Objectives To evaluate the tolerability and clinical safety of the subdermal, long-acting hormonal contraceptive Implanon®.

Methods This integrated safety analysis included 11 international studies concerning Implanon® (68 mg etonogestrel) of which 10 had a duration of at least two years. Assessments included reports of adverse events (AEs), reasons and rates of discontinuation, insertion/removal complications, and the condition of the implant site. Metabolic and coagulation parameters are briefly discussed to fully describe the clinical safety profile.

Results In total 942 women were exposed to Implanon® for 24,679 cycles over the course of one to five years. The overall discontinuation rate was 32.7%; the most frequently reported reasons for discontinuation were adverse events (13.9%), bleeding irregularities (10.4%), and planning pregnancy (4.1%). The most commonly reported drug-related AE was headache (15.3%); however, headache was reported in only 1.6% of women as a reason for discontinuation. Insertion and removal times for Implanon® were short with few complications, none of which were major. From earlier studies it is known that treatment with Implanon® has little effect on metabolic and coagulation parameters.

Conclusions Implanon® is a well-tolerated and safe method of long-acting hormonal contraception for women.