FDA Approves Extended Use of Nexplanon Implant

Earlier this year, the U.S. Food and Drug Administration approved a supplemental New Drug Application that extends the approved duration of NEXPLANON (etonogestrel implant) from 3 years to 5 years. This approval was based on clinical trial data showing continued effectiveness and safety.

What is Nexplanon?

NEXPLANON is a subdermal contraceptive implant that releases etonogestrel, a synthetic hormone. The implant is a small, flexible rod (about 4 cm long and 2 mm wide) that is placed under the skin of the upper arm. It works by preventing ovulation and thickening cervical mucus to prevent sperm from reaching an egg.

The Clinical Trial

The FDA approval was based on a study that followed 399 women who had been using NEXPLANON for 3 years and continued using it for 2 additional years (years 4 and 5). Here’s what the study found:

Participants: Women aged 18-35 years with an average age of 27. The study included women with different body types, with BMI ranging from 17.2 to 64.3 kg/m². About 38% of participants had a BMI of 30 or higher.
Results: Zero pregnancies were reported during years 4 and 5 of use. This gave a Pearl Index of 0.0, which is a measure of contraceptive effectiveness (lower numbers mean better effectiveness).
Safety: No new safety concerns were identified during the extended use period.

What Does This Mean?

The extended approval means that people who choose NEXPLANON at North Florida Women’s Care can now keep the same implant for up to 5 years instead of needing to replace it after 3 years. This reduces the number of insertion and removal procedures needed over time.

The study data also provides evidence that NEXPLANON remains effective across a range of body weights and BMI values, which has been an important question for contraceptive research.

New Safety Program

Along with this approval, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) program. This program requires healthcare providers to complete certification training before they can insert or remove NEXPLANON. The goal is to reduce complications that can happen when the implant is not inserted or removed correctly.

The REMS program starts February 23, 2026. Providers will have 6 months to complete the certification training.

Understanding the Risks

Like all medical procedures, NEXPLANON insertion and removal can have complications. These can include pain, bruising, infection, or scarring at the insertion site. If the implant is inserted too deep, it can be harder to remove or could potentially affect nearby blood vessels or nerves.

The implant should always be able to be felt under the skin after insertion. If you cannot feel your implant, it’s important to contact your healthcare provider.

Who Should Consider Nexplanon?

NEXPLANON is one option among several long-acting reversible contraceptives (LARCs). It may be worth considering if you want highly effective birth control that doesn’t require daily action and can be removed at any time if you change your mind.

However, NEXPLANON is not right for everyone. It should not be used by people who are pregnant, have a history of blood clots, have certain liver conditions, or have unexplained vaginal bleeding, among other contraindications.

Next Steps

If you’re interested in learning more about NEXPLANON or discussing whether it might be appropriate for you, schedule an appointment with us today (by clicking the schedule now button) or by calling us at 850-877-7241 to talk through your contraceptive options.

Every person’s health situation is different, and the best choice depends on your individual medical history and preferences.