First safe and effective condom for anal sex approved by the FDA

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Condoms that have passed safety and efficacy checks for anal sex have been approved by the US FDA with the aim of reducing cases of HIV infection and other sexually transmitted diseases.

The use of a condom during anal sex is important to avoid sexually transmitted diseases, as well as other types of infections, since there are large amounts of germs and bacteria in the rectum. However, this area, being less lubricated, can cause the latex to end up breaking, with the risk that this entails, especially due to HIV. Now the United States Food and Drug Administration (FDA) has approved the first safe and effective condom for this sexual practice.

One Male Condom is the commercial name of this natural rubber latex condom, which is marketed in three models: standard, fine and custom fit, the latter available in 54 different sizes that will be determined using a paper template. Its approval by the FDA has been motivated by the successful results in a study at the Rollins School of Public Health at Emory University (USA).

None of the condoms sold in the US market indicate that they can be used for anal sex, since their safety and efficacy had not been demonstrated with conclusive data provided to the FDA. However, One Male Condom has succeeded, so they will be the first to specify this use, which must be accompanied by a lubricant compatible with the use of condoms.

A failure rate of only 0.68% in anal sex

In the study, which has been published in the journal eClinicalMedicine, the condoms tested only failed in 1,895 of vaginal intercourse and 0.68% of anal intercourse between both men and heterosexual couples, a figure well below that obtained with other previously tested condoms, whose error rate was 5%, so they could not be approved.

There is a higher risk of transmission of an STI during anal sex than in vaginal sex, which is why it is intended to promote the use of these safe and effective condoms

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. FDA clearance of a condom that is specifically indicated, tested, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, FDA General Hospital Fellow.

The main objective that is intended to be achieved with this approval is to increase its use, reducing the risk of sexually transmitted infections, one of them being the HIV virus. “This authorization helps us achieve our priority of promoting health equity through the development of safe and effective products that meet the needs of diverse populations,” adds Lias.

“While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-approved condoms can still be used for contraception and STI prevention. It is important to continue using condoms consistently and correctly to reduce the risk of transmitting STIs, including HIV, and to prevent pregnancy.

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