09/10/2026
Can the etonogestrel implant stay in place beyond 3 years?
The etonogestrel implant label is changing!
In January 2026 the US FDA approved extending the use of the etonogestrel 68 mg implant from 3 to 5 years, and the UK MHRA followed in May 2026.
The approval was based on a dedicated trial (NCT04626596) of 399 women who had already used the implant for 36 months and continued it through years 4 and 5. No pregnancies occurred (Pearl Index 0.00; 95% CI 0.00–0.69) and there were no new safety concerns. About 38% of participants had a BMI ≥30 kg/m², including 10% with BMI ≥40.
This builds on earlier evidence. A WHO-sponsored multicentre trial by Ali, Bahamondes and colleagues had already shown very low pregnancy rates with extended use to 5 years (0.6 per 100 woman-years), and pharmacokinetic data showed etonogestrel levels staying above the contraceptive threshold.
Clinical takeaway: for women who wish to continue, the implant can be kept for 5 years, including women with higher BMI. Check your local label: where 5-year use is not yet approved, it remains off-label but evidence-based.
Ref: FDA approval of sNDA for etonogestrel implant 68 mg, January 2026 (NCT04626596). MHRA approval, May 2026. Ali M, Akin A, Bahamondes L, et al. Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant. Hum Reprod. 2016;31(11):2491-2498.
