FDA Approves First Condom For Anal Sex

The US Food and Drug Administration has for the first time authorised the marketing of a condom specifically indicated for anal sex. The condom which can also be used for vaginal sex will be marketed under the brand name – One Male Condom.

The One Male Condom, manufactured by Global Protection Corp, will be available in three different versions – standard, thin and fitted – and has to be used with a compatible lubricant. The fitted condoms will be available in 54 different sizes.

Davin Wedel, president and founder of Global Protection Corp, told the New York Times that “most people would be surprised to know that condoms are not approved for anal sex.”

Australia does not have any specific standards for condoms to be used for anal sex. One condom manufacturer on their website recommends the “application of additional water-based or silicone-based lubricants to the outside of the condom once on… to help reduce the risk of breakage or slippage of the condom” when used for anal sex.

“While it’s great to see FDA approval, in a lot of ways the train has left the station,” Simon Ruth CEO at Thorne Harbour Health told Star Observer.

“Our communities have used condoms as a mainstay of HIV prevention for the better part of the last four decades, and they’re now joined by PEP, PrEP, and Undetectable Viral Load (UVL) in the suite of highly effective strategies for HIV prevention. This approval is really an affirmation of a global HIV prevention strategy that’s already in play,” added Ruth.

A Condom For Anal Sex

For decades, public health and STI experts have been calling for the testing and labelling of a condom specifically for anal intercourse.

“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,” said Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health, in a statement.

“This De Novo authorisation will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster,” added Lias.

According to FDA regulations, condoms are required to have a less than 5 % failure rate. The failure rate of One Male Condom in a clinical trial was much less.

Around 252 men who have sex with men and 252 men who have sex with women were part of the clinical trial to test the safety and efficacy of the One Male Condom. “The study found that the total condom failure rate was 0.68% for anal intercourse and 1.89% for vaginal intercourse with the One Male Condom,” according to FDA.