After much prodding from sexual health advocates, the Federal Drug Administration (FDA) made three changes to the regulation of female condoms—which advocates hope will result in greater access to the condoms. These condoms act not only as contraception but also as protection against sexually transmitted infections (STIs) including HIV.
Veru Inc. and the Female Health Company are thrilled with the new status of FC2 as a “single-use internal condom!https://t.co/zhkRNmFldn pic.twitter.com/uVGSEY1eOS
— FC2 Condoms USA (@FC2USA) December 6, 2018
According to the National Female Condom Coalition (NFCC), thanks to the FDA, the condom has been:
- Renamed as a “single-use internal condom,” a change that de-genders the prevention tool and provides a more inclusive description of who is encouraged to use and benefit from it.
- Transitioned from the regulatory Class III to a Class II, a move that will lessen the burden on manufacturers when seeking FDA approval for existing and newly developing versions of internal condoms. (The internal condom is now classified under the same category as male condoms.)
- Approved for both vaginal and anal intercourse, thus endorsing use of this tool for a wider spectrum of sexual activities.
“We are thrilled to learn about these changes and so grateful for the tireless efforts of sexual health advocates across the globe who worked for years to demand greater access to this prevention method, which truly empowers people to take control of their health on their own terms,” said Sara Semelka of the AIDS Foundation of Chicago, which serves as the NFCC secretariat.
Always #BePrepared ????. Stock up on #FC2 Internal #Condoms for pregnancy / STI protection. $0 out-of-pocket expense to most insured women when prescribed by a healthcare provider, or buy directly on our site. Learn more: https://t.co/IOj4g7HFU5 pic.twitter.com/HAsRAxW940
— FC2 Condoms USA (@FC2USA) January 27, 2019
Before the FDA changes, the latest version of the female condom was sold as the FC2 female condom. The rebranded version is called the FC2 internal condom and is manufactured in the United States by Veru Inc.
The way the internal condoms work is simple: The condom is inserted in the vagina or anus before sex; an inner ring on the condom aids in insertion, while a larger, softer ring remains outside the vagina or anus and keeps the condom in place.
The internal condom is made of nitrile, which is safe for people who have latex allergies. What’s more, according to the company’s promotional materials, nitrile heats up to the body’s temperature, which makes sex with FC2 feel warm and more natural
Due to the design of the FC2 Internal Condom, some of the outside skin of the vagina is covered, which could provide enhanced protection from STIs transferred by skin-to-skin contact, such as #HPV / #Herpes. How to use: https://t.co/JEjytJEfO7 #CervicalHealthMonth #womenshealth pic.twitter.com/SD2lLHrap0
— FC2 Condoms USA (@FC2USA) January 11, 2019
You can learn more about internal condoms, including where to buy them and how to use them, at FC2.us.com.
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