Early versions of a female condom were available in the 1920s and 1960s, but they were little used and soon forgotten. It took the arrival of AIDS, and the urgent need for a wider range of female-controlled barrier techniques, to rekindle scientific interest in this method. In the 1980s, three groups in Europe and the USA began development of new female condom designs, comprising 'Femidom (Reality)', the 'Bikini Condom', and 'Women's Choice'. Apart from differences in their physical design, Femidom differs from the others in that it is made of a polyurethane membrane, which has several advantages over latex. Of the three, Femidom is the most advanced in terms of development and clinical testing, and it is the only one to have reached the marketing stage. Laboratory studies and clinical trials suggest that its contraceptive efficacy is similar to that documented for the male condom, though a direct comparison is not possible because no comparative clinical trials have, as yet, been undertaken. Reported 'typical-use' pregnancy rates range from 12.4 to 22.2% at 6 months of use in the USA and Latin America, respectively, while a study in the UK observed a rate of 15% at 12 months. As with all barrier methods, most failures appear to be associated with poor compliance or incorrect use. 'Perfect-use' pregnancy rates were substantially lower, indicating that Femidom can be very effective, if used consistently and correctly. Evidence for Femidom's effectiveness to protect against transmission of sexual disease-causing organisms, including HIV, is still very limited and based largely on laboratory studies. Whilst, in theory, the condom should confer reliable protection, its efficacy in clinical use will depend upon correct and consistent use and upon the product's ability to maintain an effective physical barrier throughout penetrative intercourse. In this respect, the results of recent and ongoing clinical studies are expected with much interest. How valuable Femidom will prove to be, in terms of sexual health and contraception, will also depend largely on its long-term user-acceptability. As is generally the case with new methods, initial public interest in Femidom is expected to be high, as was documented in numerous surveys, and there undoubtedly exists a sub-group of women who view the product as their most appropriate contraceptive/sexually transmitted disease prevention option. However, more information on the product's acceptability, based on continuation rates, as is usually applied to other contraceptive techniques, is urgently needed to permit a more reliable assessment of Femidom's position among current methods. The arrival of a female condom represents a welcome addition to the range of female-controlled barrier contraceptives and, because of its numerous potential advantages over the male condom, may play an important role in the prevention of unwanted pregnancy and sexually transmitted diseases.