Kenneth Mayer, the medical research director for Fenway Health, who was not involved in the study, tells the Times. “It’s a great thing if the package inserts could indicate anal sex because it might create an incentive for the companies to do more marketing,” Dr. However, condom companies were only allowed to market their products as safe and effective for vaginal sex. Having condoms tested and approved for anal sex will allow users to have confidence in using condoms to prevent HIV transmission.”Ī previous study led by Siegler found that 69 percent of men who have sex with other men were likely to use a condom more often if it indicated FDA approval on the label.ĭespite a lack of authorization, people have long used condoms for anal sex the Centers for Disease Control and Prevention even recommends it, per the Agence France Presse. “This is despite two-thirds of HIV transmission in the United States being linked to 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,” says Dr. Aaron Siegler, lead author of the clinical trial, in a statement. ONE Condoms has previously partnered with artists to create condom labels, including holding a Canada-themed label design contest. A secondary analysis using data only from participants that used lubricant showed similar failure rates for both anal and vaginal sex, per the study. The study instructed men having sex with men to always use lubricant, while men having sex with women were instructed to use lubricant as needed or preferred. Lubricant was used for 98 percent of anal sex during the study, while it was only used for about 42 percent of vaginal sex acts. The gap in effectiveness may have been because of differences in lubricant use. Condom failure was defined as slippage or breakage, per the study, which found a 0.68 percent total failure rate for anal intercourse and 1.89 percent failure rate for vaginal intercourse. ONE condoms have previously been approved for use during vaginal sex.
“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.”Ĭondoms need to have less than a five percent failure rate for authorization, and earlier studies have shown higher failure rates, writes the New York Times’ Pam Belluck.Ī clinical trial in 2019 tested the effectiveness of ONE condoms, manufactured by Global Protection Corporation, in 252 men who have sex with men and 252 men who have sex with women. “The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” says Courtney Lias, director of the FDA’s office of GastroRenal, ObGyn, General Hospital, and Urology Devices in a statement. This is the first time the agency has approved a condom specifically for use during anal sex. The United States Food and Drug Administration has authorized the use of ONE Condoms during anal intercourse to reduce sexually transmitted infections. ONE Condoms become the first condoms approved for anal sex by the FDA.