Mirena Pseudotumor Cerebri Symptoms Required Multiple Shunts For Brain Fluid, Lawsuit Indicates

After experiencing severe headaches and vision problems associated with symptoms of pseudotumor cerebri (PTC), a California woman indicates that she had to undergo multiple brain shunts to relieve the fluid pressure in her skull before discovering that the issues were caused by her Mirena IUD birth control implant.

The allegations were raised in a lawsuit (PDF) filed by Erica Silva last month in the U.S. District Court for the District of New Jersey, claiming that the levonorgestrel-releasing Mirena IUD system marketed by Bayer Healthcare for long-term birth control is defective and unreasonably dangerous for women.

Silva is 33 years old, and states that she had one of the T-shaped Mirena IUD birth control devices first implanted in January 2007. However, about two years later, she was diagnosed with psuedotumor cerebri (PTC), which is also known as idiopathic intracranial hypertension (IIH), and involves a buildup of fluid around the brain, which can produce symptoms like migraine headaches, double vision, blurred vision and other complications.

Since the Mirena warnings provide no information for users or the medical community about the risk that the birth control may result in pseudotumor cerebri symptoms, Silva indicates that neither she or her doctor were aware that the problems were caused by the IUD, so the birth control implant remained in place. In fact, she had a second Mirena IUD implanted in April 2010, which was removed only a few months later, in November 2010.

In efforts to relieve the fluid pressure on her brain and optic nerve, doctors gave Silva a lumbar peritoneal shunt in December 2009; a ventriculoperitoneal shunt in August 2010; an external ventricular drain in September 2010; followed by three more ventriculoperitoneal shunts in October 2010, January 2014, and February 2014; and another external ventricular drain in April 2014.

The lawsuit alleges that Bayer knew or should have known that the side effects of the Mirena levonorgestrel IUD may cause symptoms of pseudotumor cerebri, yet withheld information from women and doctors, understating the potential safety concerns. As a result, Silva presents claims against Bayer for negligence, design defect, failure to warn, strict liability, breach of implied warranty, negligent misrepresentation, fraudulent misrepresentation, fraud by suppression and concealment, and loss of consortium, seeking both compensatory and punitive damages.

The case joins a growing number of Mirena pseudotumor cerebri lawsuits filed in recent months by women who have suffered symptoms of the severe neurological side effects, 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 of pseudotumor cerebri first appeared.

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, earlier this month the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Mirena IUD PTC/IIH claims filed in federal courts nationwide be transferred to the U.S. District Court for Southern New York before District Judge Paul A. Engelmayer for coordinated pretrial proceedings.

There are currently more than 100 product liability lawsuits pending over Mirena PTC/IIH injuries. In addition, as Mirena injury lawyers continue to review and file cases over the coming months and years, it is ultimately expected that hundreds, if not thousands, of cases will be added to the litigation in the coming months and years.