Implications of laboratory tests of condom integrity.
BACKGROUND
There is sufficient evidence from Food and Drug Administration laboratory experiments and clinical studies to draw conclusions about the relative importance of holes and breakage to condoms. The laboratory test methods determined penetration of viruses or virus-size microspheres through holes in condoms under conditions that simulated or exaggerated those expected in actual use, and determined the frequency with which condoms might pass virus or microspheres and the amounts of passage in each case.


OBJECTIVE
To summarize and comment on the significance of test results on latex, polyurethane, and natural membrane condoms as barriers to virus passage.


METHODS
Published and unpublished data addressing three distinct concerns were analyzed: (1) passage of virus or microspheres through small holes or pores inherent in the material of "intact" condoms which are undetectable by the standard water leak quality assurance test, (2) passage of virus or microspheres through larger holes in "leaker" condoms detectable by the water leak test but marketed because of the finite acceptable quality level (AQL) of the test, and (3) passage of virus through condoms that break during use.


RESULTS
Extrapolating to the passage of semen expected during actual use allowed an analysis of the relative importance of breakage and water-leak-detectable or water-leak-undetectable holes.


CONCLUSIONS
The relative importance of breaks and holes is related to the volume of semen that contains an "infectious dose" of a sexually transmitted disease (STD). When 0.1 mL to 1.0 mL exposures to semen are necessary for disease transmission, the risk during latex condom use primarily results not from holes, but from breakage of condoms. For smaller volumes of semen exposure (0.00001 mL and less), the presence of holes can be as important as breaks. The same qualitative argument pertains to a comparison of "leaker" condoms to the large majority of "intact" condoms.
Carey
R F
RF
Office of Science and Technology, FDA Center for Devices and Radiological Health, Rockville, Maryland 20852, USA.
Lytle
C D
CD
Cyr
W H
WH
D001672:Biocompatible Materials; D017280:Condoms / Q000592:standards*; D004867:Equipment Design; D006801:Humans; D007840:Latex; D008863:Microspheres; D010539:Permeability; D011140:Polyurethanes; D014777:Virus Diseases / Q000635:transmission; D014867:Water
D001672:Biocompatible Materials; D007840:Latex; D011140:Polyurethanes; D014867:Water