[gimlet]

"It is estimated that around six percent of American men have sex with other men - generally anal - and many heterosexual couples take part in anal sex as well."

FDA authorizes first ever condom made specifically for anal intercourse

The FDA has approved the first ever condoms for specific anal sex use
Condoms are recommended for all anal sex already, but condoms were only approved to market for vaginal sex
Experts laud the decision as a step forward that could help the LGBT community in particular

The Food and Drug Administration (FDA) on Wednesday authorized the first condom for use during anal intercourse, green-lighting the use of the Global Protection Corp's One Male Condom.

While regular condoms are already recommended for anal sex, they are required to be marketed specifically towards vaginal sex.

The move by the FDA is seen as a victory for sexual health by experts and can especially be important for the LGBT community.


Sexual health advocates considered this an unmet public health need since unprotected anal intercourse carries the greatest risk of HIV transmission via sexual exposure, with one study finding that 69 percent of men who have sex with men would use condoms more frequently if they were FDA-indicated.

The FDA has approved the One Male Condom for use in anal sex, the first ever to get this sort of approval (file photo)
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The FDA has approved the One Male Condom for use in anal sex, the first ever to get this sort of approval (file photo)

'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 agency scientist Courtney Lias in a statement.

The condom is also indicated to prevent sexually transmitted infections -- and as a contraceptive -- during vaginal sex.

'We want people to have lots of sex -- but we also want them to be empowered and informed,' said Davin Wedel, president of Global Protection Corp.




The company held a clinical trial to test the ability of the condoms in preventing transfer of bodily fluids. The study included 252 straight men between ages 18 and 54.

The FDA had said it would accept a five percent failure rate, which previous trials had failed to accomplish.

The limit was easily surpassed in the new study, with the failure rate 0.68 percent for anal and 1.89 percent for vaginal intercourse.

The researchers behind the study, which was published in The Lancet's eClinicalMedicine, said one of the reasons the trial succeeded where others failed in the past was likely due to the provision of lubricant and inclusion of instructions on how to use the product.

Lubricant reduces friction, which in turn causes condom failure from slippage and breakage.

Another reason could be that participants were asked to keep mobile phone-based daily diaries, whereas past trials had asked volunteers to recall failure events up to several months later.

While officials already recommend people use condoms for anal sex, previously condoms were only approved to be marketed for vaginal sex (file photo)
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View gallery
While officials already recommend people use condoms for anal sex, previously condoms were only approved to be marketed for vaginal sex (file photo)

Monica Gandhi, an infectious disease doctor and medical director of an HIV clinic in San Francisco, welcomed the finding.

'The important thing about condoms is they don't just prevent HIV, but they prevent gonorrhea, chlamydia and syphilis,' she told AFP, adding it was surprising that such an authorization had taken so long to achieve.

In its statement, the FDA said the green light could pave the way for more makers to apply for similar authorization if they show equivalent results.

'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,' Lias added in a statement.

It is estimated that around six percent of American men have sex with other men - generally anal - and many heterosexual couples take part in anal sex as well.

[HYPRTCKR]

~ Otherwise just stick your head in some asshole's shit so you can get smeared.

[Azimuth]

That's some strange marketing.

The closeted or on the DL gays will certainly feel super comfortable carrying around a rubber emblazoned with cartoon characters and dayglo colors. Specifically for anal sex.

[tbone79]

Where’s the one with Luigi on it, or the Mucinex mascot?

“Rub a little loogie and phlegm on it, and ram it home….”