Classified by the FDA as a drug, Mirena is a contraceptive administered as a hormonal IntraUterine Device (IUD). It is inserted into the uterus as a long-term contraception. Manufactured by Bayer Healthcare, Mirena was approved by the FDA on December 6, 2000 as a contraceptive. It is the only hormonal IUD that has FDA approval. It was designed for long-term application. After insertion, this T-shaped polyethylene device prevents pregnancy by releasing a synthetic version of progestin hormone for up to five years. According to claims made by Bayer Healthcare, Mirena is more than 99% effective at preventing pregnancy, which would place it as one of the highest ranking contraceptives for effectiveness. However, Bayer offers no data in support of this claim. In October of 2009 Mirena was also approved for treatment of heavy periods involving heavy and excessive menstrual bleeding in women with at least one child birth. As of 2011, more than 15 million women have used Mirena IUD
- Ectopic Pregnancy (embryo attaches to outside of uterus or womb) – Up to half of pregnancies that occur with Mirena in place are ectopic. Ectopic pregnancy is a life-threatening condition to the mother.
Intrauterine Pregnancy (normal pregnancy) – Mirena should be removed, and removal or manipulation of Mirena may result in pregnancy loss.
- Sepsis (severe immune response to bacteria or other microbes) – infection with group A streptococcal (GAS), requires immediate treatment, otherwise could lead to death.
- Pelvic Inflammatory Disease (PID) – use of IUDs have been associated with an increased risk of PID. PID can cause harm to reproductive organs, leading to ectopic pregnancies or infertility, and infrequently increasing the need for hysterectomy, and even cause death.
- Irregular Bleeding and Amenorrhea (Absence of menstrual period) – Mirena can change the normal bleeding pattern, causing irregular and heavy bleeding
- Embedment – Mirena can become embedded in vaginal tissues, and in some cases may require surgical removal.
- Perforation – Perforation of, or penetration into uterine and cervix wall, which may not readily be detected until sometime later.
- Expulsion – complete or partial expulsion from uterine cavity, without the woman noticing it. This leads to severe pain and bleeding.
- Ovarian Cyst – results from enlarged follicles, observed in 12% of recipients
- Ovarian Cyst – results from enlarged follicles, observed in 12% of recipients.
- Breast cancer – Spontaneous reports of breast cancer have been received during post-marketing in clinical experience with Mirena.
FDA Warning: False, Misleading Marketing
In December of 2009, the FDA issued a warning letter to Bayer Healthcare for false, misleading and overreaching advertising. Bayer’s tactics included direct-to-consumer campaigns of “Tupperware-style” home parties in which invited celebrities promoted Mirena to groups of women in their homes. The FDA warning also accused Bayer of omitting Mirena’s most serious and frequently occurring risks, and of suggesting the drug is safer than it is. The FDA also accused Bayer of overstating the efficacy of Mirena, while failing to state its maximum five-year limitation, which wrongfully suggests the drug can be used indefinitely.