The Female Condom, Newly Redesigned, Attempts a Comeback

By Christine Cupaiuolo — November 15, 2007

So what is it about the female condom that — pardon the pun — creates a barrier to widespread acceptance and use, both in the United States and in other countries?

Scientists and health advocates are trying to figure out the answer to that question.

Part of the problem is that in 15 years, there’s never been a second-generation product produced that improved upon the original version. Michael J. Free, head of technology at PATH, a nonprofit group based in Seattle that has redesigned the female condom, commented on the lack of competition in the development. “There’s no lack of interest, but we’ve been stalled,” he told The New York Times.

PATH is now seeking FDA approval for its version (more info on it here), which is supposed to offer improved ease of use and a more natural feeling sexual experience, but the process could be lengthy:

While the F.D.A. designates male condoms as Class 2 medical devices — meaning that a new maker has to pass tests only for leakage and bursting — it puts female condoms in Class 3, the same category as pacemakers, heart valves and silicone breast implants.

That decision was made in 1999 — after much debate, and well after the condom was in use overseas — because there was no clinical data on the effectiveness of female condoms, and failure could be life-threatening if the woman’s partner had AIDS. An advisory panel suggested not even calling it a “condom” and instead labeled it an “intravaginal pouch,” but the agency rejected that advice.

Names notwithstanding, the Class 3 listing means that any new design must pass clinical trials, which would cost $3 million to $6 million.

“That’s a huge, huge impediment, close to a 100 percent block, because no one’s willing to put up that sort of money,” Dr. Free said.

Design costs and prototype development have been covered by a combination of public and private funds, but no one is putting up money for the clinical trials or factory costs. Some investors cite the smaller-than-predicted American and European markets that never warmed to the original design.

There are some issues that even an abundance of development funds and a redesigned product can’t fix: the female condom can’t be used with discretion.

For that reason, married women, now one of the highest risk groups for AIDS in poor countries, rarely use it.

“I don’t want my husband to know that I am wearing a condom,” said Lois B. Chingandu, the director of SAfaids, an anti-AIDS organization in Zimbabwe.

“Condoms are almost undiscussable within a marriage” in Africa, she added. “It is something associated with casual sex. If a wife uses a condom, the message is that you have been unfaithful. If she even initiates the discussion, it tips the power scale. Men resist quite a lot, and it can result in violence.”

The female condom has developed a following among sex workers, however. And supporters say the condom’s failure in some countries was due more to poor marketing and inconsistent availability.

“People said, ‘Oh, it failed,'” said Mitchell Warren, former director of international affairs for the Female Health Company. “Well, it didn’t fail. It just wasn’t available, or its introduction was a bad program. People need to practice with it before it catches on.”

Plus: In 2005, health experts attended the Global Consultation on the Female Condom in Baltimore to review evidence of the female condom’s effectiveness in preventing pregnancy and sexually transmitted infections and to learn about countries’ program experiences. Slide presentations and panels from that conference are available online.

7 responses to “The Female Condom, Newly Redesigned, Attempts a Comeback”

  1. Just as an example, as a 25 year old woman, it really hasn’t ever been presented as an option. You only ever hear about birth control and male condoms. While I have heard of the female condom I don’t even fully understand how it works and how it would change an experience. It is clear a lack of marketing is part of the issue.

  2. I think one of the biggest drawbacks of the female condom is the price. They typically run about $4 for a single or 3 for $10.

    The benefit of the female condom is twofold- One, it gives women more control over condom useage because they can choose to “wear” the condom themselves instead of leaving it up to the man to wear one or asking him to do so; and two, because men experience a decreased loss of sensation with the female condom than with traditional male condoms, making them less objectionable.

    Unfortunately, as the article mentioned, the FC currently on the market had a tendency to bunch up, which decreased the amount of sensation felt by the man. Think of it this way- if you put on a pair of latex medical gloves it will greatly reduce the tacitile sensory stimulation of your fingertips. If you put on an XL pair of rubber dishwashing gloves the effect would be slightly less noticable, but still apparent. But if you were to feel an object draped in a plastic drop cloth with your bare hands, there would be only a slight loss of sensation vs. touching it without the sheeting.

    Another benefit to the FC that I almost forgot to mention is that it offers greater protection against skin-to-skin transmitted STDs (HPV and genital herpes) due to the greater area of coverage. You do have to make sure that your partner enters you through the opening of the condom (some sneaks will try to slip it in through the side). I always thought it would be nice if they came with string ties (like they have on some bikini bottoms) so that you could secure it in place.

    I’m not sure if any of that made sense, but I figured I’d give it a shot. If the FC increased in popularity, it would probably bring the cost down a bit.

    • Hi I think the FC is really a hit. If any man complains of reduced sensation, he should welcome this as it prolongs the intercourse and then perhaps gives the woman more satisfaction.

  3. has been marketing the “female condoms” for the past three years and the response to our campaign is mind blowing. Women seem to be loving the huge variety of “Female Condoms”. You can find them at

    Along with that, “Female Condoms” also have many other benefits. A Female Condom, when used correctly and consistently, is a reliable protective tool against most sexually transmitted diseases as well as unintended pregnancy. It gives women the opportunity to share responsibility for the condoms with their partners. It also provides an alternative if the partner is unwilling to use a male condom due to personal, cultural, religious or other reasons.Using a Female Condom does not depend on male erection and can thus be placed inside the vagina prior to sexual intercourse. Since it can be inserted up to 8 hours before intercourse, interruption of sexual spontaneity can easily be avoided.

    Due to the nature of the material which is used for making female condoms (polyurethane or nitrite) both the water-based and oil-based lubricant can be used. The characteristics of the material also make it strong, durable and usable for people who are allergic to latex. There is also no need for special storage requirements.

  4. In reference to the previous post “Women seem to be loving the huge variety of “Female Condoms” this company must not know much about condoms as there is only 2 brands of female condoms, not a huge variety! The female condom is non latex and gives a women a choice to take control of her own situation. Female condoms can be purchased at Rip n Roll on the following page

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