Mirena IUD Pseudotumor Cerebri and Uterine Perforation Lawsuits

Mirena pseudotumor cerebri lawsuits allege that Bayer, the company that makes Mirena IUD, did not warn consumers and the medical community of pseudotumor (PTC) risks—also known as intracranial hypertension (IIH)-- and other serious Mirena side effects such as mirena uterine perforation. From 2000 to 2013 the FDA received more than 70,000 reports of Mirena IUD side effects, and hundreds of Mirena intracranial hypertension lawsuits claim that Bayer withheld information from consumers about the importance of seeking immediate medical attention if they experience severe headaches, vision problems or other symptoms of PTC after Mirena is implanted.

Mirena was approved by the FDA in 2000 as a contraceptive device and in 2009 it was approved for the treatment of heavy menstrual bleeding for women who prefer an IUD as their method of birth control. The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic progestogen, to prevent pregnancy and to treat heavy menstrual bleeding. (Progestogen is a naturally occurring hormone.) Levonorgestrel is commonly used in combined oral contraceptives, and the intrauterine form of levonorgestrel (IUL) is marketed as Mirena® in North America.

Mirena lawyers are reviewing claims for women nationwide and in Canada who have experienced side effects of Mirena, such as:
 

• Idiopathic Intracranial Hypertension (IIH);
• Pseudotumor Cerebri (PTC);
• Migration or Perforation Injury Resulting in Surgical Removal Unintended Pregnancy Resulting in Birth Defects or Injury to Mother;

 
According to more than 100 Mirena PTC and IIH lawsuits, Bayer sold the IUD birth control without providing adequate warnings and information about the risk of these serious complications. They claim that Bayer withheld information from consumers and the medical community about the importance of seeking immediate medical attention if they experience severe headaches, vision problems or other symptoms of PTC after Mirena is implanted.

The Mirena prescribing information says that the IUD should be used with caution in patients who have “migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.” This information could mean the possibility of an ischemic stroke, which involves a blood clot in the brain, but Mirena does not warn anywhere about the possibility of idiopathic intracranial hypertension or pseudotumor cerebri.

In April, 2017 the IIC and PTC lawsuits were centralized in a Multi-District Litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all federal complaints pending in the MDL. The U.S. District Judge presiding over these federal cases has approved filing of new cases directly in the multidistrict litigation (MDL).

By April 26, over 100 federal Mirena lawsuits have been consolidated (MDL No. 2767) in the District of New York.

In January, 2017 a Georgia woman filed a complaint against Bayer claiming Mirena caused a dangerous buildup of fluid pressure around her brain, known as idiopathic intracranial hypertension (IIH) or pseudotumor cerebri (PTC), resulting in severe vision problems and nerve damage to her eye muscles. Maria Pitts filed her complaint in the in the U.S. District Court for the District of New Jersey, alleging that Bayer failed to warn about the risk of IIH/PTC complications from Mirena.

In April 2016 a Mirena PTC lawsuit was filed by a Maryland woman alleging the birth control device caused her to develop idiopathic intracranial hypertension (IIH). Daphne Houck claims she experienced these symptoms shortly after the Mirena was implanted. She followed up with an MRI and CT scan that diagnosed pseudotumor cerebri and underwent a lumber puncture to remove excess cerebrospinal fluid from the skull.

In September 2015 a Florida woman filed a complaint in the U.S. District Court for the Western District of Tennessee, alleging that Mirena caused her to suffer severe migraines, cognitive problems, vision problems, memory loss and other problems. Nicole Hamill claims that she experienced PTC symptoms just one month after being implanted with the IUD in 2004. Hamill required lumbar punctures to relieve intracranial pressure and had the Mirena IUD removed. However, the punctures do not cure the condition. In March 2014 the first Mirena pseudotumor cerebri(PTC) and/or idiopathic intracranial hypertension (IIH)lawsuit was filed in Alabama. A federal judge allowed the lawsuit to proceed after plaintiff Shenika Houston sufficiently claimed negligent design, strict liability, breach of express warranty, and fraud. The lawsuit states that patients who develop PTC might continue to use Mirena because the label does not include warnings about this potential risk. This could contribute to the development or progression of PTC or IIH.

