What is Organon's Nexplanon implant now approved for?

Organon's Nexplanon implant is now approved by the FDA for up to five years of use, extended from its previous three-year limit.

How effective is Nexplanon for five years?

A trial supporting the five-year approval showed no pregnancies reported during years four and five, indicating high efficacy.

Can women with higher BMIs use the Nexplanon implant for 5 years?

Yes, the trial data included women with a wide range of BMIs, including those above 30 kg/m², showing efficacy.

Home / Health / Pregnancy Implant Extended to 5 Years by FDA

Pregnancy Implant Extended to 5 Years by FDA

20 Jan

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Summary

Nexplanon implant now approved for up to five years of use.
FDA approval based on trial data showing no pregnancies over 4-5 years.
Extended use data includes women with varying BMIs, including obesity.

Pregnancy Implant Extended to 5 Years by FDA

The U.S. Food and Drug Administration (FDA) has granted approval for Organon's Nexplanon contraceptive implant to be used for up to five years. This extension, a notable advancement from its prior three-year duration, offers women an enhanced long-acting reversible contraceptive option. The supplemental New Drug Application (sNDA) was supported by compelling data from a clinical trial assessing Nexplanon's effectiveness in individuals using it for at least 36 months.

The trial's primary objective was to evaluate the Pearl Index (PI) for pregnancy rates at years four and five. Crucially, no pregnancies were recorded during this extended period among the 399 women who participated. The study also encompassed a diverse range of body mass index (BMI) values, from 17.2 to 64.3 kg/m², with a significant portion, 38.1%, having a BMI above 30 kg/m², highlighting its efficacy across varying body types.