WASHINGTON - A polyethylene condom approved by the Food and Drug Administration in 1991 has been ordered to undergo more testing after government research showed significantly higher failure rates than the manufacturer's testing results. Nancy Alexander, chief of the contraceptive development branch of the National Institutes of Health, said the Avanti contraceptive would be subjected to testing by 200 couples over a six-month time frame to determine a more accurate ``slippage and breakage'' rate than previous testing has provided.
Manufactured by London International Holdings U.S. Inc., the condom is recommended for the 5-7 percent of the general population that is allergic to latex, the most common type of material used in the product's manufacture.
The requirement for more testing was first reported in AIDS Weekly magazine.
London's testing had shown a failure rate of 2 percent, and FDA approval was granted on the basis of that testing. However, recent ``slippage and breakage'' testing under the auspices of the U.S. National Institute of Child Health and Human Development had couples reporting product failure rates of 14 percent.