On January 16, 2026, the FDA approved a Risk Evaluation and Mitigation Strategies (REMS) program for the Nexplanon (etonogestrel) implant to mitigate the risk of complications due to improper insertion and removal. Improper insertion can result in contraceptive failure, as when implants become extruded if their insertion was incomplete. Improper insertion can also result in distant migration of the implant. Improper insertion with accidental deep insertion may result in difficulty with implant removal and cause vascular and nerve damage. If the implant migrates into a blood vessel after improper insertion, it could further migrate through the body, including to the lungs, which requires surgical removal, as described below.   

Due to the potential for serious insertion- and removal-related events (IRREs), under the REMS, healthcare providers (HCPs) must complete training on the proper insertion and removal of Nexplanon before inserting the implants. While a training program (also known as the clinical training program [CTP]) was previously available from Organon in connection with Nexplanon use, it had significant limitations that raised safety concerns, potentially allowing untrained HCPs access to Nexplanon for patient use. The FDA Adverse Event Monitoring System (AEMS) data continue to show serious IRREs, including events leading to complicated removals requiring surgical specialists. Additionally, the extension of Nexplanon’s treatment duration from 3 to 5 years further heightened concerns about a potential increase in IRREs and time for implant migration, reinforcing the need to ensure proper training. The Nexplanon training program is now required by FDA under a REMS.  

The Nexplanon REMS requires that Organon monitor who is performing procedures with Nexplanon to determine whether all providers are certified and if any adjustments in training are necessary to further reduce the risk of complications due to IRREs. The certification requirement will help ensure that HCPs accessing Nexplanon for patient use have completed necessary training. Specifically, prior to inserting Nexplanon, HCPs must be certified through the REMS by enrolling and completing training on the proper insertion and removal of Nexplanon.  

Organon has informed HCPs about enrolling in the Nexplanon REMS. 

More information is available on the REMS@FDA website (Nexplanon REMS), or by contacting the Nexplanon REMS Coordinating Center at 1-833-NXP-REMS (1-833-697-7367) or Organon’s general service number at 1-844-674-3200.