The female condom has been on the market for over ten years but despite a clear need it has not yet been adopted for wider use. In 2005 only 14 million female condoms were distributed compared to 6–9 billion male condoms around the world. However, studies in many countries have shown that the female condom is well accepted among both women and men, and that there is demand for it. One of the problems in achieving its widespread distribution in national programmes has been its cost.
In an effort to address the problem of cost, the Female Health Company has developed a second-generation female condom, FC2. This new version of the female condom has similar physical characteristics to the original female condom but is made of synthetic nitrile utilising a manufacturing process which allows greater efficiencies, particularly at higher volumes. The new device has been shown in studies to be equivalent to the original female condom and has the potential for wider acceptability and utilisation since it is expected to be more affordable for individuals and programmes.
In contrast to latex male condoms, there are currently no finalised ISO technical specifications for female condoms. The Female Health Company accordingly submitted technical information about the new device to the World Health Organization for evaluation. WHO’s technical review found the standard of manufacturing, design and physical characteristics of the new female condom functionally equivalent to the older one, and acceptable for bulk procurement by UN agencies subject to standard quality assurance measures. We also expect the product to be included within the United Nations Population Fund (UNFPA) condom procurement programme to replace the polyurethane device. The Female Health Company hopes to negotiate a public sector price and bulk rates with UN agencies, national programmes and NGOs for the new female condom, which will depend in part on the volume of public sector sales. If high utilisation rates of the new device can be achieved, the new female condoms can make a substantial contribution to prevention of unwanted pregnancies and sexually transmitted infections, including HIV.