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FDA approves first condom designed to prevent HIV during anal sex

By Malavika Pradeep

Feb 24, 2022

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Back in 2016, Reddit’s r/todayilearned (TIL) was graced with a post titled “TIL FDA [the US Food and Drug Administration] has never approved any condom for anal sex, despite recommending their use.” At the time, several users deemed the fact to be less about condom efficacy and the FDA than the “government not wanting to endorse a ‘taboo’ sexual practice”—apart from, of course, comments featuring wild analogies and alternate solutions from experiences.

Fast forward to 2022, the organisation has just authorised the sale of the ONE Male Condom, designed specifically to prevent the transmission of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) during anal sex. “The approval applies to three different types of ONE Condoms: standard, thin and myONE custom-fit which come in 54 different sizes,” a press release by the company reads. “ONE will become the first condom brand ever to be labeled for safe and effective use for anal sex.”

FDA approves first condom designed to prevent HIV during anal sex

Apart from this intended use, ONE Male condom also has the green light to be wielded during vaginal intercourse to reduce the risk of pregnancy and STIs. In the case of the former, however, the FDA recommends the contraception be used with a compatible lubricant.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse,” Doctor Courtney Lias—director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health—said in an official statement. “The FDA’s authorisation of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.”

It should be noted that condoms are a Class II medical device under the FDA, and therefore must meet strict regulatory and product labelling guidelines. Given how the organisation previously had no data on condom safety for anal sex, it has never allowed companies to include the purpose in the ‘Indication for Use’—thereby labelling them “safe and effective” only for vaginal intercourse.

All of this was until the ONE Male Condom, marketed by Global Protection Corp, was assessed in a clinical trial comprising of participants aged between 18 to 54—including 252 men who have sex with men and 252 men who have sex with women.

Led by Doctor Aaron Siegler, an associate professor of epidemiology at the Rollins School of Public Health, the study found the rate of ONE Male Condom failure (slippage, breakage or both) to be 0.68 per cent during anal intercourse and 1.89 per cent during vaginal intercourse. Furthermore, the rate of overall adverse events was 1.92 per cent. This included symptomatic STI or recent STI diagnosis (0.64 per cent), condom or lubricant-related discomfort (0.85 per cent), partner discomfort with lubricant (0.21 per cent) and partner urinary tract infection (0.21 per cent).

According to the FDA, the symptomatic or recent STI diagnoses observed in the study were self-reported by the participants. This may be the result of subjects having intercourse without a condom or may have preceded use of the One Male Condom.

As of today, the contraceptive in question has been approved through the De Novo premarket review pathway, a regulatory pathway for low to moderate-risk devices of a new type. “We want people to have lots of sex but we also want them to be empowered and informed,” said Davin Wedel, president and founder of Global Protection Corp in the press release. “This recognition from the FDA highlights the substantial protection ONE Condoms provide for anal sex, which we hope enhances trust, leads to increased use, and lessens the new cases of sexually transmitted infections.”

Change is cumming: the sex toy industry finally sets quality and safety standards

By Alma Fabiani

Oct 9, 2021

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I want you to picture your favourite sex toy in your mind—come on, I know you have one—in all its soft silicone glory. It can be a buttplug, vibrator, dildo, anything that’s intended for sexual stimulation really. Got it? Good. Now, try to think of all the awful things that could happen to you if your little jewel in the crown didn’t meet international safety standards. PVC toys containing added toxic chemicals can lead to itching, burning, rashes, and tissue damage. Sex toys that are porous make a cosy home for bacteria to grow. I’ll spare you the gory details of the risks cheap sex toys requiring batteries represent.

Now that you have a clear idea of what I’m talking about, here’s the big revelation: all these terrible possibilities you’ve probably never thought of before today are in fact quite likely to happen. Why? Because, unlike with other sectors including food, medical, and transportation, sex toy manufacturers have been able to use a labelling loophole to categorise their products as “novelty items.” This, until now, exempted them from testing and safety protocols everyone else has to abide by.

Long story short, when it came to buying sex toys, the burden of determining whether companies are honest about toxic materials, harmful design flaws, and misleading packaging fell solely on the consumer. And while not all sex toys pose a medical threat, the problem was that consumers had no way of knowing which ones are unsafe. “When you purchase a chair, you can presume that the commission has rigorously tested its utility, meaning you probably won’t fall as soon as you sit on it. But when you buy a vibrating dildo, you can only hope that it’ll screw you in the way that you want,” as Inverse superbly puts it.

Some products, especially those with rechargeable batteries, have to pass safety regulations, but this is the first time an official standard has been set that focuses on topics like material and design. The International Organization for Standardization (ISO)—an independent, non-governmental group that sets safety standards for many industries—just introduced standards for the quality of sex toys. This means that from now on, any object that is meant to go inside or around your genitals will have to meet certain requirements to get ISO certification.

ISO 3533: Sex toys — Design and safety requirements for products in direct contact with genitalia, the anus, or both” that are “intended for sexual stimulation or to enhance sexual pleasure,” reads the standard. It excludes, however, lubes, oils, gels, sprays, and foods.

According to VICE, the push for a sex toy standard began with Doctor Martin Dahlberg, a Swedish surgeon at Stockholm South General Hospital in 2018. After realising that he was “spending more and more time retrieving stuff out of people’s buttholes,” Dahlberg conducted a study where he found that in about 40 per cent of cases where patients came to the hospital with something stuck up there, it was a sex toy. He then started drafting a proposal with a team, to eventually send to the ISO.

Although this new standard for design and safety requirements for sex toys is voluntary and therefore not demanded from manufacturers in order for them to sell their products, it is a first step in setting up standards within the industry as a guide for consumers to follow and make the right choices.

Some of the requirements to meet this standard include:

Making sure plugs, beads, and things that go up the butthole can’t stay stuck up there, or could be retrieved by a medical professional if needed.
Things like chastity cages can be removed with pliers or other common household tools in an emergency—no power tools needed.
Toys with heating elements must never exceed 118 degrees Fahrenheit (the temperature that would cause a first-degree burn).
Anything going around or in any holes or genitals should be “smooth and be free from burrs and sharp edges.”

Market analysts have valued the sex toy industry at nearly $34 billion in 2020, with a jump in growth spurred by COVID-19 lockdowns—some estimate that it will reach more than $36.1 billion by 2027. Despite this, individuals, as well as companies in the sex toy industry, have struggled to be taken seriously. Having ISO standards could finally lend legitimacy to the massive industry.

 

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