Liletta IUD Duration of Use
The Liletta IUD is FDA-approved for contraception for up to 8 years and for treatment of heavy menstrual bleeding for up to 5 years. 1
Contraceptive Efficacy Duration
Liletta provides highly effective contraception for 8 years, with the device requiring removal or replacement after this period if continued contraception is desired 1
The contraceptive efficacy remains excellent throughout the 8-year duration, with a cumulative life-table pregnancy rate of only 1.32 per 100 women through 8 years of use 2
No pregnancies occurred during year 8 of use in the pivotal clinical trial, demonstrating maintained efficacy at the end of the approved duration 2
Heavy Menstrual Bleeding Treatment Duration
For treatment of heavy menstrual bleeding, Liletta is approved for 5 years 1
If continued treatment for heavy menstrual bleeding is needed beyond 5 years, the device must be removed and a new Liletta can be placed during the same office visit 1
Clinical Performance Data
The device releases levonorgestrel at an initial rate of approximately 19.5 mcg/day, declining to 9.8 mcg/day after 5 years, with a 5-year average release rate of 14.7 mcg/day 3
At 5 years, the levonorgestrel release rate remains more than double that of lower-dose IUDs at 3 years, supporting continued efficacy beyond 5 years 3
Clinical trial data through 8 years showed only 11 total pregnancies (7 of which were ectopic), with 2 pregnancies in year 7 and zero in year 8 2
Important Timing Considerations
The device must be removed after 8 years for contraception and cannot remain in place longer than this FDA-approved duration 1
Pregnancy can occur immediately upon removal, so alternative contraception should be initiated 7 days before removal if pregnancy is not desired 1
A new Liletta can be inserted during the same visit as removal if continued use is desired 1