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Mirena Lawsuits: Settlements, Symptoms & Hiring a Lawyer

Mirena IUD Lawsuits

When should you file a lawsuit over Mirena side-effects?

Two million women have been implanted with the Mirena intrauterine device since it was marketed in 2001. The Food and Drug Administration has received more than 70,000 complaints from patients experiencing complications and side effects from pain to pseudotumors to organ perforation. Learn more about Mirena lawsuits and whether you should pursue a claim.

Mirena is an intrauterine device (IUD) that releases the hormone levonorgestrel into the uterus. It’s considered an effective method of birth control that lasts about 3 to 7 years and has a failure rate of about 0.2% per year.

The pharmaceutical giant Bayer, which makes Mirena (in addition to other levonorgestrel IUDs Kyleena and Skyla), estimated that Mirena was the most-prescribed IUD in the U.S. in 2018 and that 2 million women worldwide were using the device.

An estimated 2 million women worldwide use the Mirena IUD. Tweet this

About 8.5% of women in the U.S. use a form of reversible contraception, or birth control that is long-lasting but would allow a woman to become pregnant once removed.

Why do women choose Mirena?

Mirena has been marketed as safe, easy, and effective for everyone from teens to premenopausal adult women.

It has numerous touted benefits, including:

  • Doesn’t require advance planning for intercourse
  • Doesn’t require partner participation
  • Remains in place for several years
  • Can be removed anytime and normal fertility returns quickly
  • Can be used while breastfeeding
  • Doesn’t have the risky side-effects associated with estrogen birth control
  • 20% of women stop having menstrual periods after using Mirena for 1 year (bleeding is decreased after 3 or months of use)
  • Decreased menstrual discomfort and pain related to endometriosis
  • Decreased risk of pelvic infection and endometrial cancer

Doctors also prescribe Mirena for reasons other than birth control. Some women are prescribed Mirena to ease these conditions:

  • Heavy menstrual bleeding
  • Cramping or menstrual pain
  • Endometriosis and endometrial hyperplasia (abnormal growth of the uterine lining)
  • Adenomyosis
  • Anemia
  • Fibroids

Bayer’s marketing strategy for Mirena was to target “busy moms” because Mirena would be more convenient than remembering to take a daily birth control pill.

Basis for Mirena lawsuits

Unfortunately, while Mirena IUD has worked well for some women, many others have suffered serious and painful side effects.

There have been thousands of lawsuits related to Mirena because of claims that Bayer didn’t warn of the potential danger of the device. There are also claims that Bayer knew of Mirena’s design flaws and continued to manufacture and sell a dangerous product.

Mirena lawsuits are related to injuries that include:

  • Perforated organs and device migration
  • Bleeding
  • Ectopic pregnancy
  • Pelvic inflammatory disease (PID)
  • Pseudotumor cerebri (“false brain tumor”)
Facing factsThere have been more than 45,000 adverse event reports about Mirena since its FDA approval in 2000.

There are 2 main aspects to Mirena lawsuits:

Legal claims Alleged injuries
  1. Misleading advertising about the benefits to Mirena
  2. Failure to warn patients about the risks associated with Mirena
  1. Organ perforation and device migration
  2. Pseudotumor cerebri (effects similar to a brain tumor)

Organ perforation and device migration

Some women claim that after being placed in the uterus, their Mirena IUD traveled (migrated) from its seated location in the uterus and perforated the uterine wall. Some women claim the device traveled through the uterus into their abdominal cavity and perforated or punctured other organs like the bladder, kidneys, intestines, fallopian tubes, ovaries, and cervix.

Symptoms of uterine wall perforation:

  • Nausea and vomiting
  • Abdominal swelling or bruising
  • Bowel changes
  • Severe bleeding
  • Difficulty breathing
  • Severe abdominal pain
  • Dizziness or fainting
  • Irregular heartbeat
  • Fever
Facing factsThere were more than 1,000 claims that were consolidated into New York multidistrict litigation. Bayer offered $12.2 million to settle these cases in 2018.

Pseudotumor cerebri

This condition is when increased blood pressure in the brain causes similar symptoms to a brain tumor. And, while it’s called a “fake” brain tumor, it results in very real injuries — vision loss, migraines, tinnitus, and other issues that require surgery and other treatments.

As of 2017, there were nearly 200 lawsuits alleging that Mirena caused intracranial hypertension, which is a buildup of pressure around the brain, which raises the possibility of a stroke.

Enjuris tip: Multidistrict litigation (MDL) consolidates similar cases from across the country into a single claim. This grouping streamlines the discovery process and helps the cases to move through the court system faster. Medical device lawsuits typically take the form of an MDL because there are a large number of patients experiencing similar side effects and complications from the same product.

