Taken from the July/August 2016 issue of The Women’s Health Activist Newsletter.
What do female condoms have in common with bone-grafting material, replacement heart valves, and cochlear implants? If you’re thinking not much, you’d be right. But the Food and Drug Administration (FDA) doesn’t agree. When it approved the FC2 “female condom” in 2009, the FDA assigned it the highest-risk classification for medical devices: Class III. This means the FDA thinks that the risks of using female condoms are similar to the risks of using devices like heart valves and colostomy bags. “Male” condoms, on the other hand, are Class II devices, and subject to a lower level of regulatory control.
We love the protection and choice that female condoms offer, and resent the discrepancy between the two methods’ classification — you should too! Here’s why:
The female condom is the only barrier method that is initiated by the receptive partner and protects against sexually transmitted infections (STIs), HIV, and unintended pregnancy. It consists of a pouch with a flexible ring at each end, and was approved by the FDA to be inserted into the vagina so that the inner ring fits snugly over the cervix. A new female condom is used each time a person has sex, and removal is easy — simply twist the outer ring and pull the female condom out!
Globally, the female condom is becoming increasingly popular. Some users report greater satisfaction during sex; since the penis is not restricted, it can feel more “natural” than using a male condom. Because female condoms can be inserted before sexual activity, they also allow partners to move from foreplay to sexual activity seamlessly. Female condoms allow partners to share responsibility for protection, which can be reassuring and empowering. The FC2 female condom, which is approved for sale in the U.S., is latex-free (great for people with latex sensitivities!), and can be used with both oil- and water-based lubricants.
Feeling excited about trying a female condom? Great! But, not so fast…
Even though female condoms are highly effective at preventing STIs and pregnancy, and can even enhance sexual satisfaction, their designation as Class III devices makes them subject to unnecessarily restrictive regulatory controls — which makes them more expensive to manufacture than male condoms. This discrepancy in device classification drives up the price for consumers, and ultimately limits access. Female condoms can be bought in the same aisle as other contraceptive methods, and are usually found right next to male condoms in health clinics, pharmacies, and convenience stores. But, whereas male condoms are sold for less than $1.00, female condoms cost between $2.00 – $4.00 each.
The unfair and inconsistent classification process also means that manufacturers have to overcome more barriers when they apply for FDA approval of other types of female condoms. Currently, FC2 is the only female condom approved for sale in the United States, even though there are many more types available elsewhere in the world. The result is that women and other receptive partners have fewer options and higher costs when seeking to protect themselves during sex.
Despite the FDA classification, female condoms do not pose a greater threat to consumers than male condoms. The classification discrepancy is unwarranted and is also an assault to gender equity. It’s long past time for political barriers to safer sex to be removed, starting with the female condom.
The National Women’s Health Network (NWHN) is proud to be working with partners in the National Female Condom Coalition (NFCC) to improve access to, and decrease costs of, female condoms. Last summer, NWHN staff and interns canvassed in front of the White House, garnering grassroots support for gender equity and collecting signatures on a petition to downclassify the female condom. Each year on September 16, we recognize and lift up Global Female Condom Day and work to improve access and knowledge of female condoms. And, we are working closely with our NFCC allies to advocate that the FDA reclassify the female condom in accordance with its proven safety and efficacy profile. Thanks to these efforts, the FDA has already taken the first steps to reclassify female condoms.
Both the “female” and “male” condom pose relatively few risks, are effective at preventing pregnancy and STI transmission, and empower people to take control of their sexual health. So why exactly is there a tale of two condoms? In short, there shouldn’t be. We look forward to working with the FDA to change the story from one of gender inequity to one of gender justice.
Christina Cherel, MPH, is a women’s health advocate and former NWHN Policy & Advocacy Manager. Currently, she advocates globally for reproductive health research as Program Officer for the Bill & Melinda Gates Institute and as Communications Chair for the International Conference on Family Planning.