For the first metre , the US Food and Drug Administration ( FDA ) has authorized acondommanufacturer to market their Cartesian product as protecting againstsexually transmitted infections(STIs ) during anal sex . The move comes following astudythat specifically tested the efficacy of the “ One Male Condom ” in anal retentive intercourse and found the total failure rate to be just 0.68 percent .
The condom mark a globe - first in being approved by the FDA as safe for anal intercourse , which they say conduct ahigher risk of STI transmissioncompared to vaginal penetration . They now receive other condom manufacturers to submit their intersection for the same commendation offer they can demonstrate similar efficaciousness in specifically anal retentive sex .
Sexual health experts have awaited such an approval for some time , with hopes that verifying products worthy for anal penetration will improve safe sex practice for those involve .
“ The FDA ’s authorization of a safe that is specifically signal , evaluated and labeled for anal congress may improve the likelihood of prophylactic use during anal intercourse,”saidDr Courtney Lias , director of the FDA ’s Office of GastroRenal , ObGyn , General Hospital , and Urology Devices in the Center for Devices and Radiological Health .
“ what is more , this say-so helps us execute our priority to gain health equity through the exploitation of safe and effective product that meet the needs of diverse populations . ”
The fresh approved One Male Condom is usable in received , slight , and fit versions . The latter come in 54 dissimilar sizes , and wearers are able to cite to a newspaper template to select the best sizing . The condoms are intended to be used with a lubricant .
Like other rubber , it protects against the spread of STIs by produce a smooth - proof roadblock when worn over the shaft before engaging in anal intercourse .
It was put to the test in a clinical visitation involving 252 men who have sex activity with men and 252 men who have sex with women , and find a failure pace ( condom slippage and/or breakage ) of 0.68 percent and 1.89 percentage for anal and vaginal coition , respectively . The results are usable on theFDAs website .
As well as approving the One Male Condom as marketable for anal social intercourse , the FDA have introduced a novel regulatory classification that will speed up the process for other companies assay the same approval .
“ This … dominance will also give up subsequent machine of the same type and intended use to come to the market through the 510k pathway , which could start the devices to get on the market quicker , ” Lias contribute .
[ H / T : The New York Times ]
