The first condom specifically designed for anal sex has been approved by the US Food and Drug Administration.
Previously the FDA had blocked corporations from marketing their products as an effective tool for safe anal sex.
On Wednesday, the FDA announced that Global Protection Corp.’s One Male Condom would be allowed to be marketed as a product that helps “reduce transmission of sexually transmitted infections” during both vaginal and anal intercourse.
According to The New York Times, experts believe the approval will increase condom use during anal sex, posing the most significant risk of HIV transmission.
“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.
“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. 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.”
Just last year, Global Protection Corp. requested that the FDA approve the use of the condom for anal sex as part of an update to its labeling.
The company filed the request after a study found that the One Male Condom failed for vaginal sex at 1.89 percent and for anal sex at less than 1 percent.
The clinical trial included more than 500 men, ages 18-54; 252 of them had sex with other men, and 252 had sex with women.
The FDA says the move will allow other companies to apply for similar approval.
“I think most people would be surprised to know that condoms are not approved for anal sex,” said Davin Wedel, president and founder of Global Protection Corp. “With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”
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