FDA Bulletin - June 22, 1993
Department of Health and Human Services, Food and Drug Administration

The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice.

The label must also compare the pregnancy rate for the female condom--approximately 26% per year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15% per year.

The female condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia.

In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal of Jackson, Wis., to take part in additional effectiveness studies for the product.

FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on Dec. 10, 1992.

Wisconsin Pharmacal studied 200 women who used the device for 6 months. The estimated pregnancy rate of 26% per year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%.) Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.