Abstract

PIP: Research on contraceptive implants began when it was learned that steroids could be released from Silastic rubber capsules. The six-capsule Silastic drug delivery system, which would eventually be called Norplant, was by 1974 perfected and prepared for clinical trials. By 1978, data had accumulated to indicate a failure rate for Norplant after two years of only 0.6%, so Leiras Pharmaceuticals of Turku, Finland, was licensed in 1983 to manufacture Norplant, and Finland became the first country to give regulatory approval for distribution of the new contraceptive. The World Health Organization, after a 1984 evaluation, concluded that the Norplant system is an effective, reversible, long-term method of fertility regulation which is particularly appropriate for women in need of long-term contraceptive protection. Wyeth-Ayerst Laboratories began to distribute the device in the US after it met US Food and Drug Administration approval. 24 countries have now approved Norplant for distribution and use among women. This paper describes the Norplant contraceptive system, its mechanism of action, insertion and removal, effectiveness, contraindications, and adverse effects with regard to menstrual problems, medical problems, infection or pain, drug interactions, ectopic pregnancy, foreign body carcinogenesis, and other adverse reactions. It also notes use benefits in terms of contraceptive action, convenience, the reduction of adverse reactions for former oral contraception users, and the prevention of anemia, and lists categories of potential acceptors and women who may not wish to use Norplant.