You might say Dr. Michael A. Thomas is professionally conflicted. As director of the Division of Reproductive, Endocrinology, and Infertility at the University of Cincinnati, Thomas is both a fertility guru and a contraceptive expert. “Half my day I spend helping people get pregnant,” he says, “and the other half I spend trying to come up with ways for people not to get pregnant.”
On a recent afternoon at UC, his mind is on the latter. In one hand he holds a life-sized plastic model of a vagina. In the other is a polyurethane pouch that looks like a miniature vacuum bag. It’s a female condom.
Ahem. A female what? If you’re younger than, say, 35, you might recall the female condom from a sex-ed class. But you’ve probably never seen one and almost certainly have never used one. They’ve never really caught on in America. Yet when they were invented two decades ago, female condoms promised women something momentous: a contraceptive that they could initiate and control which also provided protection from sexually transmitted diseases (STDs).
Thomas takes the opportunity to demonstrate. He stuffs the condom into the vagina, tugging it around a bit before he’s satisfied with the fit. “When you worry about female condoms,” he says, “the three things you worry about are breakage, slippage, and leakage. You want to make sure it stays in and doesn’t break.”
The condom in Thomas’s hand is called an FC1. It’s the original female condom, made by the Female Health Company in Chicago. Like the first model of any product, it has its shortcomings—including what you might call “acoustical concerns.” Users complain that during intercourse, the FC1 makes noise.
But a new female condom with radically different design is waiting in the wings. Developed by the Program for Appropriate Technology in Health (PATH), the Woman’s Condom—or WC—is meant to be a cheaper, more comfortable alternative to the original FC1. Thomas and his team have received a National Institutes of Health grant to study the efficacy of PATH’s new condom, and recruitment is underway for local volunteers willing to dedicate their most intimate moments to testing it. If the study is successful, female condoms could move from being contraceptive footnotes to international fame. Or, at the very least, to a coveted position in the worlds’ nightstands.
The male condom has been with us in some incarnation since 1000 B.C. But the story of the female condom is a modern one, beginning in 1987 in an old farmhouse on the rainy coast of Denmark. Mary Ann Leeper, new owner of a pharmaceutical company, had arrived there to visit a physician named Lasse Hessel. At the time, Hessel was the author of a New York Times–syndicated cartoon called “The Family Doctor” and the inventor of a hodgepodge of health-related products, including a women’s diet pill called Fiber Trim, which earned him a small fortune.
Hessel met Leeper at his door, led her upstairs, and sat her down at an old farm table. He placed before her a musty cigar box, the contents of which she had flown 4,000 miles to inspect.
“I open up the lid,” Leeper recalls, “and the cigar smell woofs me in my face. I look into the box and I say, ‘Oh my goodness, what have I got myself into here?’”
Several years earlier, when the scope of the AIDS crisis was just dawning on the world, Hessel developed a crude prototype of a sexual protection device for women—something that could be used when their sexual partners refused to wear a male condom. He tested it in a group of volunteers, applied for a patent, and licensed Wisconsin Pharmacal, a small American company, to produce it.
Leeper and two business partners bought Wisconsin Pharmacal in 1987 after noting in its potential product line something called a “female condom.” Which is how Leeper came to be in Hessel’s home, opening the lid on a cigar box stuffed with bits of black plastic, wires, metal rings, and chopped up diaphragms—everything Hessel had used to assemble his initial prototype. “It was a gmish!” Leeper remembers. But somewhere in that gmish she saw a future product.
Leeper and her partners spent the next six-and-a-half years refining Hessel’s idea. The final result was a 6.5-inch lubricated polyurethane tube with a flexible ring at each end. The product—now called the FC1— was the world’s first woman-initiated contraceptive and STD protection, a revolutionary development in reproductive health.
Twenty-three years later, the female condom is all but forgotten in the Western world. The Food and Drug Administration’s laborious approval process delayed its U.S. launch until 1993, and even then, Leeper admits, the FDA was lukewarm about the product. Women complained that the FC1 was difficult to insert, that the inner ring was uncomfortable during intercourse, and that the condom sometimes slipped into the vagina. Others were bothered by the sound (the polyurethane rustled during sex) and the price (these days, a five-pack costs $17 at Walgreens). They were fodder for comedians and wise-cracking journalists. “Fun with a windsock,” said one first-time user, quoted in the U.K.’s Guardian.
But criticism of the condom was clearly a Western luxury; in the developing world, women clamored for them. Sex workers from Rio de Janeiro to Rome finally had protection when their customers refused to wear a male condom. In Africa, which has more than 60 percent of the world’s AIDS cases, the FC1 gave women a new negotiating tool.
The potential of the FC1 caught the attention of PATH, a Seattle-based nonprofit that promotes healthcare in more than 70 countries. Given the obvious global need for woman-initiated sexual protection, PATH figured the female condom was too good an idea not to be improved. So in 1996, the organization launched Project Orchid, dedicated to creating a new woman’s condom by incorporating suggestions from users around the world. Thirteen years, 300 prototypes, and $6.6 million later, PATH has a design that they believe in.
