You may not have heard of Mirena yet, but you will.
Mirena is an IUD (intrauterine device) made by Bayer HealthCare Pharmaceuticals, Inc. Like the dangerous Dalkon Shield of the past, the maker of Mirena marketed the IUD aggressively and irresponsibly.
Just like the Dalkon Shield, the small “T” shaped IUD carries a risk of uterine perforation, irregular bleeding, ectopic pregnancy, pelvic inflammatory disease, ovarian cysts and amenorrhea. If a woman becomes pregnant with a Mirena IUD she risks a miscarriage. Mirena is known to migrate and can lead to scarring, infertility, hysterectomy and death.
The FDA has reportedly received more than 45,000 reports of complications from women who had the Mirena IUD implanted.
Originally approved as a treatment for heavy menstrual bleeding, Mirena is implanted in the uterus and slowly releases the synthetic progesterone levonorgestrel. It can be left in the uterus up to five years and after that point should be removed. Mirena was approved by the FDA in 2000 and is only recommended for women who have had at least one child.
Levonorgestrel is a third-generation synthetic progestin that works to thin the lining of the uterus making it difficult for the sperm and egg to unite.
To increase the profile of Mirena, Bayer invaded social media to market to young working mothers. “Mirena Parties” were part of the campaign. A busy mom would invite her friends over for a house party or to a restaurant and a representative of the Mom Central community and a nurse practitioner would host. The company even gave these women a script to use such as “look and feel great,” and “reconnect with ourselves and our partners.”
The U.S. Food and Drug Administration had problems with these promises and issued Bayer a warning letter in December 2009. The agency said Bayer, “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
Bayer stopped the parties in 2009 but that was too late for women who had the risky IUD already implanted based on the hollow promises.
Since the risks of Mirena were downplayed many women who are now symptomatic may have no idea their debilitating complications are linked to their Mirena IUD.