Changes to Mirena Indications

August 24, 2020 – The U.S. FDA has approved an expanded indication for Mirena® (levonorgestrel) intrauterine device (IUD), manufactured by Bayer. The product is now indicated for use for up to six years to prevent pregnancy. It was previously approved for use for up to five years under this indication.

In addition, Mirena is now indicated for up to five years of use to treat heavy menstrual bleeding in women who choose to use intrauterine conception as their method of contraception. Previously, there was no time limitation placed on this indication. There is limited data regarding the use of Mirena beyond five years for menstrual bleeding.

Mirena is a small, T-shaped device that slowly releases levonorgestrel, a hormone-based birth control drug, over time. Initially, the device releases the drug at a rate of 20mcg/day. This rate slows to 10mcg/day after five years, and 9mcg/day after six. Mirena must be inserted by a trained healthcare provider using strict aseptic technique. Following insertion, the patient should be re-examined and evaluated at 4-6 weeks, then annually (or more often, if indicated).

A healthcare professional should remove Mirena after a maximum of six years (for contraception) or five years (for menstrual bleeding). Mirena can be removed sooner if desired by the patient or if clinically necessary. If the patient wishes to continue treatment with Mirena at the end of six years (for contraception) or five years (for menstrual bleeding) and its use is clinically appropriate, a new Mirena IUD must be inserted.

Mirena first received FDA approval in 2000.