In May 2014, Law 360 reported that lawyers, on behalf of plaintiffs, asked a panel of federal judges to centralize nine Mirena lawsuits involving PTC/IIH into an MDL in the U.S. District Court for the Middle District of Tennessee, which is separate from the MDL 2434 (above).

Plaintiffs allege that Bayer failed to adequately warn about the link between the hormone levonorgestrel, present in Mirena, and PTC/IIH. The lawsuits allege that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor.

All plaintiffs claim that Bayer knew or should have known about the link between Mirena and levonorgestrel and PTC, and Bayer should have provided stronger warnings about the risk of PTC/IIH.

The intracranial hypertension from Mirena often presents as a swelling of the optic nerves, called papilledema. Bayer has included information about the risk of papilledema on its warning labels in several countries, such as South Africa and Hong Kong. It has not given doctors or Mirena consumers in the US the same warning.
  Levonorgestrel (Mirena) has been linked to serious side effects, including pseudotumor cerebri (PTC), a condition that occurs when the pressure inside your skull (intracranial pressure) increases for no obvious reason. The exact cause of PTC is unknown. The symptoms mimic those of a brain tumor, but no tumor is present. When no cause for the increased intracranial pressure can be discovered, PTC can also be called idiopathic intracranial hypertension (ICH). These brain injuries can lead to vision loss, damage to the optic nerve (papilledema), migraines, tinnitus, and can require surgical treatment.

In Mirena clinical trials, 7.7 percent of women reported headaches/migraines.

The Mayo Clinic lists the following symptoms associated with PTC:
 

• moderate to severe headaches originating behind the eyes that worsen with eye movement;
• ringing in the ears that pulses in time with a person' heartbeat;
• dizziness, nausea or vomiting;
• blurred vision and/or double vision;
• seeing light flashes;
• temporary or passing blindness;
• neck, shoulder or back pain.

  Back in 1995 the New England Journal of Medicine published a study where researchers concluded that certain products containing levonorgestrel, including the Mirena IUD, came with a higher risk of PTC. In June 2015, an FDA study found a higher than expected number of reports of ICH with Mirena in the FAERS database, the agency’s Adverse Events Reporting System. Also in 2015 at the annual meeting for the Association for Research in Vision and Ophthalmology, a presentation suggested that exposure to a levonorgestrel-releasing intrauterine system (such as Mirena) was significantly associated with the development of [idiopathic intracranial hypertension,” and that the use of Mirena IUD is “disproportionately more common among IIH patients than non-IIH patients.

In April 2017, the journal Neuro-Ophthalmology published “An Estimation of the Risk of Pseudotumor Cerebri among Users of the Levonorgestrel Intrauterine Device.” After reviewing medical records from databases, researchers found that Mirena users were over seven times more likely to develop pseudotumor cerebri. This study suggests that there is compelling evidence of an association between the IUD and brain injuries.
  In 2010 a joint safety information statement issued by Bayer Inc. and Health Canada stated that women in the US and Canada reported injuries related to use of Mirena. Bayer AG and Health Canada said that uterine perforation is a rare complication associated with all intrauterine contraceptive devices/systems, including Mirena. Perforation occurs at a rate between 1/1,000 and 1/10,000 insertions. The statement was issued because Bayer Inc, had received reports of uterine perforation associated with the use of its device. The statement also noted that the risk of perforation may be increased after pregnancy, during lactation, and in women with atypical uterine anatomy.

For claims involving injuries caused by migration of Mirena and perforation of the uterus, a Multi-District Litigation (MDL 2434) has been centralized in federal court in New York, involving more than 500 lawsuits. Nearly 800 additional lawsuits are pending in state court in New Jersey.
 

Mirena IUD Legal Help

If you or a loved one has suffered illness or an adverse health event resulting from the use of this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

 

Last updated on Mar-2-22