Birth Control Litigation

Mirena IUD Recall

The U.S. Food and Drug Administration (FDA) has approved the Mirena® IUD1 for the purposes of birth control in the United States. Millions of women use Mirena® IUD as a contraceptive. Some of these women have been injured as a result of using the device, which has led to questions about its efficacy and safety.

How the Mirena® IUD functions

The Mirena® IUD is a flexible plastic device that is inserted into the uterus by a health care provider. The device is designed to release a hormone that causes the cervical mucus to thicken and prevent pregnancy. It can also thin the lining of the uterus and stop the ovary from releasing eggs. The device carries some warnings, however, and is not suitable for everyone.

Understanding whether Mirena® IUD is right for you

Bayer Pharmaceuticals manufactures Mirena® IUD and claims2 that the device is suitable for women who are looking for a flexible birth control option. Mirena® IUD can be effective for up to five years and will not normally cause any permanent fertility issues.

Some people, however, should not use Mirena® IUD. The manufacturer warns against usage if:

  • You may be pregnant now
  • You have a serious pelvic infection
  • You are susceptible to infection
  • You have or suspect you may have cancer of the cervix or uterus
  • You have unexplained bleeding from the vagina
  • You have liver disease or a liver tumor

If you are uncertain whether Mirena® IUD is right for you, you should also talk to your health care provider.

Has there been a Mirena® IUD recall?

Although millions of women use Mirena® IUD without any major problem, there have been more than 40,000 adverse events3 for women using the device. This has led to some public concern, as well as legal action against the manufacturer. As of February 2013, there have been no product recalls for Mirena® IUD, but there are a number of product warnings.

Complaints about Mirena® IUD

The most common complaints related to the Mirena® IUD include device expulsion (which can require surgery), device dislocation and vaginal hemorrhage. Other issues are less common but can be very serious or even life threatening. These include infections such as sepsis and pelvic inflammatory disease.

Consumers have also complained that the marketing for Mirena® IUD does not highlight the potential risks effectively enough. The Department of Health and Human Services4 wrote to the manufacturer about this in 2009. In the same year, however, the FDA5 approved the additional use of Mirena® IUD to treat women suffering with heavy menstrual bleeding.

A Mirena® IUD lawyer will be able to look at the facts of your case and advise whether you are able to file a lawsuit against Bayer. The FDA6 relies on consumers to report adverse events via its website. The organization also suggests that you report any concerns and problems with the device to your doctor and to the manufacturer.

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