With over 15 years of safety, effectiveness and acceptability data available, the majority of Female Condoms critics have come to acknowledged that the FC1 and FC2 Female Condoms provide protection against both pregnancy and sexually transmitted infections (STIs), including HIV. FC2 gives men and women an additional choice to protect themselves against STIs (including HIV) and unintended pregnancy. The data shows that when there is more choice there is more protected sex.
The FDA approved FC2 in 2009 in the United States. The pivotal study for the approval was an effectiveness study conducted in South Africa, comparing the FC2 Female Condom to the earlier version FC1 Female Condom (Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.) as FC1 was proven safe and effective in 1993 and is the gold standard for new female condoms in development.
For more on effectiveness research, click on the PowerPoint presented by representatives from FHI and UNFPA at the Global Consultation on the Female Condom, Baltimore, MD, September 2005, titled and discussing Effectiveness of Female Condoms in the Prevention of Pregnancy and Sexually Transmitted Infections.
Critics of the FC2 Female Condom often site that the product is uncomfortable and difficult to use. However, more and more studies are detailing that the FC2 Female Condom is found acceptable to both women and men around the world, correcting comfort issues of the first generation FC1. The key to use and acceptability of FC2 Female Condoms is proper training and education. The articles below are a snapshot of this research.