"Unprotected anal intercourse carries the best sexual publicity threat of HIV transmission," the FDA mentioned.
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Bottoms up!
The US Meals and Drug Administration on Wednesday introduced its first-ever authorization of a condom particularly meant for anal intercourse to assist cut back transmission of sexually transmitted infections.
The patootie prophylactics, which will likely be rolled out by US producer International Safety Corp., will likely be marketed because the One Male Condom, the company mentioned.
In addition they are “indicated as a contraceptive to assist cut back the chance of being pregnant and the transmission of STIs throughout vaginal intercourse,” the FDA famous.
“Earlier than at present’s authorization, the FDA had not cleared or accepted condoms particularly indicated for anal intercourse,” the company mentioned.
“Unprotected anal intercourse carries the best sexual publicity threat of HIV transmission. Constant and proper condom use has the potential to considerably assist lower the chance of STIs,” it continued.
“Whereas at present’s authorization underscores the general public well being significance of condoms examined and labeled particularly for anal intercourse, all different FDA-cleared condoms can proceed for use for contraception and STI prevention,” the FDA added.
Courtney Lias, an official with the company’s Middle for Units and Radiological Well being, mentioned that “the chance of STI transmission throughout anal intercourse is considerably larger than throughout vaginal intercourse.”
“The FDA’s authorization of a condom that's particularly indicated, evaluated and labeled for anal intercourse could enhance the chance of condom use throughout anal intercourse,” she mentioned.
“Moreover, this authorization helps us accomplish our precedence to advance well being fairness via the event of secure and efficient merchandise that meet the wants of numerous populations,” Lias added.
The FDA described the One Male Condom as a pure rubber latex sheath that is available in three variations: commonplace, skinny and fitted.
The fitted ones — obtainable in 54 completely different sizes — incorporate a paper template to assist in discovering one of the best measurement for every person.
“When used throughout anal intercourse, the One Male Condom must be used with a condom-compatible lubricant,” the company mentioned.
“The security and efficacy of the One Male Condom was studied in a medical trial comprised of 252 males who've intercourse with males and 252 males who've intercourse with ladies,” it defined.
The members had been between the ages of 18 and 54.
The research discovered that the full One Male Condom failure fee was 0.68 % for anal intercourse and 1.89 % for vaginal intercourse.
Davin Wedel, president and founding father of International Safety Corp’, mentioned, “I feel most individuals can be shocked to know that condoms usually are not accepted for anal intercourse,” The New York Occasions reported.
“With this new designation from the FDA, shoppers could have essential details about the protection and effectiveness of condoms for anal intercourse,” he added.
The FDA famous that different condom corporations would now have the ability to apply for related approval by submitting claims that their merchandise demonstrated “substantial equivalence” to the proof proven for One Male Condoms.
“I don’t suppose that is considered as one thing that must be restricted, however relatively one thing that opens the door for different corporations to carefully assess their condoms and present that in addition they carry out properly for anal intercourse,” Aaron Siegler, an epidemiologist at Emory College who helped lead the research, advised The Occasions.
Firms have beforehand not been in a position to market condoms particularly for anal intercourse, based on Dr. Kenneth Mayer, medical analysis director for Fenway Well being in Massachusetts, a facility that has lengthy been a frontrunner in treating individuals who determine as LGBTQ, the newspaper reported.
“It’s an amazing factor if the bundle inserts may point out anal intercourse as a result of it'd create an incentive for the businesses to do extra advertising and marketing,” Mayer mentioned.
“You don’t see condom advertisements on homosexual social media, for instance, so this could incentivize that as a part of a part of the dialog,” he continued.
“And it’s not simply homosexual males,” Mayer added. “It’s not that heterosexuals who interact in anal intercourse are unaware that condoms exist, however there’s been little or no training, so it’s considerably out of sight out of thoughts.”
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