The US Food and Drug Administration on Wednesday announced its first-ever authorization of a condom specifically intended for anal sex to help reduce transmission of sexually transmitted infections.
The patootie prophylactics, which will be rolled out by US manufacturer Global Protection Corp., will be marketed as the One Male Condom, the agency said.
They also are “indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse,” the FDA noted.
“Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse,” the agency said.
“Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs,” it continued.
“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,” the FDA added.
Courtney Lias, an official with the agency’s Center for Devices and Radiological Health, said that “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,” she said.
“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,” Lias added.
The FDA described the One Male Condom as a natural rubber latex sheath that comes in three versions: standard, thin and fitted.
The fitted ones — available in 54 different sizes — incorporate a paper template to help in finding the best size for each user.
“When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant,” the agency said.
“The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women,” it explained.
The participants were between the ages of 18 and 54.
The study found that the total One Male Condom failure rate was 0.68 percent for anal intercourse and 1.89 percent for vaginal intercourse.
Davin Wedel, president and founder of Global Protection Corp’, said, “I think most people would be surprised to know that condoms are not approved for anal sex,” The New York Times reported.
“With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex,” he added.
The FDA noted that other condom companies would now be able to apply for similar approval by submitting claims that their products demonstrated “substantial equivalence” to the evidence shown for One Male Condoms.
“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 study, told The Times.
Companies have previously not been able to market condoms specifically for anal sex, according to Dr. Kenneth Mayer, medical research director for Fenway Health in Massachusetts, a facility that has long been a leader in treating people who identify as LGBTQ, the newspaper reported.
“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,” Mayer said.
“You don’t see condom ads on gay social media, for example, so this would incentivize that as part of part of the conversation,” he continued.
“And it’s not just gay men,” 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.”