My initial knowledge of condom failure rates came from that iconic episode of Friends where Rachel tells Ross that she’s pregnant. “We used a condom,” he says. She responds, “I know, but, you know, condoms only work, like, 97% of the time.” Ross and Joey are outraged and exclaim that the brand should put that disclaimer on the box, only to find out that it does (in the fine print).
In reality, that number is actually 98%, though this statistic only relates to effectiveness in preventing pregnancy and assumes that the condom is being used perfectly every single time. (The actual statistic, according to Planned Parenthood, is closer to 85% for people whose only birth control method is condoms.)
Though condoms are also known to be helpful in protecting against STIs and are encouraged for use during anal sex, the FDA authorized the first condom specifically for that type of sex just this week.
On Feb. 23, the federal agency said that the One male condom brand can help reduce STI transmission during anal sex, and the condoms have a less than a 1% failure rate.
The authorization was granted based on a clinical trial conducted by the Rollins School of Public Health at Emory University in conjunction with Global Protection Corp., the parent company that produces One brand condoms.
The study, led by Aaron Siegler, an associate professor of epidemiology at the public health school, enrolled 252 men who have sex with men and 252 men who have sex with women; the volunteers engaged in 4,884 sexual acts using study-provided condoms. The condom failure rate was defined as the number of slippage, breakage, or both slippage and breakage events that occurred over the total number of sex acts performed. The condom failure rate was actually lower for anal sex than it was for penis-in-vagina sex.
“We really thought that it was important to do this to have an explicit understanding of what the failure levels would be,” said Siegler, who is also the associate director of the Emory Center for AIDS Research (CFAR) Prevention and Implementation Sciences Core. “In fact, the failure levels were beyond what we had hoped.”
Specifically, the condom failure rate was 0.7% during anal sex acts, most of which also incorporated a condom-compatible lubricant. The addition of lubricant is considered a vital part of using condoms correctly for anal sex.
Unprotected anal sex is considered to be the riskiest type of sex for getting STIs like HIV due to the thinner lining of the rectum, which is more easily damaged and can result in more tearing or abrasions of the skin.
The authorization “may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, director of the FDA’s Office of Gastrorenal, OB-GYN, General Hospital, and Urology Devices in the Center for Devices and Radiological Health, in a statement.
The clinical trial participants used a water-based lubricant, but any condom-compatible lubricant will reduce friction to help prevent breaking or slipping. Siegler emphasized that oil-based lubricants can actually damage latex, so it’s critical that you use only water- or silicone-based lubricants with condoms.
The study was initially funded by a research grant for small business innovation from the National Institutes of Health. Global Protection Corp. joined the team later on and provided all condoms used in the study, which included its standard, thin, and fitted condoms, which come in 54 different sizes. (You can use a paper template to find the right condom size.)
Early stages of the research were aimed at gaining approval for condoms fitted to penile dimensions for vaginal use, and then shifted toward FDA clearance to label these condoms as safe for use during anal sex.
“I think if people believe that condoms are effective, they're more likely to use them,” Siegler said. “The confidence of a very low failure rate for anal sex, I hope, will encourage an increase in condom use.”
Technically, these condoms are similar to other condoms on the market; what sets them apart is a clinical trial demonstrating their efficacy during anal sex (and that they offer so many custom fit options).
The FDA noted that other condoms authorized by the federal agency “can continue to be used for contraception and to prevent STIs.” There are about 300 condoms authorized for use during vaginal sex. The One brand condoms can also be used to reduce the risk of pregnancy and STI transmission during vaginal intercourse.
Siegler and Davin Wedel, founder and CEO of Global Protection Corp., said the goal with this landmark labeling is more to get the information out there that condoms are safe and effective for anyone to use. So it’s a good idea to use them no matter what type of sex you are having. However, if you want to buy the only condoms on the market that have been officially tested and authorized for anal sex, we don’t blame you.
“We truly believe that there’s a public health gap here, and we were really proud to be able to help fill that,” Wedel told BuzzFeed News.
You can buy a 12-pack of One Condoms for around $9.