The Woman’s Condom is a stunning creation, unfurling from its packaging like an upturned martini glass. Behind its aesthetic appeal lies a level of engineering that NASA might devote to an interplanetary probe. The bulk of the condom is bound in an “insertion capsule” of polyvinyl alcohol, which dissolves inside the vagina before deploying the rest of the condom like a parachute. Four small pads of hydrophilic foam lightly adhere to the vaginal walls for stability. The WC is made from thinner polyurethane for extra sensation, better heat-conduction, and less rustling.
“We were trying to create a device that would be easy to handle, easy to insert, stable during use, and comfortable for both partners,” says Maggie Kilbourne-Brook, a PATH program officer. During acceptability studies in Thailand, South Africa, Mexico, and Seattle, women said the condom achieved all those goals. Importantly, men like it, too. One man told PATH’s WC Team Leader Patricia Coffey that using the condom was just “like having naked sex.”
Comfort aside, for the poor communities that PATH serves in America and overseas, it’s important that the condom be affordable. Female condoms are technically more complicated than male versions, so production costs are higher. The Female Health Company has come out with a second-generation product, the FC2, which is more affordable then the original female condom. PATH is still negotiating prices with a Chinese manufacturer, but Kilbourne-Brook says the WC will also be cheaper than the original FC1, though still more expensive than a male condom. For that reason and others, no one expects the WC to replace the gentleman’s model. But, says Kilbourne-Brook, “When women have access to more methods, more women are going to find a method that works for them. It’s all about options.”
That opinion is shared by UC’s Dr. Thomas. “One size doesn’t fit all,” he says. “As many types of choices that women can have, I think it’s better in the long run.” Statistics show that women are already interested in initiating protection, he says. In America, 54 percent of male condoms are actually purchased by women. So it stands to reason that if a woman finds a product she likes, she’ll use it.
Thomas and his team received a $608,000 NIH grant to study the efficacy of the WC; 11 other university centers around the country are participating, too. The two-and-a-half-year study may be the final phase of research before PATH can apply for FDA approval. Thomas is recruiting 75 women through UC’s medical practices to participate; he doesn’t expect it will be difficult to find willing subjects. “People want to use cutting edge stuff,” he says. Participants must be sexually active and between the ages of 18 and 40, Thomas says. They don’t have to be married, but they should be in a “mutually monogamous” relationship. And they should be having intercourse at least one to three times a week. “Or else it’s not really a contraceptive study,” he says.
Thomas is still working with NIH on the UC study’s protocol, but he says the women will keep an extensive diary, documenting the condom’s performance. “With every act of intercourse you’ll have to fill out whether or not there were any problems with the condom itself, any breakage of the condom, evidence of semen in or around the condom, that sort of thing,” he explains. Although women will be tested for STDs before and after the trial, the focus of this study is contraception; the WC has already been successfully lab-tested as a viral barrier.
Participants will be asked if any secondary issues arose from using the condom, such as irritation to either partner. Chances of this are low, Thomas says, because the WC is a non-latex, non-hormonal product. The study will focus on the WC’s practical performance rather than its social acceptability. The goal is to ensure that the device is reliable, whether it’s used in a West Chester bedroom or a Mumbai slum. “The hope is that it will be another alternative,” Thomas says. He envisions a future in which women might be able to use contraceptive methods designed specifically for them. The introduction of another female condom, he says, would be a step in that direction.
Even if the study goes perfectly, PATH doesn’t expect to be ready to file for FDA approval until 2012. This process is essential because the U.S. Agency for International Development, a major purchaser of female condoms, distributes only FDA-approved products. America is the world’s largest country-to-country female condom distributor; even so, in 2007 female condoms constituted only 1.6 percent of total condom dispersal. (Globally, 35 million female condoms were distributed in 2008 compared to 12 billion male condoms.)
Reproductive health advocacy groups like the Washington, D.C.-based Center for Health and Gender Equity (CHANGE) are eagerly awaiting the arrival of PATH’s WC in the developing world. CHANGE President Serra Sipple says more condoms on the market will drive down
cost and normalize their use. She hopes that PATH’s new product piques the interest of America’s foreign aid policy makers, who she says are not doing enough to promote female condoms. “It’s very frustrating, because female condoms are an intervention that specifically speaks to women’s needs,” Sipple says. “If we want our aid to be effective, then we need to be listening to its recipients.” And hopes are high that studies such as the one in Cincinnati will ensure that women’s voices are heard.
Even Mary Ann Leeper—who admits PATH’s condom will compete with her company’s FC1 and FC2—is supportive of the new product. “In this community, we are collaborators to a certain level, in that we believe the more options that are available, the better it is,” she says. “Women are reaching out and saying, ‘We want to be able to take care of ourselves.’”
In sub-Saharan Africa, women now constitute 60 percent of AIDS cases, and the global epidemic is becoming increasingly feminized. “The face of AIDS,” Leeper says, “is clearly the face of a woman these days.” A woman who, by all accounts, needs all the protection she can get.