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  • Title: Study to determine the correlation between condom breakage in human use and laboratory test results.
    Author: Steiner M, Foldesy R, Cole D, Carter E.
    Journal: Contraception; 1992 Sep; 46(3):279-88. PubMed ID: 1451523.
    Abstract:
    The present study examined the value of laboratory tests in predicting condom breakage for 20 lots of latex condoms which differed in age, storage history and laboratory test performance. Two-hundred-sixty-two participating U.S. couples used a total of 4589 latex condoms (mean = 229 condoms per lot, range 224-235). Breakage rates ranged from 3.5 percent for a brand new condom lot to 18.6 percent for a lot that was 81 months old at the time of the study. The statistical predictor models, separately using ultimate elongation from the tensile test, the Condom Quality Index from the airburst volume test, and the percent of condoms failing the airburst volume test as the independent variables and the condom breakage rate as the dependent variable, all appear to have a high level of accuracy in predicting condom breakage in use. The three models had correlation coefficients (R2s) of 0.81, 0.74 and 0.69, respectively. Perhaps the most unexpected result was that the age of the condom lot was the best predictor of condom breakage during use (correlation coefficient (R2) = 0.92). Although the present investigation does not provide sufficient justification to use age as the only factor for decisions on condom lot disposition, it does provide some guidance. Condom use is stressed to reduce the risk of contracting sexually transmitted diseases and unwanted pregnancies. Condoms may, however, break during sexual intercourse. This study was conceived and designed to provide the most conclusive results to date on the relationship between laboratory test data and condom breakage during vaginal intercourse. While the most sophisticated study conducted prior to this one examined breakage rates in only 4 different lots of condoms, this study investigated a sample of 20 different lots of silicone-lubricated latex condoms differing in age, storage history, and laboratory test performance. Of the 20 lots, 4 were newly manufactured from 4 different U.S. manufacturers. The remaining lots had been made by one U.S. manufacturer for the U.S. Agency for International Development and were retrieved from overseas warehouses. 262 U.S. couples employed 4589 condoms over a 4-month period. Breakage rates ranged from 3.5% in a new lot to 18.6% in one lot 81 months old. Based on these field results, tensile and airburst tests appear to be highly accurate in predicting condom breakage rates during use. Condom age, however, was the best predictor of breakage during use. Additional studies should be conducted to confirm the degree to which condom breakage may be predicted on the basis of age, especially for condoms over 2 years and under 5 years old.
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