SEATTLE, WA —The female condom has never been a big hit in the contraceptive, sexually-transmitted infection prevention market. Only about 12 million female condoms are delivered each year in Third World countries, compared with about 6 billion male condoms. Couples have complained that the female condom is awkward, unsightly, noisy, and slippery.Scientists are hoping this will change with a re-design they have come up with.
“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.”
The new design incorporates an easier to insert design that is more similar to a tampon than the original’s internal ring system, adhesive foam dots that will keep the condom in place when a woman is aroused and the condom is made of a thin polyurethane that transmits body heat between people better.
During sex, the new female condom also moves more like a vagina than the old design does, according to couples in Seattle, Thailand, Mexico, and South Africa who tested a series of prototypes, according to Joanie Robertson, project manager for the condom at PATH. PATH claims that 90-percent of couples reported enjoying using the new female condom and 98-percent said that the sex with the new female condom was “OK to very satisfactory.”
PATH is seeking approval from the FDA so the new 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 FDA 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. This makes getting the new design into the hands of the people who would use it take a lot longer.
The Class 3 listing means that any new design must pass clinical trials, which would cost between $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 observed to the New York Times.
The failure of the original female condom means that private enterprise is not scrambling to invest in the new design.
