You got your implant placed three years ago and you've been mentally preparing for the removal appointment. Then a friend texts you: apparently it's been approved for five years now. You go looking for information and find mostly news headlines, nothing that actually explains what changed or what it means for you specifically.

Here's what the trial actually showed, and what questions are worth asking your OB-GYN.

0.0 Pearl Index during years 4–5 in the FDA extension trial — meaning zero pregnancies among 399 participants
399 women enrolled in the extension study, ages 18–35, with BMIs from 17.2 to 64.3 kg/m²
38% of study participants had a BMI of 30 or above — a meaningful inclusion for a contraceptive trial

What the extension trial actually tested

The study enrolled 399 women who had already been using Nexplanon for 36 months. They continued for an additional 24 months, with pregnancy monitoring throughout. The Pearl Index — the standard measure of contraceptive effectiveness, expressed as pregnancies per 100 women per year of use — was 0.0 for both year 4 and year 5.

The safety profile during years 4 and 5 matched the first three years closely. No new adverse events emerged. The most common side effect was irregular bleeding: some women had more spotting, some had less frequent periods, some had neither. This is the same pattern seen throughout Nexplanon's existing use.

One detail worth noting: the trial included women across a wide BMI range, including 38% with a BMI of 30 or above. Contraceptive research has historically enrolled mostly average-weight participants, which creates real questions about effectiveness in higher-weight women. The Nexplanon data, across both the original trial and the extension, held consistent across weight categories.

What the FDA approval means

The FDA approved the supplemental New Drug Application on January 19, 2026. This was a formal extension of the approved labeling, not a new product. The same Nexplanon implant that was approved for 3 years is now approved for 5 years, provided it was properly inserted. The FDA simultaneously introduced a new REMS (Risk Evaluation and Mitigation Strategy) program to ensure correct insertion and removal techniques — which became available February 23, 2026. (Organon, January 2026)

What this means if you have one in now

The approval applies to implants currently in use, not just newly placed ones. If you had your implant inserted before January 2026, you may be eligible to leave it in for up to five years from the insertion date, subject to your doctor's assessment.

The key variable is when it was placed. The hormone reservoir in the implant — etonogestrel, a synthetic progestin — releases at a consistent rate over time. The trial confirmed that the release is effective and safe through year 5. If your implant is currently in year 3, you now have the option to discuss leaving it for another two years rather than replacing it.

There is one caveat: some women experience changes in bleeding patterns between years 3 and 5. The FDA approval doesn't guarantee your implant will feel exactly the same after year 3 — it confirms that contraceptive efficacy and safety are maintained. Any changes in side effects worth flagging are worth discussing with your OB-GYN.

What to tell your OB-GYN

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When to contact your provider

If your implant is approaching or has passed the 3-year mark and you haven't discussed the extension with your provider, that conversation is worth scheduling. The approval gives you more flexibility — but the decision about whether to extend, replace, or switch methods should be based on your full medical history and current situation. Any sudden changes in side effects or breakthrough bleeding patterns are always worth flagging promptly.

Medical Disclaimer: This article is for informational and educational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

References

  1. Organon. FDA approves extended duration of use for NEXPLANON (etonogestrel implant) 68mg to up to 5 years. BusinessWire. January 16, 2026. businesswire.com
  2. FDA. Highlights of Prescribing Information — Nexplanon (etonogestrel implant). Updated 2026. FDA.gov
  3. Contemporary OB/GYN. FDA approves 5-year use for etonogestrel implant 68 mg contraceptive. 2026. contemporaryobgyn.net
  4. Glasier A, et al. Offering extended use of the contraceptive implant via an implementation science framework. PMC. 2024. PMC11145768