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 increase women's access to barrier methods especially in poorer countries. In this study, the structural integrity of female condoms was tested (n = 295) after multiple acts of vaginal intercourse. Fifty women were recruited to the study. Each woman re-used one condom up to eight times and washed, dried, 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 Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all cycles were above the FDA minimum standards for seam strength and burst tests. There was no deterioration detected in condoms used 8 times when compared to new female condoms in these tests. Five holes were detected by the water leakage test across all cycles, 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 further evidence that suggests the structural integrity of the female condom after multiple use is still within FDA minimum standards, although random holes resulting from handling occur infrequently with the re-use procedure.
Beksinska
M E
ME
Reproductive Health Research Unit, Department of Obstetrics and Gynaecology, Chris Hani Baragwanath Hospital, University of the Witwatersrand, 2013, Bertsham, South Africa. mags@rhru.co.za
Rees
H V
HV
Dickson-Tetteh
K E
KE
Mqoqi
N
N
Kleinschmidt
I
I
McIntyre
J A
JA
D003075:Coitus; D019111:Single-Use Internal Condom / Q000592:standards; D004868:Equipment Failure; D017743:Equipment Reuse; D005260:Female; D006801:Humans; D008153:Lubrication; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration