A condom for females, produced by a Chinese company, has been approved by the World Health Organization and the United Nations Population Fund, allowing worldwide distribution of another safe and effective form of contraception.
The prequalification of the condom's safety and quality marks a critical step forward in expanding options for women seeking to protect themselves from pregnancy and sexually transmitted disease, including HIV/AIDS, developers said.
In 2014, there were 2 million new HIV infections globally, according to the WHO. Women account for slightly more than half of all people living with HIV in low- and middle-income countries.
The approval of the female condom allows United Nations agencies and other international purchasers to obtain the device for distribution to the public sector. Female condoms currently make up only a tiny portion of the global condom market, although demand is growing.
The recently approved model, branded O'lavie in China, was created to provide enhanced sensation for men and may also provide more protection from skin-to-skin transmitted diseases such as herpes and the human papilloma virus. It can be inserted hours before intercourse and does not require immediate removal after.
"It has great potential to address unmet needs and improve reproductive health for women, men and young people," said Mags Beksinska, research director at Maternal, Adolescent and Child Health, a government-supported organization in South Africa.
"Our recent market studies in South Africa showed that women and men, especially young people, are excited about this innovative and pleasurable female condom," she said.
The female condom was jointly developed by the Program for Appropriate Technology in Health, known as PATH, the Conrad N. Hilton Foundation and local research partners who tested the device with people in four countries.
"This milestone is a testament to the power of cross-sector collaboration," said Steve Davis, president of PATH.
With funding from the Netherlands' Ministry of Foreign Affairs, PATH established the Protection Options for Women Product Development Partnership, aimed at building a supply-and-demand model for the female condom. In 2008, it transferred production to the Dahua Medical Apparatus Corp of Shanghai, China.
"As the manufacturer, we are honored that more women and men across the world may get expanded access to this new tool," said Chen Hongxuan, the company's vice-president.
Chen said the African market now provides a major share of its overall sales volume. In many countries, including China, the female condom is on the government's purchase list and is typically distributed by local family-planning groups.
Female condoms account for approximately 0.2 percent of global condom sales, based on data from the Reproductive Health Interchange, a reproductive health procurement and information service managed by the UN Population Fund.