Cervical cap receives USFDA approval
Kopp, Z.
Ippf Medical Bulletin 23(1): 3-4
1989
ISSN/ISBN: 0019-0357 PMID: 12281959 Document Number: 363062
After a decade of investigations,, the US Food and Drug Administration (USFDA) approved the Prentif Cavity-Rim cervical cap on May 23, 1988. In use in many other countries since 1838, the findings of the USFDA-mandated study showed a theoretical-effectiveness rate of 93.6%, comparable to a 95.4% rate for the diaphragm. Use-effectiveness rates were 88.3% and 87.4% respectively. However studies revealed a wide range in reported efficacy rate and in the % of women who were able to be fitted for the cap. There are 4 cap sizes; when the cap is correctly in place a vacuum in created between the cervix and the cap. A health practitioner, trained in cap fitting, should do the initial fitting 40-60 minutes should be used to explain to and train the cap user. Contraindications to cap use include: an allergy to rubber or nonoxynol-9; inability to insert or remove the cap; and abnormal Pap smears. The USFDA study showed a 4% conversion rate from Class I to Class III Pap tests as compared to 1.7% for diaphragm users after 3 months. Beyond 3 months conversion rates were similar. Although these results have been questioned, the USFDA has requested that the manufacturer gather further data on Pap test conversions. Like diaphragm users, cervical cap users are less likely to contract sexually transmitted diseases; In contrast to a diaphragm the cervical cap can be left in place for up to 2 days; less spermicide is used, decreasing messiness; and the smaller size means increased comfort. The cervical cap should appeal to 3 groups: 1) women seeking a temporary method of family planning who are experiencing or concerned about side-effects with other methods, or for whom other methods are contra-indicated; 2) adolescents whose special needs require a temporary method with minimal side-effects which has not been found to affect future fertility; and 3) users concerned with preventing HIV infection and other sexually transmitted diseases, and who use the cap in conjunction with the condom.