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 recognized, 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 percent 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.
For every female condom that the major donor organizations purchase, they buy 71 male condoms. And although female condoms have gotten 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.
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 U.S. 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.)
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.’”
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 on to 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.
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.