FDA APPROVES MIRENA WARNING LABELS

The Mirena birth control device is at the center of numerous legal claims against the manufacturer, Bayer HealthCare Pharmaceuticals, Inc.

These lawsuits allege, among other things, that women have suffered injuries resulting from the migration of the Mirena intrauterine device (IUD) from its intended location. Many lawsuits have been consolidated in the U.S. District Court for the Southern District of New York (MDL No. 2434).

This same issue has also grabbed widespread media attention. For instance, one news report in 2013 stated that, since 2008, nearly 5,000 women had reported to the U.S. Food and Drug Administration (FDA) “device dislocation” problems involving the Mirena IUD, meaning the device had either become embedded in the uterus or migrated outside of the uterus.

Despite this litigation and public scrutiny, the Mirena IUD remains on the market. Recently, Bayer Healthcare released its FDA-approved labeling for the product, which indicates several risks, including perforation. The labeling can be viewed here.

The other side effects listed on the labeling include pelvic inflammatory disease and infections as well as pain, bleeding, expulsion and amenorrhea.

A Closer Look at Warning Label

Mirena has been described by the FDA to be a “small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy.” The device releases a hormone, synthetic progestin levonorgestrel, which prevents sperm from fertilizing the egg or stops a fertilized egg from attaching to the uterine wall.

The FDA’s last approved changes to the Mirena label occurred in 2008. It included warnings of:

• Intrauterine pregnancy with long-term effects and congenital anomalies
• Embedment
• Perforation
• Expulsion
• Ovarian cysts
• Breast cancer.

The warning also cautioned against “very common” adverse reactions occurring such as uterine and vaginal bleeding and ovarian cysts.

Bayer’s new patient warnings go to considerable lengths to explain the risks involved. For instance, the manufacturer cautions that the device may become attached to or go through the wall of the uterus, perforating it.

Not only does such perforation prevent the device from working properly, but it can also cause scarring, infection, organ damage and the need for surgeries. The label says this risk is higher in breastfeeding women.

Pelvic inflammatory disease (PID), Bayer says, is a serious infection whose risk is increased with the use of Mirena. While PID can often be treated with antibiotics, invasive surgery (including hysterectomy) is sometimes required. Pelvic inflammatory disease can also be fatal, Bayer states.