Tag Archives: lgbtq

The FDA finally approved a condom for anal sex. Here’s why it’s a good thing

Whether you’re in a committed relationship or prone to the throws of lust (or both, we’re not judging), you need to protect yourself and your partner — which usually means using a condom.

Still, as humans tend to be, we’re not always careful. We like to experiment, we sometimes falter — and pick up sexually-transmitted diseases (STDs). Whatever the reason, condoms are a great way to stay safe and can be used by people of the appropriate age just about anywhere–and they can also be lots of fun. Now, there’s a new type of condom on the block.

A victory for all genders and denominations

There’s never been an approved condom specifically for anal intercourse. Until now, condoms on the market were only approved for vaginal intercourse, which omits a large section of our society.

Condoms for vaginal sex currently on the market are recommended for use during anal or oral intercourse by the Center for Disease Control – meaning they’re legally backed by a drug agency for one activity and informally deemed effective for another in what is known as ‘off-label’ use. But the US Food and Drug Administration (USFDA) has finally approved the first condom for anal sex: the ONE Male Condom.

The approval is seen as a victory for sexual health and especially important for the LGBTQ community, who, until now, have not had a condom aimed specifically at them. Courtney Lias, director of the USFDA’s Office of GastroRenal, Obstetrics-Gynecological, General Hospital, and Urology Devices, says:

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.” 

What’s different with this condom

The newly approved condom is a natural rubber latex sheath that covers the penis. It’s available in three different versions: standard, thin and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to find the best condom size for each user to minimize leakage. Global Protection Corp, which makes the condom, stresses that during anal intercourse, users should employ a compatible lubricant with their condom and all other brands.

“We want people to have lots of sex — but we also want them to be empowered and informed,” said Davin Wedel, president of Global Protection Corp.

Scientists studied the safety and efficacy of the condom in a clinical trial comprised of 252 men who prefer sex with men and 252 men who prefer intercourse with women. All volunteers were between 18 and 54 years of age. 

Results show the total condom failure rate was 0.68% for anal sex and 1.89% for vaginal intercourse. Researchers defined the condom failure rate as the number of slippages, breakage, or both slippage and breakage events over the total number of sex acts recorded in a diary by participants.

Disappointingly, the trial didn’t calculate the STD baseline as too many variables (such as not wearing a condom) could cause infection during the trial. Therefore, the rate of STDs was not measured at the beginning of the study and compared with later data. Despite this, the trial center did allow participants to self-report any genital-based infections which could have resulted from the use of a different condom brand before or during tests.

The researchers from Emory University who were behind the study said an essential reason for the trial’s success was that volunteers used lubricant, which prevents slippage and breakage, and the inclusion of instructions.

Taken together, these findings suggest that health bodies should provide lubricant along with the billions of condoms distributed as part of HIV and STD prevention efforts to minimize failure. 

The USFDA will help get more condoms like these on the market

The USFDA is responsible for controlling and supervising food, tobacco, dietary supplements, prescription drugs, blood transfusions, medical devices, cosmetics, and animal & veterinary products. They achieve this by inspecting manufacturing premises and reviewing the safety and effectiveness of a product before a business can sell it on the market after it has undergone extensive clinical trials that can last for over a decade.

A rigid classification, under the terms of a De Novo, the submitting company, must prove that their product presents a ‘medium risk’ to humans. In contrast, under the 510(k) submission, an organization only has to show their device presents no more risk to human health than the approved equivalent product – even where the marketed product has been deemed dangerous. De Novo submissions are also more expensive than the cheaper 510(k).

Surprisingly, even though the ONE condom is already approved by the USFDA using the flexible 510(k) category for vaginal sex, the agency has cleared the new product for anal sex through the De Novo pathway. This fact certainly raises questions regarding the lack of equivalency between condoms used for vaginal sex and anal sex.

On a positive note, they have established special controls so that other devices can now show equivalence to the ONE condom using a 510(k) classification to receive quicker clearance without the need for clinical trials. 

In its press release, the USFDA said the green light could pave the way for more condom makers to apply for faster approval if they show equivalent results. They add that they expect authorization of the ONE Male Condom to help reduce the transmission of STDs, including HIV/AIDS in both anal and vaginal intercourse.

All approved condoms are an easy way to protect yourself

Experts remind all sexually-active couples that they can still use other approved condoms on the market during anal sex:

“This isn’t a groundbreaking advancement in my opinion. All condoms can (and should!) be used to make anal sex safer, so just because this one brand has FDA approval doesn’t make it any better than other condom brands on the market,” says obstetrician-gynecologist and author Jennifer Lincoln who wasn’t part of the trial, for PopSci. “Don’t let the ‘FDA approved’ label sway you when you are at the grocery store—the best condom to use for safe sex is the one you have access to and the one you will actually use.”

Still, this is a galvanizing moment for the LGBTQ movement.

“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. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster,” Lias added in the USFDA statement.

It remains to be seen whether this will trigger a longer-term movement. In the meantime, stay safe.