United States. Advisory Committee on Obstetrics and Gynecology
Published: 1968
Total Pages: 116
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Intrauterine devices (IUDs) have an antifertility effect in every animal tested, but this effect is manifested differently among the species. 6-8 million women use the IUD with a pregnancy rate in the United States of from 1.5-3/100 women during the first year of use. These rates decline with use. 80% will continue with the device in the first year, 70% for the second, and about 50% by the fifth year. Adverse reactions include irregular bleeding and cramps for the first 2-3 months and this accounts for 60% of removal. Pelvic inflammatory disease has been reported to be about 2.5% the first year, 1.5% during the second. Highest incidence was in the first month after insertion. The Committee recommended more stringent standards for inserters and devices and more care in insertion. A survey of the Fellows of the American College of Obstetricians and Gynecologists disclosed 15 instances of intestinal obstruction following perforation of the uterus, 13 in which the closed type IUD was used. "The Committee is adverse to the use of currently available closed devices, except in very unusual circumstances." Monitoring women wearing IUDs for cancer in the same manner as for normal women was suggested. The mortality figure for IUDs was .2/10,000 insertions. The current legislation under consideration by the Food and Drug Administration for certain classes of devices secured or placed in the body was considered satisfactory, with means for confidential reporting of adverse reactions recommended. The Committee recommended areas for further research. Task force reports and a bibliography of clinical reports on IUDs in the English literature 1959-1967 were presented. The report includes a list of available IUDs and exhibits of labeling submitted by some manufacturers.