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Why the FDA finally approved a condom for anal sex

It’s basic sex education—when you’re taking part in a sexual activity, use some form of protection. And when it comes to protecting yourself and partners from sexually transmitted infections, condoms are a must. 

However, there’s never been a cleared or approved condom specifically for anal intercourse—the condoms on the market are more or less recommended for “off-label” use during anal or oral intercourse by the Center for Disease Control. But just this week, the US Food and Drug Administration finally signed off on marketing of the first condom labeled and made for anal sex, the ONE Male Condom.

HIV risk is evident in pretty much any kind of sexual exposure, but unprotected anal sex has the highest risk of potential transmission of the disease. The recieving partner of anal sex has about a 1.4 percent risk of infection, compared to about a 0.08 percent risk with receptive vaginal. This is mainly due to the fragile and porous tissue in the rectum, and the high viral load of semen and pre-seminal fluid. 

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Courtney Lias, director of the FDA’s Office of GastroRenal, OB-GYN, General Hospital, and Urology Devices in the Center for Devices and Radiological Health, said in a release. “Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”

This announcement came alongside a safety and efficacy study of the ONE Male Condom in a group of 52 men who have sex with men and 252 men who have sex with women all between the age of 18-54. The condom, which is pretty much identical to common rubber latex glove-types already on the market, had a failure rate of 0.68 percent for anal intercourse and 1.89 percent for vaginal intercourse. But lubricant played a big role—in the FDA statement, the agency states that the product “should be used with a condom-compatible lubricant.” STI diagnoses were not recorded at baseline.

The way that the condoms have been approved is through a De Novo premarket review pathway for new low to moderate risk health devices. Additionally, the FDA has established special controls so that other devices can show substantial equivalence to the ONE condom and receive clearance as well. 

“Condoms are a great way to prevent STIs and HIV during all kinds of sex, including anal, vaginal, and oral,” says Julia Bennett, the director of digital education and learning strategy at Planned Parenthood. “This announcement gives people and communities another option when it comes to safer sex, which is always a good thing.”

While HIV infections have been falling steadily, including an 8 percent drop between 2015 and 2019, other STIs have been on the rise, making 2019 the sixth year in a row of rising cases. In that same time frame, rates of syphilis in newborn children have quadrupled, and people of color are still disproportionately affected. Additionally, gay and bisexual men accounted for around half of all primary and secondary syphilis cases in 2019.

But consistent use of protection—regardless of specified use—can shrink those risks. And having more accessible information and educational resources about the different ways to have sex and use protection can only help. 

“This isn’t a groundbreaking advancement in my opinion. All condoms can (and should!) be used to make anal sex safer, so just because this one brand has FDA approval doesn’t make it any better than other condom brands on the market,” says OB-GYN and author Jennifer Lincoln. “Don’t let the ‘FDA approved’ label sway you when you are at the grocery store—the best condom to use for safe sex is the one you have access to and the one you will actually use. “

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