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pubmed:otherAbstract |
PIP: The cervical cap--a small, rubber, thimble-shaped barrier contraceptive--fits tightly across the cervix and prevents sperm from entering the uterus. On May 23, 1988, the US Food and Drug Administration (FDA) announced its approval of the Prentif cavity-rim cervical cap for general use in the US, ending a nearly decade-long struggle for federal approval. The decision was largely a result of a study sponsored by the NIH showing that the cap is approximately as effective as the diaphragm, with about 17 failures per year among every 100 typical users. The FDA's approval comes with 1 string attached, however: Because of concern over its effect on cervical tissue, the cap is recommended only for women with a normal Pap smear, and the device's labeling will suggest that providers have users return for a Pap smear after 3 months of use. Although the FDA has now given the cervical cap its blessing, a few remaining problems will still limit the device's availability in the US. Because the cap comes in only 4 sizes, some of the women who might like to use the cap will be unable to do so. Another difficulty is the manufacturer has not yet reached an agreement with a distributor in the US. Finally, there may be training-related delays in the cap's availability. A great deal more training and fitting are needed for the proper use of the cervical cap than are required for the diaphragm, both for the potential user and for the clinician who trains her.
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