October 20, 2015 — Bayer HealthCare is facing a lawsuit from a woman who experienced brain injuries after using the contraceptive implant Mirena.

The lawsuit (PDF) was filed by Nicole Hamill in the U.S. District Court for the Western District of Tennessee (Case No. 2:15-cv-02645) on September 29.

Hamill was implanted with Mirena in October 2004. In February 2005, she sought treatment for migraines and other symptoms at a hospital in Florida.

She was diagnosed with pseudotumor cerebri (PTC) or intracranial hypertension (IH) and underwent repeated lumbar punctures to relieve pressure inside her skull.

Because Mirena is only effective for five years, Hamill had another Mirena implanted in her body in August 2012. She continued to suffer from migraine headaches and vision problems until October 2014, when she had Mirena removed.

Lumbar punctures, also known as spinal taps, are painful medical procedures that only temporarily relieve symptoms associated with intracranial hypertension. Over time, the condition can cause swelling of the optic nerve (papilloedema), progressive vision loss, and even blindness.

The lawsuit alleges that Bayer failed to adequately warn about the risk of PTC/IH. It further alleges that levonorgestrel in Mirena can cause hormonal side effects. According to the complaint:

“Despite the rarity of PTC/IIH, women who use levonorgestrel-containing products, like the Mirena IUS, more commonly develop the disorder. … Additionally, because Mirena is known to cause rapid weight gain in women, the risk of developing PTC/IIH is even greater with Mirena use.”


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