Health Canada Issues Warning for MIRENA and Risk of Uterine Perforation

Ottawa, ONBayer Inc and Health Canada have issued a joint safety information statement about reports of uterine perforation in women treated with MIRENA.

MIRENA, a therapeutic intrauterine system, is authorized in Canada for prevention of pregnancy and treatment of heavy menstrual bleeding. Uterine perforation is a rare complication associated with all intrauterine contraceptive devices/systems, including MIRENA. Perforation occurs at a rate between 1/1,000 and 1/10,000 insertions. Bayer Inc. continues to receive reports of uterine perforation associated with the use of MIRENA. The risk of perforation may be increased after pregnancy, during lactation, and in women with atypical uterine anatomy. Uterine perforation may occur as MIRENA is being inserted or after the insertion with limited symptoms.

MIRENA works by slowly releasing levonorgestrel directly into the uterus to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combination oral contraceptives.