FDA Approves First Condom Designed for Anal Intercourse

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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 forestall the transmission of HIV and different sexually transmitted infections all over anal intercourse has been licensed on the market in america, the U.S. Meals and Drug Management says.

The One Male Condom can be used to assist cut back the danger of being pregnant and sexually transmitted infections (STIs) all over vaginal sex.

When having anal intercourse, the FDA stated the condom will have to be used with a condom-compatible lubricant.

“The danger of STI transmission all over anal sex is considerably upper than all over vaginal sex. The FDA’s authorization of a condom this is particularly indicated, evaluated and categorised for anal sex might enhance the chance of condom use all over anal sex,” stated Courtney Lias, of the FDA’s Middle for Units and Radiological Well being.

The condom is advertised via World Coverage Corp. It was once assessed in a medical trial that integrated 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 once 0.68% all over anal sex and 1.89% all over vaginal sex.

The full fee of inauspicious occasions was once 1.92%. This integrated symptomatic STIs or contemporary STI analysis, condom or lubricant-related discomfort, spouse discomfort with lubricant and spouse urinary tract an infection, all going on in lower than 1% of contributors.

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The symptomatic STIs or contemporary STI diagnoses have been self-reported via find out about contributors, who were not checked for STIs at first of the find out about. That implies sexually transmitted infections could have took place because of having sex with out a condom or earlier than contributors began the use of the One Male Condom, in keeping with the FDA.

The condom was once licensed during the De Novo premarket assessment pathway for low- to moderate-risk gadgets of a brand new sort.

“This authorization is helping us accomplish our precedence to advance well being fairness during the construction of secure and efficient merchandise that meet the wishes of numerous populations,” Lias stated in an company information free up.

Additional information

For extra on sexually transmitted infections amongst homosexual males, see the U.S. Facilities for Illness Keep watch over and Prevention.

SOURCE: U.S. Meals and Drug Management, information free up, Feb. 23, 2022

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