In 1987, an American pharmaceutical executive called Mary Ann Leeper flew to Copenhagen to get a firsthand look at what she thought might be the world’s next great health innovation. She didn’t expect to find it tucked away inside an old cigar box.
When she arrived at the old farmhouse owned by Danish doctor and inventor Lasse Hessel, he opened the door with a cigar in his mouth. Then he fetched the box. “Inside were all these bits and pieces – metal, plastic, all different kinds of stuff,” Leeper recalls. “I took a deep breath and thought, ‘Holy mother – what have I gotten myself into?’” Somehow, these bits and pieces fit together to form a contraption that women could wear during sex to prevent pregnancy and sexually transmitted infections – the world’s first female condom.
The presentation may have been unconventional, but Leeper and her colleagues at Wisconsin Pharmacal had high hopes for Hesse’s invention. “The AIDS crisis in the United States was just fully being recognised, and it was clear to us that for women to have a product that they could use to help protect themselves would be a good thing,” Leeper says.
Indeed, when Wisconsin Pharmacal finally introduced the female condom to the USA in 1993, public health experts hailed it as a game-changer. The condom, a polyurethane pouch inserted into the vagina before sex, would protect women from sexually transmitted infections even if their male partners refused to wear condoms.
Technically, the female condom works. When used correctly, it reduces a woman’s risk of contracting HIV by around 94–97 per cent each time she had sex, according to estimates. Studies show that making female condoms available alongside the male version increases the percentage of sexual acts that are protected, and decreases the prevalence of sexually transmitted infections.
Yet, two decades after its much-celebrated introduction, the female condom still isn’t living up to its potential. Less intuitive and familiar than the male condom, the device simply never caught on. Journalists mocked it, clinicians ignored it, and women shunned it, claiming that the condom was aesthetically unappealing and technically difficult to master. Today, only 1.6 per cent of all condoms distributed worldwide are female condoms.
There may finally be an opening to change the female condom’s fate. For years, a handful of researchers, engineers and entrepreneurs have been quietly tinkering with the device. Their efforts are now maturing and an assortment of redesigned and reinvented female condoms are beginning to make their way onto the market. The introduction of new, more user-friendly products – coupled with renewed efforts to promote the technology around the globe – may finally be positioning the female condom for a breakthrough.
From the start, the female condom was a difficult project – far more difficult than Leeper had bargained for. After buying the rights to the technology, Leeper and her colleagues at Wisconsin Pharmacal needed to turn Hessel’s prototype into a marketable product. After some tweaking, they ended up with a thin polyurethane pouch with a flexible ring at each end. A woman would insert the device by squeezing the ring that sits in the closed end of the pouch and pushing it into her vagina. Once expanded inside the vagina, this inner ring would keep the condom in place. The larger ring at the open end of the pouch would sit outside the vagina, covering the external genitalia. When a man ejaculated, the internal condom pouch would trap his semen, preventing pregnancy and sexually transmitted infections.
But before Wisconsin Pharmacal could put the condom on the market, they needed approval from the US Food and Drug Administration (FDA). Because the female condom was an utterly new kind of product, the FDA decided to regulate it as a class III medical device, a category that is generally reserved for “high-risk” medical equipment – such as pacemakers and certain lasers – and that requires the highest level of regulatory scrutiny. (The FDA classifies male condoms as class II medical devices, so they are subject to fewer controls and do not require pre-market approval.)
It took six years for the female condom to wind its way through the regulatory system, and when the government finally approved it, in 1993, Leeper breathed a sigh of relief. “I thought that the hardest part was going to be getting it through FDA because it was really difficult and they kept changing the specifications, the requirements, the clinical studies,” she says. But she was wrong. The hard part was just beginning.
As Wisconsin Pharmacal prepared to launch the Reality female condom in the USA (it would go by other brand names in other countries), they made all the standard arrangements, hiring sales reps to visit medical practices and commissioning a big advertising firm to market the product directly to consumers. “We did all the checklist things that you’re supposed to do,” Leeper says. “And we fell flat on our face.”
