FDA Advisers Recommend New Female Condom

It's squeaky, squishy, baggy and bunchy. And it could help save women's lives.

That's the word on a new female condom that a Food and Drug Administration committee recommended for market approval in a 15-0 vote last Thursday.

Like the other version of the female condom -- the "FC" approved by the FDA in 1994 -- the second-generation "FC2" is made by the Chicago-based Female Health Company. Just as effective as its predecessor at preventing unwanted pregnancy, HIV and other sexually transmitted infections, the new version is made of nitrile, a cheaper material than the older version's polyurethane, and is 30 percent less expensive.

Cost estimates range from $1.40 to $2.10 for consumers and about half that for health care organizations that distribute it. The new condom has won support from women's advocates for its reduced price and because women can insert it without a sexual partner's help.

"Our interest in seeing a second-generation female condom comes from the changing face of the AIDS epidemic," says Kirsten Moore, president of the Washington-based Reproductive Health Technologies Project. "With the growing number of women becoming infected with HIV, we clearly need more and better female-controlled prevention options."

The women's health organizations that spoke before the FDA's Obstetrics and Gynecology Devices Advisory Committee included representatives of the Atlanta-based SisterLove; the Washington-based National Women's Health Network; and the Washington-based National Research Center for Women and Families. They will convene in Gaithersburg, Md., near the FDA's headquarters in Rockville, Md.

Eighty-seven U.S. advocacy groups and 50 international groups submitted petitions in favor of FC2. Other health authorities, such as the New York-based Guttmacher Institute, are submitting separate letters of support.

Health advocates say that if the government moves quickly in recommending FC2 approval, the new condom could be on U.S. pharmacy shelves -- and in the hands of aid organizations that distribute it worldwide -- some time in 2009.

Strong Research Backing

The old-style FC female condom is available in the United States and 108 other countries. It is 95 percent effective at preventing pregnancy if used correctly and 80 percent effective if not used correctly every time, reports the Washington-based Planned Parenthood Federation of America. It reduces the risk of sexually transmitted infection by 97 percent, studies from the United States and Thailand show.

Research from Japan, Great Britain and Madagascar indicates the newer version has the same efficacy rates. Except for the different material, FC2 is otherwise indistinguishable from FC. It has the same baggy, six-and-a-half-inch cylindrical shape; a tube with flexible rings at both ends, with one end open and the other end closed.

Both versions are safe for people who have allergies to the latex found in male condoms. Both can be used for anal as well as vaginal sex, and both stay in place whether or not a male partner has a full erection.

"I find it empowering to be able to take charge and put on the female condom myself," says Linda Arnade, a health worker in Chicago who has used FC for three years. "I like being able to put it in several hours before sex, and the fact that the material feels stronger than latex. I once had a male condom break, but that's never happened to me with the female condom."

Alongside these advantages come some drawbacks.

"The female condom's biggest problem is likely its cost," says Amy Allina, program director of the National Women's Health Network. "The high price makes it difficult for consumers and aid organizations to afford consistent supplies." Female condoms are roughly seven times more expensive than male condoms.