No Overnight Solution

by Robb Cribb

While at least one manufacturer is touting overnight tampon use as safe, some medical professionals fear the move has created a medical time bomb, as the threat of toxic shock syndrome is reborn in a new generation of young women.

Sidebar Toxic Shock Syndrome

Marcie Peterson's voice begins to falter when she recalls the nightmare that took away her legs and four fingers -- all because she used tampons.

``I literally watched my feet rot off, my fingers on my right hand rot off, I was on life support machines, kidney machines and, for three weeks, I could only communicate by squeezing hands or blinking. I went through the pits of hell,'' says the Kansas woman, who had both legs amputated below the knees and lost the fingers after suffering from tampon-related toxic shock syndrome (TSS).

Now, she is incensed the threat of TSS may be reborn with an advertising campaign from Tampax, telling a new generation of young women tampons are safe to wear overnight.

``It angers me that making money outweighs seeing a young woman destroyed the way I was,'' says Peterson, who lost her limbs in 1980 at age 38.

For about a year, Canadian television viewers have seen commercials featuring teenage women -- all smiles and exuberance -- spreading the news over the din of pop music.

``Did you know that overnight you don't have to wear a pad,'' asks one of the young women.
``You're kidding!'' her friend answers.
``Not when there's Tampax Tampons.''

But some medical professionals are worried the marketing of tampons for overnight use will give rise to a new round of victims -- young women who may die, lose their limbs or become severely ill, as the threat of TSS remains very real and very dangerous -- but, for some reason, mostly forgotten.

``There's no question that advising women to use tampons overnight leads to an increased risk of serious disease or death,'' said Philip Tierno, a medical researcher at the New York Medical Centre, who has been studying tampon-related health problems in women for 15 years.

``Even one useless death is too many. I'm amazed by this marketing ploy.''

BLOODSTREAM: TSS is caused by a bacterially produced toxin -- called TSST-1 -- which enters the bloodstream. In menstruating women, the toxin has been found in the vagina and almost exclusively affects women who use vaginal tampons.

To stifle the growth of the bacteria, young women have been warned by mothers and doctors for decades tampon use was to be strictly limited to a few hours -- and never overnight.

Those warnings became a fanatical cry in the 1980s, when a rash of deaths due to TSS, mostly women who were menstruating and using tampons at the onset of the syndrome's symptoms, received international media attention.

Based on new research from ``leading gynecologists,'' Tambrands Inc., which makes Tampax tampons, says the one-time industry standard of four to six hours is dated. It now recommends tampons may be worn up to eight hours with no increased risk of health problems.

``There were no alterations made to the product,'' said Bruce Garren, of Tambrands. ``We at Tambrands took a very hard look at the old four- to six-hour time frame and found no increased risk using a tampon four to eight hours. It seems it was a historical common-sense approach to good hygiene which someone wrote years ago and was followed ever since.''

SLEEP LATE: But critics point out for young women, overnight use does not necessarily translate into a neat eight-hour time frame. It is likely a young woman may use a tampon in the evening and sleep until late the next morning, so the device could remain in the body as long as 12 hours, which greatly increases the health risk.

``My daughter often sleeps for 12 hours at a time,'' says Tierno. ``And no one can tell me that is safe.''

Of the reported cases of menstrual TSS, 99 per cent have occurred in tampon users. And about 70 per cent of menstruating women in North America use tampons.

The case-fatality rate for TSS is three to five per cent, usually due to respiratory failure or irreversible hypotension.

In some cases, women have had fingers and toes or part of their legs amputated due to a loss of circulation during shock.

Peterson says the four fingers on her right hand began turning black and falling off near the middle joints about nine months after her TSS attack.

``The skin on my fingers curled up and you could see the bone deteriorating inside,'' she says. ``One day, I was dusting the TV and I heard a crunch and I looked down and there was my finger on the floor.''

The fingers on the Wichita woman's left hand also remain numb at the ends 14 years after suffering from the syndrome.

And while many believed the toxic shock death scare ended years ago, the disease continues to claim lives.

In 1992, a 22-year-old woman from Charlesbourg, Que., died of TSS, as did a 44-year-old Oklahoma woman -- and both deaths were linked to the use of rayon tampons.

The U.S. Centres for Disease Control and Prevention in Atlanta received 216 reports of toxic shock syndrome cases last year and 244 cases in 1992.

No similar statistics have been compiled for TSS in Canada, mainly because doctors are not forced by law to report the syndrome the way they are with diseases such as AIDS.

Experts say only about 10 per cent of all TSS cases are recorded due to unreliable reporting, the fact that doctors are more capable of handling TSS cases in the emergency room than they once were, and because many women suffer more mild, flu-like forms of the illness.

RISK: Many observers say the already hidden prevalence of TSS may increase as Tambrands' overnight claim makes tampons a new choice for women hoping to take advantage of their comfort and cleanliness without having to worry about the health risk traditionally associated with overuse.

The age group Tambrands is targeting with its new overnight campaign wasn't menstruating during the TSS scare of the '80s.

The company's literature, included in the tampon packaging, warns: ``The risk of developing TSS is higher for teenage girls and women under 30 years of age . . . .''

