Bayer HealthCare, the manufacturer of Mirena, is facing more than 100 lawsuits from women who were diagnosed with a rare but serious brain injury that increases pressure inside the skull. It often causes chronic headaches, progressive vision loss, or blindness.
What is Mirena?
Mirena is a birth control implant manufactured by Bayer. It helps reduce a woman’s chances of getting pregnant by slowly releasing the hormone levonorgestrel, a synthetic progestin. Mirena contains 52-mg of levonorgestrel and it is effective for up to five years.
Mirena Brain Injuries
The problem with Mirena is that levonorgestrel has been linked to dozens of cases of a rare but serious brain injury that elevates levels of cerebrospinal fluid and increases pressure inside the skull. It is also known as:
- Idiopathic Intracranial Hypertension
- Pseudotumor Cerebri
- Benign Intracranial Hypertension
- Secondary Intracranial Hypertension
Study Links Intracranial Hypertension and Levonorgestrel
In 1995, the New England Journal of Medicine published a study linking Norplant with 56 cases of intracranial hypertension. Norplant is a levonorgestrel-releasing intrauterine device (IUD), very similar to Mirena.
Mirena PTC Lawsuit Filed in Tennessee
In October 2015, a woman who was diagnosed with pseudotumor cerebri (PTC) after using Mirena has filed a lawsuit (PDF) against Bayer HealthCare for failing to adequately warn about the risk. The case was filed in federal court in Tennessee on September 29 (Case No. 2:15-cv-02645). Click here to read more.
Over 100+ Lawsuits for Mirena Brain Injuries
Bayer is facing over 1,500 lawsuits from women who say the risk of spontaneous uterine perforation was not fully disclosed. In early 2014, Bayer was hit with 9 lawsuits accusing them of downplaying risk information about brain injuries from Mirena.
Attorneys petitioned a panel of federal judges to centralize the litigation in May 2014. However, in August, the judges denied the petition because there were not enough cases. In December 2016, with at least 116 lawsuits in 17 district courts nationwide, lawyers filed another petition to centralize the cases into one federal court.
Brain Injury Diagnosis & Treatment
The condition can only be diagnosed with a painful test called a spinal tap (lumbar puncture), in which a large needle is inserted between two vertebrae in the lower back and a small sample of cerebrospinal fluid is removed. In serious cases, surgery may be needed to drain excess fluid from the skull.
Symptoms of Intracranial Hypertension
- Vision problems
- Ringing in the ears
- Nausea, vomiting
- Papilledema (swelling of the optic disc)
- Optic nerve damage