The female condom, to be marketed in Switzerland this month and later in England and France, could find its way into American bedrooms sometime this year. Called Femidom in Europe and Reality in the United States, the $2.25 device is the first of a whole wave of intriguing new gynecological products currently navigating the maze of FDA regulations (box).
The female condom is described more accurately as an intravaginal pouch by its American manufacturer Wisconsin Pharmacal. It’s actually a seven-inch-long transparent plastic bag, with a flexible ring inside the closed upper end and another ring at the wider open bottom. A woman inserts it with her fingers, pushing the top ring up behind the pubic bone. During intercourse, it is kept in place by the outer ring, which presses against the woman’s body.
In four years of testing on 1,700 women, says Mary Ann Leeper, a senior vice president of Wisconsin Pharmacal, Reality has proven resistant to slippage, tearing or penetration by viruses and bacteria. Its pregnancy-prevention rate is comparable to the diaphragm’s, about 85 percent. While 75 percent of the women and their partners who tried Reality were enthusiastic, others were put off by its appearance. “My husband thought it looked weird at first, but now he likes it,” says Carol Short, 23, of Phoenix, who tested the device. “Because it’s so large, it’s more comfortable for a man than a condom.” Reality is thinner than a male condom and transfers heat, says Leeper, which is why many couples say it feels much more like unprotected sex.
Concern about protection has spawned at least two other vaginal pouches currently in development. Unlike Reality, the Woman’s Choice Female Condomme is made of latex and is 30 percent thicker than a male condom. It has an umbrella-like cap and is inserted with a plastic applicator. Perhaps the ultimate in disease protection is the unisex “condom garment” invented by Dr. Sam Lerman of Canton, Mich., a bikinilike item made of polyurethane that has an attached “sheath” in front. Depending on which sex wears the garment, the sheath becomes either a vaginal liner or a penis cover.
The marketing of vaginal pouches could make serious inroads on the booming male-condom business. Last year 418 million condoms were purchased in the United States, at least 25 percent by women. But a senior executive at Schmid Laboratories, which makes Ramses and Sheik, isn’t worried. “I think they’ll find a niche in the condom market,” says George Gori, “but I don’t think it will be a big one.”
Disease prevention is less important to some women than finding an acceptable contraceptive. Several variations on the cervical cap are currently being tested:
Janet Tlapek, a Saranac, Mich., CPA, and her sister Margaret, a registered nurse, have designed and tested the Oves cervical cap, a disposable device made of very flexible silicone rubber, which could become available without a prescription.
Lea’s Shield is a cervical cap designed by Yama, Inc., of Millburn, N.J., to be sold over the counter. Made of silicone rubber, it can be used more than 20 times and has a loop for easy insertion and removal.
The Fem Cap, developed by Dr. Alfred Shihata of San Diego, Calif., is a silicone rubber cervical cap with a surrounding “brim” that conforms to the vaginal walls. Available in three sizes, it must be fitted by a health-care professional.
Developers of the new barrier devices claim they provide at least as much pregnancy protection as the diaphragm or condom, and since they pose few safety problems, FDA approval could come within the next two or three years. Besides expanding the options for contraception, approval of the vaginal pouches would, for the first time, put protection against STDs in a woman’s control. It could also put big money in the pockets of the entrepreneurs who are selling them.
The vaginal pouch, or female condom, won conditional approval last week from an FDA advisory panel and could be in stores by the end of the year. The device is part of a whole new wave of barrier contraceptives currently navigating the maze of FDA regulations.
Developed by Dr. Harvey Lash of Palo Alto, Calif., this latex pouch is inserted with an applicator.
Made of clear, flexible silicone rubber and developed by two sisters, this thimblelike cap is the only one that’s disposable.
This silicone barrier contraceptive has a unique loop for easy insertion and removal.
A polyurethane bikini with attached sheath, it becomes a vaginal liner or penis cover, depending on which sex wears it.
This silicone rubber cervical cap has a surrounding “brim” that conforms to the vaginal walls and helps to create an airtight seal.