For the first time, the US Food and Drug Administration (FDA) has authorized a condom manufacturer to market their product as protecting against sexually transmitted infections (STIs) during anal sex. The move comes following a study that specifically tested the efficacy of the “One Male Condom” in anal intercourse and found the total failure rate to be just 0.68 percent. The condom marks a world-first in being approved by the FDA as safe for anal intercourse, which they say carries a higher risk of STI transmission compared to vaginal penetration. They now welcome other condom manufacturers to submit their products for the same approval provided they can demonstrate similar efficacy in specifically anal sex. Sexual health experts have awaited such an approval for some time, with hopes that verifying products suitable for anal penetration will improve safe sex practice for those involved. “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 Dr Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. “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.” The newly approved One Male Condom is available in standard, thin, and fitted versions. The latter comes in 54 different sizes, and wearers are able to refer to a paper template to select the best size. The condoms are intended to be used with a lubricant. Like other condoms, it protects against the spread of STIs by creating a fluid-proof barrier when worn over the shaft before engaging in anal intercourse. It was put to the test in a clinical trial involving 252 men who have sex with men and 252 men who have sex with women, and found a failure rate (condom slippage and/or breakage) of 0.68 percent and 1.89 percent for anal and vaginal intercourse, respectively. The results are available on the FDAs website. As well as approving the One Male Condom as marketable for anal intercourse, the FDA have introduced a new regulatory classification that will speed up the process for other companies seeking the same approval. “This… authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster,” Lias added. Source
