Female condom

Female condom

Polyurethane female condom
Background
Type Barrier
First use 1980s
Failure rates (first year)
Perfect use 5%[1]
Typical use 21%[1]
Usage
Reversibility Immediate
User reminders To avoid risk of incorrect use, read the instructions carefully prior to use.
Advantages and disadvantages
STD protection Yes
Weight gain No
Benefits No external drugs or clinic visits required

A female condom (also known as a femidom) is a device that is used during sexual intercourse as a barrier contraceptive to reduce the risk of sexually transmitted infections (STIs—such as gonorrhea, syphilis, and HIV, though its protection against them is inferior to that by male condoms)[2] and unintended pregnancy. Invented by Danish MD Lasse Hessel, it is worn internally by the female partner and provides a physical barrier to prevent exposure to ejaculated semen or other body fluids. Female condoms can be used by the receptive partner during anal sex.[3][4]

The female condom is a thin, soft, loose-fitting sheath with a flexible ring at each end. They typically come in various sizes. For most vaginas, a moderately sized condom is adequate; women who have recently given birth should try a large size first. The inner ring at the closed end of the sheath is used to insert the condom inside the vagina and to hold it in place during intercourse. The rolled outer ring at the open end of the sheath remains outside the vagina and covers part of the external genitalia.

Versions and materials

An illustration of a female condom.
Reddy brand female condom

The FC1 female condom was first made from polyurethane. The second generation female condom is called the FC2 and is made from synthetic nitrile.[5] (this material change was announced in September 2005,[6] and full transition of the product line to FC2 was done by October 2009 [7]). The newer nitrile condoms are less likely to make potentially distracting crinkling noises. FC2 was developed to take the place of FC1, providing the same safety and efficacy during use, but at a lower cost. It is hoped the nitrile condoms will also allow for significant reductions in female condom pricing.[6] FC2 is manufactured by The Female Health Company. The World Health Organization (WHO) has cleared FC2 for purchase by U.N. agencies and the UNFPA (a U.N. agency) has incorporated the female condom into national programming.[8] They are sold under many brand names, including Reality, Femidom, Dominique, Femy, Myfemy, Protectiv and Care.

A recent version of the female condom is made from natural latex, the same material used in male condoms. This condom does not make the noises some experience with plastic condoms. This type of female condom is manufactured by Medtech Products Ltd, India. It is sold under various brand names, including Reddy, V Amour, L'amour, VA WOW Feminine condom, and Sutra. One more clinical trial is required before it can be considered for FDA approval in the United States.[9]

The global health nonprofit Program for Appropriate Technology in Health (PATH) has also developed a female condom tailored for use in developing countries. The Woman's Condom is manufactured by Shanghai Dahua Medical Apparatus in China and is in early introduction.[10]

Products and manufacturers

FC2

The FC2 female condom is a nitrile sheath or pouch 17 cm (6.7 in) in length. At each end there is a flexible ring. At the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place. The other end of the sheath stays outside the vulva at the entrance to the vagina. This ring acts as a guide during penetration and stops the sheath from shifting during intercourse. There is a silicone-based lubricant on the inside of the condom, but additional lubrication can be used. The condom does not contain spermicide.

The original version of the FC female condom (brand names included Reality, Femy and Femidom), was made of polyurethane. As this was a relatively expensive material, the makers of the FC female condom released the FC2 version made of the cheaper nitrile material. Large-scale production of the FC2 began in 2007. The condom was approved by the FDA in March 2009. Production of the original FC condom has now stopped.

VA W.o.W.

The VA w.o.w.® Feminine Condom (Reddy Female Condom) is manufactured by Medtech Products Ltd. This latex condom has a pouch attached to its rounded triangular opening and a sponge to secure it inside a woman’s vagina. It is available through the private sector in several countries, including South Africa, Brazil, and India. The VA w.o.w.® Feminine Condom recently received the CE mark, a certification that it meets European Union consumer health requirements. It is also under review by the WHO.[11]

The Woman's Condom

The Woman’s Condom, developed by PATH, through a user-centered design process, is a new female contraceptive designed for improved acceptability, ease of use, and good sensation. The Woman’s Condom is a polyurethane pouch that is partially enclosed in a capsule to aid insertion. The capsule dissolves quickly after insertion in the vagina, which releases the pouch. The condom is then held stable in the woman by foam pads. The Woman's Condom is packaged dry and comes with a small sachet of water-based lubricant to be applied at point of use. PATH licensed manufacturing and distribution of the Woman's Condom to the Shanghai Dahua Medical Apparatus Company in 2008. Dahua has received the South Africa Bureau of Standards (SABS) certification marking (2013), Shanghai Food and Drug Administration Approval (2011), and the CE Mark approval (2010) for the Woman's Condom, which allows for marketing and distribution of the product in South Africa, China and Europe, respectively. The Woman's Condom is currently under review by the WHO/United Nations Population Fund Technical Review Committee; the Committee's approval could lead to bulk public-sector purchase by United Nations agencies.[12]

