The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability

Figures & data

Figure 1 Levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena^®).³

Table 1 Contraindications to the levonorgestrel-releasing intrauterine system according to organizational recommendations

Condition	ACOG^Citation55	WHO^Citation13,Citation16 (for the definition of risk categories see Appendix B)	Manufacturer^Citation3
Uterine anomaly (including fibroids causing distortion of the uterine cavity)	Contraindicated	Risk category 4	Contraindicated
History of pelvic inflammatory disease	Contraindicated (past three months only)	No contraindication	Contraindicated (if no subsequent pregnancy)
Post-partum endometritis or septic abortion in the last three months	Contraindicated	Immediate insertion only, risk category not defined	Contraindicated
Active cervicitis/vaginitis	Contraindicated	Initiation of LNG-IUS is risk category 4, continuation is risk category 2 for cervicitis; both are risk category 2 for vaginitis	Contraindicated
Immunosuppression (eg, leukemia, AIDS, intravenous drug abuse)	No recommendation	Initiation is risk category 3, continuation category 2. If AIDS patient is clinically well on antiretroviral therapy, initiation is also category 2. Not contraindicated in HIV.	Contraindicated
Known or suspected cervical dysplasia/genital bleeding of unknown etiology	Contraindicated	Initiation is risk category 4, continuation is risk category 2	Contraindicated
Known or suspected breast carcinoma	Contraindicated	Risk category 4 for current, category 2 for past with no evidence of disease for the last five years	Contraindicated
Pregnancy	Contraindicated	Risk category 4	Contraindicated
Post-partum <48 hours (including insertion immediately after delivery of the placenta)	No recommendation	Risk category 1 if not breast feeding, category 3 if breast feeding	No recommendation
Post-partum ≥48 hours to <4 weeks	No recommendation	Risk category 3	No recommendation
Active viral hepatitis, liver tumor (benign or malignant), cirrhosis	Not recommended for “current liver disease”	Risk category 3 for malignant hepatoma, benign hepatocellular adenoma, or decompensated cirrhosis, category 2 for focal nodular hyperplasia	Contraindicated
History of, or condition that predisposes to, ectopic pregnancy	No contraindication	No contraindication	Recommends caution
Current DVT/PE	No recommendation	Risk category 3, category 2 if established on anticoagulant therapy	No recommendation

Abbreviations: ACOG, American College of Obstetricians and Gynecologists; AIDS, acquired immunodeficiency syndrome; DVT, deep vein thrombosis; HIV, human immunodeficiency virus; PE, pulmonary embolism; WHO, World Health Organization.

Table

Risk category	Description of category	With clinical judgment	Without clinical judgment
1	A condition for which there is no restriction for the use of the contraceptive method	Use the method in any circumstances	Use the method
2	A condition where the advantages of using the method generally outweigh the theoretical or proven risks	Generally use the method	Use the method
3	A condition where the theoretical or proven risks usually outweigh the advantages of using the method	Use of the method not usually recommended unless other more appropriate methods are not available or not acceptable	Do not use the method
4	A condition which represents an unacceptable health risk if the contraceptive method is used	Method not to be used	Do not use the method

Notes: “Clinical Judgement” means that a trained health care provider or the clinical resources to perform clinical tests and/or examinations are present.

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