Insertion- and removal-related events associated with the NEXPLANON contraceptive implant: Results from the Nexplanon Observational Risk Assessment (NORA) Study
ESC Congress Library. Reed S. 05/10/18; 208237; ESC149
Dr. Suzanne Reed
Dr. Suzanne Reed
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Objectives: To characterize the frequency of insertion- and removal-related events among NEXPLANONTM users in the US during standard clinical practice. Design and methods: This large, prospective, non-interventional cohort study followed 7,369 patients with a newly-inserted Nexplanon (IMPLANON NXTTM) implant. First-ever implant users and repeat/consecutive implant users were recruited by health care professionals (HCPs) between December 2011 and March 2014. Questionnaires were completed by patients at 6-month intervals (beginning on the day of insertion and ending 6 months after implant removal) and by HCPs who inserted or removed the implant. Data analysis characterized the frequency of procedure-related events.  Results: During 7,369 implant insertions, HCPs reported 208 events involving 189 patients (2.6% of the study population). HCPs most commonly reported device-handling issues such as difficulty removing the needle protection cap (93 insertions). A total of 49 patients (0.7% of the study population) reported an event at the time of insertion in the arm of implant insertion. The most common event was pins/needles/numbness in the arm/hand/fingers (17 patients; 2.3 per 1,000 insertions; 95% CI, 1.3-3.7), which was significantly more likely in repeat/consecutive implant users (10.1 per 1,000 insertions; 95% CI, 4.6-19.0) than first-ever implant users (1.2 per 1,000 insertions; 95% CI, 0.5-2.4). Follow-up data through July 2017 show that 349 patients reported 606 events in the arm in which the implant was inserted: pins/needles/numbness (192 patients), severe pain (166 patients), altered strength (67 patients) and other events (e.g. bruising) (100 patients). Of 4,044 successful removal procedures, 54 (1.3%) involved at least one challenge: encasement in fibrotic tissue (28), multiple removal attempts (12), local migration (4), deep implant (8) and other challenges (e.g. fragmented implants) (13). One other removal procedure was unsuccessful due to the location of the implant in deep muscle tissue.  Three patients were hospitalized for the removal procedure (1 patient had a localized infection in the arm and 2 patients had implants which were located deep in the arm). In all 3 cases, the implant was successfully removed.  Final study results will be available at ESC.  Conclusions: Procedure-related events associated with Nexplanon use are low, with rare occurrence of need for hospitalization.
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