Yes, Nexplanon is now FDA-approved for up to 5 years of use. The label was updated in early 2026 to extend the approved duration from 3 years to 5 years, based on clinical trial data showing zero pregnancies during years 4 and 5. If you already have a Nexplanon implant, this means you may be able to keep it longer than you were originally told.
What the Clinical Data Shows
The FDA’s decision was backed by a multicenter clinical trial that enrolled 399 women who had already been using Nexplanon for 3 years. Researchers followed them for two additional years to see if the implant kept working. No pregnancies occurred during years 4 or 5, giving a pregnancy rate of 0.0 per 100 women-years of use.
This aligns with earlier research published in the American Journal of Obstetrics & Gynecology, which also found zero pregnancies among implant users followed for 2 years past the original expiration date. That study measured the hormone levels in users’ blood and found that while concentrations do decline over time, they remained well above zero even at the 5-year mark, with a median level of 153 pg/mL at the end of year 5 compared to about 208 pg/mL at the 3-year mark.
The Updated FDA Label
The revised prescribing information is straightforward: Nexplanon is indicated for pregnancy prevention for up to 5 years, and the implant must be removed no later than the end of the fifth year. If you want to continue using the implant after that, a new one can be inserted at the same appointment.
This is a meaningful change. Previously, anyone with Nexplanon was told to schedule a replacement at 3 years. Now you have a 2-year buffer, which can save you the cost and hassle of an extra office visit. If you currently have an implant that’s approaching its old 3-year deadline, talk to your provider about whether you can leave it in place.
Does Body Weight Affect 5-Year Efficacy?
The clinical trial that supported the label extension enrolled a substantial number of overweight and obese participants, about 38% of the study population. The FDA’s statistical review found that efficacy results were consistent across subgroups including BMI, age, race, and ethnicity. No pregnancies occurred in any weight category during years 4 and 5.
That said, the FDA noted that 2 years of extended data may not be enough to fully resolve questions about long-term effectiveness at higher body weights, since the original 3-year approval trial had excluded women above 130% of ideal body weight. The practical takeaway: the available evidence is reassuring across weight categories, but the conversation is still evolving.
Side Effects in Years 4 and 5
One concern people have about leaving a hormonal implant in longer is whether side effects get worse. The extended-use study found the opposite pattern. The overall side effect profile in years 4 and 5 looked similar to what’s seen in the first 3 years, and in some ways was milder.
Irregular bleeding, the most common reason people have the implant removed early, was reported by 5.4% of participants in the extended-use period. For comparison, bleeding pattern changes led to discontinuation in 11.1% of participants during the original 3-year trials. This makes sense: most people who can’t tolerate the bleeding side effects have already had the implant removed within the first couple of years. If you’ve been comfortable with Nexplanon for 3 years, you’re unlikely to develop new problems in years 4 and 5.
What International Guidelines Say
The UK’s Faculty of Sexual and Reproductive Healthcare (FSRH), one of the most respected bodies in contraceptive guidance, has historically taken a more cautious stance. Their guidelines acknowledge that the risk of pregnancy in the fourth year is “likely to be very low,” but they stopped short of recommending routine use beyond 3 years because the evidence base was limited at the time their guidance was written.
The newer trial data that led to the FDA’s label change may prompt international bodies to update their recommendations. For now, if you’re outside the U.S., your provider’s advice will depend on which guidelines they follow. The underlying biology hasn’t changed, though: the hormone levels in the implant remain active well past 3 years, and no study has documented a pregnancy during extended use.
Practical Considerations
If your Nexplanon was inserted before the label change, it’s the same device. The implant itself hasn’t been reformulated. What changed is the evidence available to support leaving it in longer. You don’t need a different version of the implant to get 5 years of protection.
The 5-year limit is firm, though. Nexplanon must be removed by the end of year 5. Hormone levels continue to drop over time, and there’s no data supporting use beyond that point. If you want uninterrupted contraception, plan your replacement appointment before the 5-year mark rather than after it.