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HomeUS FDA approves first condom for use in anal sex

US FDA approves first condom for use in anal sex

By The New York Times

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WASHINGTON D.C. – For the first time, regulators in the United States have approved a condom specifically designed for anal sex.

Despite the fact that health experts have encouraged the use of condoms for all types of sexual intercourse, the US Food and Drug Administration previously prohibited companies from marketing their products as an effective tool for safe anal sex.

However, the FDA announced on Wednesday that it will allow Global Protection Corp. to market its One Male Condom as a product that helps “reduce transmission of sexually transmitted infections” during both vaginal and anal intercourse.

According to The New York Times, experts believe the approval will encourage more people to use condoms during anal sex, which “carries the greatest sexual exposure risk of HIV transmission.”

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal 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.

“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. 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.”

According to the Times, Global Protection Corp. asked the FDA last year for permission to update its labeling, specifically adding anal sex to the list of condom’s intended uses.

A study found that the One Male Condom had a 1.89 percent failure rate for vaginal sex and a less than 1% failure rate for anal sex. More than 500 men between the ages of 18 and 54 took part in the clinical trial, with 252 having sex with other men and 252 having sex with women.

The FDA says the move will allow other companies to apply for similar approval.

“I think most people would be surprised to know that condoms are not approved for anal sex,” said Davin Wedel, president and founder of Global Protection Corp.

“With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”

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