Mirena MDLs are based on a type of negligence called “product liability,” or defective products.

Mirena regulatory and litigation timeline

December 2000 Mirena is approved by the FDA to be implanted in women as a form of birth control. It is later approved for treatment of heavy menstrual bleeding.
May 2008 The FDA required the first major update to the Mirena warning label. Bayer was required to include warnings about risks related to:

  • Increased susceptibility to pelvic infections
  • Up to half of pregnancies occurring in a woman who currently have a Mirena device are ectopic (outside of the uterus)
  • Severe pain a few hours after insertion and sepsis within a few days
  • Uterine wall or cervix perforation
  • Increased risk of ovarian cysts
  • Additional precautions for breastfeeding women and interaction with other medications
July 2008 The FDA required additional safety labeling for Mirena including these warnings:

  • Intrauterine pregnancy, with the warning being that if a woman becomes pregnant the Mirena device should be removed, which could result in pregnancy loss
  • Birth defects
  • Embedment, which could result in the necessity of surgical removal
  • Perforation, which can result in migration or surgical intervention
  • Increased risk of perforation for women with certain conditions (including lactating, fixed retroverted uterus, and during the postpartum period)
  • Expulsion, which means the body could propel the Mirena device outward through the uterine cavity without the woman noticing; partial expulsion could reduce the effectiveness of the device
  • Hormonal birth control is not recommended for women who have had breast cancer or a suspicion of breast cancer
April 2009 The FDA issued a warning to Bayer about misleading marketing claims. The FDA says the device should only be marketed to women who have already had at least 1 child and should only be used for up to 5 years.
December 2009 The FDA submitted a warning letter to Bayer regarding its misleading advertising. The advertising for Mirena claimed that Mirena could help “busy moms” rekindle intimacy with their partners and that it could make them “look and feel great.”

However, the FDA said that although the convenience factor of not having to take a daily birth control pill was valid, “[the] FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.”
April 2012 The first Mirena lawsuit was filed by a woman in Ohio whose device migrated from its original implant spot in her uterus.
November 2012 FDA’s Adverse Event Report indicated that there had been 45,000 complaints about Mirena up to June 2012.
April 2017 MDL was initiated in the Southern District of New York for pseudotumor cerebri and idiopathic intracranial hypertension caused by Mirena.
August 2017 Bayer offered a $12.2 million settlement to women who suffered organ perforations. The settlement agreement was drafted in 2018.
April 2018 Discovery (evidence gathering) began to investigate whether Mirena was the cause of the pseudotumor cerebri injuries.
February 2019 A judge in U.S. District Court ruled to exclude 7 experts’ testimony. He did not believe there was enough evidence to support claims that Mirena had caused these injuries.

Types of Mirena lawsuits

Multidistrict litigation for Mirena

Approximately 2,000 cases relate to device migration, which resulted in injuries. These cases are in New Jersey’s Bergen County Court.

Enjuris tip: Experiencing pain and alarming symptoms or side effects after having an IUD inserted? Speak with your doctor first and eliminate other possibilities before pursuing a lawsuit.

Class-actions for Mirena patients

There are currently no class actions in regard to Mirena. There are a few key differences between a class action and an MDL. The general consensus is that a class action is not a good choice for medical device lawsuits.

Mirena lawsuits by individuals

If you would like to pursue an individual claim for an injury related to Mirena use, you should contact a personal injury lawyer near you for guidance on whether that’s possible. If the defendant is doing business in your state, you can file a claim in state court. If the defendant isn’t doing business in your state, the claim would be filed in federal court. Your lawyer will be able to advise on what would be the correct jurisdiction for your lawsuit.

If there’s still a pending MDL, you could be ordered to join that legal action rather than beginning an individual lawsuit.

What to do if you think you might have a Mirena lawsuit

If you believe that your Mirena implant is causing side-effects, your first stop should be your doctor’s office. An examination can reveal whether the IUD is the cause of your pain, infection, perforation or other complications. The most important thing is to keep your health under control.

If you have dealt with symptoms that your doctor believes could be related to your IUD, talk to an attorney.

Keep in mind that every state has a statute of limitations, after which you will no longer be able to file a claim. Some states only allow one year in which to file lawsuits for personal injury. You can always change attorneys later if necessary.

Here’s a worksheet with questions to ask a personal injury attorney to determine if your lawyer is the right fit.

Your First Meeting with an Attorney
A worksheet to prepare for your first meeting with a personal injury attorney – what to bring, what they'll ask
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