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.
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Mirena IUD Side Effect Claims Being Investigated
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;
Mirena Pseudotumor Cerebri Lawsuits
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.
Background: Mirena and Pseudotumor Cerebri/Idiopathic Intracranial Hypertension
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.
Mirena Pseudotumor Cerebri Studies
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.
Mirena Uterine Perforation
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.
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Toronto, ON. Nickey followed her doctor’s orders, and the Mirena manufacturer’s orders: five years after the IUD was implanted, she made an appointment to have it removed. But it wasn’t that easy. Next month will be the fourth, and she hopes final, attempt to have all of the birth control device removed from her uterus.
“On the first attempt, my OB/gyn couldn’t find the string so he sent me to another specialist where I had an ultrasound to see where exactly this Mirena was,” says Nickey. “He found the Mirena in my uterus—where it was supposed to be—but when he tried to remove it, the metal piece broke.”
Next up, Nickey had to undergo a general anesthetic, but her doctor told her during the follow-up appointment that the Mirena had perforated her uterus. “He told me that a Da Vinci surgical robot was supposed to have been used in this procedure but it wasn’t available that day,” Nickey says. he didn’t tell Nickey when and how her uterus was perforated by the Mirena. “He is definitely going to use the robot next month to retrieve this broken piece— it will be the fourth attempt to have this Mirena entirely removed.”
A study published by the International Journal of Women’s Health concluded that IUD perforation, “is a rare but serious complication of IUD use”. If a device perforates the uterine wall, it can continue to migrate elsewhere in the body and extensive surgery may be necessary to repair the damage. Nickey is 33 years old and the mother of a 10-year-old boy. She wants to have another child, so this complication is extremely worrisome.
Given the number of lawsuits filed against the manufacturer, Bayer Healthcare, alleging permanent injuries and trauma due to complications that necessitated surgical removal, IUD perforation is not so rare. (The study was conducted in 2014). Between 2000 and 2013, the FDA had received 70,072 complaints about the Mirena IUD, according to a report by
“Since the first surgery to have the Mirena removed I have had such heavy bleeding that I needed to take iron pills and often found myself shaking,” says Nickey. “As well, I had a lot of pain after the surgery—I’m not looking forward to the surgery on January 24th. And it’s a one-hour drive to the hospital. Who is paying for my time?
“If I knew what I know now about Mirena, I would never have gotten this IUD. I’m weighing my options about other kinds of birth control but before that, I have to get my body back to normal. And I am concerned that I have damage to my uterus because I want more kids one day. My doctor knows I want more kids and he has given me options if it cannot be removed. If push comes to shove, he mentioned hysterectomy. Emotionally and physically, this IUD has taken a lot out of me…I just want it out.”
If the Mirena has perforated the uterine wall, robotic surgery or laparoscopic surgery is necessary. A number of women who have undergone surgery to have the device removed have charged Bayer with manufacturing a defective product. They seek damages to cover medical expenses, lost wages, and ongoing care needs, and to compensate them for pain and suffering. Sadly, many women have also undergone hysterectomies.
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