The Female Condom, Newly Redesigned, Attempts a Comeback

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.

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