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March 7, 2000

TSS Now Rare, but Women Still Should Take Care

From FDA Consumer
by Michelle Meadows

Washington, DC (SafetyAlerts) - According to the grapevine in 12-year-old Jerri's North Carolina school, tampons not only cause AIDS, but also can be lost in a woman's body, never to be seen again.

If you're hooked into the Internet, you may notice that tampon tales such as these get more creative as they're passed around. The latest stories claim tampons are tainted with cancer-causing toxins and that rayon tampons are especially dangerous. Another Internet rumor suggests that manufacturers add asbestos to tampons to promote excessive bleeding and boost sales.

"It can be hard to tell what stuff is true," says Jerri.

The truth is that tampons can't get lost forever in a woman's body. Rayon tampons are as safe as cotton ones. And asbestos has never had anything to do with fibers that make up tampons.

"The only way asbestos could be connected to tampons would be through tampering," says Mel Stratmeyer, Ph.D., chief of the Food and Drug Administration's health sciences branch. "And we haven't received any reports of such tampering."

FDA regulates tampons as medical devices, and "we ensure that tampon design and materials are safe through a solid, scientifically valid premarket review process," says Colin Pollard, chief of FDA's obstetrics and gynecology devices branch. Tampon manufacturers conduct a battery of safety studies, and tampons must pass through FDA review and clearance before they can be marketed.

FDA also regulates the absorbency ratings for tampons. While high levels of absorbency were initially linked to an infection called toxic shock syndrome (TSS), FDA recently proposed a rule to provide an absorbency term for 15- to 18-gram tampons (ultra absorbency) that may help women manage heavier menstrual flows. (See "Understanding Absorbency.")

"Tampons with this absorbency are available in other countries with very low rates of toxic shock syndrome," explains Kimber Richter, M.D., deputy director of FDA's office of device evaluation. TSS is the only disease with a proven association to tampon use, according to FDA and the national Centers for Disease Control and Prevention.

Tampons and TSS

Any fear still surrounding tampon use likely dates from a time when TSS was first identified. About half of all cases occur in women using tampons, although the exact link between TSS and tampons remains unclear.

Tampons enjoyed a quiet history from 1933--when the first ones hit the market--until about 1980. That's when CDC noticed a sharp rise in the number of cases of TSS, a serious and sometimes fatal disease caused by toxin-producing strains of the Staphylococcus aureus bacterium. Experts believe the bacterium releases one or more toxins into the bloodstream.

Between October 1979 and May 1980, 55 TSS cases and seven deaths were reported. Most were among women who experienced onset of illness within a week following their periods. The TSS epidemic reached its peak in 1980 with a total of 813 cases of menstrual-related TSS, including 38 deaths, according to CDC.

CDC carried out national and state-based studies to pinpoint TSS risk factors and used its national surveillance system to track trends. Research suggested one factor was the use of very highly absorbent tampons made from new materials.

Studies showed that women who used Proctor & Gamble's Rely tampons were at substantially greater risk for TSS than other tampon users. This brand consisted of polyester foam and a special type of highly absorbent cellulose, a combination no longer used in tampons. "TSS was not limited to Rely, but it did play a major role," says Pollard. Proctor & Gamble voluntarily withdrew that tampon from the market in 1980, and competing manufacturers of tampons made from other superabsorbent materials began removing them as well.

TSS Cases Drop Dramatically

Compared with the 813 menstrual TSS cases in 1980, there were only three confirmed cases in 1998 and six in 1997. "Although there is some underreporting of cases, this is a real decline," says Rana Hajjeh, M.D., a medical epidemiologist with CDC's division of bacterial and mycotic diseases. She attributes the drop in TSS rates to the removal of Rely from the market and advances in the way FDA regulates tampon materials and absorbency. Women also are much better educated about TSS prevention, she says.

FDA took its first step to protect the public in 1982, when it required that all tampon labels include TSS warning signs. In addition, packages had to include a note that the risk of menstrual TSS can be reduced by not using tampons and by alternating tampons with sanitary napkins. FDA also required that labels advise women to use the lowest absorbency needed to control their flow. CDC studies suggested that, in general, higher tampon absorbency was related to higher TSS risk.

In response to CDC findings and FDA regulatory activities, manufacturers standardized and, in some cases, lowered tampon absorbency. "What's considered superabsorbent today is much less absorbent than superabsorbent tampons used in 1980," Hajjeh says. In 1980, 42 percent of tampon users used very high absorbency tampons, according to CDC. That number dropped to 18 percent by 1983 and to 1 percent by 1986.

