Nearly six years in the making, the new "female condom" has arrived. And while women aren't necessarily beating down the doors of area health centers to get a sample of the new device, interest is steadily growing.
Planned Parenthood of Maryland's Howard Street office has sold out of its first batch of condoms. And in Harford County, AIDS educator Barbara Hernan-Clark has had little trouble rustling up an audience at county health department clinics in recent weeks for a sneak preview of the device that's been touted as protection against pregnancy and sexually transmitted diseases, including acquired immune deficiency syndrome.
"This is the first product available for sexually transmitted disease prevention that we as women can control," she tells a group of women at the Bel Air Health Center. "It may not be for everyone, but you should be aware of it as an alternative."
The condom for women won FDA approval last May, and Wisconsin Pharmacal Co., with exclusive rights to distribute it in this country, began marketing it under the brand name "Reality" to nonprofit clinics at a discount for demonstrations and limited distribution last fall.
Consumers won't find it for sale in drugstores until May or June, but some health officials are getting the word out now.
At the Johns Hopkins University Student Health Clinic, health practitioners are doing an educational blitz on the female condom this week, which is National Condom Week. The university has participated in the Valentine's week promotion of condoms and STD education since the mid-'80s, says Marilyn Gall, nursing administrator at the clinic.
She says that the clinic will provide information on the condom and will sell them to interested students and that the condom will likely be a topic in a series of educational programs conducted for freshmen and sophomores in the dorms during spring semester.
She says that, eventually, the condoms will be sold along with other over-the-counter contraceptives at the health clinic, but a price has not been established yet.
"It does take self-discipline to use it consistently and to become comfortable with it," she says, but notes that using the device is similar to using a diaphragm or cervical cap and that some women may not find it as awkward as others.
Ms. Hernan-Clark, who heads Harford's AIDS Education Office, ordered 600 samples of the condom using money in her outreach budget and scheduled a series of informal demonstrations during busy clinic hours at the county's regional offices in Bel Air, Aberdeen and Havre de Grace. While many of the women stopped by on their way into or out of various clinics, others came specifically for the demonstration.
"Reality," a polyurethane sheath with a flexible ring at either end, has been described as a combination condom/diaphragm. Designed for one-time use, it is inserted by a woman so that the closed ring rests against the pubic bone, below the cervix, and the open ring remains outside the body. The pouch lines the vagina and prevents skin-to-skin contact during intercourse.
The 'control' factor
"I like the idea of being able to control it and not having to depend on someone else for your own safety," says Tania Williams, a 24-year-old from Edgewood, who took some samples home from the demonstration in Bel Air.
In fact, advocates say, the "control" factor is the chief selling point among women. The device can be inserted up to eight hours before intercourse. While it was made to act as a barrier against pregnancy as well as sexually transmitted diseases, its role in preventing human immunodeficiency virus infection seems paramount in the minds of many women.
"AIDS is the leading cause of death in 20- to 25-year-olds today," Ms. Hernan-Clarke tells her audiences, which include alcohol- and drug-abuse recovery groups and other meetings of at-risk women. "And if I don't know if my partner is positive or negative, I need more than the pill for protection."
The FDA approved the condom for sale in the United States last spring, contingent on its approval of the worldwide manufacturing facility in Great Britain, where the condom is already being produced for European distribution. The plant, which is operated by Chartex International, has been inspected by the FDA, and approval is imminent, says Holly Sherman, a spokeswoman for Wisconsin Pharmacal, which began efforts to market the condom in the United States in 1988.
She says that Wisconsin Pharmacal has been using its small production plant in Jackson, Wis., for research and limited distribution of "Reality" but that the plant does not have the capacity for commercial distribution.
While some eagerly await the product's general introduction, not all health officials are sold on the product's effectiveness.
A six-month FDA study of "typical use" indicated the condom had a 13 percent failure rate in preventing pregnancy. That compares unfavorably with other barrier methods, including the male latex condom (8 percent), diaphragm (8 percent), cervical cap (10 percent) and sponge (12 percent).
Another drawback is the price. While nonprofit organizations paid about $1.25 each for the introductory shipments, the condom likely will sell for $2.25 to $2.50 each at the retail level. Ms. Sherman says the product will be packaged three to a box, requiring an outlay of $7 or more at a time.
"It's not for everyone," says Dr. Doris Tirado, medical director of Planned Parenthood of Maryland, "but it gives women another choice and some control over being partner-dependent." She says the private, nonprofit agency began introducing the condom to its clients in all seven centers from Frederick to Salisbury about three months ago.
After an introductory period that included demonstrating the device and giving away some samples in reproductive health education classes, Planned Parenthood began selling them at $5 for a box of three.
Dr. Tirado says by far the most positive response has been at the Baltimore City office on Howard Street, where the first case of 60 condoms sold very quickly. She says that some women have come back for more and that a few men have called the office for more information or come in to purchase them.
Other centers, she says, have shown only mild interest. And teen-agers, even though specifically targeted in an agency-sponsored "teens at risk" program, "weren't terribly impressed."
"They felt uncomfortable and embarrassed by it and said it was cumbersome to use," she says, adding that older clients have similarly complained that the new device is aesthetically unappealing.
But she says Planned Parenthood will continue to make "Reality" available to interested women.
"Obviously, it's better than not using anything, and it does protect against STDs. And not everyone can use the pill or Norplant or a condom."
Kathleen Edwards, director of the state AIDS Administration, voices some reservations about the product. She says that while Harford County was allowed a budget modification to purchase the female condom with AIDS education funds, the agency has not authorized such expenditures across the board by local health departments.
"Money is extremely tight, and though I like the idea of a barrier method, there really is not enough information yet on who wants these and how well they are being accepted," she says.
Even with state subsidies, "Reality" would cost county health departments about 82 cents apiece, compared with 5 cents apiece for male condoms purchased in bulk, says Ms. Edwards.
While the AIDS Administration is not embracing the new condom, the Maryland Department of Health and Mental Hygiene has authorized local health departments to purchase condoms through their family planning budgets.
Says Johns Hopkins' Marilyn Gall, "I think it's another alternative, and it's important that we have as many alternatives as possible, but I'm anxious to see longer-term research."