Mirena IUD Approved For Treatment Of Heavy Menstrual Bleeding

The FDA has approved the use of the Mirena (levonorgestrel intrauterine system) IUD for the treatment of heavy menstrual bleeding in women who have given birth. The Mirena IUD is the only intrauterine device currently approved for this indication. This type of contraceptive is small and flexible, and releases hormones into the uterus that prevent pregnancy. Only a qualified health care professional can insert the device.

The Mirena IUD was originally approved for contraceptive use in 2000. Since its' approval, the most serious and rare side effects of the Mirena IUD have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disese (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix.

More common side effects that were reported by patients in the clinical trial using the Mirena IUD to treat heavy menstrual bleeding included irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.

Source: FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184747.htm. Accessed 10/07/2009