October 20, 2015 — A woman who was diagnosed with pseudotumor cerebri (PTC) after using Mirena has filed a lawsuit against Bayer HealthCare for failing to adequately warn about the risk.
The lawsuit (PDF) was filed in federal court in Tennessee on September 29 (Case No. 2:15-cv-02645).
The plaintiff, Nicole Hamill, was implanted with the Mirena intrauterine device (IUD) in October 2004. Within months, she developed migraine headaches and other symptoms consistent with intracranial hypertension (IH).
The symptoms included high pressure inside the skull due to increased cerebrospinal fluid and vision problems. Over time, PTC/IH can cause papilledema (swelling of the optic nerve), double-vision, and permanent vision loss.
She was diagnosed withe PTC/IH and was forced to undergo multiple lumbar punctures (spinal taps) to relieve pressure inside her skull.
Unfortunately, because the label on Mirena does not warn about the risk of PTC/IH, Hamill was implanted with another Mirena IUD in August 2012. Her symptoms continued until October 2014, when she removed Mirena.
Hamill accuses Bayer of downplaying the risk of hormonal side effects from Mirena, misleading women with labels indicating it as a “low” hormonal contraceptive. In reality, the hormone levonorgestrel is known to cause serious side effects in rare cases.
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.”