The challenge, in part, was the era, and the public’s squeamishness about a sex-related product. “In those days, you couldn’t talk ‘condom’ out loud,” Leeper recalls. “Male condoms were referred to as ‘rubbers’. You said them in a whisper and they were held behind the counter by the pharmacist.” And although the AIDS crisis was raging, for many American women, the risk of contracting HIV was abstract, something that happened to other people and not to them. While women in focus groups had said they liked the idea of the condom, according to Leeper, “when push came to shove, when they were in that bedroom, the female condom was out on the dining-room table”.
There were other barriers, too. The condoms cost as much as $5 a piece, compared to male condoms, which can typically be had for $1 or less. Krissy Ferris recalls hearing about female condoms when she was a student at Oberlin College in Ohio, but the price was a deterrent. “I didn’t actually try one until I got free samples,” recalls Ferris, who now works at a medical practice in Cleveland, Ohio. “Am I going to buy $6 worth of condoms to try this out a couple times? It seems like maybe not. You’re getting male condoms for free everywhere when you’re in your 20s.”
What’s more, the female condom was, frankly, strange. Unlike the male condom, which is sold rolled up and compressed, the female condom came fully open. Women and men alike were turned off by the unfamiliar, big, plastic-bag-like device they found when they undid the packet. Though some women did eventually come to like the condoms, there was a definite learning curve and as many as one-third to one-half of women had difficulty inserting them. Once in place, the condom had a tendency to squeak or rustle during sex.
The media pounced on these complaints, and utterly skewered the female condom. They ridiculed its aesthetics with seemingly limitless creativity. As sociologist Amy Kaler recounts in her 2004 paper on the condom’s introduction, journalists compared the product to: “a jellyfish, a windsock, a fire hose, a colostomy bag, a Baggie, gumboots, a concertina, a plastic freezer bag, something to line Boston’s Inner Harbor with, a cross between a test tube and a rubber glove, Edvard Munch’s The Scream, something designed for a female elephant, something out of the science-fiction cartoon The Jetsons, a raincoat for a Slinky toy, or a ‘contraption used to punish fallen virgins in the Dark Ages.’”
© Alex Hedworth/Eye Candy
Though the media treatment was especially harsh, journalists “were picking up on what were genuine design issues of the first generation of the female condom,” says Kaler, an assistant professor at the University of Alberta in Canada. “It wasn’t the most beautiful thing in the world. It was easy to make fun of. It was kind of laughed out of existence before it really got a chance to take off.”
Still, there were signs that Wisconsin Pharmacal was onto something. In 1995, two years after bringing the condom to market, Leeper got a call from an official at Zimbabwe’s Ministry of Health and Child Welfare. The health worker had received a petition demanding that the government of Zimbabwe bring the female condom into the country. It had been signed by 30,000 women.
Though Leeper had initially envisioned selling the female condom in America’s private sector, the call from Zimbabwe, coupled with the condom’s poor reception in the USA, prompted the company to shift course.
International nonprofit groups and aid organisations have long been big buyers of male condoms. The United Nations Population Fund (UNFPA), the US Agency for International Development, Population Service International and others regularly purchase male condoms in bulk and then donate them – or sell them at a deeply subsidised price – to clinics and programmes that serve particularly high-risk populations.
In 1996, Wisconsin Pharmacal changed its name to the Female Health Company and began to focus on this global public sector, working with governments, global health organisations and aid agencies to get the condoms into the hands of at-risk women in low-income countries. The female condom became a particularly important tool in several countries in sub-Saharan Africa, where, in the early 2000s, 60 per cent of new HIV diagnoses were made in women, who often contracted the virus through their long-term partners.
Patience Kunaka, who was teaching nursing and midwifery students in Zimbabwe when she first heard about female condoms, knew these risks all too well. Two of her cousins had died of AIDS-related causes, and three additional family members were infected with HIV. Like many other women, she was not initially impressed by the female condom. “When I first saw one my immediate reaction was, ‘Wow! How does it remain inside with penile movement?’” she recalls. “I thought it would be sliding in and out and what a messy act! I also thought the plastic would crumble inside me causing discomfort.”
