Update on Internal (Female) Condoms

While commonly known as the female condom, the FDA recently issued a proposal to rename the “female condom” as the “internal condom” to more accurately reflect its possible uses vaginally and anally, broadening its accessibility, particularly to the LGBTQ community. The name “female condom” suggests that it will only be used vaginally, as well as reinforces the flawed notion that all women have vulvas and vaginas and that all men have penises. Though the name change won't become official until the FDA proposal is finalized, the NWHN chooses to use the term “internal condom” as a more accurate depiction of the contraception.

The internal condom is a nitrile pouch with a flexible ring at each end. When vaginally inserted, the inner ring fits snugly around the cervix to stay in place and the external ring remains outside the vagina. When anally inserted, the inner ring fits into the rectum and the external ring remains outside the anus. The internal condom can be inserted up to eight hours before sexual activity. Internal and external condoms should not be used together and each internal condom should only be used once. With perfect use, internal condoms are 95 percent effective; with typical use (which includes incorrect and/or inconsistent use), they are about 80 percent effective.

Despite being simple, safe, and extremely similar to external condoms, the Food and Drug Administration (FDA) currently classifies internal condoms as a “Class III medical device” — the same classification as pacemakers and breast implants. The external condom, comparatively, is regulated as a Class II device. This unfair and unnecessary labeling discrepancy makes it harder for manufacturers to get new types of internal condoms approved for sale and on the market in the United States. Presently, the FDA has only approved one brand of internal condom: Veru’s FC2. However, Veru recently decided to take FC2 condoms off pharmacy shelves and make them available exclusively through prescription.

A December 2017 proposal by the FDA would update the internal condom to a Class II medical device, rolling back current restrictions and creating the opportunity for a greater variety of options in the U.S. Decreasing barriers to internal condom access greatly expands choices and empowers many in their reproductive health. The National Women’s Health Network (NWHN) as well as our partners in the National Female Condom Coalition (NFCC) are excited about this possibility and encourage the FDA to move forward with this reclassification. Everyone deserve access to the full range of family planning and STI/HIV prevention methods without unnecessary obstacles.

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