Superthin plastic condom gets thicker

FDA doesn’t inform public of changes

Two years after an AIDS Alert investigative series led the Food and Drug Administration to order new safety studies of the Avanti condom, the studies’ results have yet to be publicized. Instead, the agency allowed the manufacturer of the first polyurethane condom to quietly replace Avanti with a thicker version.

London International Group US Holdings, based in Atlanta, replaced the superthin Avanti with a thicker version in May 1996. The FDA allowed the change even though the packaging and box remain identical to the thin version, except for a yellow sticker placed on recent boxes that warns consumers the condom is approved for latex-sensitive users only.

The agency’s decision to OK the switch without informing the public is the latest in a series of unusual marketing and regulatory maneuvers that has haunted the innovative condom since it appeared on drugstore shelves in late 1994. Advertised as thinner, stronger, and more sensitive than latex condoms, Avanti was expected to revolutionize the condom industry while at the same time increase condom use in the era of AIDS.

That hasn’t happened, say condom experts.

"Clearly, due to this whole fiasco with FDA and London International, they have almost destroyed its [Avanti’s] cachet and credibility within certain circles," says Adam Glickman, owner of Condomania, a Los Angeles-based condom specialty shop.

James Trussell, PhD, director of the office of population research at Princeton (NJ) University and an expert on condom research, also has closely followed the Avanti’s career. "It’s been a mess," he says. "The whole thing has been handled poorly."

A leading manufacturer of latex condoms, including well-known brands Sheik and Ramses, London International pushed aggressively to offer consumers a condom that is not only safe for latex-sensitive users, but is odorless, impermeable to HIV, and can be used with oil-based products. Most condom experts predict that, once perfected, polyurethane condoms will outperform and eventually replace latex ones. In the meantime, however, the FDA has struggled over what standards polyurethane condoms should meet — particularly what rate of breakage is acceptable.

Safety a concern from beginning

Ever since it cleared Avanti for marketing, the FDA has been concerned over possible excessive breakage of the polyurethane condom, which is about half as thick as the average latex condom. Once the company’s in-house studies showed that the condom broke less frequently than latex, the agency gave it the green light in 1991. By the time London International worked out kinks and launched the superthin condom in 13 western states in November 1994, the federal National Institutes of Health had completed five pilot safety studies on Avanti in preparation for the first pregnancy study of the condom. When Avanti’s breakage reached an average of 9%, four times more frequent than latex condoms, the trial was stopped.

"We abandoned it. We told the company that if you don’t make it thicker and get the breakage rate lower, we can’t go forward," says Ron Frezieres, MPH, director of research for the Los Angeles Regional Family Planning Council, which the NIH contracted to conduct the studies. In late 1993 the company provided Frezieres with a thicker version, and after a sixth pilot study showed breakage rates comparable to latex (about 2%), the contraceptive efficacy trial got under way with the thicker Avanti condom.

FDA concerned about latex allergy

Although the FDA was alerted to the unpublished NIH studies and had approved the thicker version of Avanti as early as 1994, it allowed the thin version to go on the market. FDA officials argued then that Avanti was the only latex-free, HIV-impermeable condom available to the estimated 1% to 3% of the population allergic to latex; better to provide those consumers a faulty condom rather than no condom at all, they reasoned.

That is not to say London International got everything it wanted. After a protracted battle, the FDA forced labeling on Avanti just prior to its marketing that was highly restrictive — the condom could make no claims about its effectiveness against pregnancy and sexually transmitted diseases. Labeling also had to state that the condom was intended for latex-sensitive users and not the general public.

In addition, the FDA made the unusual request for further safety studies of Avanti in May 1995, even though it had been on the market for five months. Both NIH and London International were asked to conduct six-month slippage and breakage studies. The results would reconcile the differences in conflicting breakage rates and determine the fate of Avanti’s future.

Meeting a pent-up demand for a novel, more sensitive condom, Avanti generated strong sales among general and latex-sensitive users alike. Avanti quickly became one of the top three best selling condoms at Condomania, which has sold more than 100,000 in the United States and abroad through its mail-order business and World Wide Web site, says Glickman.

Soon, however, Glickman and other condom merchants grew concerned about anecdotal reports that Avanti was breaking at disturbingly high rates.

Customers complain of breakage

Condom Sense, a condom specialty store in Atlanta, received enough customer complaints that the store stopped selling Avanti, says owner Carla O’Brien. "I had too much feedback of breakage and I returned all six gross back to the company," she says. "I didn’t think it was worth it because it defeats the purpose of what we are using them for."

Complaints to the FDA’s medical device reporting system regarding Avanti all pertain to breakage. One consumer reported breakage with his first Avanti condom, possibly exposing him to his partner’s active herpes lesions. Another consumer, an experienced condom user who had never broken a condom, stated "this is the first polyurethane tried and it failed during normal vaginal receptive intercourse."

Originally, London International had planned to expand Avanti sales nationwide by mid-1995. Amid increased reports of breakage and preliminary results from the FDA-ordered studies, the company delayed its expansion plans. In May 1996, the company decided to stop manufacturing the thin condom and to sell the thicker version without making any changes to the box or its labeling. FDA officials say the company offered to make the switch and the agency was willing to accommodate its request.

"We didn’t request them to do it," says Lillian Yin, PhD, director of the FDA’s division of OB/GYN in the Office of Device Evaluation. "They decided to do it and we thought it was a great idea."

Without results from the breakage studies in its hands, the FDA had no basis for recalling the thin condom, Yin says. Moreover, a recall would have scared consumers and made them less likely to use not just Avanti but latex condoms as well.

"With the AIDS epidemic still going, on it is important not to unnecessarily alarm the public," she explains. "It is important that people have something rather than nothing. We used the same rationale for the female condom. We let it go on the market even though the pregnancy rate is high, because women needed something for themselves to control."

Trussell agrees that Avanti should have been approved for the benefit of latex-sensitive users. Where the FDA went wrong was in allowing the thinner condom on the market instead of the thicker one, he says.

"It’s a great argument, but it’s false in this case because there was another product that was better," he says. "They could have avoided the problem of having a thin one on the market all these years."

Although the NIH breakage study of the thin condom was completed in August, the agency is not releasing the results until the study is accepted for publication in a medical journal. The company’s study of the thin condom "will be available early next year and these results will be reviewed with the FDA immediately [sic] they are available," the company states.

Frezieres, whose clinic also conducted the FDA-ordered NIH breakage study, could not comment on the results. However, he tells AIDS Alert they are comparable to the safety pilot studies of Avanti.

"There was definitely a need for this follow-up study and I think our research results have been consistent for years," he says. With the thin condom no longer on the market, Frezieres acknowledges the irony that his long-awaited results are now moot.

"We will be breaking this news to people that the condom does or doesn’t break and the company’s position will be, ‘We don’t even sell it anymore.’ But still, I think people should know how something that has been sold for two years did," he says.

Asked why it replaced the condom, the company responded in a written statement 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 program. Only product meeting this revised specification has been shipped since this date."

As late as December 1996, Avanti could be purchased at an Atlanta Eckerd drug store with 1995 manufacturing dates.

Yin expressed surprise that the thin condoms were still on the market.

"They said they stopped shipping them in April," she says, adding that she believed the number of thin condoms still being sold is small.

How the thicker condom will be labeled will depend on the results of the NIH pregnancy study of the condom, which could be released this spring. At that time, the FDA must decide what labeling to put on Avanti. If the thick condom compares favorably to latex condoms, it may receive an indication for the general public, Yin says. If the results are not comparable, then the agency will consider labeling that will fully disclose the study results, she adds.