In 1990, FDA standardized absorbency labeling, allowing women to compare absorbencies across brands. Before the regulation, super absorbency in one brand could have been the same as regular in another brand. Now, FDA's labeling requirements ensure that a Playtex junior absorbency has an absorbency range of 6 grams of fluid or under, just as an O.B. junior absorbency does (see "Understanding Absorbency").

FDA's Pollard points out that the material of the Rely tampon and its absorbency were very different from that of tampons on the market today. "FDA also has improved its premarket review process and has begun looking at additional tampon characteristics," he says. He adds that all tampon manufacturers, including those introducing new materials, report to FDA on absorbency, as well as on the safety of all components of a tampon, including the cover, string and applicator, and on the chemical composition of any fragrances and color additives.

Companies conduct clinical tests in tampon users to look for bacterial growth and adverse effects, such as allergies and ulceration, with tampon use. Through toxicological testing, manufacturers must show that the tampon will not enhance the growth of Staphylococcus aureus or increase the production of toxic shock syndrome toxin.

"This testing is ongoing for new tampon products," Richter says. "We continue to monitor tampons for safety issues."

FDA also tracks medical device problems through its MedWatch system, which allows consumers and health professionals to report adverse effects from FDA-regulated products.

Though TSS is extremely rare, tampon users should still be aware of it, says Richter. "All tampons are associated with the risk of TSS, and it's important for women to know the signs," she says. "If a woman becomes ill or has any concerns at all about TSS, she should remove her tampon immediately and contact her doctor." (See "TSS Warning Signs.")

Today, tampon manufacturers in this country produce tampons made of rayon, cotton, or a blend of the two. Cotton is commonly referred to as "natural," while rayon is considered "synthetic." But consumers shouldn't assume that "synthetic" means bad and "natural" means safer, says Jay Gooch, Ph.D., a toxicologist and senior scientist at Proctor and Gamble. Rayon is made from cellulose fibers derived from wood pulp. "Technically speaking, rayon is synthetic, but it's more like natural cellulose than it is different," Gooch says. "There is a lot of confusion out there about what rayon is and a lot of unsupported allegations about the safety of the two fibers." Previous CDC studies have found no increased risk with rayon versus cotton for the same absorbency and brand of tampon.

Other Tampon Ingredients

John McKeegan, spokesman for Johnson and Johnson, makers of O.B. tampons, says his company tells women who call with questions about the presence of cancer-causing dioxin in tampons that the company uses elemental chlorine-free bleaching, which does not produce dioxin.

Chlorine gas, which can produce a small amount of dioxin, used to be the bleaching agent for rayon used in tampons, says Gooch. "But elemental chlorine-free bleaching uses a chlorine dioxide agent. Chlorine dioxide may sound like chlorine gas, but they are two very different things," he says. Bleaching is necessary because all fibers have impurities associated with them that will inhibit absorbency. "Bleaching cleans and purifies raw material, but it does not leave toxins," he explains. And unlike what some people think, he adds, the white color of tampons is a consequence of the purification process, not an appearance goal.

Using a method approved by the Environmental Protection Agency, major tampon manufacturers have tested their products for dioxin. Data show that dioxin levels in tampons range from undetectable to 1 part in 3 trillion, far below the level that occurs through daily environmental exposure and considerably below the level FDA believes would put consumers at risk, Stratmeyer says.

"That doesn't mean that dioxin couldn't get there from another source," he adds. "You could end up with dioxin in rayon or cotton simply because of decades of pollution." It can be found in air, water or the ground before the wood pulp or the cotton is produced. "But what we know today is that you will find more dioxin already in your body than in any tampon," he says.

Many experts say the proof of tampon safety lies in its long history. But others want more research into diseases other than toxic shock syndrome. Rep. Carolyn Maloney (D-N.Y.) introduced the Tampon Safety and Research Act in 1997 and again in March 1999. The bill, which was referred to the Subcommittee on Health and Environment, proposes to provide NIH with research support to determine the extent to which dioxin, synthetic fibers, and other additives in tampons pose health risks such as cancer, endometriosis, infertility, and pelvic inflammatory disease.

But from FDA's perspective, there is no indication right now that such research is necessary, Stratmeyer says. "We are not aware of evidence that would call for a large-scale study on tampons' relation to these diseases."

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Michelle Meadows is a writer in Laurel, Md.

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