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America’s FDA approves condom for anal sex for first time ever

Maggie Baska February 24, 2022
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This illustration photo shows "One" condoms displayed on a table

The FDA has authorized the first condom for use during anal intercourse, in what was hailed as a victory for sexual health by experts. (Olivier Douliery/AFP via Getty)

The US Food and Drug Administration (FDA) has finally authorised the first condom specifically designed to be used for anal sex.

On Wednesday (23 February), the FDA approved the One Male Condom, which is made by Global Protection Corp, to be marketed as a product that helps “reduce transmission of sexually transmitted infections (STIs)” during anal sex.

The natural rubber latex condom will have three different versions: standard, thin and fitted. The fitted condoms will be available in 54 different sizes, and there will be a paper template to help people find the best size for each individual.

According to a press release from the FDA, the US regulator had not approved condoms specifically indicated to be used for anal sex. The FDA said that “consistent and correct condom use” had the potential to “reduce the risk of STI transmission, including HIV”.

Courtney Lias – director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health – said the new approval could help increase the “likelihood of condom use” during anal sex.

“The FDA’s authorisation of a condom that is specifically indicated, evaluated and labelled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Lias said.

“Furthermore, this authorisation helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.

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”.

Wedel hoped that, with this new designation, consumers will have “important information about the safety and effectiveness of condoms for anal sex”.

The FDA previously stated that condoms need to have a less than 5 per cent failure rate, the New York Times reported. However, early studies of condoms specifically designed for anal sex showed failure rates higher than this rate.

The One Male Condom was studied in a clinical trial involving 252 men who have sex with men and 252 men who have sex with women. All participants were aged between 18 and 54.

The condom’s failure rate was 0.68 per cent for anal sex and 1.89 per cent for vaginal intercourse.

The researchers attributed one of the reasons why the trial succeeded was likely because the study encouraged the use of lubricant and inclusion of instructions on how to use the product.

According to the New York Times, the researchers encouraged lube to be used every time during anal sex. However, in line with public health guidelines, they only encouraged lube to be used “as needed or desired” during vaginal sex.

Wedel said in a separate statement that the clinical trial had finally confirmed “something that we believed but had no clinical proof – the use of lubricant makes condoms even more effective than they already are”.

“We’re ecstatic to bring this information to our health educator partners, and continue to educate people about the importance of lubricant,” Wedel said.

In its statement, the FDA said that the One Male Condom “should be used with a condom-compatible lubricant” when used during anal sex.

More: anal sex, condoms, fda

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