Natural Sensation Female Condom

The Natural Sensation Panty Condom is distributed in the US exclusively by the ACME Condom Company. It is manufactured by Natural Sensation Compañia Ltda. (NS) based in Bogotá, Colombia. The product is made of a polyethylene resin, which is stronger and thinner than latex. Unlike latex, polyethylene is anti-allergenic, ultra sensitive, transparent and odorless. Natural Sensation’s condoms are lubricated and may be used with either oil- or water-based lubricants.

Silk Parasol Female Condom

The Female Panty Condom is manufactured by Silk Parasol. It is made of biodegradable latex. It has not yet been approved by the FDA and is currently undergoing clinical trials.

The Phoenurse Female Condom

The Phoenurse™ is made of a dumbbell-shaped polyurethane sheath and comes with an insertion tool, a water- or silicone-based lubricant, sanitary towels, and disposal bags. It is manufactured by the Tianjin Condombao Medical Polyurethane Tech. Co. Ltd. and is approved for sale in the European Economic Area. The Phoenurse female condom is also available in Brazil, Sri Lanka, China, Kenya, and Mexico. It has not been approved by the FDA.

Cupid's Female Condom

The Cupid’s Female Condom is made of natural latex rubber and manufactured in India by Cupid Ltd. It is approved for distribution in Europe and was prequalified for distribution by WHO in 2012. It is currently undergoing clinical trials to gain approval by the FDA.

Origami Female Condom

The ORIGAMI Female Condom™ (OFC) is fabricated in molded silicone for anatomical conformity. It was validated as 100% biocompatible and non-allergenic in independent pre-clinical lab testing. The condom is not yet approved for sale and must be reviewed by the WHO, the C-Mark (EU), And the FDA to meet regulatory safety requirements. The OFC is in clinical trials in San Francisco, CA in collaboration with the Women’s Global Health Imperative at RTI, International. Large-scale clinical trials will follow in 2014, to evaluate its performance and safety. It is expected to reach the market in late 2015, pending regulatory pre-market approvals.

Proper usage

To insert an FC2:

During vaginal intercourse, it is normal for the female condom to move side to side. Stop intercourse if the penis slips between the condom and the walls of the vagina or if the outer ring is pushed into the vagina. As long as the partner has not yet ejaculated, the condom can be gently removed from the vagina to add extra spermicide or lubricant and inserted once again. Some consumers use the FC2 for anal intercourse, although it is not tested or FDA approved for this off-label use. Nonetheless, some consumer have followed the vaginal use instructions to insert FC2 into the anus however it is not recommend to remove and reinsert.

To remove an FC2:

Reusing an FC2 is not recommended.[13]

Costs and "reuse" of the original FC and FC2

The per unit price of female condoms is higher than male condoms but there is some evidence to suggest that polyurethane female condoms can be washed, disinfected, and reused.

Re-using the polyurethane female condom is not considered as safe as using a new one, however the WHO says, "Batches of new, unused female condoms were subjected to seven cycles of disinfection, washing, drying and re-lubrication, reflecting the steps and procedures in the draft protocol, but at considerably higher concentrations of bleach and for longer durations. All female condom batches met the manufacturing quality assessment specifications for structural integrity after the test cycles. ... Disinfection, washing, drying, re-lubrication and reuse of the device were not associated with penile discharge, symptomatic vaginal irritation or adverse colposcopic findings in study volunteers."[14] A presentation at the 1998 International AIDS conference concluded that "washing, drying and re-lubricating the female condom up to ten times does not significantly alter the structural integrity of the device. Further microbiological and virological tests are required before re-use of the female condom can be recommended."[15]

Research suggests that the FC2 female condoms are a cost-effective method of HIV prevention even at low levels of use. The data shows that the cost-effectiveness would increase significantly at higher levels of use. A study conducted in 2005 by Dr. David Holtgrave, Chair of the Department of Health, Behavior and Society at Johns Hopkins University's Bloomberg School of Public Health, examined the projected public health impact that the FC2 female condom would have at different levels of use in two developing countries: South Africa and Brazil. The study concluded that FC2 use would generate significant cost savings at all levels of implementation by preventing thousands of HIV infections and saving millions of dollars in health care costs.[16] There is some evidence to suggest that the effectiveness of female condoms in preventing transmission of HIV may be similar to that of male condoms.[17]

Lubrication

As with all barrier contraceptives, water or silicone-based lubricants are safe to use with any female condom. Oil should not be used with a female condom made of latex.

