FDA approves condom for use during anal intercourse for first time

By UPI Staff

One Male Condom, available in three versions and 54 different sizes, is the first condom approved by the FDA for use during anal intercourse, as well as during vaginal intercourse. Photo courtesy of One Male Condoms

Feb. 24 (UPI) -- For the first time, the U.S. Food and Drug Administration has approved condoms specifically indicated for anal intercourse.

Sexual health experts have long sought such an authorization because the risk of sexually transmitted diseases spread through anal intercourse is much greater than through vaginal sex, previous research has shown.

"The FDA cited low risk of breakage for One Condoms, which are now approved for both anal and vaginal sex," Planned Parenthood of Southern New England said Thursday on Twitter.

The agency's decision backing the One Male Condom, announced Wednesday, may help reduce transmissions of sexually transmitted infections, including HIV, officials said.

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"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," Courtney Lias, director of the FDA's Office of Gastro Renal, ObGyn, General Hospital and Urology Devices in the Center for Devices and Radiological Health, said in a press release.

The fitted condoms come in 54 different sizes and three different versions, with efficacy rates for anal intercourse over 99% in clinical trials, according to the FDA.

Until now, there wasn't enough data to prove that condoms are safe during anal sex.

The efficacy of One Male Condom was tested in a clinical trial including 252 men who have sex with men and 252 men who have sex with women. All participants were between the ages of 18 and 54 years old.

"While today's authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention," the FDA said.

One Condoms on Wednesday noted, while celebrating the approval on Twitter, that it's products continue to be effective during vaginal sex, in addition to the protection they offer during anal sex.

"There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data," lead study author Dr. Aaron Siegler said in a press release from One Condoms.

"This is despite two-thirds of HIV transmission in the United States being linked to anal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission," said Siegler, an associate professor of epidemiology at Emory University and associate director of the Emory Center for AIDS Research.

According to Planned Parenthood, the FDA is also exploring approvals for other brands that demonstrate similar reliability