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  • Federal regulators have approved the marketing of the first condom specifically designed for anal intercourse.
  • The One Male Condom is a natural rubber latex sheath available in 54 sizes.
  • Experts say the new product could help ease the rise in sexually transmitted diseases that occur during anal sex.

The Food and Drug Administration (FDA) has approved the first condom specifically designed for anal use, meant to help lower transmission of sexually transmitted infections (STIs) during anal intercourse.

Marketed as the One Male Condom, the product will also work as a contraceptive and a barrier to STIs passed through vaginal intercourse.

The marketing authorization was granted to Global Protection Corp.

The One Male Condom is a natural rubber latex sheath covering the penis. It has three versions: standard, thin, and fitted.

The fitted condoms are available in 54 sizes and incorporate a paper template to aid in finding the best condom size for each user.

When used during anal intercourse, the FDA recommends the condom be used with a condom-compatible lubricant.

While there may not be a big difference between the One Male Condom and traditional vaginal condoms, FDA officials said there is a need for better performing condoms, especially when it comes to anal sex.

“Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission,” the FDA statement said. “Consistent and correct condom use has the potential to significantly help decrease the risk of STIs.”

“While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention. It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy,” agency officials added.

“What makes this product unique is it has a low failure rate,” Dr. Benjamin Gibson, a pharmacist and certified functional specialist and biomedical engineering in San Antonio, told Healthline.

Gibson noted the failure rate in a 2019 study was 0.68 percent for anal sex and 1.89 percent for vaginal sex. He added that the inclusion of lubricant did not make the condom fail.

The low failure rate and the fact that the One Male Condom will be marketed specifically for anal use is how the product can make a difference, Dr. Alex Spinoso, the CEO of Genesis Lifestyle Medicine, based in Las Vegas, told Healthline.

“Nothing has changed to make this necessary now,” Spinoso told Healthline. “This has always been necessary as the risk of STI transmission, especially HIV, during anal intercourse is significantly higher than during vaginal intercourse. In fact, two-thirds of HIV transmission cases in the United States are linked to anal sex. This is the first condom ever to be approved based on anal sex data.

“While the condom is no different from regular condoms, the FDA’s authorization of a condom that is specifically indicated, studied, and labeled for anal intercourse may increase the publics’ acceptance in use of condoms during anal intercourse,” he added.

Spinoso noted that while there isn’t much of an apparent difference between the One Male Condom and traditional condoms, other factors make the product safer.

“The original study was published in 2019 showing that failure rates for One Male Condom during anal intercourse was lower than those for vaginal intercourse,” Spinoso said.

He also noted the rate of new HIV infections declined 73 percent between 1984 and 2019, with the death rate dropping more than 80 percent since its peak in 1995.

“STD rates, however, are quite the opposite,” he said.

Spinoso pointed to data published in April 2021 that shows recorded STD cases in the United States reached an all-time high for the 6th consecutive year from 2014 to 2019. There were approximately 2.6 million cases in 2019 versus 1.9 million new cases in 2014.

Gibson told Healthline the necessity for condoms being used during anal sex could be considered greater from a disease standpoint simply because of the difference in body function from the vagina.

Among other things, past research has indicated the lining of the anal cavity is more delicate and likely to produce micro-tears during sex, putting the person receiving anal sex more at risk.