Reality Female Condom Press Clippingscollected in the AIDS News Service and CDC AIDS Daily Summary
Statement by the Food and Drug AdministrationThe Food and Drug Administration announced [on 27 April 1993] that it is prepared to approve -- with restrictive labeling -- the Reality Female Condom [Editor's Note: See "Female Condom Approved" below], the first barrier contraceptive for women that also offers limited protection against sexually transmitted diseases (STDs). The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, it is important to use latex condoms for men. The female condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside partially covering the labia. In addition to the required endorsement of the safety offered by latex condoms for men, the approval for the product will be granted with these conditions:
"The female condom is not all we would wish for, but it is better than no protection at all," FDA Commissioner David A. Kessler, M.D., said. "I have to stress that the male latex condom remains the best shield against AIDS and other sexually transmitted diseases. Couples should go on using the male latex condom." FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the Obstetrics and Gynecology Devices Advisory Panel at its meeting on Dec. 10, 1992. The agency gave the product an expedited review because it saw an urgent need for a means whereby women can protect themselves without depending on the cooperation of their partners. FDA had reservations about the limited data available on protection the female condom offered against STDs, as well as about the high pregnancy rate among users, the small number of women in the clinical studies and the short duration of the studies, which lasted less than a year. Eventually, the agency decided to approve the female condom as the only product of its kind ready for marketing. The manufacturer -- Wisconsin Pharmacal of Jackson, Wisc. -- studied 200 women who used the device for six months. In the study, the six-month pregnancy rate among U.S. women was approximately 12.5 percent--or an estimated 26 percent per year. This high rate is believed to have been the result of improper use of the device. It compares to an expected rate of 85 percent among women not using any contraceptive method. Women who use the device correctly each and every time they have intercourse can expect a much lower pregnancy rate. Details of the required studies on the product's effectiveness are being worked out.
(Department of Health and Human Services,
Food and Drug Administration, April 27, 1993.)
REALITY is a new barrier device for women to wear. It was designed explicitly to be use at the woman's discretion to provide protection against sexually transmitted diseases (STDs), including AIDS, as well as unintended pregnancy. Because of its innovative design, REALITY is less likely to disrupt the natural spontaneity of sex. Most women report that is comfortable and easy to use. REALITY was developed by a Danish physician who was concerned about transmission of STDs and felt that women needed a protective method to use themselves. Wisconsin Pharmacal Company (WPC) licensed the marketing rights for REALITY in the United States and Canada in the fall of 1987. Since then, WPC has undertaken extensive development work, including studies to establish that the AIDS virus (HIV) and the hepatitis B virus, the smallest virus known to cause an STD, do not penetrate the REALITY sheath. In addition, more that 1,700 couples to date--involving more than 30,000 uses of the device-- have participated in formal clinical studies in 10 countries. These studies have shown that when used properly and with every act of intercourse, REALITY helps to protect against AIDS, other STDs and unintended pregnancy. Like any other barrier contraceptive, it is not 100% effective. REALITY is a soft, thin polyurethane sheath with two flexible rings. One of the rings lies inside the sheath at its closed end and serves as an insertion mechanism, holding it in place, so that is fits over the cervix much like a diaphragm. the other ring forms the external edge of the sheath, and remains outside the vagina after insertion. The sheath provides a physical barrier between the partners during sexual intercourse, covering the base of the penis as well as the labia. REALITY does not require fitting by a health care professional or precise placement over the cervix by the user. REALITY has the advantage that it can be inserted by the woman minutes or hours prior to sexual intercourse. REALITY's use is controlled by the woman. She may insert it at anytime before sexual intercourse. It comes prelubricated and extra lubricant is supplied. The penis can move freely inside the REALITY sheath. Participants in the clinical studies report that REALITY is comfortable, easy to insert and remove, particularly after they have had experience using the disposable device on one or two prior occasions. Most women report that sensation is either the same or better that their usual sexual experience. REALITY is made of polyurethane for several reasons. Polyurethane is strong and unlikely to rip or tear. Polyurethane is used medically for many purposes, including surgical implants, bandages and certain prosthetic units. The type of polyurethane used for REALITY is soft and easy to handle. It transfers heat, so it warms to body temperature soon after insertion. REALITY will be marketed in the United States by Wisconsin Pharmacal Company, which is based in Jackson, WI. It will be available over the counter just like traditional male condoms; no prescription will be necessary. The one-size-fits-all barrier device will retail at approximately $2.25 each. REALITY will be marketed outside the United States and Canada as FEMIDOM. (Wisconsin Pharmacal Company, 1992.)
[Editor's Note: See also: The Female Condom. The Medical Letter on
Drugs and Therapeutics. 1993 Dec 24;35(912):123-4.]
