So why hasn't the FDA approved it?
TAO CHUAN YEH / Staff
The first time I saw a female condom, I thought it was ridiculous. It looked to me like a cross between a sandwich baggy and a trash-can liner. It's not stretchy, and flops around like an ill-fitting sweater. Surely, I thought, I would never, ever use this weird device. Then one day on a whim I slid a female condom over a sex toy and found that it made anal play with toys much cleaner and more comfortable. When I found myself bottoming for a very well-endowed man, I suggested he use the female condom like a conventional condom. That was when I went from thinking the female condom was a silly fad to thinking it is the future of safe sex.
A few weeks ago, I went to Amazon to stock up on my usual supply of FC2s, and panicked when I saw that the product had been pulled from online retailers. When I read that they had switched to a prescription-based distribution model, I was crestfallen.
The FC2 female condom has been on the US market for years as the only "internal condom," as they're called. Despite their monopoly, the FC2 has never quite taken off in over-the-counter sales, says Brian Groch, Chief Commercial Officer for Veru Healthcare (the company that manufactures the FC2). According to Groch, one big-name national retailer sold $10.75 worth of their product last year, even though they were on the shelves of hundreds of stores. Groch says that people simply don't know what to do with a female condom, and only come to use them after being shown by a healthcare provider. It was for this reason that the FC2 switched to a prescription-based model in April 2017. Groch hopes that by getting clinicians to demonstrate and recommend the FC2, they'll be able to increase use of the product. Also, the Affordable Care Act's contraception mandate means that more people can get the FC2 for free now with a prescription (as long as the ACA exists, anyway). Groch reports that the move to the prescription-based model has increased awareness of their product, which has correlated with increased sales.
What makes the FC2 so different from a male condom is the material it's made out of: nitrile. This synthetic form of rubber took off in the late-90s as an alternative to latex, with clinicians using nitrile exam gloves because they or their patients had a latex allergy (purple or blue gloves are almost always nitrile). Health and Safety International, a journal for employee protection, describes nitrile as superior for its softness and tactility, as well as its ability to dissipate body heat. Groch says this softness and ability to transfer heat is what makes the FC2 more pleasurable than a condom, because it doesn't feel like there is as much of a barrier between sexual partners. Nitrile is also more puncture-resistant than latex. Chemical resistance is another benefit: In the lab, latex is known to dissolve under many common chemicals. Nitrile won't. Latex condoms cannot be used with oil-based lube because they will rip apart. The nitrile FC2 can be used with any lube.
The FC2 is intended to be placed inside a vagina, where it creates a complete interior lining. The FC2 then extends outside the body to cover the vulva. In this sense, the FC2 is superior to a male condom—it actually provides more protection from pathogens like herpes, which are spread via skin-to-skin contact. A male condom may roll up during sex and expose part of a penile shaft that's shedding herpes or HPV, and this can lead to infection.
I've been using the FC2 just like you would a male condom, and I love it. As a bottom, I find that male latex condoms feel dry and often produce a painful friction, no matter how much lube I use. Nitrile, on the other hand, feels much closer to natural. One guy I hook up with has a massive dick; we could use a traditional male latex condom on him, because they can stretch to fit even the most well-endowed man. But trying to get a latex condom over his member is a fiddly challenge, and if he loses some of his stiffness, it makes it even harder to get a latex condom over it. Taking that big of a dick inside me is hard enough, but combine it with the dry friction of a latex condom, and forget it. The FC2 is far superior. I also use the female condom over oddly-shaped sex toys like the Fort Troff Raw Dog, which helps ensure my toys stay clean for each use.
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Groch acknowledges that a large part of their market is gay men using the FC2 in a similar fashion to women (here's a great how-to video for using the FC2 for anal sex), lining their rectum so a guy can top without a male latex condom. Unfortunately, the FC2 is only FDA-approved for vaginal sex, so it cannot be marketed to gay men who want to use it for anal sex. Surprisingly, the FC2 isn't alone here.
"The FDA does not currently endorse use of any type of condom (male or female) for prevention of HIV or other STIs with anal intercourse—regardless of the sexual or gender identity of the folks involved," says Nikole Gettings, a nurse and specialist in sexual health. While working with Choices, a clinic at the Memphis Center for Reproductive Health, she surveyed all the research on female condoms for anal sex, and found a frustrating lack of published data on the subject.
Essentially, any claim made by a medical device manufacturer has to be approved by the FDA. Both male and female condoms are considered medical devices, and are subject to the same strict FDA rules that prescription medicine or insulin pumps would be. To receive FDA approval, a company must submit extensive research and testing to prove efficacy of their product. The CDC recommends condoms for anal sex based on evidence that they reduce the spread of STIs, but to date, no condom manufacturer (male or female) has done the necessary work to have their product actually approved for anal sex.
According to Gettings, the studies for female condoms and anal sex have major gaps. One study found that female condoms produced more irritation in the anus; however, that study from 2003 was from a previous model that had a seam going up the side and was not made of nitrile. The new FC2 doesn't have the seam, and has (theoretically) the softest material for mucosal linings, but Gettings says there is no study on the new model for anal sex. Another 2011 study found that both gay and straight people used the female condom for anal sex, but that their sample size was so small no real conclusions could be drawn. That study ended with the conclusion, "These results highlight the urgent need to evaluate the safety and efficacy of the female condom in anal intercourse to fill this knowledge gap and help people make informed choices about the methods they use to protect themselves during anal intercourse."
"Nitrile is less likely to cause abrasions than latex, and that alone decreases the likelihood of STI transmission," Gettings says. Still, though, she says the female condom is more likely to slip during anal sex than a male condom, which means fluids are more likely to pass between partners. Until more studies are done, the FC2 for anal sex is a mixed bag of incomplete information.
Groch assures me that I can continue to buy the FC2 online, despite the fact that it's been pulled from Amazon. Previously, I had been paying approximately $2 apiece; now the FC2 will be available online at $1.60 a unit to everyone. As it turns out, a prescription isn't necessary to buy them—just to get them for free. Both women and men can request a prescription from their doctor for the FC2 and then get them from any pharmacy.
Ultimately, these changes in distribution for the FC2 can be a win-win for both users and the sellers, but the general public needs to learn about this product. The male condom has been the default standard for so long, that it can be hard to think of another option for safe sex. Yet, the male condom has some flaws, most notably the latex, which reduces sensation and pleasure. Given that we're in the middle of an STI epidemic, we need to fund studies on alternatives to male condoms that can help reduce risk. Or, at least, a condom manufacturer should be ready to invest the time and effort in making a product proven safe, effective, and comfortable for both anal and vaginal sex. The reality of our society is that people, both straight and gay, want to enjoy many types of sex—we should know how to keep ourselves safe when we have fun.
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