
The FDA approved Nexplanon implant for 5 years of pregnancy prevention, extending use from the previous 3-year limit based on trial data showing zero pregnancies during years 4 and 5. Study included 399 women with BMI range 17.2 to 64.3 kg/m², with 38% having BMI over 30 kg/m².
⚖️ PROFESSIONAL IMPACT
- Extended duration eliminates need for replacement at 3 years, reducing patient procedures and potential insertion/removal complications for those desiring longer-term contraception.
- Zero pregnancies reported in years 4-5 (Pearl Index 0.0, 95% CI 0.0-0.69) across 7,752 cycle equivalents validates efficacy through extended timeframe.
- New REMS program mandates enhanced provider training for insertion and removal techniques, requiring compliance beyond existing Clinical Training Program.
- Broad BMI inclusion (up to 64.3 kg/m²) in approval trial addresses real-world patient population, though efficacy in higher BMI ranges warrants continued monitoring.
🎯 ACTION ITEMS
- Update patient counseling materials to reflect 5-year duration option versus 3-year replacement schedule.
- Complete new REMS training requirements for Nexplanon insertion and removal before placing or removing implants.
- Document year of insertion clearly in patient records to ensure timely removal by end of year 5.
- Counsel patients that most common adverse effect remains intermenstrual bleeding throughout extended duration.
More on Contraception/Birth Control
PATIENT EDUCATION
OBESITY/WEIGHT MANAGEMENT
EXERCISE/TRAINING
LEGAL MATTERS
GUIDELINES/RECOMMENDATIONS