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A Tennessee woman indicates that she has experienced severe headaches, blurred vision and vision loss due to the side effects of the Mirena IUD, which caused a dangerous build up of fluid pressure around the brain, known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH).
In a complaint (PDF) filed in the U.S. District Court for the District of New Jersey on December 22, Marsha Sapp Hankins indicates that Bayer failed to adequately warn women or the medical community about the risk of PTC/IIH associated with implanting their intrauterine device (IUD) for long-term birth control.
Hankins indicates that she received a Mirena IUD in October 2011, without incident. However, after the T-shaped implant was placed into her uterus, the lawsuit indicates she began to experience dizziness, intense headaches, blurred vision, double vision and eventually began to suffer loss of vision. It was not until January 2016 that the condition was diagnosed as pseudotumor cerebri (PTC), and she had the Mirena IUD removed in June 2016.
PTC and IIH are interchangable medical terms used to describe complications caused by elevated levels of cerebrospinal fluid that cause increased pressure on the brain. This typically causes severe migraine headaches and potentially permanent vision problems as a result of pressure on the optic nerve.
The Mirena IUD is designed to prevent pregnancy for up to five years, involving an implant that releases the hormone levonorgestrel (LNG). The device is used as a form of long-term, and “worry free” birth control for millions of women, but an increasing number of Mirena IIH/PTC lawsuits allege that the manufacturer withheld information from consumers and the medical community about the risks associated with the IUD.
According to Hankin’s lawsuit, she is unlikely to recover what vision loss she suffered. Though there may be recovery in rare cases, the best she and most others with IIH/PTC can do is prevent further vision loss progression. The lawsuit notes that the lack of a Mirena warning could result in some women losing more of their vision than necessary, both because they could have used another kind of birth control, and because neither they nor their doctors may have linked the vision problems to the Mirena IUD and had it promptly removed.
“Failure to correctly diagnose and treat PTC or IIH may lead to permanent vision loss and even blindness,” the lawsuit states. “There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred.”
Hankin’s case joins a growing number of Mirena IUD lawsuits over PTC/IIH, each raising similar allegations that plaintiffs may have avoided severe and potentially life-long problems from permanent optic nerve damage if the drug maker had provided warnings about the importance of removing the device once symptoms first appeared.