FC2 Female Condom comes pre-lubricated with a non-spermicidal, silicone based lubricant. The FC2 is made of nitrile so oil-based (or water-based) lubricants can be added on the inside and outside of FC2 Female Condom or on the penis.

Effectiveness

When used correctly, the female condom has a 5% failure rate. Inconsistent or incorrect usage has been shown to result in a 21% failure rate.[18]

Some benefits of female condoms over other methods of birth control include:[19]

Some disadvantages to the female condom include:[20]

Advantages

FC2 Female Condom gives women control and choice over their own sexual health; women can protect themselves when their partner does not want to use a male condom; female condoms may provide enhanced sensation for men as compared to male condoms;[21][22] FC2 is hypo allergenic and is safe to use with people who are allergic to rubber latex; FC2 may be inserted hours before intercourse; female condoms are not dependent on the penis being erect for insertion and does not require immediate withdrawal after ejaculation; FC2 is not tight or constricting; FC2 is highly lubricated and the material warms to body temperature.[23]

The external genitals of the wearer and the base of the penis of the inserting partner may be more protected (from skin-to-skin transmitted STDs such as herpes and HPV) than when the male condom is used, however see studies below.

Worldwide use

Sales of female condoms have been low in developed countries, though developing countries are increasingly using them to complement already existing family planning and HIV/AIDS programming.[24] Probable causes for poor sales are that inserting the female condom is a skill that has to be learned and that female condoms can be significantly more expensive than male condoms (upwards of 2 or 3 times the cost). Also, reported "rustling" sounds from the original version of the female condom during intercourse turn off some potential users, as does the visibility of the outer ring which remains outside the vagina.[25]

In November 2005, the World YWCA called on national health ministries and international donors to commit to purchasing 180 million female condoms for global distribution in 2006, stating that "Female condoms remain the only tool for HIV prevention that women can initiate and control," but that they remain virtually inaccessible to women in the developing world due to their high cost of 72¢ per piece. If 180 million female condoms were ordered, the price of a single female condom was projected to decline to 22¢.[26]

In 2005, 12 million female condoms were distributed to women in the developing world. By comparison, between 6 and 9 billion male condoms were distributed that year.[26]

Awareness and access

Recently, a number of initiatives have been undertaken by international and intergovernmental organizations to expand access to the female condom. In 2012, the United Nations Commission for Lifesaving Commodities for Women and Children (UNCoLSC) endorsed female condoms as one of its 13 Life-Saving Commodities, catalyzing inter-organizational efforts to overcome several commodity-specific barriers currently inhibiting women in the developing world from benefiting from this product.

Price has been one of the key obstacles in expanding access to female condoms on an international level. Female condoms cost, on average, US $2–4, depending on local market factors. At the 2012 Family Planning Summit in London, the Female Health Company pledged to increase access to the FC2® female condom for the world’s poorest countries and announced a prospective pricing arrangement based on aggregate purchases and 5 percent free goods based on the prior year’s purchases, together with a multiyear agreement to provide $14 million in training and education by FHC over the next six years.

The Cupid™ female condoms have been sold in Kyrgyz Republic through UNFPA for their public distribution system. The Woman’s Condom has been sold to the public sector in China. Globally, it is acknowledged that further price reductions are necessary to achieve universal access to female condoms. Based on market analysis it is expected that sustainable price reductions are feasible.[27]

Campaigns

Prevention Now!

The Center for Health and Gender Equity’s Prevention Now! Campaign promotes the use of male and female condoms as a means of preventing the spread of HIV/AIDS; reducing instances of unintended pregnancy, unsafe abortion, and other unsafe outcomes of unprotected sexual intercourse; promote the sexual and reproductive health and rights of all persons; and expand choices for those living with HIV/AIDS.

Put a Ring on It!

The Chicago Female Condom Campaign is a coalition of HIV/AIDS, reproductive justice, women’s health, and gay men’s health organizations dedicated to increasing access, affordability, availability, awareness, and utilization of female condoms. Lead partners include the AIDS Foundation of Chicago, Chicago Women’s AIDS Project, Illinois Caucus for Adolescent Health, Pediatric AIDS Chicago Prevention Initiative, Mujeres Latinas en Accion, and Planned Parenthood of Illinois.

