PATH: New female condom?

Redesigning A Female Condom So Women Will Use It

[ watch the Condomerie video for instructions of use Female Condom ]

The female condom has never caught on in the United States. But in the third world, where it was introduced in the late 1990s, public health workers hoped it would overthrow the politics of the bedroom, empower women and stop the AIDS epidemic in its tracks.

It did not. Female condoms never really caught on there, either.

Only about 12 million female condoms are delivered each year in poor countries, compared with about 6 billion male condoms. Couples complained that the female version was awkward, unsightly, noisy and slippery -- or, as Mitchell Warren, who was one of its earliest champions, now says, ''the yuck factor was a problem.'' Many women tried it, but in the end, it was adopted mainly by prostitutes.

Now scientists are trying again. A new design -- much the same at one end, different at the other -- has been developed, and its makers hope it will succeed where its predecessor failed.

''Over 15 years, there's been no real competition, no second-generation product,'' said Michael J. Free, head of technology at PATH, a nonprofit group based in Seattle that did the redesign. ''There's no lack of interest, but we've been stalled.''

However, the new design does not overcome the glaring drawback that doomed the first to be a niche product: it cannot be used secretly. 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.''

But for couples who have agreed on condoms, and for sex workers whose clients cooperate, the new design has several advantages.

The redesigned female condom is made of softer, thinner polyurethane to better transmit warmth. It is easier to insert; one end is bunched up as small as a tampon, an improvement on the old design, which resembled the stiff rubber ring of a diaphragm and had to be folded into a figure 8 for insertion.

During sex, the new female condom also moves more like a vagina than the old design did, according to couples in Seattle, Thailand, Mexico and South Africa who tested a series of prototypes, said Joanie Robertson, project manager for the condom at PATH. The old design hung passively from the rubber ring, which could shift around and sometimes hurt; the new design has dots of adhesive foam that adhere to the vaginal walls, expanding with them during arousal.

According to PATH, more than 90 percent of the couples were satisfied with the ease of use and comfort of the new condom, and 98 percent found the sensation of sex to be ''O.K. to very satisfactory.''

Nonetheless, progress is now stalled.

PATH is seeking approval from the Food and Drug Administration so the condom can be sold in the United States. And with the drug agency's approval, it would be much easier to license the condom in poor countries or get a World Health Organization endorsement.

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.

The United States Agency for International Development, the Bill & Melinda Gates Foundation, the Lemelson Foundation and others paid for design costs and prototypes, but they are not willing to pay for clinical trials and the cost of building a factory. Private investors have also balked because the American and European markets for the original design proved smaller than had been predicted.

The failure of the original design -- made by the Female Health Company of Chicago and marketed worldwide under names like Femidom, Female Condom, FC1, Reality, Dominique, Femy and Protectiv -- is still galling to AIDS experts.

''Their use has remained frustratingly and tragically low,'' said Dr. Peter Piot, executive director of UNAids, the United Nations AIDS agency.

In the 1990s, Mr. Warren, former director of international affairs for the Female Health Company, visited 24 countries trying to get the female condom accepted. Brazil, South Africa and Zimbabwe were the most receptive, said Mr. Warren, who now works on AIDS vaccines.

''It had some elements of success,'' he said, ''but hasn't had the blockbuster numbers the company had hoped for.''

But, as Ms. Chingandu noted, even in Zimbabwe, after an initial flurry of excitement from women, the condom settled into a niche: a tool of the sex trade.

Whether the condom did well or poorly in a particular country, Mr. Warren said, was determined mostly by how it was introduced. Brazil's rollout order was for one million. Bangladesh, by contrast, tried to start with only 20,000. And Uganda bought one million but then did little marketing and no training in how to use it.

''People said, 'Oh, it failed,''' he said. ''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.''

He called the new design ''a better mousetrap'' but said it still faced another problem it shares with the original: it is expensive compared with male condoms.

While those are made by simply dipping molds in latex, the female one uses complex thin-film polyurethane. The most closely related technology is that used for blood bags, so PATH is visiting companies that make them.

But as Ms. Robertson noted, companies that make blood bags have little expertise in marketing sexual products.

Source: The New York Times / Author: DONALD G. McNEIL Jr.

 

 

 

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