Safety, efficacy, and acceptability of two-rod contraceptive implant among women implanted attending family planning settings in Bangladesh

Background: Femiplant, a locally manufactured two-rod levonorgestrel (LNG) containing long-acting reversible contraceptive (LARC) implant, has been offered for three years of contraception since 2020. However, a scarcity of data is obvious in the literature regarding its contraceptive efficacy, safety, acceptability, and pharmacokinetic (PK) profile. Aim: We had an attempt to evaluate the efficacy, safety, acceptability, and pharmacokinetic (PK) profile regarding the device as a LARC implant among women who had implanted attending four family planning settings in Bangladesh. Methods: This observational cohort study enrolled 370 married women aged 18–45 years, screened from 400 existing implant users across family planning settings in Bangladesh. We followed up the study participants at 1, 6, 12, 24, and 36 months’ post-implant insertion and serum LNG concentrations was quantified using a validated LC-MS/MS method. In addition, we determined pharmacokinetic parameters using non-compartmental analysis. Pregnancy rates were measured by using Pearl Index and self-reported safety and acceptability data were analyzed. Results: Two pregnancies were detected, one in the third and the other in the fourth year, yielding a Pearl Index of 0.18 per 100 woman-years, demonstrating high contraceptive efficacy. Mean serum LNG levels declined from 561.5 ± 12.3 pg/mL at one month to 224.5 ± 21.0 pg/mL at the end of three years, remaining above the ovulation suppression threshold (200 pg/mL). Common side effects included irregular menstruation (80.7%) and altered bleeding patterns (95.5%) during the initial period of implantation. Overall satisfaction was 82.7%, with 80.3% of women expressing willingness for implant reinsertion after expiry of the existing one. Conclusion: Femiplant revealed high contraceptive efficacy, satisfactory safety, and strong user acceptability over the intended duration of use, with pharmacokinetic characteristics comparable to international LNG implants. Its incorporation into national family planning programs could expand access to effective LARC options in Bangladesh.