FDA Approves First Condom Designed for Anal Sex

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News Picture: FDA Approves First Condom Designed for Anal Sex

WEDNESDAY, Feb. 23, 2022 (HealthDay Information)

The primary condom particularly designed to stop the transmission of HIV and different sexually transmitted infections throughout anal intercourse has been permitted on the market in the USA, the U.S. Meals and Drug Administration says.

The One Male Condom will also be used to assist scale back the chance of pregnancy and sexually transmitted infections (STIs) throughout vaginal intercourse.

When having anal intercourse, the FDA mentioned the condom ought to be used with a condom-compatible lubricant.

“The chance of STI transmission throughout anal intercourse is considerably larger than throughout vaginal intercourse. The FDA’s authorization of a condom that’s particularly indicated, evaluated and labeled for anal intercourse could enhance the probability of condom use throughout anal intercourse,” mentioned Courtney Lias, of the FDA’s Middle for Gadgets and Radiological Well being.

The condom is marketed by World Safety Corp. It was assessed in a medical trial that included 252 males who’ve intercourse with males and 252 males who’ve intercourse with girls. All have been between the ages of 18 to 54.

The speed of condom failure (slippage, breakage or each slippage and breakage) was 0.68% throughout anal intercourse and 1.89% throughout vaginal intercourse.

The general charge of adversarial occasions was 1.92%. This included symptomatic STIs or current STI prognosis, condom or lubricant-related discomfort, associate discomfort with lubricant and associate urinary tract infection, all occurring in lower than 1% of members.

The symptomatic STIs or current STI diagnoses have been self-reported by research members, who weren’t checked for STIs firstly of the research. Meaning sexually transmitted infections could have occurred attributable to having intercourse with out a condom or earlier than members began utilizing the One Male Condom, based on the FDA.

The condom was permitted via the De Novo premarket overview pathway for low- to moderate-risk units of a brand new kind.

“This authorization helps us accomplish our precedence to advance well being fairness via the event of secure and efficient merchandise that meet the wants of numerous populations,” Lias mentioned in an company information launch.

Extra info

For extra on sexually transmitted infections amongst homosexual males, see the U.S. Centers for Disease Control and Prevention.

SOURCE: U.S. Meals and Drug Administration, information launch, Feb. 23, 2022

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