Condom Bust

The FDA refused to recall the Avanti condom, despite ominous test results.

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.)

The National Institutes of Health, meanwhile, began to run tests that the Avanti would have to pass for the company to claim the condom was safe and effective. In the five pilot tests, from 1991 to 1994, the Avanti broke between 4.4 and 15 percent of the time -- an average of more than 9 percent, compared to the 2 percent average for latex condoms.

"We told the company, 'If you don't make it thicker and get the breakage rate lower, we can't go forward [with the tests],'" says Ron Frezieres, research director for the Los Angeles Regional Family Planning Council, which conducted the NIH studies.

FDA officials argued it was better to provide a product for people allergic to latex than not to offer them anything at all.

"We used the same rationale for the female condom," says Lillian Yin, a director in the FDA's Office of Device Evaluation. "We allowed it to go on the market, even though the pregnancy rate is high, because women needed something for themselves to control."

In December 1994, Avanti hit store shelves, along with a claim on the condom's foil package that it was "effective against pregnancy, HIV (AIDS) and STDs" -- even though it still had not passed the required tests.

By January 1995, the FDA told the company to drop the labels. But the FDA didn't force the company to recall any packages with the label, because LIG, the world's leading condom maker with 1996 sales of about $500 million, claimed financial hardship. "They said that to throw away all those boxes will cost several million dollars," Yin said at the time.

The FDA did eventually require LIG to reprint Avanti boxes with a warning -- in small type on the back -- that read: "The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection) are not known for this condom." The FDA also demanded more safety trials from both the NIH and LIG -- even though the condom now had been on the market for six months.

The Avanti, with its box boasting, "Thinner & More Sensitive Than Latex," took off. Because of a misleading marketing strategy, the Avanti is packaged in regular and "superthin" varieties, even though the two varieties are actually the same condom coated with different amounts of lubricant.

LIG refuses to release sales figures, but some indicators suggest the Avanti has enjoyed wide success. Condomania, a Los Angeles-based condom specialty chain, reports that the Avanti became one of its top three bestsellers, with sales of more than 100,000. LIG reports that in the Avanti's first year, it captured 3 percent of condom sales in its trial market.

Soon, however, the FDA and condom merchants received reports that the Avanti was breaking. One report came from Mike Kemmerrer, a San Jose, Calif., AIDS prevention counselor who tried out the condom before distributing it to his high-risk clients. He says the first time he used the Avanti, it broke. "I have been sexually active for years and had never had a condom break on me before."

He says the Avanti also broke on nine co-workers and clients. Only after several negative HIV tests, Kemmerrer says, did his own fear subside.

Meanwhile, with the FDA's approval, LIG prepared to replace the original Avanti with a thicker version. Acting on a tip, Mother Jones had a recently manufactured Avanti condom's thickness measured and compared with the first Avanti's reported measurement. It was 15 percent thicker.

When Mother Jones confronted LIG, the company responded in writing, stating that "following...preliminary results from the clinical studies it was decided to change the specifications for Avanti in May 1996 as part of our continuous improvement programme." After further questioning, LIG confirmed that the new condom is thicker.

LIG states that the change was meant to "ensure continuity of production, increase yields and improve end user acceptability." It would not say whether the change was made for safety reasons. But LIG also has voluntarily added a sticker to the condom's box that warns: "Intended for Latex Sensitive Condom Users Only."

The FDA approved the change. "They decided to do it," Yin says, "and we thought it was a great idea."

But as of late December, Mother Jones was still able to purchase the thinner Avanti condom, with a 1995 manufacturing date, at an Eckerd drugstore in Atlanta. And in a brief survey of stores that sell condoms in the San Francisco Bay Area -- which has the highest HIV infection rate in the country among gay men -- at least eight stores still carried the older condoms. The product's manufacturing date is printed in small letters on the left side of the package.

When told, Yin seemed surprised: "They said they stopped shipping them in April." Still, she says a recall on the earlier condoms would be a mistake. "With the AIDS epidemic still going on, it is important not to unnecessarily alarm the public."

"That's ridiculous," Kemmerrer says. "Precisely because the AIDS epidemic is still going on, you want people to damn well know if there's a condom out there that breaks."

Skip Connett edits AIDS Alert, which first raised concerns about the Avanti condom.

So, just how many busts are we talking about here? Try our handy Condom Calculator and find out.