Did you know there are four different female condom models on the market?
This is news to most Americans because only one model, the FC2, has received FDA approval so far, making it available in the United States.
Though female condom (FC) use historically has been low in the United States and worldwide, new efforts are underway to increase awareness and demand. In light of the massive disparity between female and male condom promotion and distribution, this advocacy is long overdue.
One organization, , is an initiative of three Dutch civil society organizations and the Dutch government that was launched in 2009 to challenge the major barriers to sustainable, widespread FC access: high price, lack of competition within the FC market, and the lack of FC programming in most countries.
At its 2013 meeting in Addis Ababa, UAFC’s International Advocacy Platform – comprised of experts from 35 countries with experience in sexual and reproductive health and rights, HIV/AIDS, development policy and reproductive health supply chain issues – heard briefings by the main FC manufacturers and discussed international policy developments. A central topic was the , which had named FCs, along with contraceptive implants and emergency contraception, as one of the three reproductive health commodities most essential to curtailing fatalities in countries where maternal and infant mortality rates are highest.
American advocates were represented at the meeting by the , a network of NGOs, health department personnel and advocates. The Coalition is currently supporting FC campaigns in seven of the 12 U.S. cities with the highest HIV incidence. Coalition members are raising FC awareness and skills among health care providers and community-based organizations, and collaborating with businesses and health departments to ensure that FCs are accessible and affordable in diverse settings.
Nationally, the sale of “3-packs” of the FC2 increased by read than 40 percent in the United States between 2012 and 2013.1 Finally, the time may be right for female condoms. One HIV prevention educator in Philadelphia that her clients “were in favor of it [FC] for many reasons, most of all because it gives the female power.”
Let’s look at the various FC models currently on the market and consider what read needs to be done to make the female condom available and accessible worldwide.
Popular FC Models
The FC2, pre-lubricated and made of nitrile (the material used to make surgical gloves), has the largest share of the global market with 62 million distributed in 132 countries during 2012. Produced by the Female Health Company, it is an updated version of the FC1 that entered the market in 1993.
In addition to FDA approval, FC2 also has CE marking (allowing it to be sold in Europe), and “pre-qualification” approval from the World Health Organization (WHO) and the United Nations Population Fund (UNFPA). The latter allows it to be is purchased in bulk by international donors for low- or no-cost distribution in developing counties.
Produced in India by Cupid.Ltd., the Cupid female condom is made of latex. Its closed end contains a soft polyurethane sponge that helps to hold it in place during intercourse. The sponge also absorbs semen and, according to the manufacturer, contributes to male pleasure during sex. The Cupid is available in 23 countries in Europe, Asia, Africa and South America. In 2012, it received the WHO/UNFPA pre-qualification, thus expanding its uptake.
HLL Lifecare Ltd. (formerly Hindustan Latex Ltd.) introduced the Velvet, a female condom also made of nitrile and similar to the FC2 in design, in 2007. HLL manufacturing approximately 3 million FC annually for Indian and international markets. A non-profit initiative called the Hindustan Latex Family Planning Promotion Trust, founded by HLL in cooperation with the India’s National AIDS Control Organization and other partners, has launched a Female Condom Scale-Up program in nine Indian states. focuses primarily on and other women at high risk of HIV.
PATH, a non-profit, international NGO based in the United States, developed the Woman’s Condom and licensed it to the Shanghai Dahua Medical Apparatus Company for production. It is currently sold in China under the brand name O’lavie and in South Africa simply as V. The Woman’s Condom has CE marking and approval from Chinese and South African regulatory authorities, and its WHO pre-qualification application is pending.
The design of the Woman’s Condom is a departure from previous FCs because its pouch is packaged in a narrow dissolving capsule shaped like a tampon, to make vaginal insertion easier. The capsule dissolves within 30–60 seconds of insertion, and the condom expands to line the vaginal cavity. Four tiny foam dots on the pouch gently cling to the vaginal walls during sex to hold the condom in place, and release easily when the condom is removed.
Made of polyurethane, this Woman’s Condom is unlubricated and comes with a packet of water-based lubricant. Since pre-lubrication would cause the capsule to dissolve prior to insertion, lubricant (of whatever type the user prefers) can be applied only after insertion.
FC Models Occupying Single-Country Markets
Other FC models also occupy some single-country markets. Phoenurse is an FC marketed in China that comes with an optional insertion stick that attaches to the inner ring to guide insertion of the product.
The Panty Condom is a reusable nylon panty with a rolled-up polyethylele (plastic) sheath placed in the crotch. The panty, left on during sex, holds the condom in place – fulfilling the function of the outer ring or frame in other FCs. A new condom sheath is inserted into the panty crotch and secured before each use.
New Designs in Development
Now under development, the Origami FC represents a major innovation in FC design. Made of silicone, it unfolds like an accordion when the penis pushes it into the vagina, and its exterior circular flange serves as an outer ring, keeping the condom in place. Like a diaphragm or cervical cap, the Origami is designed to be washed and reused repeatedly. The product is currently being tested for effectiveness and is not on the market.
Origami is also developing a condom specifically for use during anal sex. Although no FC has yet been approved by regulators for anal use, many couples (heterosexual and homosexual) who have anal sex use them this way. recommend female, as well as male, condoms for anal use, emphasizing that use of any effective condom is safer than sex without a condom.