See also

References

  1. 1 2 Trussell, James (2011). "Contraceptive efficacy". In Hatcher, Robert A.; Trussell, James; Nelson, Anita L.; Cates, Willard Jr.; Kowal, Deborah; Policar, Michael S. (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 779–863. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. Table 26–1 = Table 3–2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception, and the percentage continuing use at the end of the first year. United States.
  2. ↑ MedlinePlus Encyclopedia Female condoms
  3. ↑ Female condoms for anal sex archive 20090430
  4. ↑ "How to Put on a Female Condom (For Anal Sex)" (PDF). Retrieved 2013-01-04.
  5. ↑ "Product". Femalehealth.com. Retrieved 2013-01-04.
  6. 1 2 "Female Health Company Announces International Availability of Second — Generation Female Condom at Significantly Lower Price" (PDF) (Press release). Female Health Company. September 29, 2005. Archived from the original (PDF) on 2008-09-12. Retrieved 2006-08-03.(PDF)
  7. ↑ "Female Health Company". Female Health Company. Retrieved 2011-06-12.
  8. ↑ "UNFPA". UNFPA. Retrieved 2013-01-04.
  9. ↑ "The Female Condom". Avert.org. 2010-09-14. Archived from the original on 2013-12-28. Retrieved 2013-01-04.
  10. ↑ "PATH's woman's condom". Path.org. Retrieved 2013-01-04.
  11. ↑ "VAW.O.W. Feminine Condom". PreventionNow.net. Retrieved 2010-06-11.
  12. ↑ "The Woman's Condom". PreventionNow.net. Retrieved 2010-06-24.
  13. ↑ "How do I Use Female Condoms?". Planned Parenthood. Retrieved 2013-06-24.
  14. ↑ "WHO information update: Considerations regarding Reuse of the Female Condom". Who.int. Archived from the original (PDF) on 2006-02-02. Retrieved 2013-01-04.
  15. ↑ McIntyre J, Pettifor A, Rees VH (June 28 – July 3, 1998). "Female condom re-use: assessing structural integrity after multiple wash, dry and re-lubrication cycles". 12th International AIDS Conference. abstract no. 33124. Archived from the original on 2012-03-09.
  16. ↑ Dowdy, DW; Sweat MD; Holtgrave DR. (Oct 24, 2006). "Country-wide distribution of the nitrile female condom (FC2) in Brazil and South Africa: a cost-effectiveness analysis.". AIDS. 20 (16): 2091–8. doi:10.1097/01.aids.0000247567.57762.fb. PMID 17053355.
  17. ↑ Gallo, MF; Kilbourne-Brook, M; Coffey, PS (March 2012). "A review of the effectiveness and acceptability of the female condom for dual protection". Sexual health. 9 (1): 18–26. doi:10.1071/SH11037. PMID 22348629.
  18. ↑ "Female Condoms". Planned Parenthood. Retrieved 2015-08-24.
  19. ↑ "What Are the Benefits of Female Condoms?". Planned Parenthood. Retrieved 2013-06-24.
  20. ↑ "What Are the Disadvantages of Female Condoms?". Planned Parenthood. Retrieved 2013-06-24.
  21. ↑ "Understanding The Finer Nuances Of The Female Condom". Women's Health Line. 2009. Retrieved 2011-06-12.
  22. ↑ Dawn Stacey, M.Ed, LMHC (2009). "Fc Female Condom". About.com. Retrieved 2011-06-12.
  23. ↑ "The Product". FC & FC2 Female Condom. Female Health Company. 2005. Retrieved 2006-08-03.
  24. ↑ Global Consultation on the Female Condom. Baltimore, MD: PATH. September 26–29, 2005. Archived from the original (PDF) on 2006-06-16. Retrieved 2006-08-03.
  25. ↑ Boston Women's Health Book Collective. Our Bodies, Ourselves : A New Edition for a New Era. New York, NY: Touchstone. ISBN 0-7432-5611-5.
  26. 1 2 "Statement of Dr. Musimbi Kanyoro, General Secretary, World YWCA" (Press release). PRNewswire. November 21, 2005. Archived from the original on 2011-11-22. Retrieved 2006-08-03.
  27. ↑ "Female Condom Product Brief: Safety, Efficacy, and Acceptability" (PDF). Reproductive Health Supplies Coalition. Retrieved 2013-06-24.
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