A Woman's Way to Make Sex Safer

By Christine Gorman

As if men and women did not have enough to fight about in the bedroom, they will soon be able to squabble over who should wear the condom. Last week the Food and Drug Administration announced that it was preparing to approve a female condom -- a plastic pouch that lines the inside of the vagina. Named Reality by its U.S. manufacturer, Wisconsin Pharmacal, the product is similar to male condoms in that it is designed to prevent both pregnancy and the spread of AIDS and other sexually transmitted diseases.

The female condom is not as effective as its male counterpart, and at a cost of up to $2.50, it will be more expensive. However, given the well-documented reluctance of many men to wear condoms, it may provide some women with their only means of protection. A recent study found that among sexually active young women, only 20% have partners who use condoms. "Women need the option," says Mary Ann Leeper, senior vice president for development at Wisconsin Pharmacal. "Right now, she has to ask him to wear a condom. If he says no, she has no option."

Invented by a Danish physician in 1984, the female condom is already available under the name Femidom in Britain, the Netherlands, Portugal, Norway and Switzerland, and will go on sale this month in France. The version made by Wisconsin Pharmacal is a 7-in.-long polyurethane sheath with a ring on each end. The inner ring is inserted into the vagina, much like a diaphragm, while the other ring remains outside.

Before giving the Reality condom final approval, the FDA asked that two caveats be put into the labeling. First, the agency wants a statement that male condoms are still the best protection against disease. Wisconsin Pharmacal thinks the polyurethane used in the female condom may be more effective against viruses than the latex of male condoms, but not enough studies have been done to know for sure.

The second FDA demand is that the label compare the effectiveness of female condoms with that of other barrier methods of birth control. According to the FDA, in a study of 150 women who used the female condom for six months, 26% became pregnant. The manufacturer contends that the pregnancy rate was 21% -- and only because many women didn't use the condom every time they had sex. With "perfect use," company officials say, the rate is 5%, in contrast to 2% for male condoms.

Resolving the dispute over what failure rate to put on the label has delayed approval. However, the FDA is eager to get the product on the market, since it could be a lifesaver for women whose partners refuse to use a condom. Says FDA Commissioner David Kessler: "The female condom is not all we would wish for, but it is better than no protection at all."

With reporting by Dick Thompson/Washington