But Kunaka suspected her partner at the time of being unfaithful and was – in her own words – “obsessed about sexual hygiene”, so she decided to give the female condom a shot. It didn’t go well at first. “I had problems inserting it and felt discomfort from the inner ring,” she says. Slowly, after some practice, she got the hang of it. Kunaka even came to like the device, especially “the fact that I don’t have to beg my partner to use a condom”.
She became a female-condom convert. “In my African context, where men are at liberty to have as many partners as they can have, they give me power to negotiate for safer sex,” she says. She even went on to get a job as the condoms and training manager for Population Service International Zimbabwe, and now spends her days spreading the word about female condoms to men and women throughout the country.
The female condom received a better reception in Africa than it had in the USA, and as the Female Health Company sought to expand its global reach, it tweaked its original product, switching from a polyurethane condom to one made of nitrile, the same material used in many medical gloves. The nitrile condom, called the FC2, is significantly cheaper than its polyurethane predecessor, now commonly referred to as the FC1, and also less noisy during sex. In 2007, the UNFPA ‘pre-qualified’ the FC2, making it eligible for bulk purchasing by public-sector agencies, and between 2007 and 2010, the number of female condoms distributed globally doubled from 25 million to 50 million.
Not bad for a contraceptive device that’s been likened to The Scream, but it’s still a drop in the ocean compared to male condoms. For every female condom that the major donor organisations purchase, they buy 71 male condoms. And although female condoms have got cheaper, price remains a limiting factor. An aid agency purchasing the FC2 in bulk will pay anywhere from $0.55 to $0.88 per condom but can get male condoms for as little as $0.02 a piece.
In many clinics in low-income countries, the supply of female condoms can be inconsistent, and the situation’s not much better in the private sector. While pharmacy shelves overflow with male condoms of every imaginable kind – ribbed, studded, ultrathin, warming, aloe-enriched, neon pink, glow-in-the-dark, bubblegum-flavoured – it can be difficult to find female condoms for sale at all.
In some places, the condoms are stigmatised, thanks to clinical trials and distribution programmes that initially focused on sex workers. Elsewhere, the devices are still saddled with the baggage of the product’s first, failed introduction. In March 2013, for instance, a writer for Jezebel, a popular feminist blog and news site, published a post titled ‘Stop Trying to Make Female Condoms Happen’. She expressed scepticism that “women will change their minds about wanting to line their vaginas like a waste paper basket”, and concluded by noting that “female condoms are just ew”.
More than two decades after the first female condom hit the shelves, this is not exactly the revolution that public health experts had in mind.
© Giles Revell
For nearly 40 years, PATH, a global health nonprofit based in Seattle, Washington, has been radically reinventing basic medical technologies. The group’s designers and engineers, for instance, created the Uniject: a disposable syringe pre-loaded with a single dose of vaccine. They built a one-size-fits-all diaphragm, removing the need for women to visit a doctor to have one specially fitted. And they invented a portable, handheld scale that health workers can bring to home deliveries. The scale requires no electricity, can be read in the dark, and is decipherable even to birth attendants with low literacy, making it easy to identify underweight infants.
In the late 1990s, PATH turned its attention to the female condom. “The Female Health Company did an incredible thing,” says Maggie Kilbourne-Brook, a programme officer at PATH. “They created a product that had never existed, and they got it approved, and they got it registered and marketed in more than 100 countries. They actually changed people’s perceptions of what barrier protection could be.” But as it became apparent that the condoms weren’t quite living up to their potential, some experts began to think that perhaps a radical makeover was in order. “In product development,” says Kilbourne-Brook, “We always expect first-generation devices will need to be improved.”
