Mirena is an intrauterine device (IUD) that has been linked to spontaneous uterine perforations and a rare brain disease that can cause chronic headaches and blindness. Now, thousands of women have filed lawsuits accusing Bayer of failing to warn about these risks.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Mirena induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a uterine perforation or brain injury, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Mirena is a type of birth control known as an intrauterine device (IUD). Mirena is sold by Bayer HealthCare and it was approved by the FDA in 2000. Since then, more than 2 million woman have used Mirena. It is more than 99% effective at preventing pregnancy for up to five years.
How Does Mirena Work?
Mirena is inserted into a woman’s uterus (womb), where it slowly releases levonorgestrel (a synthetic version of the hormone progestin). It thickens cervical mucous, which helps prevent sperm from entering the uterus. It also makes the lining of the uterus thinner, which reduces the chances that a fertilized egg will implant and grow.
What is the problem?
Thousands of lawsuits have been filed by women who accuse Bayer of failing to warn about the risk of spontaneous uterine perforations that occur months or years after Mirena is inserted. Because the label on Mirena does not include these warnings, many doctors and women are not aware of the danger. When threads go missing, they assume Mirena has simply fallen out.
Uterine perforation is a very serious, life-threatening complication. When Mirena moves into the abdomen, it can perforate the intestines or cause organ damage. In many cases, it requires immediate surgery. When serious complications occur, a woman may suffer irreversible scarring and/or damage to the uterus. This may cause permanent infertility.
In June 2013, federal panel of judges created a Multi-District Litigation (MDL No. 2434) to centralize lawsuits alleging that Mirena caused uterine perforations in the U.S. District Court for the Southern District of New York.
As of February 2016, over 1,250 cases were pending under U.S. District Judge Cathy Seibel. Another 2,000 cases are pending in state court in New Jersey, bringing the total number of cases to about 3,000.
Judge Seibel has selected cases for the first trials in April 2016. However, just before trials were set to begin, she blocked testimony for plaintiffs’ experts and dealt a major blow to women with uterine perforations. As lawyers scramble to replace the experts, it becomes more likely that trials will be delayed.
FDA Warning Letters for Mirena
In December 2009, the FDA sent a Warning Letter (PDF) to Bayer due to a promotional program for Mirena. The marketing program featured parties hosted by experts who claimed that Mirena could help a woman “look and feel great,” improve a woman’s sexual relationships, and quality of life. According to the FDA:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
The FDA also pointed out that many women do not “feel better.” In fact, about 5% of women who use Mirena actually reported a decrease in libido, which could potentially harm sexual relationships.
Failure to Warn About Side Effects
The FDA also sent Bayer a Warning Letter (PDF) in March 2009. This time, the FDA was concerned that Bayer’s sponsored links on internet search engines are misleading because they make representations and/or suggestions about the efficacy of Mirena, but fail to communicate any risk information.
By law, advertisements for drugs and medical devices must include risk information. By omitting important risk information, including the most frequently occurring risks and side effects, the ads misleadingly suggest that Mirena is safer than it really is. By August 2013, the FDA had received over 70,000 reports of adverse events associated with Mirena.
Mirena Side Effects
- Perforation of the uterus
- Migration of the device into the uterus, or outside the uterus
- Organ damage
- Intestinal perforation or obstruction
- Pelvic Inflammatory Disease
- Ectopic pregnancy
- Surgical removal
Other Serious Risks
- Abdominal pain
- Ovarian cysts
- Irregular bleeding
- Expulsion of the device
- Embedment in the uterus
- Erosion into the uterus or adjacent areas, such as the vagina
- Peritonitis (inflammation of the membrane in the abdominal cavity)
Mirena Brain Injury Lawsuits
In early 2014, Bayer was hit with nine lawsuits accusing them of downplaying risk information about brain injuries from Mirena, including:
- Idiopathic Intracranial Hypertension (IIH)
- Pseudotumor Cerebri (PTC)
- Benign Intracranial Hypertension (BIH)
Attorneys petitioned a panel of federal judges to centralize the litigation in May 2014. However, in August, the judges denied the petition because there were not enough cases. The cases will proceed individually at the state level. In October 2015, a woman who was diagnosed with PTC after using Mirena has filed a lawsuit against Bayer HealthCare for failing to adequately warn about the risk.
Mirena Class Action Lawsuit
The Schmidt Firm, PLLC is nationally recognized as a class action law firm. However, our lawyers are not filing a Mirena class action at this time. Thousands of lawsuits have been filed, but not as a class action. Instead, they are individual lawsuits. Our attorneys are currently filing individual lawsuits on behalf of women who experienced spontaneous uterine perforations or brain injuries.
Do I have a Mirena Lawsuit?
The Schmidt Firm, PLLC is currently accepting Mirena induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a uterine perforation, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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