The Mirena hormonal IUD (intrauterine device) is a T-shaped plastic contraceptive device that is inserted into the uterus, where it acts to prevent pregnancy through the release of a version of the hormone progestin, according to the Mayo Clinic. Mirena was fairly unique when it was first introduced to the market and approved by the FDA in 2000, but today it is one of a number of hormonal IUDs that have been approved by the agency. Mirena is manufactured by Bayer, and like many medical devices, comes with certain risks.
In this article, we'll look at known complications associated with Mirena, potential links between progestin (progesterone) and the development of cancer, and the current landscape of product liability lawsuits over Mirena.
Complications Associated With the Mirena IUD
According to Bayer and the Mayo Clinic, complications and known side effects associated with Mirena include:
- pregnancy (including higher risk of ectopic pregnancy)
- pelvic inflammatory disease
- breast tenderness
- unusual bleeding
- ovarian cysts
- pelvic pain
- acne
- headache, and
- risk of the IUD attaching to or perforating the wall of the uterus.
Cancer Precautions and the Mirena IUD
The Mirena IUD contains a synthetic version of progesterone (progestin), which has long been considered a hormone that raises the risk of some cancers. According to a 2011 Michigan State University study:
Researchers have identified how the hormones progesterone and estrogen interact to increase cell growth in normal mammary cells and mammary cancers, a novel finding that may explain why postmenopausal women receiving hormone replacement therapy with estrogen plus progestin are at increased risk of breast cancer.
That's one reason why a doctor will almost certainly recommend removal of Mirena if a patient has had, is at risk of, or actually develops certain forms of cancer, including breast cancer, cervical (endometrial) cancer, and uterine cancer.
Lawsuits Over Mirena
Despite concerns over a possible link between Mirena and certain cancers, much of the litigation over the IUD device revolves around other kinds of health problems— specifically, the risk that Mirena can perforate or otherwise injure the walls of the uterus. But a significant setback for patients in these kinds of cases came in 2016, when a New York federal judge ruled in favor of Bayer (and against almost 1,300 consolidated plaintiffs who were suing the company) and essentially dismissed allegations that use of Mirena caused uterus perforation after the device was inserted.
When health problems associated with a medical device are the subject of a lawsuit, the manufacturer of the device might be held legally responsible for harm to the patient under a legal theory known as "product liability." If you’re experiencing complications related to the use of Mirena, or if you feel you're at unique risk because of your medical history, it’s important to talk with your doctor about what’s happening. And in situations where you've suffered injury as a result of a product like Mirena, it may also make sense to talk to an experienced attorney to discuss your legal options.