Women across the country who say they have suffered internal injuries from the Mirena intra-uterine IUD contraceptive device have filed lawsuits against Bayer for misleading doctor and patients and putting a device to market with unsafe tendencies.
Lawsuits over the Mirena IUD device began building in 2011 and plaintiffs in the lawsuits say that Mirena IUDs caused severe injuries after insertion, and that Bayer failed to warn consumers of about these dangers.
The most commonly reported adverse events associated with Mirena IUD devices include severe pain, device migration, and allergic reactions. More serious side effects include perforation of the uterus, pseudotumor cerebri or intracranial hypertension.
Joe Lyon is a highly-rated product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation and Mirena IUD Injury claims against pharmaceutical and Medical Device Companies.
What is a Mirena IUD?
Mirena is a hormonal intrauterine device (IUD) inserted into the uterus for long-term pregnancy prevention. The plastic T-shaped device prevents pregnancy by stopping sperm before it reaches the uterus and fertilizes an egg. The IUD releases a controlled dose of hormones called levonorgestrel. Mirena is designed to prevent pregnancy for up to five years and is one of the most common IUDs in the United States.
There are an estimated 150 million women implanted with the Mirena IUD around the world, although an increasing number of women have reported serious side effects such as perforation of the uterus, pelvic inflammatory disease (PID) and ectopic pregnancy.
Mirena Side Effects & Complications
Many complaints about Mirena devices involve serious complications like device expulsion and device migration. Since 2008, over 4,000 women have reported a “device dislocation,” which describes when the IUD becomes embedded in the uterus, or when an IUD has migrated outside the uterus. Other birth control devices like Kyleena, Skyla, and Liletta and Essure have been known to cause similar complications.
Other short-term and long-term adverse events in patients include the following:
- Persistent abdominal, pelvic or back pain
- Perforation of the uterus and/or fallopian tubes
- Intra-abdominal or pelvic device migration
- Irregular bleeding
- Weight fluctuations
- Hair loss
- Autoimmune disorders
- Device failure
- Mood changes, including depression
- Joint or muscle pain
- Allergic or hypersensitivity reactions
- Breast tenderness
- Ovarian cysts
- Pelvic inflammatory disease (PID)
- Idiopathic intracranial hypertension (IIH)
- Pseudotumor cerebri (PTC)
- Vision issues
- Chronic headache/migraines
Mirena May Cause Abnormal Bleeding
Up to 20 percent of Mirena users may experience amenorrhea (the absence of periods) or oligomenorrhea (infrequent periods). Excessive Mirena IUD bleeding may require medical attention or the removal of the device.
Be aware that prescription blood thinners, and other medications can increase your risk of severe bleeding with an IUD. The FDA has received tens of thousands of reports of women suffering from bleeding complications while using Mirena devices. Common abnormal bleeding symptoms may include:
- Irregular bleeding
- Heavy bleeding
- Continuous bleeding
- Frequent menstruation
Mirena Lawyer & IUD Injury Lawsuits
Since Mirena was introduced to the marketplace, doctors and patients have reported various health-related problems. More than 45,000 adverse event reports relating to Mirena complications have been submitted to the U.S. Food & Drug Administration (FDA).
In 2009, the FDA sent a warning letter to Bayer, implying that the company exaggerated the efficacy of Mirena while downplaying the risks. In fact, the FDA required an update to the warning label, including the following changes:
- Pelvic infections—women suffer from conditions associated with increased susceptibility to pelvic infections
- Ectopic Pregnancy—up to half of pregnancies that occur with Mirena in place are ectopic
- Sepsis—severe pain can occur within hours of insertion followed by sepsis within days
- Uterine Perforation—perforation or penetration of the uterine wall or cervix may occur during insertion
- Ovarian Cysts—the risk of ovarian cysts is present
Hundreds of lawsuits have been filed against Bayer for a number of adverse health outcomes and yet the device remains on the market. Lawsuits allege that dangers were understated by the manufacturer and also allege the devices were both defective and unreasonably dangerous.