At the end of last year, the U.S. Food and Drug Administration (FDA) approved new rules for “female” condoms that not only change the device’s name but ease some other strict regulations. Now called the “single-use internal condom,” the device is approved for both vaginal and anal sex and has the same regulatory classification as the “male” condom. The internal condom has never enjoyed widespread popularity in this country, and recent changes to how the manufacturer distributes it have made it even harder to access.
Advocates — who have been pushing for these rule changes for years — are hopeful that they will lead to increased use of this important prevention tool by removing barriers for both users and manufacturers.
The internal condom — which was first introduced in 1993 and redesigned as FC2 in 2006 — is a sheath or pouch now made out of a synthetic rubber called nitrile. There is a flexible ring inside the closed end that can be inserted into the vagina to help the condom stay in place. The open end stays outside the body, creating a barrier that blocks the exchange of semen and other bodily fluids during intercourse to prevent pregnancy and sexually transmitted infection (STI). Though originally only approved for vaginal sex, research suggests that the device is used during anal sex as well.
The internal condom is an important prevention method, because it is the only barrier method controlled by receptive partners, who are at more risk for STIs and HIV than insertive partners. However, it has not been a widely popular method in the United States. The National Survey of Family Growth suggests that fewer than 0.2% of women who use contraception rely on this as their primary method of pregnancy prevention (compared to 8.7%, for example, who rely on the “male” condom). It is possible that more people rely on it for STI/HIV prevention, but there is little data on this type of use.
What we do know, however, is that in 2017, Veru Healthcare, the only company in the U.S. that manufactures the product, stopped making it available in retail stores and pharmacies because it simply wasn’t selling there. As TheBody reported at the time, a company representative pointed to one large pharmacy chain that stocked the product in numerous stores and had only done $12 worth of sales over the previous two years. Most users get the product through health departments or community-based organizations.
Advocates believed that FDA’s rules and classifications might have something to do with the product’s lack of popularity and have been pushing the agency for rule changes, starting with the name. The National Female Condom Coalition, which spearheaded these efforts, argued that the gendered name may prevent receptive partners who do not identify as female from using the condom. Research suggests, for example, that between 13% and 21% of gay and bisexual men have used the product during anal sex. It could be appropriate for some transgender and non-binary individuals as well, but they might also be turned off by the name. In a sample letter to the FDA, the coalition wrote: “De-gendering the product name will reduce the perception that it is only intended and appropriate for use by women.” The coalition suggested the name “internal condom” because it had already been commonly used among public health professionals and sex educators.
The perception that this product is solely for women, however, was not limited to its name. Until now, the device had only ever been approved for vaginal sex. The coalition argued that the internal condom is an important method of STI protection during anal sex, both for men who have sex with men and for women in heterosexual relationships. In the sample letter, the coalition pointed to studies suggesting that up to 12% of sexually active women engage in anal sex, and most do so without a condom. The letter says, “This exposure to risk can be reduced by clearly labeling the female condom as a product designed for anal, as well as vaginal, use.”
The final change made by the FDA has to do with the regulation of manufacturers. Since they came on the market, internal condoms were considered a Class III device, which meant manufacturers had to go to greater lengths to get FDA approval for new brands or updated versions of these devices. Advocates argued that downgrading it to a Class II medical device — which is the same classification held by “male” condoms — could ease the burden on manufacturers and ultimately help bring competitors into what is now a single-source market.
The FDA released proposed changes to the rules in December 2017 and encouraged public comment. The final rules were announced last September in the Federal Register. “We are thrilled to learn about these changes and so grateful for the tireless efforts of sexual health advocates across the globe who worked for years to demand greater access to this prevention method, which truly empowers people to take control of their health on their own terms,” Sara Semelka, a National Female Condom Coalition representative, said in a statement.
By Martha Kempner