Tag Archives: condom

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.

Scientists develop self-lubricating, smart condoms

Scientists have reportedly found a way to make condoms lubricate themselves when they come in contact with human skin. This could make sexual intercourse mode pleasurable, encouraging more people to use condoms, and thus reduce infections and unwanted pregnancies.

Condoms have been around for a long time — there are references to condoms being used to avoid sexually-transmitted infections (STIs) as early as the 16th century. In all that time, the materials have changed dramatically, but the overall design and function have remained largely unchanged — and so too have the problems.

Condoms do a very good job when used properly, both in terms of preventing STI transmission and as contraception. The main problem (aside from availability) is the reduction of pleasure: many people, particularly men, find condoms to be a turn-off and reduce pleasure. As a result of this discomfort, condoms can be used incorrectly or foregone altogether.

With this in mind, a team of researchers supported by the Bill and Melinda Gates Foundation have developed a new type of condom, which features a special lubricious coating.

The lubricant is a key issue — without enough lubricant, sex can be more unpleasant or even painful, and condoms have a much higher chance of breaking. People can, of course, use extra lubricant, but this is messy and just adds an extra step, in a moment where no one really wants extra steps.

The new self-lubricating condom, which becomes very slippery when it comes in touch with human skin, bypasses this problem. The study, spearheaded by Benjamin Cooper from Boston University, explains that people enjoy this more than conventional condoms. The coating also lasts for at least 1,000 thrusts.

“A majority of participants (73%) expressed a preference for a condom containing the lubricious coating, agreeing that an inherently slippery condom that remained slippery for a long duration would increase their condom usage. Such a coating shows potential to be an effective strategy for decreasing friction-associated pain, increasing user satisfaction and increasing condom usage.”

This is consistent with previous findings. A nationally representative sample of Americans was found to agree that lubricants make sex more enjoyable — a sensation which is derived from a reduction in surface friction and an increase in perceptions of wetness and slipperiness.

The new condoms were tested in a lab setting, after which a group of 33 participants (13 males and 20 females) of different ages (24–58 yrs) were asked to feel and compare three material samples (before and after submergence in and removal from water, to represent physiological fluid during intercourse), and asked which condom they would prefer; 73% of participants chose the condom with the special coating. Out of the participants who ‘never’ use condoms, 57% agreed they would consider using such a condom.

This is not the only recent innovation in condom design. A group of Austrian researchers is working on developing condoms made from hydrogel instead of latex, which makes them feel more like real skin.

The study has been published in RSOS.

Grass could help design comfy, super-thin condoms

Grass could enable researchers to create the new generation of condoms and make our lives a little bit better. A team from the University of Queensland found a feasible way to extract nanocellulose from the grass and use it as an additive in latex.

If you think about it, condoms haven’t changed that much in past decades. Ever since latex became dominant, things have become pretty stagnant in the industry (although recent efforts are being made; 1, 2). However, you wouldn’t expect grass to the rescue… thin, pointy spinifex grass.

Spinifex. Image via Wiki Commons.

Professor Darren Martin from UQ’s Australian Institute for Bioengineering and Nanotechnology (AIBN) said that the nanocellulose from the spinifex significantly improves the physical qualities of the latex.

“The great thing about our nanocellulose is that it’s a flexible nano-additive, so we can make a stronger and thinner membrane that is supple and flexible, which is the Holy Grail for natural rubber,” Professor Martin said.

Not only can they make condoms thinner, but also sturdier and cheaper.

“We tested our latex formulation on a commercial dipping line in the United States and conducted a burst test that inflates condoms and measures the volume and pressure, and on average got a performance increase of 20 per cent in pressure and 40 per cent in volume compared to the commercial latex control sample,” he said.

“With a little more refinement, we think we can engineer a latex condom that’s about 30 per cent thinner, and will still pass all standards, and with more process optimisation work we will be able to make devices even thinner than this. Late last year we were able to get down to about 45 microns on our very first commercial dipping run, which is around the width of the hair on your head.”

“Because you would also use less latex, your material cost in production would potentially drop as well, making it even more attractive to manufacturers.”

Of course, it’s not only the condom industry that could benefit from this, but everything that’s made from latex, such as gloves, and that could actually be a good thing. Thinner gloves would provide doctors (especially surgeons) much more hand sensitivity which could be important.

