Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication

Establishing the safety of re-using the female condom could significantly i ncrease women's access to barrier methods especially in poorer countries. I n this study, the structural integrity of female condoms was tested (n = 29 5) after multiple acts of vaginal intercourse. Fifty women were recruited t o the study. Each woman re-used one condom up to eight times and washed, dr ied, and re-lubricated between each use. Structural integrity was measured using standard quality control testing; water-leakage, air-burst, and seam tensile strength. All results were compared to the United States Food and D rug Administration (US FDA) standards for an unused female condom. The resu lts of the structural integrity tests for all cycles were above the FDA min imum standards for seam strength and burst tests. There was no deterioratio n detected in condoms used 8 times when compared to new female condoms in t hese tests. Five holes were detected by the water leakage test across all c ycles, of which three were detected by the subjects themselves and reported to the investigators, therefore, giving a breakage rate of 1.7%. The holes were not associated with increased number of uses. This study provides fur ther evidence that suggests the structural integrity of the female condom a fter multiple use is still within FDA minimum standards, although random ho les resulting from handling occur infrequently with the re-use procedure. ( C) 2001 Elsevier Science Inc. All rights reserved.