Global Campaign for Microbicides

Home

Home » More Prevention Options » Female Condom

Female Condom

What are female condoms?

The female condom is a thin pouch that a woman can insert in her vagina before sex to prevent pregnancy and sexually transmitted infections (STIs), including HIV. It is the only proven, female-initiated method of HIV prevention currently available. The most widely distributed female condom design is the FC2®, which is manufactured by the Female Health Company (FHC). FC2 is a second-generation design that replaced FHC’s FC1® female condom. Additional female condom designs are on the market while others are still in development. 

Many women find that their ability to negotiate safer sex with a male partner is enhanced by having access to female condoms because it enables a woman to say, “If you don’t want to use your condom, I will use mine.” Some couples prefer the female condom to the male condom because it is not constricting, it transfers body heat, and the external ring may provide increased stimulation.
 

 

How does the female condom prevent HIV?

The female condom is a barrier method that keeps the penis and sperm from contact with the vagina and cervix. The female condom also covers part of the external female genitalia, offering additional protection from external STIs.  

The World Health Organization (WHO) and the US Food and Drug Administration (USFDA) approved the FC2® female condom for vaginal use only. However, some individuals use female condoms for anal sex. It is important to note that there have been no studies on the STI prevention efficacy of female condoms for anal sex, and safety data is inconclusive[1].

Female condoms are more effective when used correctly and consistently. Instructions for vaginal use can be found here, and instructions for anal use can be found here.


What evidence is there that female condoms work?

The most rigorous effectiveness studies were undertaken with the FC1® female condom. The FC1® is no longer on the market and has been replaced by the FC2®. While the FC1® data cannot be applied to all female condoms, they do provide a basis for discussion. The WHO and USFDA indicated that the FC2® is deemed equivalent to the FC1®. This means it is safe to assume that the studies conducted on FC1® would produce similar results for the FC2®. 

STI/HIV prevention
In vitro studies of the FC1® confirm that the product provides an effective barrier against many common STIs, including HIV. Calculations based on correct and consistent use estimate a 97.1 percent reduction in the risk of HIV infection for each act of intercourse[2].

Pregnancy prevention
Estimates on the contraceptive efficacy of the FC1® are within the range of other barrier protective methods, such as male condoms. Over the course of one year, the accidental pregnancy rate ranges from 15 to 25 percent for actual use to as low as 5 percent for correct use with every act of intercourse[3].
 

What female condoms products are available?

The first-generation female condom (FC1®), manufactured by the Female Health Company (FHC), was a silicone-lubricated polyurethane sheath with flexible rings at each end to aid insertion into the vagina and hold the condom in place. The FC1® was launched on the market in 1992 but is no longer manufactured. It has been replaced by FHC’s second-generation product, the FC2®. The FC2® has the same design and dimensions as the FC1® but is made of nitrile rubber, a synthetic latex. The FC2® has regulatory approval from the USFDA, is cleared by the WHO for public-sector purchase, and carries CE marking—meaning it can be marketed and sold in the European Union. In 2010, the FC2 was distributed in 114 countries[5]. Its brand names in various countries include Reality, Femidom, Dominique, Femy, Myfemy, Protectiv, Elegance, Della, and Care.

In addition to the FC2, there are four other female condom designs available on the market today: the VA w.o.w®, Cupid™, Woman’s Condom, and Phoenurse. As of early 2012, none of these products have WHO clearance or USFDA approval, though all are currently in review at WHO to determine their suitability for public-sector purchase. 

The VA w.o.w.® or “Reddy” female condom, manufactured by MedTech Products Ltd. of India, is made of natural rubber latex, comes pre-lubricated with silicone, has a triangular outer frame, and uses a sponge to secure the condom in the vagina.VA w.o.w.® has been distributed in many countries including  India, Brazil, Portugal, South Africa, and the United Kingdom. 

The Cupid™ female condom, manufactured by Cupid Ltd. of India, is made of natural rubber latex, comes pre-lubricated with silicone, has an octagonal outer frame, and uses a sponge to hold the condom in place in the vagina. It has CE marking and is approved by the India Drug Control Authority. Cupid™ is distributed in India and has small scale distribution in Brazil and Indonesia.  

The Woman’s Condom, manufactured by Dahua Medical Apparatus Company of Shanghai, China, is made of thin polyurethane film. The pouch folded into a capsule that quickly dissolves after insertion in the vagina. Once the capsule dissolves, the condom unfolds, releasing four foam shapes that cling lightly inside the vagina and hold the condom in place. The Woman’s Condom is packaged un-lubricated, and each piece is supplied with an individual sachet of water-based lubricant to be applied at point of use. It holds CE marking and Shanghai Food and Drug Administration approval in China. The Woman’s Condom is available in limited private-sector distribution channels in China under the brand name O’lavie™.  

The Phoenurse female condom, manufactured by Tianjin Condombao Medical Polyurethane Tech. co. Ltd., is made of polyurethane, has an inner ring to hold the condom in place, comes pre-lubricated with a water-based lubricant, and is packaged with an insertion tool, sanitary towel, and disposable bag. It has approval from the Tianjin Food and Drug Administration in China. Phoenurse is available in limited private-sector distribution channels in China.
 

