- Theresa Hoke, PhD, MPH
Theresa Hoke, PhD, MPH
- Health Services Research
- Katherine M Stone, MD
Katherine M Stone, MD
- Medical Epidemiologist
- Markus J Steiner, PhD
Markus J Steiner, PhD
- Senior Epidemiologist
- FHI 360
- Lee Warner, PhD, MPH
Lee Warner, PhD, MPH
- Chief, Applied Sciences Branch
- Division of Reproductive Health
- Centers for Disease Control and Prevention
The female condom covers the cervix, lines the vagina and shields the introitus, thus providing a physical barrier between genitalia and secretions during sexual intercourse. It is designed to protect against both pregnancy and sexually transmitted infections (STIs), and is available without prescription. No contraindications exist to its use, but it may not be appropriate for women who are not comfortable touching their genitals or who may have other problems with insertion. Female condoms account for less than 1 percent of condoms produced globally .
In 2012, the World Health Organization (WHO) and United Nations Population Fund (UNFPA) published WHO/UNFPA Female Condom: Generic Specification, Prequalification and Guidelines for Procurement to provide a technically sound, systematic process to support the manufacture, prequalification, procurement and distribution of quality female condoms that meet the needs of different populations in a broad spectrum of challenging environmental conditions. In 2015 the US Food and Drug Administration announced it was considering reclassification of the female condom from a Class III to a Class II device. This change would reduce regulatory control to the level assigned to male condoms, potentially expanding innovation opportunity for female condoms .
TYPES OF FEMALE CONDOMS
All female condoms currently available or in development have an anchor (eg, ring, frame) outside the vagina to prevent the condom from being pushed inside the vagina during use; the anchor is also used for removing the condom. Female condoms have been made out of natural rubber latex, synthetic latex (nitrile), and polyurethane. They prevent preejaculatory fluid, semen, and vaginal secretions from entering the users’ vagina. No spermicide is required, but a lubricant is often needed. An illustration can be seen at the US National Library of Medicine.
The most widely available female condom today is FC2, manufactured by the Female Health Company (Chicago, Illinois). It is a soft, loose-fitting nitrile sheath or pouch with two flexible rings. One ring is contained within the closed end of the sheath and serves as an insertion mechanism and internal anchor. The other ring forms the external, open edge of the device; it remains outside the vagina after insertion. Silicone-based lubricant lines the inside of the condom, but additional lubrication for the inside and/or outside could be used. The condom is about 17 cm (6.5 inches) in length (similar to a male condom).
In 2009, FC2 replaced the FC1, the first condom marketed to women also manufactured by the Female Health Company. FC2 is similar in design to FC1, but made of nitrile (rather than polyurethane) and without a seam. In comparative trials, it performed as well as the FC1 in terms of patient satisfaction, breakage, slippage, and invagination (ie, when the outer frame of the condom pushes into the vagina during intercourse) [3,4]. No data on pregnancy prevention or STI prevention are available for FC2 specifically, but effectiveness is assumed to be similar to the FC1 given the similar design, specifications, and functionality. The FC2 is indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections . It may make less noise during intercourse than the FC1 and is projected to be cheaper when mass produced. It is available in about 100 countries. It has been approved by United States Food and Drug Administration (FDA); has CE Marking, which certifies that the device meets consumer safety standards and can be marketed in countries in the European Union; and has been cleared by the World Health Organization (WHO) for purchase by United Nations agencies.
- Center for Health and Gender Equity. Saving lives now: Female condoms and the role of US foreign aid. Takoma Park, MD, 2008.
- US Food and Drug Administration. Retrospective review of premarket approval application devices; striking the balance between premarket and postmarket data collection. https://www.federalregister.gov/articles/2015/04/29/2015-09884/retrospective-review-of-premarket-approval-application-devices-striking-the-balance-between (Accessed on May 26, 2015).
- Smit J, Beksinska M, Vijayakumar G, Mabude Z. Short-term acceptability of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. Contraception 2006; 73:394.
- Beksinska M, Smit J, Mabude Z, et al. Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. Contraception 2006; 73:386.
- Second generation of female condom receives FDA committee approval. Contraceptive Technology Update 2009; 30:25.
- Beksinska ME, Piaggio G, Smit JA, et al. Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet Glob Health 2013; 1:e146.
- Beksinska M, Smit J, Joanis C, Potter W. New female condoms in the pipeline. Reprod Health Matters 2012; 20:188.
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- Beksinska M, Smit J, Joanis C, et al. Female condom technology: new products and regulatory issues. Contraception 2011; 83:316.
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- Trussell, J. Contraceptive efficacy of the Reality female condom. Contraception 1998; 58:147.
- Vijayakumar G, Mabude Z, Smit J, et al. A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence. Int J STD AIDS 2006; 17:652.
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- French PP, Latka M, Gollub EL, et al. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis 2003; 30:433.
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- Peterson, K, Herman, L, Fiske, L, Marseille, E, Kahn, JG. Smarter Programming of the Female Condom: Increasing Its Impact on HIV Prevention in the Developing World. FSG Social Impact Advisors, Boston 2008.
- Renzi C, Tabet SR, Stucky JA, et al. Safety and acceptability of the Reality condom for anal sex among men who have sex with men. AIDS 2003; 17:727.
- Joanis C, Latka M, Glover LH, Hamel S. Structural integrity of the female condom after a single use, washing, and disinfection. Contraception 2000; 62:63.
- Potter B, Gerofi J, Pope M, Farley T. Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication. Contraception 2003; 67:65.
- Pettifor AE, Rees HV, Beksinska ME, et al. In vitro assessment of the structural integrity of the female condom after multiple wash, dry, and re-lubrication cycles. Contraception 2000; 61:271.
- TYPES OF FEMALE CONDOMS
- Pregnancy prevention
- Sexually transmitted infections
- ADVANTAGES AND DISADVANTAGES
- General advantages
- General disadvantages
- INSTRUCTIONS FOR USE OF FC2
- Obtaining female condoms
- SOCIETY GUIDELINE LINKS
- INFORMATION FOR PATIENTS
- SUMMARY AND RECOMMENDATIONS