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FDA Approves First Condom for Anal Sex

-FDA Approves First Condom for Anal Sex

Public health experts have long advised condom use to prevent HIV and other sexually transmitted infections, but the FDA has not previously permitted any condoms to be promoted for this purpose.

The U.S. Food and Drug Administration (FDA) has approved the first condom specifically designed to protect against STIs during anal sex, not just vaginal intercourse.

People who have anal sex have long been advised by public health experts, including the Centers for Disease Control and Prevention (CDC), to use condoms to prevent HIV and other STIs. But the February 23 decision by the FDA marks the first time a company will be allowed to tout this benefit on condom packaging and advertising in the United States.

The newly approved condoms, which will be marketed as the One Male Condom, can be promoted as protecting against STIs during both anal and vaginal sex.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” said Courtney Lias, PhD, the director of the FDA Office of Health Technology 3, which approved the new condoms, in a statement.

“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,” Dr. Lias said.

Survey Finds Men Are More Likely to Use FDA-Approved Condom

This may be especially true for men who have sex with men, a group at the highest risk of sexually transmitted HIV. A study published in Sexual Health in 2019 surveyed more than 10,000 men who have sex with men about condom use during anal sex.

Seven in 10 men said they would be more likely to use a condom for anal intercourse if it was FDA approved and promoted for this use, this study found. Men also said they expected condoms to fail 15 percent of the time.

But the failure rate of the One Male Condom was much lower than 15 percent in a clinical trial the FDA reviewed as part of the approval process.–2022-107tVLHqY2…..55082-2022…..88-2022-hd—tw1080phd-quality-107tVLIPB6…..2022-hd-tw×901te9aoe4ul5
Condom Failure Rate Was Less Than 2 Percent

This study examined the safety and effectiveness of the One Male Condom in 252 men who have sex with men and 252 men who have sex with women. The condom failure rate — the number of times it broke, slipped, or both — was less than 1 percent for anal sex and less than 2 percent for vaginal intercourse, this study found.

It’s possible that the condom failure rate was lower for anal sex because people used lubricant 98 percent of the time during this type of intercourse, compared with only 42 percent of the time during vaginal sex.

When researchers looked at adverse events associated with condom use in this study, they found new or symptomatic STIs, partner discomfort with lubricant, and partner urinary tract infections occurred in less than 1 percent of cases. The study results were published in eClinicalMedicine in 2019.

While this trial didn’t look specifically at HIV prevention, previous studies have found condoms highly effective at preventing HIV transmission from anal sex even with higher failure rates. A study published in AIDS in 2018, for example, found condoms were 91 percent effective at preventing HIV transmission during anal sex, with a 9 percent failure rate.

Condoms tested and approved specifically for anal sex are long overdue, according to Aaron Siegler, PhD, the lead author of the One Male Condom trial and an associate professor of epidemiology at the Rollins School of Public Health at Emory University in Atlanta.

“There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data,” Dr. Siegler said in a statement released by Global Protection Corp., which makes the One Male Condom.

“This is despite two-thirds of HIV transmission in the United States being linked to anal sex,” Siegler said. “Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”

The One Male Condom is made of latex and comes in three versions: standard, thin, and fitted. The fitted version comes in 54 sizes, along with a paper template to aid users in finding the optimal fit. For anal intercourse, these condoms should be used with silicone or water-based lubricant that’s safe for use with latex condoms.



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