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Contraception UPDATE

Update on the Female Condom

Jill Schwartz, MD

A less expensive version of the female condom (FC) was recently approved by the FDA. Will this increase the use of this contraceptive form, which offers several important benefits for women?

Male condoms have played an important role in global HIV prevention over the past few decades. In recent years, women have become increasingly vulnerable to HIV, especially in highly afflicted sub-Saharan Africa. Since women are not always able to insist on the use of male condoms, there is a great global need for affordable and accessible woman-controlled barrier methods that provide dual protection against unintended pregnancy and the transmission of sexually transmitted infections (STIs), including HIV/AIDS.

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FC1/FC2 Female Condoms

The Reality Female Condom (Female Health Company [FHC], Chicago, Ill), was approved by the FDA in 1993 as the first barrier contraceptive for women that offered some protection against STIs. It is currently sold as the FC Female Condom (FC1).1,2 The failure rates for this first-generation polyurethane FC are listed in Table 1.3 FC1 has been marketed or available under a variety of brand names through various channels in more than 100 countries and has the features described in Table 2. The FC2 was recently developed to replace the FC1, and is made of synthetic latex (nitrile), a newer material that allows for a significant reduction in FC pricing (Figure 1). The FC2 has been approved by the World Health Organization and, as of March 11, 2009, the FDA. In a comparative study of the FC1 to the FC2 with respect to the 4 FC failure modes (breakage, invagination, slippage, and misdirection), the risk of failure of the FC2 during use was equivalent to FC1 and both were found to be acceptable in overall experience, ease of insertion, and comfort (Table 3).4-6

Despite a global need for a female initiated barrier device, sales of FCs have been disappointing in developed countries such as the United States, although donor agencies such as US Agency for International Development and United Nations Population Fund have increasingly purchased them for use in family planning and HIV/AIDS programs in developing countries. Worldwide sales in 2008 were 34.7 million units. Differing acceptability ratings have been reported in short-term FC studies and problems identified include insertion difficulty, discomfort, and suboptimal performance during intercourse.6-9

As the price per unit of female condoms is higher than male condoms, it is hoped that the reduction in cost of the FC2 might lead to greater accessibility and wider popularity than the original female condom. Efforts to develop new and improved female condoms are ongoing.

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TABLE 1. Pregnancy Rates of FC13

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TABLE 2. FC1 and FC2 Features

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TABLE 3. Acceptability of FC1 and FC26

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Figure 1. Comparison of FC1 and FC2 female condoms. Image courtesy of The Female Health Company.

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Available But Not FDA Approved Female Condoms

The Reddy Condom (Medtech Products, Ltd., Chennai, India) and the Natural Sensation Panty Condom (Natural Sensations, Columbia) are available but have not been approved for use by the FDA as contraceptives or HIV/STI prevention methods. The Reddy FC has received the CE mark for distribution in the European Union and is sold primarily through the private sector in several countries as the VA w.o.w. condom (Figure 2). It is made from highly elastic latex, and when unstretched, it is much shorter than the FC1 or FC2, measuring only 9 cm (3.5 inches) in length. It consists of a latex pouch with a triangular polyethylene frame at the open end and a polyurethane sponge inside the closed end to anchor the device inside the vagina. The Natural Sensation Panty Condom, a reusable thong panty with replaceable condoms, has been marketed in Latin America, but has not gained momentum among large private or public procurers.

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Figure 2. VA w.o.w. female condom. Image courtesy of Medtech Products Ltd.

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Female Condom Products in Development

Several additional novel FC products are in various stages of development but it will take several years for any of them to be available. PATH, a nonprofit organization, has used an iterative user-driven development process to produce a novel FC product. The PATH Woman’s Condom (WC) has a 23-cm (9-inch) pliable polyurethane pouch, a flexible soft outer ring, and 4 oblong foam pieces on the outside of the pouch that cling to the vagina to stabilize the device. The distal end of the pouch and foam pieces are packaged in a capsule that serves as an insertion aid and dissolves quickly after insertion (Figure 3). The WC performed well in a short-term acceptability study and in a comparative crossover study with the FC1.10,11 PATH has identified a manufacturer for the WC (Shanghai Dahua Medical Apparatus Company, Shanghai, China), and anticipates the device will be marketed first in China.

