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Plaintiff Claims Mirena Caused Intracranial Hypertension

female patient with doctor Jacqueline Goyena of North Carolina is demanding that Bayer Healthcare Pharmaceuticals be held liable for injuries that allegedly stemmed from her use of the defendant’s birth control device, Mirena.

Specifically, she claims she was diagnosed with pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IH), which is a serious condition that may lead to permanent complications. The plaintiff claims that the defendant “intentionally, willfully, and maliciously concealed and/or suppressed” information regarding the serious risks allegedly associated with Mirena.

Her Mirena IUD lawsuit is proceeding in the U.S. District Court for the District of New Jersey, Newark Division. She is demanding compensatory damages in excess of $75,000, along with punitive damages.

Plaintiff suffers brain injury

The plaintiff, who was 29 years of age at the time the lawsuit was filed, received Mirena in February of 2007. Mirena is an intrauterine device (IUD) that is inserted into a woman’s uterus by a healthcare provider for the purpose of preventing pregnancy. According to her lawsuit, her healthcare provider noted that no complications occurred at the time of the insertion. Goyena read and relied upon the Mirena Patient Information Booklet when deciding to use the product.

About one year after receiving the Mirena IUD, Goyena began experiencing severe side effects. These included blurry vision, migraines, and occipital and posterior neck pain. On April 16, 2009, the plaintiff underwent an uncomplicated removal of the Mirena IUD. Many other plaintiffs who have filed lawsuits against Bayer Healthcare have had to undergo surgery to remove the device after it migrated and perforated the uterine wall.

Prior to removal of the IUD, on January 22, 2009, the plaintiff sought treatment for blurred vision and floaters. She was diagnosed with bilateral papilledema, which refers to swelling of the optic nerves. Not long afterward, she underwent a diagnostic lumbar puncture. The results of this invasive test resulted in a diagnosis of PTC/IH. Idiopathic Intracranial Hypertension (IIH) is a brain disorder that is characterized by increased spinal fluid pressure in the patient’s brain. If not detected and left untreated, this condition causes progressive vision loss and possibly permanent blindness.

Lawsuit links Mirena to PTC/IH

Goyena’s lawsuit claims that the IUD directly caused her PTC/IH because the device releases levonorgestrel into the body. Levonorgestrel is a hormone known as a progestin that works to prevent unintentional pregnancies. However, the plaintiff claims, it may also increase the risk of PTC/IH. The plaintiff contends that the defendants failed to adequately disclose the extent to which Mirena increases levonorgestrel in patients’ blood serum levels and that exposure to levonorgestrel increases the risk of PTC/IH – both directly and indirectly.

The lawsuit contends that the Norplant birth control implant, a product that required the insertion of tiny rods into a woman’s arm, was linked to an increased risk of PTC/IH in various medical studies and that this heightened risk was attributed to the levonorgestrel in Norplant.

The plaintiff claims that the history of PTC/IH associated with levonorgestrel substantiates her allegation that the defendants willfully concealed knowledge of Mirena side effects and risks from the healthcare community and patients.