The Food and Drug Administration approved the first so-called female condom on May 7. Despite limited data on the effectiveness of the Reality~ Vaginal Pouch in sexually transmitted diseases (STDs) and a relatively high pregnancy rate among users, the device was approved because it is the first barrier contraceptive for women that provides some protection against STDs. The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice. The label must also compare the pregnancy rate for the female condom--approximately 26% per year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15% per year. The female condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia. In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal (Wisconsin Pharmacal Company, P.O. Box 198, Jackson, WI 53037. (800) 635-0844; (414) 677-4121), to take part in additional effectiveness studies for the product. FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on Dec. 10, 1992. Wisconsin Pharmacal studied 200 women who used the device for 6 months. The estimated pregnancy rate of 26% per year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%.) Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.
(FDA BULLETIN, Department of Health and Human Services, Food and
Drug Administration, June 22, 1993.)
The Food and Drug Administration approved the first female condom, even though there were questions about its efficacy in preventing pregnancy and protecting against sexually transmitted diseases. The move was announced by the condom's manufacturer, Wisconsin Pharmacal of Jackson, Wis., and confirmed by the FDA. The device would be shipped to doctors offices, clinics, and facilities treating sexual diseases in about eight to ten weeks, said the manufacturer. Wisconsin Pharmacal said it intends to make the female condom, known as Reality, available nationwide by the end of this year. The Reality condoms would be priced at $2.50 each. The device is essentially a polyurethane sheath that lines the vagina. It is about six and a half inches long, and is held in place by two flexible plastic rings, one at the cervix and one outside the body. The condom is intended for one act of intercourse. The agency's approval was contingent upon the company's inclusion of labeling that stressed that male latex condoms seemed to be better protection against pregnancy and disease. One statement reads: "If you are not going to use a male latex condom, you can use Reality to help protect yourself and your partner." While more than six months of testing in the United States showed that Reality protected against pregnancy to some degree, the rate of conceptions among those using the product was higher than with other barrier methods. FDA said this information had to be mentioned on the label. Wisconsin Pharmacal attributes the high pregnancy rate to improper use of the condom by women in the study, and said that it would be much lower if the product had been used correctly. Related Stories: Washington Post (05/11) P.
A5; Baltimore Sun (05/11) P. 9A. (Leary, Warren E. New York Times,
May 11, 1993, P. C5.)
The Food and Drug Administration's recent approval of the Reality Female Condom was received with continued doubt of the condom's efficacy. This reaction was due to the resistance to the device by the FDA itself. The agency continues to ignore that women constitute the fastest-growing AIDS population. The FDA requires that the Reality package must state that the male latex condom remains the best protection against HIV and other sexually transmitted diseases. But Dr. Erica Gollub of the HIV Center for Clinical and Behavioral Studies, affiliated with Columbia University in New York City, argues that "Male condoms have never been subjected to the rigors that female condoms, and all new birth control in fact, have been put under." Mary Ann Leeper, senior VP of development at Wisconsin Pharmacal, Reality's manufacturer, said that in laboratory tests, the female condom could not be permeated by HIV or various other sexually transmitted viruses. "If you use it and it doesn't rip or tear it's going to protect you," she said. The rip and tear rate in clinical trials was 0.2 percent, whereas the rip and tear numbers for the male condom is as high as 14 percent. One of the reasons for the delay of Reality's release is the FDA's finding of a 26 percent rate of pregnancy protection. According to Wisconsin Pharmacal and Gollub, the number is a result of bad math, bad science, and the FDA's bias toward male condoms. (Coleman, Beth. Village Voice 1993 May 19;38(21):25.)
New York--The lack of demand for Reality's female condom may be due to the conclusion of the Food and Drug Administration that the device has a failure rate of 26 percent. James Trussell of Princeton University, however, found the female condom to be about as effective as the male condom and the diaphragm. Furthermore, he says, it may be ideal for men and women who dislike male condoms. "It's the only method that prevents both pregnancy and sexually transmitted diseases that is under the control of the woman," notes Trussell, a Reality consultant. "There wouldn't be a need for the female condom if males used condoms at every act of intercourse." Plus, says Mary Ann Leeper, who directed development of the device at Wisconsin Pharmacal, the polyurethane from which it is made is less likely to rip or tear than latex male condoms. "We know that the HIV virus can't get through the sheath," she said. "Logic says you're going to be protected." Trussell says that 21 percent, not 26, of women using the female condom would become pregnant during one year of "typical use," meaning sometimes using it, sometimes not. Typical use of the male condom is thought to have a failure rate of 15 percent. With perfect use--with each act of intercourse--the female condom has a failure rate of only 5 percent, compared to 3 percent for the male condom, says Trussell. But Dr. Lillian Yin of the FDA says that there is not yet solid data on the device. She said the female condom was approved on the basis of a six-month study, rather than the usual year-long study, because of the condom's value to AIDS prevention. That meant that the female condom could be approved more quickly, but that the FDA was less sure of its effectiveness. (Raeburn,
Paul. Associated Press. December 13, 1993.)
