Pseudotumors and mirena



Mirena IUD Linked to the Development of PCI

A growing number of lawsuits are being filed by women who received a Mirena implant, claiming that Bayer Healthcare, maker of the device, failed to adequately warn them about the associated health risks. The Mirena intrauterine device (IUD) is a long-term birth control device that releases a synthetic progestin called levonorgestrel, which has been linked to increased risk of pseudotumor cerebri (PTC).

Pseudotumor cerebri–which means “false brain tumor”– is a medical condition that occurs when there is too much cerebrospinal fluid inside the skull, increasing pressure on the brain and optic nerve. The condition, also known as idiopathic intracranial hypertension (IIH), produces symptoms that mimic a growing brain tumor, including chronic migraines and blindness.

What Are the Symptoms of Pseudotumor Cerebri?

Headaches are one of the most common symptom of PTC. These headaches can range from a dull ache that starts behind the eyes to severe migraine-like headaches.

Symptoms also include vision problems. These can include moments of vision loss in one or both eyes, loss of peripheral vision or double vision. These issues become worse as the pressure inside the skull increases.

Headaches are a symptom of idiopathic intracranial hypertension

Headaches are a common symptom of PTC.

Headaches are a common symptom of PTC.

Other warning signs may include:

  • Ringing in the ears
  • Pain in the neck, back, or shoulders
  • Nausea and vomiting
  • Dizziness
  • Sensitivity to light
  • Problems with balance and special awareness

Lack of Adequate Warnings

Because of Bayer’s alleged failure to warn both physicians and their female patients of the link between Mirena and pseudotumor cerebri, most doctors were not aware the the IUD implant could be a potential source of problems. Such is not the case in other places in the world, including South Africa and China. In these countries, Mirena warning labels include information about the risk of increased intracranial pressure as a possible side effect.

“Defendants (Bayer) knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel, causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition that can also lead to permanent blindness,” according to one complaint. “Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risks of developing IIH/PTC with Mirena.”

Widespread Implications

Almost 62% of women in the United States use some form of birth control. They are increasingly choosing long-acting reversible methods like IUDs, according to a report by the National Center for Health Statistics. The report shows that 11.6% of women who used birth control in the US between 2011-2013 chose long-acting reversible contraceptives, up from just 2% in 2002.

While most forms of birth control are usually safe, some makers–in their rush to get their products to market–neglect adequate testing and/or leave medical warnings off labels, putting potential users at unnecessary risk. The Mirena lawsuits being filed against Bayer are seeking to shed light on a problem that has had severe consequences for many women.