The FDA, the US Food and Drug Agency, has cleared the first condom designed for anal sexual intercourse. In reality, there are two commercial brands referring to the same company, One Condoms And myOne Fitted Condoms: They can help reduce the spread of sexually transmitted diseases with a failure rate less than 1%.
The authorization was provided on the basis of a clinical trial conducted in 2019 by the Rollins School of Public Health at Emory University together with Global Protection, the company that produces the new devices. The study involved 252 men who had sex with men and 252 who had sex with women for a total of 4,884 intercourse protected by the condom in question. The condom failure rate was defined by evaluating the number of slips, breaks, or slips and breaks events that occurred out of the total number of sexual acts performed. The condom result was actually lower for anal sex than for vaginal sex.
“We really thought it was important to do this to have an explicit understanding of what the failure levels would be – explained the lead author of the study. Aaron Siegler, who is also associate director of the Emory Center for Aids Research Prevention and Implementation Sciences Core – in fact, failure levels are better than we hoped for. ” The rate over the course of anal intercourse was in fact assessed just 0.7%. It should be noted that a compatible lubricant (based on water or silicone, not oil). On the other hand, the use of lubricant is considered an essential part of the correct use of condoms for anal sex.
Unprotected anal sex is considered the riskiest practice to contract sexually transmitted diseases like theHIV due to the thinner lining of the rectum, which is more easily damaged and can cause more lacerations or abrasions of the skin. The authorization “may increase the propensity to use condoms during anal intercourse,” he said Courtney Lias, director of the Office of Gastrorenal, OB-GYN, General Hospital and Urology Devices of the FDA at the Center for Devices and Radiological Health. “Furthermore, this authorization helps us realize our priority of promoting health equity through the development of safe and effective products that meet the needs of different populations.”
The first phases of the research aimed at obtaining approval for vaginal use, for which they are obviously valid and authorized, while the further phases were instead dedicated to obtaining the authorization for label these condoms as safe for use during anal sex. “I think that if people believe that condoms are effective they are more likely to use them – added Siegler – I hope that the confidence of a very low failure rate for anal sex will encourage an increase in condom use.”
Technically these condoms are similar to others on the market. What, in fact, differentiates them is the presence of a scientific study that demonstrates their effectiveness in the course of anal intercourse. In addition to the fact that there really are different sizes. Siegler and Davin Wedel, founder and CEO of Global Protection, concluded that the goal of this label is to spread more information that condoms are safe and effective for everyone and that it is a good idea to use them regardless of the type of sex you practice.
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Source: Vanity Fair

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