FDA Officially Approves First Condom For Safe Anal Sex

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On Feb. 23, the United States Food and Drug Administration (FDA) authorized One condoms to be used for protection against STIs during anal sex, marking the first time that the FDA granted condom approval specifically for anal penetration. The condoms, marketed as One Male Condom and manufactured by Global Protection Corp., had a failure rate (breakage and/or slippage) of less than one percent (0.7) in a clinical study of “252 men who have sex with men and 252 men who have sex with women,” the FDA stated.

Lead author of the National Institutes of Health-funded study, Aaron Siegler, PhD, associate professor of epidemiology and assistant director of the Prevention Core in the Emory Center for AIDS Research at Emory University, said in a statement on the One condoms website: “There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data. This is despite two-thirds of HIV transmission in the United States being linked to anal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”

The FDA noted that “unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission.” In fact, the risk of HIV through unprotected “receptive” anal sex is as much 18 times greater than unprotected “receptive” vaginal sex, according to Stanford Health Care.

Courtney Lias, PhD, director of the GastroRenal, ObGyn, General Hospital, and Urology Devices, said in an FDA statement that the FDA’s authorization of a condom specifically for anal sex could make it more likely that people will use condoms during anal sex overall. Kenneth Mayer, MD, medical research director for Fenway Health, similarly told The New York Times that this will open doors to increase marketing and “normalize the conversation” around anal sex.

The One Male Condom is also indicated for use to help reduce the risk of pregnancy and STI transmission during vaginal sex — that won’t change — but its “intended use” claim will now include anal sex for three different styles: fitted, thin, and standard. The fitted condoms are available in 54 different sizes and have a “paper template.” The FDA stated that people should apply lube compatible with condoms when using the One Male Condom for anal sex.

The FDA said that other companies can apply for approval by demonstrating that their condoms have “substantial equivalence” to One Male Condom products.

Editor’s Note: We at POPSUGAR recognize that people of many genders and identities have vaginas, not just those who are women, and the same goes for people who have penises. The aforementioned study implied that researchers classified people with penises as men and people with vaginas as women.

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