The first condom specifically designed for use during anal sex has gained FDA approval.
Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Wednesday announcing the decision. And though the CDC has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
FDA: “FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse.”
Courtney Lias, PhD, director, FDA Office of GastroRenal, ObGyn, General Hospital, and Urology Devices.
EClinicalMedicine: “Levels of clinical condom failure for anal sex: A randomized cross-over trial.”
Milla Impola, director, marketing and communications, Global Protection Corp.
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