Abstract
This controlled cohort study aimed to evaluate the safety and efficacy of Norplant
contraceptive implants in developing countries. Women initiating Norplant implants
were index subjects and women initiating intrauterine devices (IUDs) or surgical sterilization
were controls. Consenting participants at 32 clinics in eight developing countries
were admitted and followed-up every 6 months for 5 years. Major and less serious health
events during follow-up were recorded. Incidence rate ratios of health events adjusted
for clinic were estimated for initial and current method use. This paper reports non-reproductive
health events. The study involved 7,977 women initiating use of Norplant, 6,625 of
IUD, and 1,419 of sterilization. Five years follow-up was completed for 94.6% of the
women. The study accumulated 78,323 woman-years of observation. The initial method
chosen accounted for 84.4% or more of observed woman-years in users of Norplant, IUD,
or sterilization. Twenty-two of the recorded 34 deaths were due to accidents, suicide
or homicide. Few deaths or major health events were due to cancer or acute cardiovascular
diseases and were not associated with the contraceptive method used. The incidence
rates of major health events were low and with two exceptions, there was no significant
excess risk of serious morbidity for Norplant users compared with controls; among
Norplant initiators gallbladder disease occurred at an incidence rate of 1.5 per 1,000
woman-years and was weakly associated with use of Norplant (rate ratio 1.52 [95% C.I.
1.02, 2.27]). For current Norplant users compared to controls, the rate ratio of a
combined variable of hypertension and borderline hypertension was significantly elevated
(1.81, [1.12, 2.92]). The occurrence of less serious health events was also low and
several of them were significantly more often reported among Norplant users. Headache-migraine,
weight gain, mood disturbances, pruritus, eczema, and acne had incidence rates among
Norplant users of 11.5, 4.5, 2.8, 1.5, 1.4, and 0.9 per 1,000 woman-years, respectively,
and were significantly higher than in controls. Respiratory health problems, nonspecific
symptoms, and several ill-defined conditions were also significantly more often reported
for Norplant users, but some of the excess incidence may be attributable to reporting
and detection bias. The study confirms the safety with respect to serious disease
of Norplant, IUDs, and sterilization.
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Article info
Publication history
Accepted:
January 15,
2001
Received in revised form:
January 9,
2001
Received:
February 28,
2000
Identification
Copyright
© 2001 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
