Mirena: Turning a Blind Eye

iStock_000085123163_LargeWhat is Mirena®?

Mirena® is an intrauterine system manufactured by Bayer Pharmaceuticals which releases the hormone levonorgestrel directly into the uterus to prevent pregnancy. Although the manufacturer of Mirena has admitted it is unsure exactly how the product works, they believe it may thin the uterine lining and thicken cervical mucus, reducing sperm survival and preventing pregnancy.

What is the problem?

Levonorgestrel has been linked to a condition called pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH). This condition develops when a person’s cerebrospinal fluid builds up in the skull causing increased pressure on the optic nerve. Complications include migraines, papilledema, optic nerve damage, blurred vision, double vision, vision loss, or blindness and may be temporary, permanent, or recur throughout the patient’s lifetime. A diagnosis typically will involve a MRI or CT scan to rule out other causes such as a tumor or blood clot along with a lumbar puncture or spinal tap to evaluate the fluid in the skull.

What did they know?

Birth controls like Norplant® and Jadelle®, which also contain levonorgestrel, have warned about the risk of developing idiopathic intracranial hypertension or pseudotumor cerebri (IIH/PTC) as far back as 1993. In 1995, the New England Journal of Medicine noted that levonorgestrel may have contributed to several reported instances of IIH/PTC.  By the mid-1990s, Norplant faced tens of thousands of lawsuits, some claiming the drug caused IIH/PTC. In 1996, the FDA received a citizens petition requesting Norplant be removed from the market because of a number of adverse events including IIH/PTC. Despite all of these red flags linking levonorgestrel to this serious medical condition, the FDA and Bayer turned a blind eye. Mirena was approved by the FDA and then put on the market in 2000 without any mention of pseudotumor cerebri or idiopathic intracranial hypertension in its label.

How can I take action?

At Ferrer, Poirot Wansbrough, Feller, Daniel, Abney & Linville, we are committed to helping victims of harmful products and devices. We believe big corporations should be held accountable when they turn a blind eye and put harmful products on the market without warning of potential serious side effects. If you or a loved one suffered from Mirena side effects and are interested in a Mirena lawsuit, please call our office at 1-800-521-4492 to speak with our experienced staff who can connect you to a Mirena attorney.

Mirena® is a registered trademark of the Bayer HealthCare Pharmaceuticals, Inc. and is used here only to identify the product in question.