About Mirena IUD

Mirena intrauterine device (IUD) is a small, T-shaped plastic device inserted into the uterus to provide long-term pregnancy prevention and to treat heavy periods in women. Mirena releases a controlled dose of a hormone called levonorgestrel and is designed to prevent pregnancy for up to five years, by stopping sperm from entering the uterus and fertilizing an egg. The birth control implant is one of the most widely-used IUDs in the United States and is marketed by Bayer Pharmaceuticals as a good birth control alternative for women who prefer not to take oral contraceptives. However, serious concerns have been raised in recent years about Bayer’s failure to adequately warn patients and the medical community about the potential risk of Mirena IUD side effects.

In 2008, the FDA issued a series of safety communications requiring changes to the Mirena IUD label to include the risk of complications like ectopic pregnancy, ovarian cysts, organ perforation and device expulsion. In 2009, the FDA issued a warning letter to Bayer accusing the company of making misleading claims about Mirena’s efficacy. The letter cited the company’s failure to indicate that the birth control implant should only be used for up to five years before being replaced and that it is primarily recommended for use by women who already have at least one child.

In the years since, additional concerns have been raised about the safety of Mirena IUD, and in its January 2018 QuarterWatch report, the Institute for Safe Medication Practices (ISMP) reported that there were more than 8,000 adverse event reports associated with Mirena over a two-year period ending in June 2017. At this rate, the Mirena adverse event reports outnumbered those submitted in connection with four other popular birth control methods combined.