What Your Doctor May Not Be Telling You About Mirena
If you are considering birth control, you may have heard about Mirena. Before making the decision to use this or any other form of birth control, you should research your options, talk to your doctor and become informed.
What is Mirena?
Mirena is an intrauterine birth control device, an IUD, which is inserted into the uterus by a healthcare professional and is made and marketed in the United States by Bayer Healthcare.1
You may heard things about Mirena which weren’t correct. In 2009, the FDA warned that one of Mirena’s marketing programs was misleading to potential users.
Bayer, Mirena’s manufactuer, hired momcentralconsulting.com—a marketing services website connected to momcentral.com—to market and promote Mirena through parties at the homes of “mom bloggers” who were members of momcentral.com or at restaurants hosted by momcentral.com. The script for these events included a presentation by a nurse practitioner promoting Mirena and a fashion show.
According to the FDA, the momcentral.com presentation was false or misleading because it overstated Mirena’s efficacy, made unsupported claims and minimized or omitted mention of Mirena’s risks and side effects. The FDA charged that statements in the presentation “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.” Further, the presentation suggested that Mirena would improve users’ sex lives and help them “look and feel great,” 2 but that there was no evidence that these statements were true.
In fact, participants in clinical trials had reported decreased libido and painful side effects “which could adversely affect a woman’s feelings relating to romance or intimacy.” 3
One blogger who had hosted such a party wrote that the event was funded by momcentral.com, that the invitations said the event was sponsored by Mirena and that she didn’t recall hearing anything about risks or side effects of Mirena at the event.4
Does Mirena work? Is it safe?
The FDA acknowledged that Mirena was effective in reducing the chance of pregnancy.5 The FDA has warned that Mirena may increase the chance of an ectopic pregnancy and has identified other risks connected with the use of Mirena as well. 6
What if I’m already using Mirena?
If you are concerned about the safety of the device, see your doctor. Never try to remove an intrauterine device yourself as injury may result. Only a medical professional should remove an IUD.
Learn everything you can about Mirena before you start using it.
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1 http://www.mirena-us.com/what-it-is/index.jsp
2 Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, (30 December 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf; Forbes.com “Ten Misleading Drug Ads,” http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety_slide_5.html
3 Ibid.
4 “When Mirena Meets Mommybloggers” (comment by ChefDruck) (7 February 2009), http://evilslutopia.com/2010/02/when-mirena-meets-mommybloggers.htm; ChefDruck Musings (28 February 2009), http://chefdruck.blogspot.com/2009/02/two-worlds-collide.html
5 Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, (30 December 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf; Forbes.com “Ten Misleading Drug Ads,” http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety_slide_5.html
6 Food and Drug Administration, “Mirena (levonorgestrel-releasing intrauterine system)” (last updated 19 June 2009), http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm119274.htm