A husband and wife from California are suing Bayer Pharmaceuticals, alleging the wife suffered brain injuries caused by the side effects of using Mirena IUD birth control.

The wife, Gia Z., claims that Mirena is “defective and unreasonably dangerous,” and caused her to develop severe headaches and possible vision damage.  Her husband, Fernando, is alleging loss of consortium, and is seeking separate damages for his inability to have normal marital relations with his wife due to her severe injuries.

According to their Mirena lawsuit, Gia first had the Mirena IUD implanted in February 2005, and suffered no initial complications during the IUD insertion.

By 2009, however, Gia had experienced weight gain, headaches, ear pain, dizziness, and blurred vision. In September 2009, the Mirena lawsuit claims she started seeing black spots and floaters, which led her to consult with her optometrist. She was soon diagnosed with bilateral disc edema, and it was ultimately concluded that she had developed pseudotumor cerebi (false brain tumor).

To treat this condition, Gia had to undergo a lumbar puncture to test her levels of cerebral spinal fluid. A build up of this fluid will cause pressure to increase in the skull, which can cause tumor-like symptoms. After it was confirmed that her spinal fluid levels were quite high, the plaintiff was treated with weight loss management and a prescription of Diamox (acetazolamide).

At the time, neither Gia nor her physician had linked her birth control use to her complications.

Gia renewed her Mirena IUD prescription in 2010, and had her IUD removed and replaced. However, when she noticed that her side effects worsened when the IUD was re-implanted, the plaintiff and her healthcare physician became suspicious that her birth control was the culprit behind her symptoms. When her suspicions were eventually confirmed, she had the Mirena IUD removed in February 2013.

The Mirena lawsuit notes that at the time Gia was first offered the Mirena IUD, as well as when it was time to renew it, she had not been aware of the product’s association with pseudotumor cerebri. This potential birth control side effect was not mentioned on the product’s label and she received no warnings from her healthcare provider.

Gia and her husband insist that she never would have used the Mirena IUD if she had known about the possibility of developing a false brain tumor.

Gia is filing the Mirena lawsuit against Bayer Pharmaceuticals for failing to warn her and other patients about this potential complication. She claims that Bayer had the civil responsibility to protect women against any product defects, as well as to provide adequate product safety information.

So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous product, Gia and Fernando are suing Bayer Pharmaceuticals. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.

The Mirena IUD lawsuit is Gia Zamudio-S. and Fernando S. v. Bayer Pharmaceuticals, Case No. 5:15-cv-00209-NC, in the U.S. District Court of Northern California, San Jose Division.

Overview of Mirena Pseudotumor Cerebi

The Mirena IUD was approved for use in the United States in 2000 to be used as a long-term birth control method. Ideally, this small plastic device would be implanted into the woman’s uterus to prevent pregnancy in a hassle-free manner for five years.

The IUD works by releasing a synthetic hormone called levonorgestrel into the bloodstream, which prevents sperm-to-egg fertilization and ovulation. It has proven to be a very popular birth control method with women, with over 15 million prescribers worldwide. Unfortunately, this device has been linked to a number of medical complications relating to device perforation and migration, and the lasting consequences patients suffer.

Recently, women have come forward to also complain about the painful phenomena known as psuedotumor cerebi. As mentioned before, this complication occurs when cerebral spinal fluid builds up and causes pressure in the skull.

Currently, medical experts are unsure as to why this Mirena side effect may be occurring, but they suspect it has to do with the device’s release of the hormone levonorgestrel.

Pseudotumor cerebri is appropriately named as its symptoms often scare patients and their physicians into thinking there is an actual tumor inside their brains. Mirena side effects that patients have reported include: severe migraines, hearing a ‘whooshing’ sound, blurred vision, double vision, temporary blindness, or possible permanent blindness.

Despite having similar symptoms to a brain tumor, pseudotumor cerebri is not a fatal condition. However, this condition can lead to permanent blindness if not treated promptly.

Patients from all over the country are suing Bayer Pharmaceuticals after suffering this side effect, alleging that the company deliberately concealed the link between levonorgestrel and pseudotumor cerebri.