FDA Orders Retesting of Avanti Plastic Condom

Further testing has been ordered on a plastic condom that was previously approved for use by the Food and Drug Administration.

The condom, sold under the name Avanti, was approved for sale by the FDA in 1991 and is recommended for people who are allergic to latex. But new data from “slippage and breakage” studies have raised questions, said Dr. Susan Alpert of the FDA.

FDA approved the condom after its manufacturer, London International Holdings U.S. Inc., submitted test results showing that the plastic material used in the condom was impervious to both sperm and viruses, and that the condoms had a failure rate of less than 2% in breakage and slippage tests conducted by volunteer couples.

However, independent slippage and breakage tests were conducted recently by the National Institute of Child Health and Human Development, and couples participating in those tests reported a failure rate of about 14%. Alpert said this prompted the FDA to order more research.

“We have asked both groups to go back and test the condoms again,” Alpert said. About 5% to 7% of the population cannot use latex, she said.

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