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Mirena Recall and FDA Warnings

side effects of mirenaAs more women turn to alternative methods of birth control, long-term contraceptives like IUDs have become increasingly popular. The Mirena IUD, manufactured by Bayer, is now used by more than 2 million women each year in the United States and 15 million women worldwide.

Unfortunately, experts have linked IUD contraceptives to severe side effects. While there has not been a Mirena recall to date, hundreds of women are pursuing legal claims for their injuries.

The FDA has received thousands of reports of women suffering complications from Mirena IUDs, including uterus perforation or embedment into the uterine wall, pelvic inflammation, infection, ovarian cysts, irregular bleeding, pregnancies resulting in miscarriage and movement of IUDs into the abdomen.

Many of these side effects are of such severity that patients have to undergo surgery to remove the devices. Some have even caused infertility or intestinal injury as a result.

Reports from Bayer indicate they were aware that as many as 1 in 1,000 women using Mirena could suffer such injuries. Due to their failure to properly warn patients of the risks or issue a Mirena recall, they face liability for those affected.

If you or a loved one suffered complications which required removal of a Mirena IUD device, it is important to learn about your legal options. Contact us today to speak with a lawyer.

The small, t-shaped Mirena IUDs were designed to be implanted in the uterus by a healthcare professional, where they release hormones to prevent pregnancy or treat heavy menstrual bleeding. However, reports have shown the plastic devices can move or damage the delicate uterine wall.

So far, the FDA has received over 45,000 adverse reports of women suffering complications linked to Mirena IUDs. However, under current regulations, a Mirena recall is unlikely without more public outcry.

The FDA has warned Bayer several times for failing to disclose safety risks of Mirena, while marketing the devices as a way to help busy moms with intimacy and make them “look and feel great.” However, they have not required a Mirena recall.

Court records show a growing number of Mirena lawsuits have been filed against Bayer in several states including New Jersey, where the company is headquartered. Due to the number of claims expected, experts predict the cases may eventually be consolidated into a special federal court.

A lawyer can explain the current litigation involving Mirena, as well as whether your case may qualify and how long you have to take action.

Before choosing a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The DrugRisk Resource Center only recommends law firms that specialize in medical device injuries and have handled thousands of claims.

For more information on the side effects, warnings and legal action related to the Mirena IUD, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.