PubMed · 6222288
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A Gartland. A case for concern?. https://pubmed.ncbi.nlm.nih.gov/6222288/
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OBJECTIVE: Norplant and Norplant-2 have been available for use by Finnish women since 1984 and 1986, respectively. The objective of this study was to explore Norplant users' experiences of insertions, removals and medical treatments. DESIGN: A questionnaire was sent to women who had received Norplant or Norplant-2 implants one to two years earlier (n = 262) in normal clinical settings; the response rate was 79%. RESULTS: At insertion, problems were experienced by 9% and at least some pain by 23% of women. During the first year 20% of all users (14% of Norplant and 33% of Norplant-2 users) had their implants removed. Problems were experienced at removal by 33% of women and pain was experienced by 40%; nevertheless most users were satisfied with the device. Findings were similar for the two types of Norplant. Forty-two percent of the women had received minipills containing levonorgestrel before Norplant insertions in an attempt to assess Norplant's suitability, and 8% had received drugs for adverse effects caused by Norplant. CONCLUSIONS: Studies including perspectives of Norplant users and the whole lifespan of Norplant (including removal) should be conducted in all clinical settings where Norplant is provided.
Norplant implantable contraceptives were developed mainly for use in Third World countries, but first were approved for marketing in Finland in 1983 and in Sweden in 1985. Since then Norplant has been approved in more than 40 countries, most of them in the Third World. The authors analyzed the clinical documentation submitted to the Finnish and Swedish drug control authorities, and the assessments made of the data. The Finnish review process lasted for three years, and the number of data increased substantially during that time. The authors have not been allowed to publish the clinical data submitted in Finland, but a reconstruction from the Swedish data showed that the clinical data were of poor quality and were mainly focused on assessing efficacy. Side effects, acceptability, and requirements of the health care system for proper use of Norplant were poorly studied. This example of Norplant licensing in Finland shows that licensing of drugs in industrialized countries is insufficient for guaranteeing their safety in Third World countries.