FDA approves first condom sold for anal sex

Bottom up!

The US Food and Drug Administration announced on Wednesday the first approval of condoms specifically aimed at anal sex to reduce the transmission of sexually transmitted diseases.

Patuty prophylaxis, deployed by US manufacturer Global Protection Corp., will be marketed as One Male Condom, officials said.

They are also “shown as contraceptives to help reduce the risk of pregnancy and the transmission of sexually transmitted infections during vaginal intercourse,” the FDA said.

“Before today’s approval, the FDA had not cleared or approved the condom specifically shown for anal intercourse,” the agency said.

“Unprotected anal intercourse carries the greatest risk of sexual exposure to HIV infection. Consistent and correct use of condoms can help significantly reduce the risk of sexually transmitted infections.” I continued.

“Today’s approval emphasizes the public health importance of condoms specifically tested and labeled for anal intercourse, but all other FDA-approved condoms can continue to be used for contraception and STI prevention. “Masu,” the FDA added.

“The risk of sexually transmitted infections during anal sexual intercourse is significantly higher than during vaginal sexual intercourse,” said Courtney Rias, an employee of the Agency’s Device and Radiation Health Center.

“FDA approval of condoms specifically shown, evaluated and labeled for anal sexual intercourse may improve the likelihood of condom use during anal sexual intercourse,” she said.

“In addition, this authorization helps us achieve our priority of increasing health equity through the development of safe and effective products that meet the needs of diverse people,” Rias added. ..

The FDA described the One Male Condom as a natural rubber latex sheath offered in three versions: standard, thin, and fitted.

The attached ones (available in 54 different sizes) have built-in paper templates to help each user find the optimal size.

“When used during anal intercourse, the One Male Condom should be used with a lubricant compatible with condoms,” the agency said.

“The safety and efficacy of condoms between men was studied in a clinical trial consisting of 252 men who have sex with men and 252 men who have sex with women,” he explained.

Participants were between the ages of 18 and 54.

The study found that the total failure rate for One Male Condom was 0.68 percent for anal sexual intercourse and 1.89 percent for vaginal sexual intercourse.

“I think most people will be surprised to find out that condoms aren’t approved for anal sex,” said Davin Wedel, president and founder of Global Protection Corp. The New York Times reported..

“This new designation from the FDA will give consumers important information about the safety and effectiveness of condoms for anal sex,” he added.

The FDA may apply for similar approval by submitting claims that other condom companies have shown that their products are “substantially equivalent” to the evidence shown for one male condom. I said that it would be.

“I think this shouldn’t be restricted, it opens the door for other companies to scrutinize condoms and show that they’re also good at anal sex,” said Emory University epidemiologist Aaron.・ Ziegler states. The university that helped lead the research told the Times.

Until now, companies have been unable to sell condoms specifically for anal sex, according to Dr. Kenneth Mayor, director of medical research at Fenway Health, Massachusetts.

“If the package insert indicates anal sex, it’s great because it can create incentives for companies to do more marketing,” Mayer said.

“For example, gay social media don’t show ads for condoms, so we’ll encourage them as part of the conversation,” he continued.

“And it’s not just gay men,” Mayer added. “It’s not that heterosexuals having anal sex aren’t aware of the existence of condoms, but they’re a little out of their minds because they’re barely educated.”