As promoted by Bayer, its manufacturer, the Mirena IUD is a highly effective birth control device that can remain in the uterus for as long as five years. The product website also warns that it’s not indicated for women with a pelvic infection, who get infections easily or those who have certain cancers.
What the website doesn’t say is that the FDA has received more than 47,000 reports of injuries and complications from people who have used the device. According to AboutLawsuits.com, Adverse Events, a private company, analyzed adverse event reports submitted to the feds to come up with these troubling figures.
Most of the problem reports concern the IUD:
- being expelled from the body (3.6 in 10 reports);
- migrating outside their placement position in the uterus (1 in 10 reports);
- causing vaginal hemorrhaging (slightly less than 1 in 10 reports).
Adverse Events analyzes reports submitted by consumers and health-care professionals to the FDA’s Adverse Events Reporting System (FAERS) and summarizes them in charts and graphs of timelines, side effects and demographic information. The Mirena report concerns thousands of reports the FDA received between November 1997 and August 2012.
The Mirena IUD prevents conception by releasing a synthetic hormone, levonorgestrel, to prevent the ovaries from releasing eggs into the uterus. Some women use it to treat heavy periods.
The Mirena website list of possible side effects includes migrating through the uterus wall, but, as AboutLawsuits says, concern has ratcheted up and a”growing number of women throughout the United States are now pursuing a Mirena injury lawsuit against Bayer.” They claim that the company failed to adequately warn about the risk of complications, “which could cause infections, damage to internal organs and often results in the need for surgery to remove the IUD.”
According to the reports, about 6 in 100 women were hospitalized because of the Mirena problems, and Adverse Events said more than 50 deaths might have been associated with the adverse event reports it reviewed.
Millions of women have had a Mirena IUD implanted, and AboutLawsuits says that as of early April, at least 50 lawsuits had been filed throughout the federal court system, and that’s probably just the beginning.
If you have a Mirena IUD, discuss the benefits and risks of it with your doctor, and ask about alternatives for contraception or other problems for which you have the IUD. If you’ve had problems with the device, report them to the FDA’s MedWatch program.