The Food and Drug Administration (FDA) on Wednesday authorized the first-ever condom intended for safe anal intercourse.
Authorization of the One Male Condom is expected to help reduce the transmission of sexually transmitted infections (STIs), including HIV/AIDS in both anal and vaginal intercourse, the FDA said in a press release.
“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,” said Courtney Lias, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.
“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 continued.
The One Male Condom is produced by the Global Protection Corp and is available in dozens of sizes and fits.
Before seeking FDA approval, the company conducted a trial of 252 men who had sex with other men and 252 men who had sex with women. Participants, all aged between 18 and 54, were asked to track sexual activity in a journal.
The results, published in the journal Lancet in 2019, showed failure rates were lower for the One Male Condom during anal intercourse than for vaginal intercourse, according to the FDA.
David Wedel, the president and founder of Global Protection Corp, called the FDA’s approval of the One Male Condom a “landmark shift” in the public health sphere.
“I think most people would be surprised to know that condoms are not approved for anal sex,” he said in a statement. “With this new designation from the FDA, people will have more confidence using condoms for anal sex.”
Aaron Siegler, an associate professor of Epidemiology at the Rollins School of Public Health at Emory University who led the study, said “over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data.”
“This is despite two-thirds of HIV transmission in the United States being linked to anal sex,” Siegler said in a statement. “Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”
During the pandemic, condom sales across the world have fallen.