Bayer’s 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 (LNG) for up to five years.

In June 2015, plaintiff Marlene M. had the Mirena IUD implanted into her body. Not two years later, she filed her Mirena IUD lawsuit.

After having the IUD implanted, Marlene says she began to experience “headaches, with associated neck, back and shoulder pain, tinnitus, as well as vision problems including blurriness and loss of vision.”

In mid-July 2016, Marlene sought help for her symptoms and was diagnosed with pseudotumor cerebri, allegedly caused by her Mirena IUD.

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.

Even though there is no way to reverse permanent optic nerve injuries caused by increased intracranial pressure, relief from the built up fluid is possible through a lumbar puncture. Marlene’s doctor inserted a hollow needle into the lumbar area and drew some of the excess cerebrospinal fluid from her in late September 2016.

Diagnostically, this procedure can allow the fluid to be tested to rule out infection or inflammation in the fluid. Patients such as Marlene experiencing pseudotumor cerebri have fluid that tests normal.

The Mirena IUD lawsuit says, “As a result of the injuries she suffered as a result of the defective and unreasonably dangerous Mirena IUD, she has been permanently injured and has incurred or will occur past and future medical expenses, has experienced or will experience past and future pain and suffering, has incurred or will incur lost wages, and is subject to an increased risk of future harm.”

Mirena IUD Lawsuit Accuses Bayer of Negligence

“A reasonable manufacturer would or should have known that the risks created by Mirena were unreasonably greater than that of other contraceptives and that Mirena had no clinical benefit over other such contraceptives that compensated in whole or part for the increased risk,” alleges the Mirena IUD lawsuit.

Bayer should have known that the synthetic hormone LNG  “causes and/or contributes to the development of IH/PTC, a severe and possibly irreversible brain condition that can also lead to permanent blindness.”

Marlene says that in the face of an increasing number of adverse event reports of IH/PTC symptoms in Mirena users, Bayer still has not warned the medical community or consumers regarding such risks, says the Mirena IUD lawsuit.

Bayer “knew or should have known that an additional risk factor for developing IH/PTC is sudden weight gain – a common side effect of Mirena – and defendants did nothing to warn patients, physicians, or the healthcare community that Mirena could cause rapid or sudden weight gain, which increases the risk of developing IH/PTC.”

The Mirena IUD Lawsuit is Case No. 1:17-cv-05686-UA in the U.S. District Court for the Southern District of New York.