“Likewise, it would also be possible to produce latex gloves that are just as strong, but thinner, giving a more sensitive feel and less hand fatigue to users such as surgeons.”

They want to start cultivating and processing the spinifex in a large, controlled environment, especially in hot rural parts of Australia where the plant thrives (and where job opportunities are scarce).



Brain scans help researchers develop better condoms

It’s no secret that when it comes to condoms, the pleasure factor plays a big role – some people simply don’t want to use condoms because it diminishes their pleasure. With that in mind, researchers from Australia are now working to create condoms that feel just like bare skin… or even better!

Different types of existing condoms – all made from Latex. Image via Wikipedia.

This year, over 27 billion condoms have been sold, but that’s not nearly enough. The effectiveness of condoms isn’t called into question, but the design of the product has remained largely unchanged for the past century. Scientists from Swinburne University of Technology in Australia want to change that and develop condoms using a material called hydrogel that feels just like human skin, and has some amazing properties.

Hydrogel is a term generically used for solid, jelly-like materials with a range of special properties.

“Hydrogels are mostly made of water, held together by molecular chains called polymers. They have properties very close to human tissue, and can be tailored to feel a lot like skin,” says Bridgette Engeler Newbury, one of the project leads at Swinburne.

In this case, the hydrogel doesn’t only feel as good as nothing at all, but can also be laced with medicine to fight sexually transmitted infections. It’s also tougher and thinner than latex – the material currently being used for condoms.

“Hydrogels are mostly made of water, held together by molecular chains called polymers,” Newbury added. “They have properties very close to human tissue, and can be tailored to feel a lot like skin.”

But before they move on with their design, they have to answer a deceivingly complex question: how good do the hydrogel condoms actually feel?

In order to answer this question, they used EEG scanners to see how a person’s brain responds when they touch different materials (with their hand).

“Measuring changes in brain activity is an effective way of determining whether or not the hydrogel is more preferable than existing condoms,” said Joseph Ciorciari, who is leading the brain scan study.

Using neuroscience to gauge how nice different materials feel was his idea, and after the first tests were promising, they moved on to a larger sample size.

“The EEG allows us to measure the brain’s subconscious responses to the material, before the participant has even had the chance to decide whether or not they are going to respond positively to it,” Dr Ciorciari says. “This removes any bias or pre-existing influences from the equation. Measuring changes in brain activity is an effective way of determining whether or not the hydrogel is more preferable than existing condoms.”

The trial is being funded by the Bill & Melinda Gates Foundation, under the Grand Challenges and Explorations Grants.

Teens create condom that changes color if you have an STD

A group of UK teenagers have invented a condom that changes colors and glows if you or your partner hav an STD. Aptly named the S.T. EYE, the condom has a built-in chemical detector that detects infections such as chlamydia and syphilis, and lets you (and your partner) know.

Image via Kmoj FM.

The future is here – we have color-changing condoms that help prevent the spread of STDs; just imagine, in the heat of the moment, the last thing on your mind is thinking about infections, and yet over 1,400,000 chlamydial infections are reported every year in the US alone. Three pupils, Daanyaal Ali, 14, Muaz Nawaz, 13 and Chirag Shah, 14 – from at Isaac Newton Academy in Ilford, Essex wanted to figure out a way to solve that.

The three highly creative teenagers created a concept for a smart condom that would alter its luminescent hue when exposed to common STDs. The condom would be covered in antibodies that react in a very specific way when they encounter bacteria, causing the condom to change color.

“We knew that STIs were a huge problem in the U.K.,” Daanyaal told the press. “We saw a gap in the market and we wanted to help people feel safer.”

The three participated (and won) the TeenTech awards in London, taking out the best health innovation title. They, and the contest judges believe that this invention could help millions of people in the future.

“We wanted to make something that makes detecting harmful STIs safer than ever before, so that people can take immediate action in the privacy of their own homes without the invasive procedures at the doctors,” she said. “We’ve made sure we’re able to give peace of mind to users and make sure people can be even more responsible than ever before.”

The group received about $2041 (£1000) and a trip to Buckingham Palace, but it’s not clear if they’ll present their condom project to the queen.