What Are the Negative Side Effects of Mirena?

Reviewed on 9/1/2021

Possible serious side effects of Mirena, an intrauterine birth control method, include risk of ectopic pregnancy, severe infection or sepsis (which may be life-threatening), pelvic inflammatory disease (PID), perforation, partial or complete expulsion of Mirena, and ovarian cysts.
Possible serious side effects of Mirena, an intrauterine birth control method, include risk of ectopic pregnancy, severe infection or sepsis (which may be life-threatening), pelvic inflammatory disease (PID), perforation, partial or complete expulsion of Mirena, and ovarian cysts.

Mirena (levonorgestrel-releasing intrauterine device) is a progestin-containing intrauterine system (IUS, also called an intrauterine device, or IUD) indicated for: 

  • Prevention of pregnancy for up to 7 years 
  • Treatment of heavy menstrual bleeding for women who choose to use 
  • Intrauterine contraception as their method of contraception for up to 5 years

Common side effects of Mirena include:  

Possible serious side effects of Mirena include: 

  • Risk of ectopic pregnancy, which is when a pregnancy occurs outside the uterus
  • Severe infection or sepsis (which may be life-threatening), including Group A streptococcal sepsis (GAS)
  • Pelvic inflammatory disease (PID)
  • Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix)
  • Partial or complete expulsion of Mirena
  • Ovarian cysts
  • If left in place during pregnancy: 
    • Severe infection
    • Miscarriage
    • Premature birth
    • Death of the mother 

Who Should Not Use Mirena?

Mirena is not recommended for all women, including those who: 

  • Are or might be pregnant
  • Have had pelvic inflammatory disease (PID)
  • Have a current untreated pelvic infection 
  • Have had a serious pelvic infection in the past 3 months after a pregnancy
  • Get infections easily, such as: 
    • Women who have multiple sexual partners or who have a partner who has multiple sexual partners
    • Women who are immunocompromised
    • Women who use or abuse intravenous drugs
  • Have or suspect they might have uterine or cervical cancer 
  • Have unexplained vaginal bleeding 
  • Have liver disease or a liver tumor
  • Have or have had breast cancer or any other cancer that is sensitive to progestin
  • Already have an intrauterine device 
  • Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
  • Are allergic to levonorgestrel, silicone, polyethylene, silica, barium sulfate or iron oxide

QUESTION

Which of the following are methods for contraception? See Answer

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Reviewed on 9/1/2021
References
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021225s042lbl.pdf