risen to 10, and attorneys for the current plaintiffs estimate that the MDL will encompass upwards of 60 total complaints.

Women who believe that their IIH is linked to their use of the Mirena IUD should first consult their doctor and then consider consulting a Mirena brain injury lawyer.