Mirena and Pseudotumor Cerebri

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Mirena and Pseudotumor Cerebri Schmidt National Law Group 1

Mirena and Pseudotumor Cerebri

Mirena is a type of long-acting reversible birth control known as an IUD, or intrauterine device. IUDs protect against pregnancy for several years and the insertion procedure is quick and nonsurgical. Millions of women rely on IUDs like Mirena for birth control yet some have come under fire for the potential complications and side effects they can cause. Mirena, manufactured by Bayer Healthcare, has been linked to a serious complication called pseudotumor cerebri, or PTC. Hundreds of women have filed lawsuits against Bayer alleging the Mirena IUD caused them to develop PTC, and more lawsuits are expected to be filed in the future.

Mirena PTC Lawsuits

If you were harmed by the Mirena IUD, you may be entitled to financial compensation. There may be significant payouts and cash settlements awarded to those affected by the Mirena device.

More than 300 lawsuits have been filed by women harmed by the birth control device Mirena, accusing manufacturer Bayer Healthcare of failing to warn about the device’s potential risks. The lawsuits claim Mirena can cause pseudotumor cerebri, or PTC, a condition caused when too much spinal fluid builds up in the skull and puts pressure on the brain. The symptoms of PTC can mimic a brain tumor, even though no tumor is present.
Clinical studies have linked the hormone in Mirena IUD to an increased risk of PTC. If you had Mirena IUD and developed the serious complication PTC, you may qualify for a Mirena PTC lawsuit. Call the experienced lawyers and attorneys at Schmidt National Law Group today for a free consultation.
Mirena PTC lawsuits allege a number of legal claims against Bayer, including:
• Failing to warn about the link between levonorgestrel, the hormone in Mirena, and PTC
• Failing to warn about Mirena’s potential risks
• Misrepresenting the safety and effectiveness of Mirena
• Failing to adequately test Mirena
• Negligence
• Fraud
• Breach of implied and express warranty

Mirena PTC MDL

In April 2017, the Judicial Panel on Multidistrict Litigation ruled to consolidate Mirena PTC lawsuits into a multidistrict litigation, or MDL. The lawsuits were centralized in the Southern District of New York before U.S. District Judge Paul A. Engelmayer in MDL 2767 [IN RE: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II)]. As of October 2017, there were over 300 Mirena PTC lawsuits consolidated in the litigation.

Why MDLs?

MDLs help speed up the litigation process by bringing similar lawsuits together in one court. Attorneys on both sides are able to collaborate during the discovery process, which saves time and resources. A few cases are usually picked to be tried first. These are called bellwether trials. Bellwether trials give attorneys the chance to test out legal theories before a jury and can help inform settlement negotiations.
Verdicts or settlements awarded in an MDL are handed down individually in each case. This means global settlements are not split equally among all plaintiffs, like in a class action lawsuit. Instead, they are distributed among plaintiffs on a case by case basis and are often determined by the extent of the plaintiff’s’ injuries.

What is the Mirena IUD?

Mirena is a type of birth control device called an intrauterine device, or IUD. IUDs are small, t-shaped devices inserted into the uterus to provide birth control. Some IUDs, like Mirena, contain hormones that are released slowly over time to prevent pregnancy. IUDs can provide pregnancy prevention for up to 12 years depending on the device. Mirena IUD contains a synthetic hormone called levonorgestrel and protects against pregnancy for up to 5 years.

How Does Mirena Work?

Mirena works by releasing the synthetic hormone levonorgestrel into the body to prevent pregnancy. Mirena is inserted into the uterus by a doctor in a nonsurgical procedure and can prevent pregnancy for up to 5 years. It is not known exactly how this hormone works to prevent pregnancy; however, it is known that levonorgestrel and the Mirena design work in some combination to prevent pregnancy by: inhibiting sperm from reaching the egg, thinning the uterine lining, and thickening cervical mucus to prevent sperm from entering the cervix.

Mirena IUD Birth Control

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Mirena Problems & Side Effects

Mirena is associated with a number of side effects, including more serious problems that can become life-threatening. Pseudotumor cerebri is one example of the potentially serious complications associated with the Mirena IUD.
The most common side effects of Mirena include:
● Pain, bleeding, dizziness during or after placement
● Expulsion
● Missed menstrual period
● Changes in bleeding
● Cysts on the ovaries

Serious complications associated with Mirena include:
● Pelvic inflammatory disease, or PID
● Life-threatening infection
● Perforation
● Pseudotumor cerebri, or PTC

What is PTC?

Pseudotumor cerebri occurs when pressure inside the skull increases because of a buildup of spinal fluid. Symptoms of PTC can mimic those of a brain tumor, though no tumor is present. PTC occurs most often in women of childbearing years who are obese, but can occur in children and adults.
PTC is a serious condition that, if left untreated, can cause vision loss or blindness due to the increased pressure in the skull and swelling of the optic nerve.
The exact cause of PTC in most people is unknown; however, some medications, including the birth control hormone levonorgestrel, have been associated with an increased risk of the condition.

Symptoms of PTC

According to Mayo Clinic, pseudotumor cerebri signs and symptoms include:
● Moderate to severe headaches that may originate behind your eyes and worsen with eye movement
● Ringing in the ears that pulses in time with your heartbeat
● Nausea, vomiting, or dizziness
● Blurred or dimmed vision
● Brief episodes of blindness, lasting only a few seconds and affecting one or both eyes
● Difficulty seeing to the side
● Double vision
● Seeing light flashes
● Neck, shoulder, or back pain

Clinical Study Links Mirena to PTC

A recent clinical study found an increased risk of PTC (called intracranial hypertension in the study) associated with Mirena, even when compared to other oral contraceptives. The study, published in the journal Therapeutic Advances in Drug Safety in June 2015, used the U.S. Food and Drug Administration’s adverse event reporting database, or FAERS, to determine the risk associated with Mirena and pseudotumor cerebri.
At the conclusion of the study, the authors found a higher than expected number of reports of PTC with Mirena in the FAERS database. They stressed the importance of investigating this risk further, given new recommendations by the American Academy of Pediatrics regarding young women and IUDs like Mirena.
“Our study is the first large epidemiologic study that has examined the risk of ICH [intracranial hypertension] with Mirena,” the study authors wrote. “The recent recommendations from the American Academy of Pediatrics stressing on the use of IU[D] by young girls as the main method of contraception underscores the importance of the results of this study. In light of these recommendations and the possible increase in the use of IU[D]s, the risk of ICH with Mirena must be clearly conveyed to young women who are planning to use them.”

The number of lawsuits being filed against Bayer Healthcare over Mirena and PTC risk is another reason why further studies are needed.

Contact Schmidt National Law Group today for a free case evaluation by calling 1-800-631-5656 or use the form at the bottom of this article.

Schmidt National Law Group handles cases throughout the entire United States including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

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Mirena Prescribing Information. Bayer Healthcare. 2017. Retrieved from: https://labeling.bayerhealthcare.com/html/products/pi/Mirena_PI.pdf

Pseudotumor Cerebri. Mayo Clinic. 2017. Retrieved from: https://www.mayoclinic.org/diseases-conditions/pseudotumor-cerebri/symptoms-causes/syc-20354031

MDL Statistics Report. Judicial Panel on Multidistrict Litigation. October 2017. Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-October-16-2017.pdf

“Risk of intracranial hypertension with intrauterine levonorgestrel.” Mahyar Etminan et al. Therapeutic Advances in Drug Safety. June 2015.
Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4519742/

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