Mirena Complications and Injuries
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed March 05, 2024
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Many women seeking a long-term birth control solution have turned to the Mirena IUD. Doctors place this small, T-shaped plastic birth control device in a woman's uterus. This is where your body releases the hormone levonorgestrel to prevent pregnancy.
Since the Food and Drug Administration (FDA) approved the device in 2000, Mirena has become popular among women and gynecologists. Bayer designed the device to last up to five years. But in August 2022, the FDA approved the device for up to eight years.
Generally, IUDs require less maintenance than condoms and birth control pills. Your doctor can also remove your IUD at any time. Like most birth control methods, Mirena carries the risk of potential health complications.
Mirena's side effects and injuries have led to mass tort litigation and government warnings.
Common Complications
Most women with an IUD don't experience any severe problems. The Mirena IUD has proven to be 99% effective in preventing pregnancy. But for the 1 in 100 women who do become pregnant with the device, there are serious health risks.
According to Bayer, women who become pregnant while having the Mirena IUD may encounter the following:
- Ectopic pregnancy
- Severe infection
- Miscarriage
- Premature birth
Most women who suffer an ectopic pregnancy require surgery. Even if your doctor removes the IUD device, this type of pregnancy can be life-threatening. This is why you must ensure you aren't pregnant before your gynecologist implants the IUD.
Even women who don't become pregnant with the Mirena IUD may suffer adverse side effects. These include:
- Organ perforation of the uterine wall or cervix
- Device migration
- Pelvic inflammatory disease (PID)
- Bladder infections
- Infertility
Some of the less severe Mirena side effects include:
- Headaches
- Breast pain and tenderness
- Irregular menstrual bleeding
- Pelvic pain
- Cramping
- Ovarian cysts
- Vaginitis
Mirena complications generally require device removal. Removal can lead to:
- Additional medical costs
- Time off work
- Pain and suffering
More severe cases can require surgery to remove the device and treatment for the damaged internal organs.
Mirena IUD and Pseudotumor Cerebri
One of the more severe complications of the Mirena IUD is a condition called pseudotumor cerebri (PTC). PTC is similar to a brain tumor. It's also known as idiopathic intracranial hypertension.
With this condition, patients experience the accumulation of cerebrospinal fluid in the skull.
Some of the symptoms of PTC include migraine headaches and vision problems. Researchers argue that the synthetic progestin in the Mirena IUD contraceptive device (levonorgestrel) causes PTC. Many Mirena IUD lawsuits involve patients suffering from this condition.
Government Warning and Lawsuits
Mirena IUD's problems didn't go unnoticed by the government. In December 2009, the Food and Drug Administration issued a warning letter to Bayer Healthcare Pharmaceuticals.
The letter alleged that Bayer's promotional materials overstated Mirena's effectiveness at rekindling intimacy. It also claimed that Bayer's advertisements minimized and omitted risks of infections and pregnancies. The letter further claimed that Bayer's promotional materials falsely claimed that using Mirena requires no monthly routines. The FDA requested Bayer stop using these inaccurate promotional materials.
In addition, many women filed suit against Bayer Pharmaceuticals. The plaintiffs alleged they sustained health complications by using Mirena. They claim it was a defective medical device.
Product liability law requires that products meet the ordinary expectations of consumers. Defective products may suffer from a design or manufacturing defect. Some product liability cases involve improper or misleading marketing efforts. Many Mirena IUD lawsuits focus on the promotional materials the FDA cited in its 2009 warning letter.
Mirena IUD and Medical Malpractice Lawsuits
Some Mirena cases involved medical malpractice by gynecologists and other medical professionals. For example, a doctor who improperly implants an IUD into a patient or fails to discuss the possible risks involved with the procedure can be liable for medical malpractice.
If you successfully sue your doctor for malpractice, you can demand the same damages you'd demand in a product liability lawsuit.
Continued Use of the Mirena IUD
Despite lawsuits and FDA warning letters, neither Bayer nor the FDA have recalled the Mirena IUD. It remains a popular choice. Most medical professionals also continue to stand by IUDs as an effective form of birth control. But women who experience Mirena complications may want to consult an attorney to learn more about their legal options.
Discuss Your Mirena Claims With an Experienced Attorney
Many women have turned to the legal system after using the Mirena device. You may have a legal claim for damages if you suffer an injury after having the Mirena IUD. Discuss your case with an experienced personal injury lawyer.
Most law firms offer new clients a free case evaluation. Contact an attorney with experience with drug and medical device cases who can help you understand all your options and protect your legal rights.
Next Steps
Contact a qualified product liability attorney to make sure your rights are protected.
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