The world's first "plastic" condom, the Avanti, hit the U.S. market in late 1994 with some big promises from its maker, the London International Group (LIG). For starters, it was half as thick as the usual latex condom and promised consumers greater sensitivity. It could be used with oil-based lubricants, such as petroleum jelly. And it could be used by the estimated 1 to 3 percent of the population allergic to latex.
But there was one thing LIG didn't say: The polyurethane Avanti might break as often as one out of every 10 times it's used. That's five times more often than the latex condoms approved by the Food and Drug Administration.
The FDA knew this, but instead of recalling the condom, the agency let LIG replace it with a thicker version -- without making any change to the box and without alerting the public. From December 1994 to May 1996, the original, thinner condom was sold in 13 Western states and a few national pharmacy chains. An informal survey by Mother Jones found that those condoms are still in stores.
An expert on condom research says the FDA should have issued a recall. "I am sure the company didn't want to do that, but it means the thin one is still out there," says James Trussell, director of Princeton University's Office of Population Research. And at press time, the FDA had yet to report whether even the thicker condom adequately protects against unwanted pregnancy or HIV and other sexually transmitted diseases.
So how did such a potentially dangerous product make it past the FDA?
In 1991, the agency approved the Avanti, calling it "substantially equivalent" to the latex condom. But the FDA relied solely on the company's own research data, which claimed the Avanti had a lower breakage rate than latex condoms. (The FDA now requires more extensive clinical testing.)