Clinics first to receive female condom
Contraceptive Technology Update 14(3): 50-51
1993
ISSN/ISBN: 0274-726X PMID: 12318087 Document Number: 325395
The US Food and Drug Administration (FDA) is expected to soon approve the Reality female condom (polyurethane sheath lining the vagina) which will be distributed to sexually transmitted disease (STD) and family planning clinics instead of retail outlets. The importer and eventual manufacturer, Wisconsin Pharmaceutical Company in Jackson, Wisconsin, aims to educate providers first. It plans to sell Reality to clinics at about half the commercial price which is $2.50. The FDA's Obstetrics and Gynecology Devices Advisory Panel asked the manufacturer for the results of a contraceptive efficacy study in January 1992 before it would grant its full recommendation for approval which it did in December 1992. Reality had a contraceptive effectiveness rate of 88% with typical use and of 95% with perfect use. Since the study was only 6 months, the panel requested the manufacturer to include on the label that the clinical data are limited. The study revealed that there was only a 2.8% probability of exposure to semen due to rips, tears, and outer ring movement. Reality had a lower rate of breaks and tears than the male condom 1% vs. 4%). Health workers did not note any sperm or vaginal trauma or change in bacterial flora in women who used the female condom on multiple occasions. None of the Reality users who had earlier had trichomoniasis became infected again while almost 15% of women in a control group and in a group of intermittent Reality users became reinfected with trichomoniasis. Neither HIV nor the hepatitis B virus could pass through the female condom. No one has claimed significant allergic reactions to or side effects from Reality. Overall, women liked Reality, the most common complaint being the outer ring rests outside the vagina.