Safety and efficacy of levonorgestrel implant, intrauterine device, and sterilization.
OBJECTIVE
To evaluate safety and efficacy of levonorgestrel-releasing contraceptive implants (Norplant; Leiras Oy, Turku, Finland) in developing countries.


METHODS
We used controlled cohort methodology. Women attending family planning clinics in eight developing countries selecting Norplant were enrolled, together with women of similar age choosing intrauterine devices (IUDs) or surgical sterilization. Participants were interviewed and examined at semi-annual visits and followed-up for 5 years regardless of change of contraceptive methods. Incidence rate ratios of health events were estimated for initial and current method use.


RESULTS
Altogether, 7977 women initiated Norplant, 6625 IUD, and 1419 sterilization. The overall follow-up rate was 94.6% and 78,323 woman-years of observation were accumulated. Pregnancy rates for Norplant, copper IUDs, and sterilization each averaged less than 1 per 100 woman-years. With two exceptions, no significant excess risk of serious morbidity was detected for Norplant users compared with controls. The incidence of gallbladder disease was higher in women who initiated Norplant use than in controls (rate ratio 1.52, 95% confidence interval [CI] 1.02, 2.27), as was the incidence of hypertension and borderline hypertension in current implant users (rate ratio 1.81; CI 1.12, 2.92). Other new findings were increased risks of respiratory diseases and decreased risks of inflammatory disease of the genital tract in Norplant users compared with IUD users and sterilized women.


CONCLUSIONS
The study confirms the safety with respect to serious disease and the high contraceptive efficacy of Norplant, copper IUDs, and sterilization.
United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland/
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Meirik
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Farley
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Sivin
D000328:Adult; D016022:Case-Control Studies; D015331:Cohort Studies; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D003906:Developing Countries; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007434:Intrauterine Devices / Q000009:adverse effects*; D016912:Levonorgestrel / Q000009:adverse effects*; D013246:Sterilization, Tubal / Q000009:adverse effects*
D003271:Contraceptive Agents, Female; D004343:Drug Implants; D016912:Levonorgestrel