FDA Warning

Mirena is an FDA-approved intrauterine device (IUD) recommended for women who have already had a child. The Mirena IUD is a soft, plastic, T-shaped device that is inserted by a healthcare professional. It is over 99% effective at preventing pregnancy.

To prevent pregnancy, Mirena releases hormones into the body. It can be effective for up to 5 years. Despite its effective pregnancy prevention, the FDA released a Mirena warning in 2008. The Mirena FDA warnings included a list of revised safety labeling changes by the Center for Drug Evaluation and Research (CDER).

While doctors are not explicitly certain how Mirena prevents pregnancy, it is believed to:

  • Thin uterine lining
  • Inhibit the fertilization of the egg
  • Thicken the cervical mucus, which prevents sperm from entering the uterus

The Mirena IUD and Pregnancy

According to the Mirena FDA warnings, in the event of a pregnancy, Mirena should be removed. The Mirena FDA warnings also cited that the device may result in the loss of the pregnancy. Approximately half of the pregnancies conceived while Mirena was in use resulted in ectopic pregnancies.

Congenital Anomalies from Mirena

Long-term use of high doses of birth control, such as the Mirena IUD, can cause congenital anomalies. Specifically, long-term use of Mirena is shown to cause masculinization of female genitalia in fetuses. The Mirena FDA warnings stated that this can still occur after the mother discontinues Mirena use.

Embedment of Mirena

Mirena FDA warnings cited that embedment or unintended positioning of the Mirena IUD device can occur. In some cases, Mirena became embedded into the patient’s uterine wall. The Mirena FDA warnings stated that this decreased contraceptive effectiveness and made Mirena removal difficult. Embedment of Mirena also increases the patient’s risk of pregnancy. If embedded, Mirena should be removed immediately. In some cases, this requires surgery.

Uterine Perforation and Mirena Migration

The FDA warned that Mirena may perforate the uterine wall or cervix of the patient. Lactating women displayed an increased risk of Mirena uterine perforation. According to the Mirena FDA warnings, in some cases, Mirena migrated outside of the patient’s uterine cavity. In the event of Mirena migration, the device must be removed because there is an increased chance of pregnancy.

Mirena Expulsion

Partial or complete expulsion of Mirena may occur, along with symptoms including bleeding or pain. According to the Mirena FDA warnings, as menstrual flow typically decreases during Mirena use, an increase of menstrual flow may indicate IUD expulsion. Partial Mirena expulsion may decrease the effectiveness of the device. The Mirena FDA warnings state that Mirena may be replaced after pregnancy has been ruled out.

Ovarian Cysts from Mirena

The Mirena FDA warnings state that symptoms of ovarian cysts aren’t always present. However, patients may experience pelvic pain or dyspareunia if they develop ovarian cysts while using Mirena. Dyspareunia is defined as painful sexual intercourse that can result from medical or psychological conditions.

Breast Cancer

Mirena FDA warnings remind patients that Mirena is a hormonal contraception. As a result, women who currently have breast cancer, or have previously had breast cancer, should not use the Mirena IUD. This is because breast cancer is a hormone-sensitive type of tumor.

Sepsis from Mirena

Previous Mirena FDA warnings indicated severe pain that was reported by patients. The severe pain occurred within hours of Mirena insertion by the healthcare professional. There are medical reports that this led to sepsis, or a dangerous infection, in some cases. Sepsis from Mirena occurred within a matter of days after the IUD device was inserted.

FDA Examines Inaccurate Claims

In 2009, The Department of Health and Human Services published a letter under the Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications regarding Mirena’s promotional materials. A Mirena representative had made claims suggesting Mirena would add “simplicity” and “intimacy” to relationships. However, the product’s warning label suggested otherwise.

Mirena product labeling indicated at least 5% of clinical patients experienced:

  • Decreased libido
  • Abdominal or pelvic pain
  • Nausea
  • Headache
  • Nervousness
  • Depressed mood

The FDA researcher also concluded the claims by the Mirena representative that suggested Mirena helped users “look and feel great” were false. This was made apparent with commonly-reported side effects such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain or tenderness, and acne. Finally, Mirena’s claims to eliminate “monthly routines” were declared false, as the patients were instructed to check monthly if the threads attached to the product were intact.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

View Sources

  1. Newcomer, Carrie. United States. United States Food and Drug Administration. RE: NDA 21-225 Mirena® (levonorgestrel-releasing intrauterine system) MACMIS
  2. United States. United States Food and Drug Administration. Mirena (levonorgestrel-releasing intrauterine system) Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — May 2008. Maryland: , 2008. Web. https://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm119274.htm
  3. United States. United States Food and Drug Administration. Mirena (levonorgestrel-releasing intrauterine system) July 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) — July 2008. Maryland: , 2008. Web. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf

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