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Figure 3. PATH Women’s Condom. Image courtesy of PATH/Glenn Austin.

Other designs include the Belgium Female Condom (Mediteam, Brussels, Belgium), made of natural latex and designed to cover the entire vulva and base of the penis, and the Silk Parasol Panty Condom (Silk Parasol Corporation, Bodega, Ca), a reusable panty with refill condoms.

To obtain comparative information on the acceptability of the 3 FCs working toward FDA review (the FC2, Reddy, and PATH WC), a novel acceptability study was funded by USAID and conducted by Family Health International in Durban, South Africa. In this study, the 3 FCs were tested by 180 women in a crossover design measuring functionality, safety, and acceptability outcomes. A subset of 130 women participated in a simulated market study to determine preference. Results from this study are expected soon.

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Clinician’s Role in Female Condom SucceSs

The clinician may play a pivotal role in helping women make decisions about the benefits of FCs, and other barrier method use based on their individual risk of unintended pregnancy and STI exposure. A woman who has frequent intercourse, is young, or has had previous unintended pregnancies with barrier methods may not be an ideal candidate for exclusive use of an FC. However, a woman at high risk for STI exposure and unable to use male condoms might benefit from the dual method use of effective contraceptives, such as hormonal contraceptives and FCs. Although FCs are available over the counter, the clinician can play an important role in helping women use these products successfully.

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Conclusions

Despite the many potential benefits of FCs in maintaining reproductive health, they have not yet achieved their full potential. It is hoped that the upcoming availability of the less costly FC2 will help galvanize its acceptability and use in appropriate populations. Efforts are ongoing to develop more user-friendly products with unique insertion and anchoring mechanisms, but much greater efforts are needed to promote the FC and help it achieve its full dual prevention potential.

The author reports no actual or potential conflicts of interest in relation to this article.

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Jill Schwartz, MD, is Medical Director and Research Associate Professor, CONRAD/Eastern Virginia Medical School, Arlington, VA.

References

1. Farr G, Gabelinick H, Sturgen K, Dorflinger L. Contraceptive efficacy and acceptability of the female condom. Am J Public Health. 1994;84(12):1960–1964.
2. Soper DE, Shoupe D, Shangold GA, Shangold MM, Gutmann J, Mercier L. Prevention of vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis. 1993;20(3):137–139.
3. Hatcher HA, Trussell J, Nelson AL, Cates W, Stewart F, Kowal D. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
4. Beksinska M, Smit J, Mabude Z, Vijayakumar G, Joanis C. Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women. Contraception. 2006; 73(4):386–393.
5. Beksinska M, Joanis C, Manning J, et al. Standardized definitions of failure modes for female condoms. Contraception. 2006;75(4):251–255.
6. 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(4):394–398.
7. Jivasak-Apimas S, Saba J, Chandeying V, et al. Acceptability of the female condom among sex workers in Thailand: results from a prospective study. Sex Transm Dis. 2001; 28(11):648–654.
8. Deniaud F. Dynamics of female condom acceptability among prostitutes and young women in Abidjan, Ivory Coast. Contracept Fertil Sex. 1997;25(12):921–932.
9. el-Bassel N, Krishnan SP, Schilling RF, Witte S, Gilbert L. Acceptability of the female condom among STD clinic patients. AIDS Educ Prev. 1998;10(5):465–480.
10. Coffey PS, Kilbourne-Brooke M, Austin G, Seamans Y, Cohen J. Short-term acceptability of the PATH Woman’s Condom among couples at three sites. Contraception. 2006;73(6): 588–593.
11. Schwartz JL, Barnhart K, Creinin MD, et al. Comparative crossover study of the PATH Woman’s Condom and the FC Female Condom. Contraception. 2008;78(6): 465–473..

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