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GUEST VIEWPOINT Reclassifying "female condom" can revolutionize contraceptive industry
by Sara Semelka
2018-01-29

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If you've had safe, penetrative sex at some point in your life, you've probably used the "male" condom, which is designed to be worn by a person with a penis. Over the years, this device has been credited as one of the most effective tools to combat HIV, with different variations developed to appeal to a wide array of audiences.

But just like Kim overshadowed the other Kardashian siblings for so long, so too has the male condom stolen the spotlight from its more receptive sibling: the female condom. It's designed to be put inside the vagina or butt to provide superb sexual protection. Most consumers are completely unaware this contraceptive tool is even an option to them or, perhaps worse, have a negative idea about them being cumbersome, weird or just too novel to take seriously.

While an individual's condom preference may seem insignificant ( as long as some sort of protection is being used, we're good, right? ), the accessibility to one's desired device in the United States is directly linked to its Food & Drug Administration ( FDA ) classification. According to the current FDA classification, a male condom is categorized more favorably than internal condoms. ( What a surprise … the patriarchy strikes again. ) Male condoms are a Class 2 medical device, which require only minimal testing and approval before it becomes available to consumers. Internal condoms, however, have been deemed a Class 3 device — the same level as a pacemaker — which require much lengthier approvals, more thorough testing and data, and additional investment from manufacturers before they're accessible to the public.

This current classification has crushed the female condom industry. Since it's so expensive to ramp up the creation of a female condom model, there's only one on the market, and you can't find that model on store shelves. With this extreme lack of access to this tool, few know about it and even fewer are using it. But without demand, there's little impetus for a new manufacturer to go through the hoops of getting a new model on the market that might theoretically be used by more people. It's a contraceptive "chicken-or-the-egg" conundrum.

Fortunately, though, a solution could be on its way. After years of lobbying from the National Female Condom Coalition ( NFCC ) and other sexual health orgs, the FDA is considering a rule change: that the "female" condom be changed from a Class 3 medical device to a Class 2, the same class ascribed to the male condom. The current classification is crippling the female condom industry, but a reclassification provides opportunity for the research and implementation of existing products to enter the U.S. that are already recognized by the World Health Organization ( WHO ) and on the market in other countries ( such as Africa, Brazil, and throughout Europe ).

NFCC is also seeking a name change from "female" condom to "internal" condom. The hope is that by changing its name, the device could be seen as a less niche and novel condom and be used by people of all genders. Finally, it's being recommended for use in not just vaginal sex but anal sex as well ( which female condom users have been doing all along ). This quick change would automatically expand how it can be used by different communities — such as same gender-loving men — which would be a huge win in the fight against HIV/AIDS.

Now that the proposed rule change is getting serious consideration, the FDA's Subcommittee on Medical Devices is accepting public comment until Feb. 2 and will be considered during their deliberation.

Advocates are asking the public to submit their own comments and express their thoughts on the potential reclassification. The NFCC welcomes support from organizations, healthcare professionals, advocates, women's health/family planning experts, or anyone interested in the discussion.

If you want to give female condoms the spotlight they deserve, we at the NFCC encourage you to provide a public comment by the Feb. 2 deadline. Specific ways you can help make a difference for this campaign are outlined here: nationalfccoalition.org/fda-campaign.

Sara Semelka is the Prevention Technology Education Manager at the AIDS Foundation of Chicago and head of the National Female Condom Coalition.


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