Mirena IUD May Be Convient, But it Still Carries Risks

Considering using the Mirena IUD for birth control? If you are a busy mom, there’s a good chance you think Mirena would be ideal. That’s not surprising, considering that’s the way Mirena has been marketed by Bayer Inc. But you should know that, like any contraceptives, the IUD comes with serious risks.

The Mirena IUD was originally approved as an intrauterine contraceptive, and later as a treatment for heavy menstrual bleeding in women who have given birth. It works by slowly releasing the progestogen levonorgestrel into the uterus. Mirena is indicated for intrauterine contraception for up to 5 years.

One of the ways Bayer marketed Mirena was through now-discontinued “Mirena Parties”. Working with the social networking site Mom Central, Bayer had created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner. T

According to an FDA Warning letter issued to Bayer in December 2009, the claims made in the script used during the program “clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.”

The letter went on to say that the FDA was “not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great.” The agency also said the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement “look and feel great.” Finally, the FDA faulted the script for including a statement that Mirena “has no daily, weekly, or monthly routines to comply with,” which the agency said was false.

Since its approval, serious Mirena side effects have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.

« »