Performance & Safety Assessment
Four “second generation” FC models (all developed after the FC1) were compared in a randomized controlled, non-inferiority trial. The results, , compare the functional performance and safety of the Woman’s Condom, the Cupid, and the VA wow (a predecessor of the Cupid), and the FC2. These female condoms were evaluated for frequency of breakage, misdirection (the penis going around the FC), invagination (the FC being pushed into the vagina), slippage, and failure.
Enrolling 900 women in China and South Africa, the trial asked each woman to use each type of condom five times and report their experiences. The study demonstrated that all four were equally effective with regard to safety and performance. The study authors , however, that “studies of contraceptive effectiveness and those showing reductions in STI incidence with these new female condoms are still needed.”
Low Priority Given to Female Condoms
According to , a UNFPA-managed information service, only 1.3 percent of the condoms purchased by international donors and distributed globally are female condoms. This reflects the low priority given to female condoms because donors ship these supplies to individual countries in response to what they specifically order.
The paints a similar picture. In 2010, 96 percent of the condoms UNFPA purchased for distribution in Stream 1 countries (those receiving sustained, multi-year support) were male condoms, and 4 percent were female condoms. Among the countries receiving less intensive assistance, 99.3 percent of UNFPA condoms distributed were male condoms and 0.7% were female condoms.
This disparity is driven by a vicious circle of factors. Due to low demand, FC production costs have not yet been reduced by high volume manufacturing, making them read expensive to manufacture than male condoms. The high cost results in low government demand and procurement, and little or no governmental investment in FC promotion. This leaves most potential users unaware of FCs – and most providers without the resources to educate their clients/patients about using them.
When sporadic efforts are made to increase FC uptake, low levels of consistent procurement result in frequent stock-outs, which further discourages people from getting into the habit of using FCs regularly. As a result, supplies expire in warehouses which, in turn, discourages governments from increasing procurement rates.
Breaking this cycle requires long-term, community-based and high level advocacy to mobilize awareness of FCs as a highly effective, user-friendly, multi-purpose tool for preventing STIs, including HIV, and unintended pregnancy. In addition, increased funding is needed to support both FC procurement and promotional and educational activities directed at both health care providers and consumers.
The third factor, a reduction of the cost of FCs, can be expedited by increased demand (read units produced equals lower cost per unit) and by increased competition among FC manufacturers. The latter is emerging as new FC models and brands enter the market and increase consumer choice.
Groups Collaborate to Promote Access
In addition to important work with manufacturers, international funders and public policy-makers, FC advocates are also spreading the word and stimulating community-level demand for FC through pop culture and innovative outreach methods.
Sept. 16 has now been designated Global Female Condom Day – an event created by the National Female Condom Coalition in collaboration with an expanding global network of partners to educate, advocate and increase awareness, access, and use of female condoms. In 2013, events were organized in read than 50 countries. In Kenya, South Africa, China, Nigeria, Cameroon, the Netherlands, and in several U.S. states, films and personal video messages were used to spark community conversations. Other American, Italian, Ugandan, and Zimbabwean FC supporters got educational messages on the air and, in dozens of countries, prevention educators visited hair salons, malls, and the streets to teach about female condoms.
Working with , PATH, and the Center for Health and Gender Equity (CHANGE), the National Female Condom Coalition also initiated “,” a competition inviting filmmakers from around the world to submit short films (1-5 minutes) that illustrate women’s and men’s needs for FCs. Dozens of films from five continents were submitted in 2013, and the $5,000 award went to nine FC activists in Mozambique who created “”
In the United States, young activists founded the (CFCC) in 2010 and kicked off a local campaign to “put a ring on it.” Comprised of HIV/AIDS, reproductive justice, women’s health, and gay men’s health organizations, the CFCC used Beyonce’s hit song as a soundtrack to promote FCs as a safe, sexy tool for contraception and disease prevention and to frame FCs as a hip way for women to initiate condom use during sex.
CFCC is also focused on building familiarity and acceptance among pharmacy, family planning , and health center staff and has trained read than 450 providers from 125 agencies throughout the state, primarily in areas hardest hit by HIV, to promote FCs in their communities.
So, with advocacy for FCs accelerating locally and globally, new FC models becoming available, and a growing body of evidence proving that they are as effective and easy to use (after a little practice) as male condoms, why has uptake been so slow?
Read women than men are living with HIV worldwide. Male condom use is difficult, if not impossible, for many women to negotiate. So why haven’t FCs been front and center in HIV prevention?
Alcohol consumption, advancing age, and other factors make it difficult for some men to maintain an erection when using a male condom. , which can be used without a full erection?
At a 2012 UAFC conference, one panelist responded to this question with three words, “cost and vaginaphobia.” She may well be right.
Once again, we are challenged to de-mystify and de-stigmatize aspects of the female body still considered disgusting or taboo. Breast cancer was a taboo topic until advocates said “breast” out loud often enough remove the shock value and make it about women’s lives. We can’t allow the most effective woman-initiated HIV prevention tool currently in existence to go unused because it “looks funny” or because it’s different.
Women – and men – deserve read options. As a Chicago advocate put it, “We’re tired of asking permission to save our lives.”
1. Personal e-mail communication with Mary Ann Leeper, Senior Advisor, Female Health Compant, 22 December 2013. [back to text]