PATH prides itself on its user-centred design process, and so, in an effort to create a female condom that women would want to use, those at PATH decided to do something both radical and obvious: consult actual women. In 1998, PATH began convening focus groups in four countries – South Africa, Thailand, Mexico and the USA – asking women and men what they thought about female condoms and what they wanted from them.
From Durban to Seattle, it turns out that users’ desires were pretty basic: “a product that was going to be easy to use, easy to insert, stable during use,” says Kilbourne-Brook. Plus, “if it was possible, they wanted something that was more aesthetically pleasing”.
These requests became the guiding principles for the designers and engineers working at PATH’s product development laboratory in Seattle. The team ran an iterative, multi-step design process, building prototypes of potential new condoms in the lab and then sending them out to heterosexual volunteers in each of the four countries. These women and men handled and examined each model, sharing their impressions with researchers, and couples received samples of some of the more advanced prototypes to try out in their bedrooms. The product designers used the feedback to refine – and sometimes utterly rethink – their designs and then sent new, tweaked models back for further testing.
Early generations of female condoms had relied on a ring-based design. One of PATH’s first prototypes was similar, with a polyurethane pouch anchored between two fixed rings. But some women reported that it was difficult to push the inner ring into the vagina – the same complaint often made about the FC1 and FC2 – and that it was painful once inside. “Device is stable but uncomfortable,” one Mexican tester reported. So PATH decided to scrap the rings entirely. They briefly tested a prototype that could be inserted using a tampon tube applicator, but the condom didn’t deploy reliably.
They spent a lot of time talking about how to improve insertion. “We know from a user perspective, if you have a difficult time the very first time you try to use a device, a woman may never come back,” says Kilbourne-Brook. “We wanted this to be not only easy to use, but it needed to be easy to use for someone who’s never used it before.”
According to Kilbourne-Brook, the ultimate breakthrough was inspired by feedback from testers and researchers in Thailand, who said, “Wouldn’t it be wonderful if you had some kind of insertion device that helped you insert it and then it got out of the way?”
By 2003, they had hit on the solution: a dissolving applicator. The engineers created a condom that looked like a funnel, with a thin sheet of polyurethane that narrowed into a rounded tip. This tip contained the main pouch of the condom, collapsed inside a dissolving capsule. To insert the condom, women would simply push the capsule inside, much the same way they’d insert a tampon. Once it came into contact with the moisture of the vagina, the capsule would melt away – often within 30 to 60 seconds – releasing the full condom pouch.
The product designers gave the condom stability by attaching four small, thin pieces of polyurethane foam to the outside of the condom. Once the pouch expanded, these foam pieces nestled up against the vaginal wall, keeping the condom in place. Like other female condoms, the model also featured a flexible outer ring to cover the external genitalia.
Between November 2003 and January 2004, 60 couples received samples of this prototype to try at home. They were impressed. Eighty-eight per cent of the women said it was easy to insert and 97 per cent said the pouch was stable during sex. The vast majority of men and women asked said the condom was comfortable, and 98 per cent of women and 100 per cent of men said it allowed for satisfactory sensation during sex.
It had taken six years and more than 300 unique prototypes, but by early 2004, PATH had found its female condom.
The final product, which PATH named the Woman’s Condom, is “just a brilliant design,” says Kaler, who was not involved in its creation. “When you look at it visually, it isn’t huge. It’s clear what you do with it. And the way that it’s been designed with these foam pads means that it doesn’t move around.”
A series of larger clinical trials – conducted in Mexico, South Africa, Thailand, China and the USA – has reinforced what PATH found in its initial testing, with users reporting that the Woman’s Condom is comfortable, stable and easy to insert. Several studies have found that both men and women tend to like the Woman’s Condom better than the FC1 and FC2. Users’ main complaint was that it does not come pre-lubricated, as the FC2 does. Instead, each condom comes with a packet of lubricant that users can apply themselves.
In 2011, the Woman’s Condom received the stamp of approval from the Shanghai Food and Drug Administration and is currently under review by the UNFPA; approval is expected in 2014. In the meantime, limited quantities are already being sold in China and South Africa.
