Tuesday, August 9, 2022

FDA Approves First Condom Specifically for Anal Intercourse

man holding condom
Male hand holding Condom. Safe sex concept.

*For the first time ever, the United States Food and Drug Administration (FDA) has approved a condom specifically for anal sex.

“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, Ph.D., 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. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster.” 

READ MORE: Chicago Public Schools to Pass Out Condoms to Elementary Kids

Per the FDA, Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse. 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.”

Per Insider, In a clinical trial, researchers tested a natural rubber latex condom, the One Male Condom from Global Protection. They found it had a 0.68% failure rate — defined as slippage or breakage — during anal intercourse, leading the FDA to authorize, for the first time ever, a condom for anal sex.”

Here’s more from the FDA’s press release:

The One Male Condom is a natural rubber latex sheath that covers the penis. It has three different versions: standard, thin and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to aid in finding the best condom size for each user. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant.

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. All participants were between 18 through 54 years old.  

“It’s definitely not a one-size-fits-all kind of kind of environment,” Dr. Kenneth Mayer, the medical research director for Fenway Health and a doctor to LGBTQ patients, told the New York Times. “It will help normalize the conversation because there’ll be an economic incentive for the companies to advertise condoms for anal sex.”

Ny MaGee
Ny MaGee is an entertainment reporter with over 15 years of experience working in the film industry in areas including production and post-production, marketing, distribution, and acquisitions. She has worked for legendary film producer Roger Corman, Quentin Tarantino's production team at Miramax, the late Larry Flynt, MTV/ VH1, Hallmark Channel, Paramount, Jim Henson Co., Parade Magazine, and various LA-based companies representing above-the-line talent.

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