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FDA approves first condom specifically intended for anal sex

The One Male Condom will be the first permitted to use a "safe and effective use" label for reducing sexually transmitted infections during anal sex.

The U.S. Food and Drug Administration this week approved the first condom specifically indicated for anal intercourse. 

While the One Male Condom is not markedly different from the hundreds of other condoms on the market, it is the first that will be allowed to use the “safe and effective use” label for reducing sexually transmitted infections during anal sex. It is also approved for use as a contraceptive and as a means to reduce STIs during vaginal intercourse.

“This landmark shift demonstrates that when researchers, advocates, and companies come together, we can create a lasting impact in public health efforts,” Davin Wedel, president and founder of Boston-based Global Protection Corp, maker of the One Male Condom, said in a statement. “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.”

Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital and Urology Devices, noted 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,” Lias said in a statement. “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.” 

Anal sex poses the highest risk for contracting HIV, with the risk of HIV transmission from receptive anal sex about 18 times higher than receptive vaginal sex. Gay and bisexual men accounted for 69 percent of the 36,801 new HIV/AIDS diagnoses in the U.S. in 2019, according to the Centers for Disease Control and Prevention. Queer men of color were overrepresented within this group, with Black men representing 37 percent, Latino men representing 32 percent and white men representing 25 percent of these new diagnoses, according to the CDC. 

One Male Condoms are available in standard, thin and fitted versions, and the fitted version is available in 54 different sizes. 

A clinical trial of 252 men who have sex with men and 252 men who have sex with women found the One Male Condom has a failure rate of 0.68 percent for anal sex and 1.89 percent for vaginal sex, according to the FDA, which defined condom failure as condom slippage or breakage.

Dr. Will DeWitt, clinical director of anal health at the Callen-Lorde Community Health Center in New York City, said the newly approved condoms could be a helpful tool for HIV/AIDS prevention. 

“The hope would be that people would be more willing to use condoms for anal sex and to have that direct encouragement would increase the rates of people using them,” DeWitt said. “Condoms still remain an important tool for people who don’t want to or can’t use PrEP.” 

PrEP, or pre-exposure prophylaxis, is typically taken in the form of a daily pill to prevent HIV/AIDS in people who are not diagnosed with the virus. Last year, the FDA also approved an injectable PrEP shot that can be given every two months. 

DeWitt did, however, add that he is worried the One Male Condom name and marketing could alienate those who engage in anal sex but do not identify as male. 

“Anal sex really does belong to everyone,” DeWitt said. “Even if it’s the perspective of who has to wear the condom, it’s not just male bodies and male identified folks who need to use it.” 

While health experts have long encouraged the use of condoms for STI prevention through anal sex, DeWitt said FDA’s official approval is long overdue. 

“Here we are in 2022, and we are only now getting condoms approved for anal sex,” DeWitt said, noting that it’s been more than three decades since the start of the HIV crisis. “It’s a little frustrating that it’s taken this long to have this kind of official endorsement.

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