A Mirena IUD hypertension lawsuit has been filed against Bayer by a woman who claims the birth control device caused her severe injuries.
Mirena is an intrauterine device (IUD) in the shape of a “T” that is inserted into the uterus for birth control. Mirena releases a synthetic progestin hormone known as levonorgestrel for up to five years.
Plaintiff Lauren H. had the Mirena IUD inserted into her body in September 2015. In August 2016, she went to a hospital emergency room because of headaches and blurred vision.
In October 2016, Lauren was diagnosed with pseudotumor cerebri after she undwerwent a diagnostic lumbar puncture to evaluate the increased pressure in her skull.
Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IH), is the medical term for the neurological disorders caused by the cerebrospinal fluid pressure within the skull becoming too high.
Permanent blindness can occur if the condition is not correctly diagnosed and treated in time. Although permanent optic nerve injuries caused by increased intracranial pressure are irreversible, relief from the built-up fluid is possible through a lumbar puncture such as the one Lauren endured.
Mirena IUD Hypertension Lawsuit Alleges Norplant-like Side Effects
Norplant, a set of six silicone capsules designed to be implanted in the upper arm, was released in 1991 as a birth control system. Each Norplant capsule contained 36 mg of levonorgestrel (LNG), the same hormone used in Mirena. By February 1993, Norplant maker Wyeth-Ayerst Laboratories requested adding “idiopathic intracranial hypertension” to its list of precautions on Norplant’s physician labeling.
According to the Mirena IUD hypertension lawsuit, “[b]y 1995, several reports of women developing pseudotumor cerebri or idiopathic intracranial hypertension were reported in The New England Journal of Medicine.” By 2001, Norplant amended its label to add a warning section for idiopathic intracranial hypertension.
Mirena’s marketing literature states that only small amounts of the hormone LNG enter the system, but it allegedly neglects to mention a wide variance in serum LNG can be possible among Mirena users.
The Mirena IUD hypertension lawsuit delves into the chemical anomalies regarding different LNG products, and alleges Bayer left out important information “in order to mislead and defraud healthcare providers, patients, the FDA, and the public regarding Mirena’s systemic effects and hormonal side effects.”
Even though information is available to Bayer that links LNG with intracranial hypertension, Mirena’s label does not warn of either pseudotumor cerebri or idiopathic intracranial hypertension.
Bayer is accused of “overstating the efficacy of Mirena while understating the potential safety concerns,” says the Mirena IUD hypertension lawsuit.
Lauren H. is currently 23 years old and says she “has been permanently injured” by “the defective and unreasonably dangerous Mirena.”
If you or someone you love has received implantation of the Mirena IUD and developed pseudotumor cerebri or idiopathic intracranial hypertension, you could be eligible for compensation through legal representation.
The Mirena IUD Hypertension Lawsuit is Case No. 1:17-cv-06181-UA in the U.S. District Court for the Southern District of New York.
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