For the first time, the U.S. regulators have approved a condom for anal sex.
Sexual health experts have been seeking the FDA's decision to encourage more people to use condoms during anal sex to protect themselves against sexually transmitted infections.
The risk of sexually transmitted diseases is higher during anal sex, according to an F.D.A. official. There isn't enough data to show that condoms are effective during anal sex.
The F.D.A.'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.
The ONE male condom is manufactured by Global Protection Corp. The company asked the F.D.A. to allow it to add anal sex to the condom because of a study showing a failure rate of less than 1 percent during anal sex.
According to the F.D.A., other condom companies will be able to apply for approval if they show that their condoms are equivalent to the evidence shown for ONE condoms.
I don't think this is something that should be restricted, but rather something that opens the door for other companies to rigorously assess their condoms and show that they also perform well for anal sex.
Most people would be surprised to know that condoms are not approved for anal sex. With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.
Earlier studies of condoms for anal sex had shown failure rates higher than the 5 percent federal agency had previously said condoms needed to have.
The World Health Organization and the Centers for Disease Control and Prevention recommend the use of condoms for anal sex, but it has been considered an off-label use in the United States. The medical research director for a community health center in Massachusetts said that companies have not been able to market condoms for anal sex.
It would be great if the package inserts could indicate anal sex, because it would encourage companies to do more marketing.
Gay men are not the only ones who engage in anal sex.
Since the advent of a method to prevent H.I.V. infections called pre-exposure prophylaxis, orPrEP, condom use during anal sex has declined. According to the most recent statistics from C.D.C.'s National H.I.V., about half of men who have sex with men are having anal sex without condoms.
There can be issues with cost and access. The C.D.C. reported that only a third of men at high risk for H.I.V. are taking the drug.
Hundreds of thousands of people were involved in the study that led to the F.D.A.'s decision.
He said condoms are the most effective protection against sexually transmitted infections, including syphilis, which has been increasing in the United States.
The company met with the F.D.A. and designed a study to gather data that could lead to the approval of condoms for anal sex.
The largest study to date on condom effectiveness during anal sex was funded by the National Institutes of Health. The researchers took several steps to encourage more consistent and accurate data than previous studies, and it involved 504 men, half of whom had sex with men and half of whom had sex with women.
After being trained in proper condom use, the men were asked to fill out a daily diary on a phone app to answer questions about whether they had sex that day and whether the condom they used broke or slipped. The participants had sex with 2,533 people during the study period.
The team had expected the condom failure rate to be low enough to pass muster with the F.D.A., but had not expected it to be as low as it was.
The researchers attribute the higher failure rate to the fact that the study only encouraged lubricant to be used during vaginal sex, not anal sex.
Only 42 percent of people who had vaginal sex used lubricant, while 98 percent of people who had anal sex used lubricant. The failure rate in the vaginal group was 1.1 percent when the researchers only looked at people who used lubricant.
The F.D.A. said that condoms should be used during anal sex.
There are three different types of the One condom, standard, thin and fitted, which come in 54 different sizes. They did not have any of the characteristics. Each participant was given a sample of each type of condom. The study found that the fitted condoms had the same failure rate as the other two varieties.
Before conducting the condom study, the team wondered if adding anal sex to a condom label would encourage more men to use condoms.
Does this matter? He asked if it would change use. 69 percent of men who had sex with men said they would use condoms if the F.D.A. approved them for anal sex.
I don't see condoms andPrEP as mutually exclusive options, I see them as options that can support each other and allow people to choose. I think we can increase the population level protection against H.I.V. if we improve people's access to and understanding of different prevention options.
Adding a label to condoms could help improve the use of all protective measures.
It is definitely not a one-size-fits-all environment.
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