What is the duration of effectiveness of Nexplanon (etonogestrel) before it needs to be replaced?

Nexplanon Duration of Effectiveness

Nexplanon is FDA-approved and should be replaced after 3 years of use, though emerging evidence demonstrates continued contraceptive effectiveness for up to 5 years. 1, 2

Standard Approved Duration

• The etonogestrel implant (Nexplanon) is approved for 3 years of use and maintains contraceptive efficacy with failure rates of less than 1% throughout this period 1, 3
• The implant should be removed by the end of the third year according to current FDA labeling 2
• Real-world effectiveness studies confirm a Pearl Index of 0.04 (95% CI, 0.02-0.09) during the approved 3-year period 4

Extended Use Beyond 3 Years

High-quality research demonstrates that Nexplanon remains highly effective beyond the approved 3-year duration:

• A multi-center randomized trial with over 200 women using Nexplanon for at least 5 years showed zero pregnancies occurred during years 4 and 5 5
• The 5-year cumulative pregnancy rate was 0.6 per 100 woman-years (95% CI: 0.2-1.8), demonstrating continued excellent efficacy 5
• Evidence exists of contraceptive effectiveness even at 4 years, with one case report documenting positive serum etonogestrel levels 6 years after insertion 6

Clinical Decision-Making Algorithm

For standard practice:

• Replace Nexplanon at 3 years as per FDA approval 1, 2

For extended use consideration (off-label):

• Women who reach 3 years but desire continued use may continue for up to 5 years based on research evidence 5
• This is particularly relevant for women with barriers to healthcare access or those wishing to avoid removal/reinsertion procedures 5
• Counsel patients that extended use beyond 3 years is off-label but supported by strong clinical evidence 5

Important Caveats

• Weight considerations: The extended use data included few women ≥70 kg, so efficacy beyond 3 years in higher-weight individuals is less certain 5
• Pharmacokinetic data show etonogestrel levels remain elevated at 3 years, supporting the biological plausibility of extended effectiveness 5
• Rapid return to fertility occurs once the implant is removed, regardless of duration of use 2, 6