How often should Mirena (levonorgestrel-releasing intrauterine system) be replaced for contraceptive purposes?

Mirena Replacement Interval

Mirena is FDA-approved for 5 years, but clinical evidence supports extended use up to 8 years for contraception with maintained efficacy and safety. 1, 2, 3

FDA-Approved Duration vs. Extended Use

• FDA approval: Mirena (52 mg levonorgestrel IUD) is officially approved for 5 years of contraceptive use 1, 2
• Extended efficacy: Clinical studies demonstrate effectiveness for up to 7-8 years beyond the initial approval period 1, 2, 3
• CDC guidelines: Women using Mirena for extended periods up to 8 years experience a cumulative failure rate of only 0.68% during years 6-8 1

Evidence for 8-Year Use

The highest quality recent evidence comes from the Mirena Extension Trial (2022), which specifically evaluated extended use:

• Pearl Index for years 6-8: 0.28 (95% CI: 0.03-1.00), indicating extremely high contraceptive efficacy 3
• Only 2 pregnancies occurred among 362 participants during years 6-8 of use (one ectopic, one of undetermined location) 3
• User satisfaction: 98.7% of women who completed 8 years remained satisfied with continued use 3
• Bleeding patterns: Approximately half of women experienced amenorrhea or infrequent bleeding during extended use 3

Clinical Decision Algorithm

For contraception only:

• Replace at 5 years if following FDA labeling strictly
• Can safely extend to 8 years if patient desires continued contraception and is counseled about off-label use 1, 3, 4

Important caveat for heavy menstrual bleeding:

• The therapeutic indication for menorrhagia remains FDA-approved for 5 years only 1, 2
• Insufficient data exists for extended use beyond 5 years specifically for heavy bleeding treatment 3

Key Counseling Points

• Patient autonomy: Women should be counseled that device removal is available at any time if bleeding patterns or side effects become unacceptable 1
• Return to fertility: Rapid return to fertility occurs after removal, with a 77.4% pregnancy rate within 12 months among women discontinuing for pregnancy 3
• Safety profile: The favorable safety profile is maintained through 8 years, with discontinuation rates primarily driven by desire for pregnancy rather than adverse events 3

Common Pitfall to Avoid

Do not automatically replace Mirena at 5 years in women who wish to continue contraception and are satisfied with the device—this creates unnecessary procedures, costs, and insertion-related risks when the device maintains efficacy through year 8 3, 4.