Despite lukewarm government endorsement, the female condom is gaining acceptance among the first women to try it, according to informal discussions with clients. Reality, manufactured by Wisconsin Pharmacal Company in Jackson, Wis., is not yet available in drugstores, but the company has sold some 50,000 of the condoms to public health, family planning, and AIDS clinics in more than 100 cities across the country, which are distributing them for free or at reduced prices to patients. According to the clinics, over half of the women who have tried Reality say they like it. The attraction, say the clinics, is that the condom can be inserted well before intercourse, that it feels better than the male latex condom, and that it gives women more control over precautions against HIV and other sexually transmitted diseases. Women who say they do not like the female condom complain that it squeaks-- something the makers say will happen if it is not adequately lubricated--and that it inhibits foreplay. Others say the device is visually offputting--it is held together by two rings, one of which is inserted into the vagina and another that remains outside of the body. Nevertheless, due to laboratory results indicating that it is an "effective barrier to viruses, including HIV," the Centers for Disease Control has recommended use of the female condom as a safe-sex option. Price, however, may be a barrier, as the condoms are expected to sell for $2.50 each once they are on the U.S. market. (Navarro, Mireya. New York Times. December 15,
1993, P. B1.)
Not all women who tried the new female condom liked it, but they did find themselves amply protected against both pregnancy and HIV infection, according to researchers from the University of Vermont, Princeton University, and elsewhere. The international study of 353 women found that the polyurethane prophylactic reduces that chances of HIV infection by approximately 90 percent a year. The study was conducted at nine family planning centers in the United States and Latin America. Based on preliminary studies, the researchers estimated that the female condom reduced the odds of HIV transmission from 1 in 5 to 1 in 167, assuming sex twice weekly with an infected male partner. "Some people liked the product, and some people didn't," said study director James Trussell of Princeton. "The biggest complaint was that it was aesthetically unappealing." (Boston Globe, April 7, 1994, P. 3.)
Awaiting only Food and Drug Administration approval of the London factory that will mass-produce the female condom, Wisconsin Pharmacal Co. Inc. is ready to begin manufacturing the product for national distribution. According to Mary Ann Leeper, president of the firm's female health division, female condoms eventually will be available in most places where male condoms are sold. They will, however, be marketed in a very different manner. "It's going to be a very straight-ahead approach," she says. "It's going to discuss negotiating its use and the expectations." Leeper estimates that 75,000 condoms have been distributed and women that have used tried them indicate their appreciation of the greater control the female condom gives them when dealing with sex. "It definitely gives women some control," says Leeper. "If the man won't wear one, the woman can." The condom, to be sold under the brand name Reality, is a large, polyurethane version of the male condom designed primarily for prevention of sexually transmitted diseases, even though it can be used as a contraceptive. Early research shows that loss of sensation--a primary initial concern, was not a cause for concern at all. About 80 percent of the men liked the female condom, while more than 60 couples said they would use it again. (Across the Board. 1994 May;31(5):38.)
Wisconsin Pharmacal of Jackson, Wis., began shipping [on 19 July 1994] quantities of Reality, the first FDA-approved female condom, to drug and supermarket chains across the United States. National distribution is scheduled for completion by September. The device should be on shelves by August, according to Wisconsin Pharmacal's Mary Ann Leeper, who described the condom as the only protection against AIDS and other sexually transmitted diseases that is "under a woman's control." Federal studies, however, have said that the condom is not as effective as traditional sheaths as a method of birth control. (United Press International. July 20,
1994.)
Marketing the first female condom, due in American stores next month, will not be an easy task. Sales of over-the-counter female contraceptives, including spermicidal sponges, jellies, and foams, have been falling at a steady pace, according to Towne-Oller Associates. And, despite an aggressive advertising campaign by the federal government, male condom sales were flat in the first four months of 1994. Wisconsin Pharmacal, maker of the Reality female condom, admits the hurdle this presents. Fearing that women who buy the product without understanding it will become discouraged and never buy it again, the company says it will focus its first phase of advertising on educating the consumer, instead of pushing the product. Print ads--which will appear in fall editions of such magazines as Essence, Mademoiselle, and Cosmopolitan--inform women that "Reality female condoms were designed to protect you and your partner against sexually transmitted diseases, especially AIDS." (Goldman, Kevin. Wall Street Journal. July 27, 1994, P. B4.)
Wisconsin Pharmacal Co. plans to put its female condom on sale for the first time this month at drugstore counters nationwide. The condom, which is named Reality, comes in a small white box, with pages of instructions and 11 diagrams. Wisconsin Pharmacal plans a $4 million ad campaign emphasizing the condom's role in preventing sexually transmitted diseases as well as pregnancy. The cost is approximately $2.75 each, compared to about a dollar for a male condom. The FDA warns that about 25 percent of Reality's users could get pregnant during a year of use, compared with a 15 to 17 percent rate for male condoms, diaphragms, or sponges. (Philadelphia Inquirer (08/16/94) P. A3; Sakson, Steve)
(PRNewswire (09/13/94) [email protected] (Fri Sep 16 13:48:38 1994) |