FDA Makes First Approval For Condom Optimized For Anal Intercourse NSFW
Image via Global Protection Corp / PR Newswire
In any form of sexual intercourse, it’s always advisable to use a condom to stave off sexually transmitted infections (STIs). Although this recommendation stretches to include anal sex, there hasn’t been a product authorized for it.
That is, until now. The US Food and Drug Administration has finally approved the first condom suited for anal intercourse.
In doing so, the FDA hopes to encourage the habit of using protection before engaging in anal sex—which poses a higher risk of transmitting STIs, including HIV—as well as inspire other brands to introduce condoms in this category.
It’s worth noting that the ONE male condom, as it is called, can similarly be used for vaginal sex to prevent the spread of STIs or unwanted pregnancies. To be clear, it’s the first FDA-approved condom for anal sex because it has proven to stay in place during nearly 100% of anal intercourse.
The company behind the ONE condom, Global Protection Corp, tested the rubber on 252 men who have male partners and 252 others who have sex with women. It found that the condom had a 0.68% failure rate (the tendency of it slipping off or breaking) during anal sex and a 1.92% failure rate during vaginal sex.
As reported by the New York Times, the FDA expects condom makers to work to achieve a failure rate of below 5%, but earlier research has revealed that condoms built for anal sex have higher slippage or breakage rates.
Less than 1% of participants who tested the ONE male condom reported an STI or a recent STI diagnosis. However, some of them could have already had the STI before the clinical trial.
The ONE male condom arrives in three varieties: standard; thin; and fitted, which is available in 54 sizes to ensure the perfect fit. The rubber should be used with a condom-friendly lubricant.
“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,” explains Courtney Lias, PhD, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health, in the federal agency’s announcement. “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.”
The condom’s maker hails this authorization as a “landmark shift.”
“I think most people would be surprised to know that condoms are not approved for anal sex,” responds Global Protection Corp’s president and founder Davin Wedel. “With this new designation from the FDA, people will have more confidence using condoms for anal sex."
[via Gizmodo and The New York Times, cover image via Global Protection Corp / PR Newswire]
