On March 9, 2009, FDA approved a second version of the female condom, called the FC2 Female Condom
STATEMENT BY THE FOOD AND DRUG ADMINISTRATION The Food and Drug Administration today announced it is prepared to approve -- with restrictive labeling -- the Reality Female Condom, the first barrier contraceptive for women that also offers limited protection against sexually transmitted diseases (STDs). The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, it is important to use latex condoms for men.
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 required endorsement of the safety offered by latex condoms for men, the approval for the product will be granted with these conditions:
* The label must compare the pregnancy rate for female condom users -- approximately 26 percent per year -- to rates for other women's barrier contraceptives, which are lower.
* The manufacturer must take part in additional effectiveness studies for the product.
"The female condom is not all we would wish for, but it is better than no protection at all," FDA Commissioner David A. Kessler, M.D., said. "I have to stress that the male latex condom remains the best shield against AIDS and other sexually transmitted diseases. Couples should go on using the male latex condom."
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 Obstetrics and Gynecology Devices Advisory Panel at its meeting on Dec. 10, 1992.
The agency gave the product an expedited review because it saw an urgent need for a means whereby women can protect themselves without depending on the cooperation of their partners. FDA had reservations about the limited data available on protection the female condom offered against STDs, as well as about the high pregnancy rate among users, the small number of women in the clinical studies and the short duration of the studies, which lasted less than a year. Eventually, the agency decided to approve the female condom as the only product of its kind ready for marketing.
The manufacturer -- Wisconsin Pharmacal of Jackson, Wisc. -- studied 200 women who used the device for six months. In the study, the six-month pregnancy rate among U.S. women was approximately 12.5 percent--or an estimated 26 percent per year. This high rate is believed to have been the result of improper use of the device. It compares to an expected rate of 85 percent among women not using any contraceptive method. Women who use the device correctly each and every time they have intercourse can expect a much lower pregnancy rate.
Details of the required studies on the product's effectiveness are being worked out. FDA is one of the eight Public Health Service agencies within HHS.