Fact: internal condoms — also known as “female condoms” — are not as popular as external condoms. Some people argue that’s because they’re more difficult to use. Some people say they’re just not comfortable or they’re too big. But probably the biggest reason why internal condoms aren’t as popular as external condoms has less to do with comfort or ease of use and more to do with access. (After all, plenty of people have very similar complaints about external condoms.) And that’s about to change.
The FDA just approved a reclassification of internal condoms from a Class 3 medical device to a Class 2 medical device — the same class as external condoms. Under Class 3 medical device classification, internal condoms were more highly regulated than external condoms. Unlike external condoms, they weren’t available over-the-counter and people could only buy them with a prescription or directly from the manufacturer. As a result only one company currently manufactures and dispenses internal condoms in the United States — Veru’s FC2 Female Condom.
“By reducing the regulatory burden for approval, the FDA intends to encourage more manufacturers to bring single-use internal condoms to market in the United States,” the FDA writes.
Increased access is the main goal of this change, advocates say. Because the regulatory barriers are so high and so expensive, we haven’t seen much innovation in internal condoms in the United States market. That lack of variety — in addition to other factors, including cost — has contributed to the unpopularity of internal condoms in the United States.
“That’s the thing we’re most excited: the opportunity to bring more of these types of products to the U.S. and have FDA approval to put them on the shelves,” Sara Semelka, the AIDS Foundation of Chicago Prevention Technology education manager, which was one of the groups advocating for the change, tells Bustle. “That’s our hope and that’s what we’ll be working toward.”
In addition to reclassifying internal condoms, they’re also changing the name. This type of condom was originally called a “female condom” because it was designed to be worn inside the vagina. But it soon became clear, based on how people actually used it, that it was also effective for anal sex. In fact, a lot of people even prefer it for anal sex to an external condom, due to the fact that it’s less likely to tear and also because it warms to temperature of the receptive partner’s body.
By changing the name of single-use female condoms to single-use internal condoms, the FDA is acknowledging the fact that internal condoms can be a great option for people of all genders — and not just in vaginas. It’s a great move that better reflects the actual use-case of this health care product and will hopefully make more people who aren’t women or don’t have vaginas open to the possibility of using them.
“It’s a big deal, because we used to have to say ‘It’s not FDA-approved for anal intercourse, but we encourage you to do it from a harm reduction perspective,’” Semelka says. “We add a little caveat that maybe can be a barrier for people or put a question in their mind. But now that it’s approved for that, we can just straight up say ‘This can be used for vaginal and anal intercourse.’”
The reclassification is also important because internal condoms are the only barrier method of protection controlled by the receptive partner. By classifying it as a more regulated item than external condoms, the FDA was impeding access to a device that women and other receptive partners (read: people having anal and vaginal sex) have direct control over. By changing the classification, they’ll hopefully not only open the doors to more manufacturers but will also definitely increase the number of non-hormonal options that women and other people with uteruses have for birth control. And more options for birth control and STI protection is always a good thing.