What is happening now?

 

50 million female condoms were distributed globally in 2009[6]. While that sounds like a large number, female condoms are still out of reach for most women. About 10 billion male condoms are distributed globally each year and even that number does not meet the worldwide need. Almost all condoms distributed globally are male condoms. Female condoms make up only 0.2% of the total condom supply worldwide[7]. Only a tiny fraction of women who could benefit from access to female condoms are actually getting them. Several factors cause this:

  1. High price: While theFC2® costs about one third less to manufacture than the FC1®, its public-sector price is US 55 cents. Male condoms cost less than US 4 cents, which can make it difficult for some decision makers to justify spending more on female condoms when both offer dual protection from STIs/HIV and pregnancy.[8] In addition, only one female condom design—the FC2®—has the regulatory approvals needed for purchase and distribution by United Nations agencies and bilateral donors like the U.S. Agency for International Development. Additional female condom designs currently in review at WHO may help bring down prices through competition if they are approved for bulk purchase by public-sector agencies. But the fact remains that female condoms are more expensive than their male counterparts, which disincentives investment in them
  2. Perceived and real acceptability issues: Female condom uptake has been slow, and some people claim they are cumbersome, hard to use, or uncomfortable.  Yet studies done in more than 40 countries show that once people become familiar with the female condom, it is viewed as acceptable by people from a wide range of social and economic backgrounds and ages.[9] Most user concerns about the female condom can be resolved with programming that positively introduces the product to both potential users and providers; makes it affordable; and encourages women to practice inserting and removing it until they feel comfortable with using it.
  3. In addition, second generation female condom products can help address acceptability and performance.Not enough donor and policy-maker support: Higher cost and claims that women “do not like” female condoms have led to low interest among some major donors and governments. They are reluctant to fund large female condom purchases and the programming needed to assure good uptake of the product.
  4. Discomfort among "gatekeepers” such as health care providers and HIV and AIDS program implementers: In many countries, health care providers, HIV and AIDS program officials and other public health gatekeepers share the wide-spread public discomfort with talking about a product that is used vaginally. Discussion of how it is inserted and used—and of female sexuality generally—raises taboos that are difficult to overcome[10].

What advocacy needs to be done?

Strong advocacy for the female condom, coming up from the community level, is needed to stimulate demand and increase access and availability. To help get this advocacy going, you can:

Develop an advocacy campaign to demand that your government:

  • include female condoms in its commodities purchasing plans. 
  • fund programming that effectively introduces and promotes female condoms in HIV prevention and reproductive health programs.

Advocate for the inclusion of female condoms in your country’s

  • National Strategic Plan used to guide country-level purchasing and programming decisions.
  • Country Operational Plan submitted to the Global Fund to Fight AIDS, TB and Malaria.

Ask your government to join the UNFPA’s Female Condon Initiative (part of their Comprehensive Condom Programming Initiative) and collaborate with them on developing a national campaign. Read The Female Condom: A Powerful Tool for Prevention at http://www.path.org/publications/details.php?i=1267

Join the Prevention Now! Campaign – which is working to support and catalyze efforts to increase female condom access. For more information, see www.preventionnow.net.

 


[1] Mantell J, Kelvin E, Hoffman S, and Exner T. Female condom use for anal sex: Future directions for policy, practice, and research. Power point presented at the Universal Access to Female Condoms International Female Condom Conference, The Hague, November 18, 2011. Accessed: http://condoms4all.org/newsarticle/550/Presentations_at_Int_Conference

[2] Trussell J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive efficacy of the female condom and other barrier methods. Family Planning Perspectives. 1994;26:66-72.

[3] Trussell et al. (1994).

[4] Reproductive Health Supplies Coalition (RHSC). Product Brief: Female Condom. Brussels: RHSC, 2012.

[5] Female Health Company (FHC). 2010 Annual Report: Working for the Health of Women Worldwide. Chicago: FHC, 2011.

[6] Female Health Company. 2010.

[7] Center for Health and Gender Equity. Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid. Washington, DC: Center for Health and Gender Equity, 2008.

[8] Center for Health and Gender Equity. Female Condoms and U.S. Foreign Assistance: An Unfinished Imperative for Women’s Health. Washington, DC” Center for Health and Gender Equity, 2011.

[9] UNDP/UNFPA/WHO/World Bank Special Programme of Research on Human Reproduction. The Female Condom: A Review. Geneva: World Health Organization, 1997; Cecil H, Perry MH, Seal DW, et al. The female condom: what we have learned thus far. AIDS and Behavior 998:2(3):241-56.

[10] Global Campaign for Microbicides and UN Coalition on Women and AIDS, “Observations and Outcomes from the Experts’ Meeting on Female Condom, December 10, 2004” available online at http://www.global-campaign.org/clientfiles/FemaleCondomMeeting-Dec2004.pdf.