Defective Medical Devices

Mirena Users File Lawsuits Claiming IUD Caused Serious Injuries

This Alert Affects:

Women who experienced serious side effects after being implanted with Mirena.

What Is Mirena?
Mirena is an intrauterine device (IUD) that is inserted in the uterus and prevents pregnancy by releasing a medication known as levonorgestrel.
What Are the Allegations?
Lawsuits allege that the maker of Mirena failed to adequately warn women that the device can embed itself in the uterus, perforate the uterus or travel into the pelvic area, causing infections, scarring, organ damage, adhesions, intestinal obstruction and hemorrhages. If a woman becomes pregnant after receiving Mirena, she may also be at risk for an ectopic pregnancy, a miscarriage or infertility.
Manufacturer
Bayer
FDA Warning
In 2009, the FDA demanded that Bayer immediately cease its marketing program known as "Mirena parties." The agency said that these events were misleading because they overstated the efficacy of Mirena, while minimizing its risks.
Type of Lawsuit
Mass Tort

Hundreds of women have filed lawsuits against Bayer, the maker of Mirena, alleging that the intrauterine device (IUD) puts women at risk for serious side effects that greatly outweigh the benefits of using the contraceptive. These lawsuits claim that Bayer knew, or should have known, that women were suffering infections, organ damage and other complications following implantation, but failed to adequately warn the public about these risks. Bayer “had a continuing duty to warn consumers…and the medical community of the dangers associated with Mirena,” lawsuits claim, and now may be liable for medical bills and other damages incurred by IUD victims across the country.

Were you injured after using Mirena? If so, you may be entitled to compensation. At ClassAction.org, we help clients get in contact with lawyers who can help them file lawsuits and hold major pharmaceutical companies like Bayer accountable for their actions. 

Mirena Side Effects Include Infections, Organ Damage and Hemorrhages

Lawsuits claim that Mirena can damage the uterus or cause other injuries if the IUD migrates from its original position. Some plaintiffs allege they experienced infections, organ damage, hemorrhages and scarring after being fitted with Mirena, and others claim they needed to have the device surgically removed. In some cases, women reported undergoing hysterectomies or oophorectomies (removal of one or more ovaries) to resolve their problems.

It has been alleged that certain women may be more susceptible to uterine perforation, including those who are lactating, have had an abortion, are in the post-partum period or have an atypical anatomy of their uterus. Furthermore, women who have undergone a C-section or other cervical surgeries may be at an increased risk of injuries.

What Are the Lawsuits Saying About Mirena?

The Mirena lawsuits allege:

  • Mirena is defective, dangerous and not suited to be used as intended
  • Bayer did not perform adequate testing to determine the safety and efficacy of the IUD
  • Bayer concealed its knowledge that Mirena could put users at risk for serious side effects
  • Bayer took part in a marketing campaign known as “Mirena parties,” which misled women and further diluted warnings for potential side effects
  • There are other contraceptives available that are equal to or greater in effectiveness and that carry far less of a risk
  • Bayer failed to adequately warn women and doctors about serious side effects associated with Mirena

These lawsuits are seeking compensation for past and future medical bills, pain and suffering, and loss of consortium (marital relations). Since it has been alleged that Bayer acted in wanton and willful disregard for the public’s safety, the plaintiffs are also seeking punitive damages, which a judge may award to punish the defendant and discourage other companies from engaging in similar conduct.

Is This a Class Action?

This is not a class action lawsuit. Rather, the Mirena lawsuits will proceed individually, which means that each woman who suffered an injury after being implanted with Mirena will have to file her own lawsuit. If you need help filing a lawsuit or have questions about your rights, ClassAction.org may be able to connect you with an attorney who can help. For more information on why this is not a class action, click here.

In 2013, the Mirena lawsuits were consolidated to a single court in a procedure known as multidistrict litigation (MDL). The MDL is currently being overseen by Judge Cathy Seibel in the U.S. District Court Southern District of New York. By having one judge oversee pre-trial proceedings in hundreds or thousands of lawsuits, the MDL will save time and money for all parties involved and help ensure consistent rulings. Although the lawsuits have been consolidated, each plaintiff will retain his or her attorney, lawsuit, and right to an individual award.

How Much Does a Lawyer Cost?

Typically, this will depend on whether your attorney wins the case. If the case is successful, your attorney will collect a percentage of the final verdict or settlement award as his or her payment for working on the case. In most instances, you will not be responsible for paying your lawyer if he or she does not win your case.

Bayer’s “Mirena Parties” Misled Women and Minimized Risks, FDA Says

In a warning letter the FDA sent to Bayer in 2009, the agency said that the manufacturer’s promotional campaign, known as “Mirena parties,” violated the Federal Food, Drug and Cosmetic Act by overstating the efficacy of the birth control, while minimizing its risks.

At these parties, a nurse practitioner and a representative from a social media website working with Bayer would read from a script that promoted Mirena for “busy moms.” The script stated that the birth control device required “no daily, weekly or monthly routine,” and claimed that the IUD could help “increase intimacy” and make women “look and feel great.”

In its warning letter, the FDA noted that women had to continuously monitor two strings attached to the Mirena IUD; otherwise, it would not prevent pregnancy. Therefore, the agency pointed out that claiming the IUD required no routine was false and misleading. Furthermore, the agency said that there was no evidence available to support claims that the birth control would increase levels of intimacy or emotional satisfaction. In fact, at least five percent of clinical trial patients reported decreased libido after using Mirena.

While the “parties” did point out some side effects of the birth control device, the FDA stressed the dangers of becoming pregnant after being fitted with Mirena, which could put women at risk for ectopic pregnancy (pregnancy outside of the womb), pregnancy loss and a permanent loss of fertility.

According to the FDA, clinical trial patients also reported the following side effects with Mirena:

  • Feelings of depression
  • Nervousness
  • Pelvic inflammatory disease (PID)
  • Ovarian cysts
  • Irregular bleeding
  • Amenorrhea
  • Abdominal/pelvic pain
  • Nausea
  • Headache
  • Back pain
  • Weight increase
  • Breast pain/tenderness
  • Acne

Some women claim that the misleading information presented at these parties led them to choose the IUD for its alleged “convenience.”

Can I Sue the Maker of Mirena?

If you or a loved one suffered from an IUD injury after using Mirena, you may be entitled to compensation. At ClassAction.org, we help clients get in contact with attorneys who may be able to answer questions about their legal rights and help them file lawsuits. 

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Case Resources

Johnson v. Bayer Healthcare Pharmaceuticals Inc. Complaint
Case number 1:12-cv-00852, U.S. District Court for the Southern District of Ohio
In re Mirena IUD Products Liability Litigation Transfer Order
MDL number 2434, U.S. District Court for the Southern District of New York
FDA Warning Letter, December 2009
The FDA warns Bayer HealthCare that its "Mirena parties" overstate the efficacy of the IUD, and make false and misleading representations about the device.
Mirena Parties Script Excerpts
"Mirena Parties" touted that the IUD had "no daily, weekly or monthly routines," among other misleading statements the FDA criticized.
Journal of the Society of Laparoendoscopic Surgeons Article, January 2011
Researchers report on the experiences of two women who suffered uterine perforation after receiving the Mirena IUD.