The Woman’s Condom isn’t the only new female condom on the scene. In 2012, the UNFPA pre-qualified the Cupid, which is manufactured by an Indian condom company. The Cupid relies on a ring-shaped foam sponge tucked into the closed end of the condom pouch for internal stability. Made of natural latex, the Cupid may be the cheapest female condom yet, and is now available for purchase in both the public and private sectors.
Several other condoms, each slightly different in design, are currently under UNFPA review. For instance, the Phoenurse, which is currently sold in China, comes with an optional insertion stick. Then there’s the panty condom, in which a condom pouch is affixed to a pair of reusable panties with an opening over the vagina. Before sex, a woman can push the condom inside with her finger – or a man can with his penis – without her having to take off the undergarment.
And there are still more designs in the early stages of development. Origami Condoms, based in Los Angeles, California, has developed a silicone female condom that unfolds like an accordion as it’s pushed into the vagina. The company just completed a small phase I acceptability study – overall, participants preferred the Origami condom to the FC2, though they said the FC2 felt more stable during sex. The company plans to conduct a larger clinical trial this year.
Not every product will be right for every woman or couple, but that’s precisely the point. “In the studies we’ve done, we’ve found that some women will say, ‘I really love this one and I don’t like this one at all’,” says Mags Beksinska, research director at the division of maternal, adolescent and child health at the University of the Witwatersrand, South Africa. “There are different aspects that appeal to different women in the different designs. So it would be good if there was a wider choice.”
Krissy Ferris, the woman who was initially turned off by the cost of female condoms, came to see their advantages while dating a man who had trouble maintaining an erection with a male condom. “It was definitely a barrier to male condom use, and I was not ready to compromise on using a barrier method,” she says. The female condom was a “low-stress” solution.
Over the years, Ferris has tried several different products, including the FC1, the FC2 and the VA w.o.w., which, like the Cupid, uses an internal sponge to hold the condom pouch in place. Ferris found that she preferred the VA w.o.w. because the sponge made it feel more secure during sex. “If you’re using something with this desire for safety, having this extra measure of security was definitely a positive for me,” she says. But the FC1 and FC2 felt more natural, she acknowledged, and for some women, that may be more important.
There is some evidence to suggest that women are more likely to have safe sex – and less likely to become pregnant or contract sexually transmitted infections – when a larger selection of contraceptive and barrier products is available. Giving women a greater choice in female condoms may increase the odds that they choose any female condom at all.
Meanwhile, male condoms are also getting a redesign. In November 2013, the Gates Foundation awarded 11 grants of $100,000 to designers, engineers and scientists with ideas for a ‘next-generation condom’ – male or female – that would be easier and more pleasurable to use. The winning proposals include a male condom that is packaged with a built-in applicator, allowing the condom to be removed from its foil wrapper and donned in a single smooth motion, and a one-size-fits-all male condom designed to tighten during sex.
Of course, upgrading a product is merely a first step. While the FC1 certainly had its flaws, they weren’t the only reason that female condoms didn’t take off. “Some technologies are harder than others,” says Laura Frost, a partner at Global Health Insights, a research and consulting firm. “Compared to other products where there’s one huge issue, like affordability or awareness, this one had those barriers at every stage.”
That’s why, for the female condom to truly break through, advocates will need to invest in comprehensive marketing and education campaigns at the local, national and global levels. “It takes more than just putting it on the shelf,” says Susie Hoffman, an associate professor of epidemiology at Columbia University in New York.
Female condoms remain less straightforward than male condoms, and one of the major lessons of the last two decades is that women often need a little bit of training to use them correctly. That means that clinicians and counsellors may have to do more than simply tell women that female condoms exist – they’ll need to give them the opportunity to practise inserting one, either on a pelvic model or on themselves.
In addition, women may need help figuring out how to broach the subject with their male partners. Though the condoms have won praise for being female-initiated, they’re not entirely invisible, and most men will notice if their partners are wearing them. “In many cases, she’s probably going to want to mention to her partner before having sex that this is a new product that she’s going to try,” Hoffman says. “Ideally there’s going to be some kind of a conversation about it, and women need help in figuring out how to do that.”
