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FDA Approves First Condom Designed for Anal Sex

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A study showed that the condoms had a failure rate of less than 1 percent during anal sex.

The U.S. Food and Drug Administration announced on Wednesday that it has authorized the marketing of the first condoms designed for anal sex.

The condoms will be marketed as the One Male Condom, according to a statement by the FDA. The condoms are made to help decrease the transmission of STIs during anal sex while also serving as a contraceptive to reduce the risk of pregnancy and transmission of STIs during vaginal sex.

This is the first condom designed for anal sex that the FDA has approved.

In its announcement, the FDA said that unprotected anal sex has the “greatest sexual exposure risk of HIV transmission.” The agency said that other FDA-approved condoms can continue to be used as a contraceptive and to reduce STI transmission.

“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 office that issued the approval, said in the announcement.

The company behind the One Male Condom, Global Protection Corp., asked the FDA last year to allow it to put anal sex in the intended use section of the item’s product label, according to The New York Times.

The request was based on a study that showed that the condoms product failure rate was less than 1 percent (.68 percent) during anal sex. For the product, the overall percentage of adverse events — such as symptomatic STI diagnosis, discomfort for wearer, partner discomfort, etc. — was 1.92 percent, according to the FDA.

Other companies may now also apply for similar approval if they meet similar criteria as the One Made Condom did.

“I don’t think this is viewed as something that should be restricted, but rather something that opens the door for other companies to rigorously assess their condoms and show that they also perform well for anal sex,” Aaron Siegler, an epidemiologist at Emory University who helped lead the above study, told the Times.

The paper notes that the FDA has previously stated that condoms need to have a less than 5 percent failure rate. Earlier tests and studies for anal condoms showed failure rates much higher than that.

“I think most people would be surprised to know that condoms are not approved for anal sex,” Davin Wedel, president and founder of Global Protection Corp, said. “With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”

This is also a breakthrough in marketing condoms for queer populations, Dr. Kenneth Mayer, the medical research director for Fenway Health, a community health center in Massachusetts that treats LGBTQ+ patients, told the Times.

“It’s a great thing if the package inserts could indicate anal sex because it might create an incentive for the companies to do more marketing,” Dr. Mayer said. “You don’t see condom ads on gay social media, for example, so this would incentivize that as part of the conversation.”

“And it’s not just gay men,” Dr. Mayer added. “It’s not that heterosexuals who engage in anal sex are unaware that condoms exist, but there’s been very little education, so it’s somewhat out of sight out of mind.”

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