Patients with menstrual TSS ranged from 11 to 60 years of age, but almost 60 per cent were between 15 and 24 years old. And 98 per cent were white.

Ann Montgomery, a Toronto biochemist who has researched tampon-related TSS, says the new advertisements for overnight use sends a dangerous message to young women.

``Their bodies have never seen the (TSS) toxin before and their immune system has not had the opportunity to build up the immunization process. They're getting all of their information from TV but they aren't being told about the dangers.''

Both Playtex and Johnson and Johnson (which makes OB tampons) continue to recommend four- to six-hour use for their tampons

The toxic shock causing bacteria, called staphylococcus, thrives on synthetic fibers such as rayon or viscose, found in all major tampon brands.

Tierno says that according to his research, only all-cotton tampons are safe to wear overnight.

Wilhemina Nolan, a 39-year-old, who suffered TSS symptoms when she was 15, owns a Toronto store called Bio Business International, which imports a brand of all-cotton tampons called Terra Femme.

"Overnight use is a particular problem when you are wearing a tampon made of rayon." Nolan says, "Rayon fibers actually amplify the growth of the toxin which causes TSS."

LAWSUIT: In May, three lawyers in the United States filed a class-action lawsuit against Tambrands Inc. and Playtex Family Products Corp., alleging the manufacturers refuse to change to all-cotton tampons despite having known for at least a decade that rayon puts women at risk.

If successful, the suit will likely be turned into a global suit affecting Canadian victims.

"These manufacturers treat TSS victims as the cost of doing business." said Bob Perkins, a Kansas City lawyer involved in the suit. "Their own research has shown that their product is killing and maiming women, but it makes more business sense to continue using rayon and pay off any lawsuits from injured women as they arise."

The tampon industry is worth about $650 million in the United States alone. All three major tampon manufacturers have worldwide distribution.

Depending on the degree of permanent injury a claimant has sustained, avarage settlements with tampon manufacturers range from $25,000 to several millions of dollars, says Mark Hutton, a Kansasa lawyer also involved in the suit who has represented as many as 400 TSS victims since 1960, about 20 of whom had died

Hutton worked on one of the largest TSS settlements ever in North America- worth 11.5 million- involving a 21-year old Kansas mother of two who died after using a Playtex product in 1986.

So if all-cotton tampons provide a completely safe alternative to synthetics, why haven't tampon manufacturers simply changed in an effort to avoid negative publicity and finantial loss?

Perkins, who has represented about 200 TSS victims since the mid-'80s, says tampon manufacturers have resisted change because the cost of pure cotton is prohibitive and the companies would have to retool their equipment at a significant cost.

"And another big element here is that these manufacturers have already represented to their insurance carriers that their product is safe, so taking the rayon product off the market would be equivalent to admitting that their product is dangerous," said Perkins.

QUALITY As well, a move to cotton would make tampon manufacturers vulnerable to the fluctuating quality and cost of cotton crops, which could lead to significant finantial losses.

Garren says the reason his company hasn't changed to all-cotton production is simple - rayon is perfectly safe even when worn overnight and even when the wearer oversleeps beyond the prescribed eight-hour time limit.

But Health Canada isn't so sure

The Federal department, which monitors health product claims and performance, recently ordered Tambrands to remove the crescent moon on its packaging which heralds the safety of overnight use.

"We remain a little unhappy with what Tampax may have done." said William Freeland, acting division chief of the device evaluation of Health Canada. "When they say 'overnight,' it's not the same thing as saying eight hours." "'Overnight' will not stand by itself because it has no specific time with it."

Mary-Jane Bell, a scientific evaluator in Health Canada's device evaluation division, says that while there is probably no health risk if a woman wears a tampon for an hour or two past the eight-hour time limit,"I would not want to get into 10 or 14 hours. Personally, I don't recommend overnight use at all."

ADVISORY: An advisory fact sheet on menstural tampons from the Health protection branch of Health Canada in Febuary continues to urge women to "change tampons every four to six hours," and use "external protection overnight"

In fact, most health professionals continue to advise their patients against overnight tampon use despite the claims of new research being provided by tampon companies.

Liz Armstrong, co-author of the 1992 book, Whitewash, which explored the issue of chlorine content in menstural products and diapers, says tampon companies regularly downplay the possible health risks of TSS when marketing their products.

"There's an awful lot of nonsense in this kind of overnight recommendation." sais Armstrong, who lives in Erin, north of Toronto. "It's expedient for them to gloss over some of the problems associated with tampon use."

MARKETING STUNT: Indeed, some health professionals are also suspicious that the move to overnight use may be a marketing stunt based on self-funded research, in order to improve sales for Tampax, which already has about 50-per-cent of the tampon market share in the US and Canada.

"I never believe advertising," said Smith. "Any drug company tends to have their stable of doctors that substantiate that company's claims. You take everything with a grain of salt."

Tierno and his research partner Bruce Hanna are the only two independent tampon researchers in North America who aren't funded by tampon companies which retain the option of reviewing the research and may prevent researchers from publishing their findings in some cases.

"The bulk of medical researchers who are talking are paid by tampon companies - people who need to keep their grants worth hundreds of thousands or even millions of dollars going," said Tierno. "It's more than just playing politics with research - we're talking about life and death for tampon manufacturers here."

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