Male partners are also a potential market. “Men probably feel, when it’s called the ‘female condom’, that it’s not something that’s for them,” Mags Beksinska says. But “there’s no reason that a man shouldn’t take one and bring it home and introduce it to his partner”. In fact, she adds, once men get used to the female condom, they often prefer it to the more constricting male version. Female condoms even enhance sex for some people: the outer ring can be used to stimulate the clitoris, while the inner ring of some designs can bump up pleasurably against the tip of the penis.
The female condom may remain a tough sell, but the good news, experts say, is that there are now more organisations trying to make the pitch. “Now we’re seeing a much bigger coalition of advocates, which is what we need,” Frost says. Some existing agencies, most notably the UNFPA, have stepped up their support, while champions have created a variety of new advocacy and awareness groups, including the National Female Condom Coalition in the USA, and the Universal Access to Female Condoms Joint Programme, based in the Netherlands.
Alongside this, the condom’s supporters are getting more creative in their promotion efforts, establishing Global Female Condom Day – the first one was held on 12 September 2012 – and holding female-condom-themed fashion shows and film festivals. Several organisations have turned salons and barbershops in Zimbabwe, Malawi, Cameroon and elsewhere into female condom distribution centres, training hairdressers to promote and sell the product to both male and female clients. And all-out media blitzes in Africa – in which the condoms are promoted on billboards, television and the radio – have fed a sharp increase in demand.
“I think people had kind of written off the female condom,” says Beth Skorochod, a senior technical adviser at Population Service International. “But now people are beginning to say, ‘OK, with more competition and more interest, maybe this deserves another look’.”
There may even be hope for the hard-to-crack private sector in higher-income countries. After winning FDA approval for the FC2 in 2009, the Female Health Company relaunched the female condom in the USA, creating female condom campaigns and programmes in a handful of major American cities, including New York, San Francisco and Washington, DC.
Some local US groups are also beginning to lay the groundwork for the future. Staff members at the Chicago Female Condom Campaign now show off samples of some of the newest products – including the Cupid and the Woman’s Condom – in their training and education sessions. The goal is to make sure that healthcare providers and consumers will be familiar with the products if and when they appear in the USA. But there’s an added benefit. “Frankly what this also does is it helps to cultivate new female condom advocates,” says Jessica Terlikowski, who coordinates the Chicago Female Condom Campaign and the National Female Condom Coalition. Seeing other products, she says, can prompt women to ask, “‘How can I get that?’ ‘Why don’t we have that here?’ People can’t ask for or demand what they don’t know about.”
Women may soon have choices beyond the conventional condom. Scientists have been developing interventions that would be truly invisible to women’s partners: oral antiretroviral pills and vaginal gels that prevent HIV. Despite the enormous excitement surrounding these drugs, they won’t be magic bullets either, and the public health community will still have to grapple with the thorny issues of education, access and adherence. In 2013, for instance, researchers announced that a clinical trial of two different HIV prevention pills and one vaginal gel, conducted among women in three African nations, failed because women weren’t using the medications regularly.
Such outcomes are making it increasingly obvious that the global fight against HIV and other sexually transmitted infections is unlikely to be won with any one technology, no matter how elegantly designed. Instead, it will require an arsenal of weapons, a diverse array of tools that allow women and men to protect themselves. The female condom may never be as cheap or as popular as the male condom, but that doesn’t mean it has no role to play.
Among those optimistic about the female condom’s future is Lasse Hessel, the Danish doctor who started it all. The condom’s champions made some mistakes in the early years, Hessel says, but he’s encouraged by the recent resurgence of interest and the new products that are hitting the shelves. In fact, he wishes other inventors had redesigned his condom sooner, especially because there was so much room for improvement: “How can my ugly, clumsy female condom get any worse?” Hessel says. “It can only get much better.”