FDA’s ENG Label Change: What To Know

Implanon (etonogestrel implant) first received FDA approval in 2006, followed by the improved, radiopaque version, Nexplanon, approved by the FDA in 2010, which is now the only contraceptive implant available in the U.S. It was originally FDA approved for a 3-year use duration, although peer reviewed clinical data had demonstrated efficacy through year 5. Now, as of January 2026, the FDA has formally agreed to extend the label for 5-year use. In this episode, we will review the clinical data that prompted the FDA’s decision, based on a multicenter, single-arm, open-label study evaluating contraceptive efficacy and safety during years 4 and 5 of im...