Will Americans Ever Actually Use the Female Condom?

The reputation of the female condom, or internal condom, of being weird or gross is one of its biggest barriers to gaining popularity, according to sexual health researchers. Indeed, a 2004 survey of news reports following the initial approval of the product in 1993 found that journalists and their sources variously compared it to a jellyfish, a colostomy bag, a plastic freezer bag, “something to line Boston’s Inner Harbor with,” a cross between a test tube and a rubber glove, and Edvard Munch’s “The Scream,” among many other unsexy objects. Since then, the design has become slightly sleeker, though the product hasn't gained popularity.

But some sexual health advocates say internal condoms have pleasurable benefits, and they’re also currently the only way for people who get penetrated during intercourse to have total control over their own sexual protection.

Until now, however, strict regulations over the internal condom in the US by the Food and Drug Administration have made it a pain to produce and distribute, which hinders proper access to the product and education on how to use it. And last June, the only company still manufacturing the product stateside pulled it from drugstore shelves in an attempt to boost profits by switching to a model in which they focus on supplying to medical insurers and health-care practitioners rather than individual consumers.

But all that could soon change. The FDA is currently considering reclassifying and renaming what is now legally known as the “female condom,” which could open up the market. If the changes do go through, proponents say there’s a decent chance that internal condoms could finally become familiar and move from the fringes to the mainstream.

Stateside, though, internal condoms mostly faces mockery, distrust, and grossed-out reactions. A 2013 Jezebel post referred to them as “just ew.” And in 2014, an XOJane writer likened using one to having sex with a plastic bag.

The current (and only) model sold in the US is a sheath about seven inches long and made of nitrile, a material like latex but stronger and thinner. It contains two rings: the flexible inner ring keeps the condom in place (for a vagina), or can be removed (for an anus), while the outer ring hangs outside the opening to keep the condom in place. Essentially, it’s protection for receptive partners—anyone getting penetrated in the vagina or anus. So “female condom” is a bit of a misnomer.

Sara Semelka is the head of the National Female Condom Coalition (NFCC), a campaign network of researchers, health workers, and related organizations, based out of the AIDS Foundation of Chicago. “A huge issue has been the gendering of this product, and I think that kind of gives a signal for who it is and isn’t for,” she explains. “When you look at the package of a female condom, it’s all vaginas all the time.”

Nicole Holmes, a sexual health educator in Chicago who works with queer communities, says she mainly sees internal condoms being used by men having sex with men. (Some gay men report that sex with internal condoms feels more natural, particularly when the penetrating partner has a large penis.) Still, they only make up 0.2 percent of the world’s total condom supply.

Internal condoms do have a higher failure rate than male condoms when it comes to pregnancy (five percent versus two percent with perfect use). But they also offer potential benefits: Because they hang outside the body, they offer extra protection from pathogens spread by skin contact, like herpes. Some users report more pleasure from increased warmth as well, as the inner ring stimulates the penis and the outer ring rubs up against the clitoris. Also, nitrile is softer than latex and less likely to tear. (Tears can happen, however. Tears, spillage, and manufacturing defects are some reasons for failure rate even with perfect use.)

But for many, perhaps the most attractive characteristic of the internal condom is its potential to grant receptive partners more agency over their bodies during sex. They can be useful for people who face issues with condom negotiation, including sex workers, people whose partners complain about having to wear condoms, and people who want to protect themselves against non-consensual condom removal.

Semelka says she’s worked with plenty of people who find it empowering to directly control who’s wearing the condom. With an internal condom, she says, “You know your body. You know that the condom’s in.”

The FDA is also proposing a change in the official category of internal condoms from Class III to Class II, the same classification as the external condom. There are three classes of medical devices regulated by the agency. Class III—which also includes major medical implants like pacemakers and replacement heart valves—is considered the highest risk and has the most regulation, including specific requirements for manufacturing and marketing.

It made sense initially for internal condoms to be Class III, since when they were first classified, in 1993, there was so little research and scientific knowledge about them. But now that the condom has been tested for over 20 years, Semelka argues that there’s enough data to show the product is safe and effective enough for looser regulation.

Dr. Erica Gollub, a health professor at Pace University who has researched female condom use for decades and was involved the product’s initial FDA approval hearings, agrees. “The overriding justification for easing regulatory burdens on this very safe device is clear: to provide another choice in protection against STI/HIV and unplanned pregnancy to both the insertive and the receptive partner in vaginal or anal intercourse,” she says.

Advocates hope that the reclassification will have practical benefits, too. The idea is that once the paperwork and conditions become less onerous, more manufacturers will start producing internal condoms—and, hopefully, producing different kinds of internal condoms, such as models that come with tampon-like applicators for the more squeamish. The greater competition might then drive down prices.

Over the years, several companies have attempted to redesign the female condom. The global health nonprofit PATH has produced a “Woman’s Condom” that replaces the internal condom’s inner ring with foam, and features a dissolvable tip to aid insertion. The “Cupid” female condom also uses foam to stay in place, and is made of latex rather than nitrile. Meanwhile, the “Phoenurse” version is packaged with an insertion stick. But these products haven’t taken off—in part because of the time and money needed to achieve FDA approval. In addition, a startup has been working on a silicone accordion-like condom, the “Origami,” but legal battles have put its production on ice.

Cost and availability are especially important now in light of the decision by Veru Healthcare, the only FDA-approved manufacturer of internal condoms in the US, to make female condoms solely available through a prescription or via its own website in 12- or 24-packs.The cost works out to a couple of dollars per condom. Not exactly a cheap or spontaneous option.

These obstacles affect not just individuals, but also public health programs. Timothy Kordic is a project advisor for the HIV/AIDS prevention unit of the L.A. Unified School District. He says he has seen a change over the last five years or so, as younger generations express more comfort with internal condoms than older folks who still see them as a joke or an anomaly. But internal condoms aren’t covered as much in the district’s education programs because of their higher price point and lower availability. Reducing cost while expanding access, he feels, will make a big difference.

Despite advocates’ strong belief in the internal condom, the battle to popularize it to the level of its external counterpart is a precipitously uphill one. And even if they’re more readily available, there’s a good chance that Americans still won’t embrace them. After all, there’s less regulatory red tape in Europe, but internal condoms are still not commonly used their either.

Still, Semelka is cautiously optimistic. After the FDA’s public consultation period ends on February 2, the agency will consider the comments and determine final action. If the reclassification and renaming does get passed, she says, “It will be on us, then, to take the ball and run with it. The ball is in the FDA’s hands now.”