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Updated: Thursday, 19 May 2011, 5:21 PM EDT
Published : Tuesday, 17 May 2011, 11:12 PM EDT
INDIANAPOLIS (WISH) - Our investigation "Toxic Shock" is already prompting national change for millions of women in this country. I-Team 8 has uncovered toxic shock syndrome cases here in Indiana, with a young girl dying as recently as last summer. But more than 30 years after this story first made headlines, the question is why.
Part 1: What's killing Indiana women? | Watch the video
Amy Elifritz, Columbus, Ind., thought she had the flu. Within days, the 20-year-old died from toxic shock syndrome that was related to tampon use.
"She walked into the hospital," Amy's mom, Lisa Elifritz, remembered. “She walked in, and within two days she was gone.”
Another victim of the illness, Brittany Kanovsky, 15, survived but had to have part of her toes amputated. Her family said their doctor believes a piece of tampon fiber broke off and dissolved into her bloodstream.
Toxic Shock Syndrome made headlines in 1980, when 38 women died from using tampons.
"I said, 'This is it. This is the reason for toxic shock syndrome,'" said Philip Tierno, PhD, a microbiologist at New York University Langone Medical Center as he held up a box of Rely tampons.
The "Rely" brand tampon was pulled off the market.
As he showed the inside of a tampon, he noted: "These little white chips are carbo-methocellulose".
In his lab, Tierno found that was one of four synthetic fibers creating what he calls a "toxin factory". He said the fiber - still on the market - is still a toxin.
"The first three were taken off the market primarily because they were killing women, and there was a lot of litigation, " Tierno said.
The fourth synthetic, Viscose rayon, remains in use, to make tampons absorbent.
Some scientists believe toxic shock is no longer an issue. Two scientists wrote about it in the Journal of Infectious Diseases, saying rayon tampons are as safe as cotton tampons. Tierno and other scientists disagree.
I-Team 8 wanted to know if it toxic shock deaths are still happening, and if young girls are dying, why aren't people hearing about it?
"I think much of the litigation is hush-hush," Tierno answered.
The doctor has been at the center of the debate for 31 years. He often testifies against the tampon manufacturers.
"My research clearly showed any synthetic can amplify the toxin TSS T1," he said.
As early as 1982, the FDA was asked to require ingredient labeling for tampons, yet the FDA declined.
Five years later, the Centers for Disease Control finds women are more likely to get toxic shock with the more absorbent tampons. Again, the FDA waited another 8 months to respond.
In 1989, a lawsuit was filed against the FDA. Several federal officials were accused with unreasonable delay in failing to regulate tampons. A judge ruled the FDA "failed to adequately inform and protect the public."
Meanwhile, lawsuits piled up. A Kansas mother died. The judge found Platyex "disregarded the studies and medical reports linking high absorbency tampon fibers."
In 1988, then-teenager and Indianapolis resident Krystal Rinehart won a lawsuit against Playtex, alleging the warning statement on the packaging was inaccurate. She was 16 at the time.
Then in 2000, 20 years after the first round of deaths, the FDA amended the regulation of tampons with new rules on absorbency.
"One thing we learned from 1980 is absorbency plays a role in toxic production,” Tierno said.
But what about the Centers for Disease Control? TSS isn't reportable to the CDC, but it gives out numbers on potential deaths. We wanted to know why, and we have been repeatedly asking the governmental agency for a full month. We still haven't received a reply.
The tampon box will tell you 1 to 17 of every 100,000 menstruating women per year will get toxic shock syndrome.
The Indiana State Department of Health only has numbers from 2009. One death is on record.
A New York congresswoman first tried 13 years ago to pass legislation to fund research to determine if dioxin posed a risk in tampons. The legislation repeatedly, year after year, never made it out of committee.
Our investigation and pushing for answers has prompted the congresswoman to bring back the legislation.
"See, you single-handedly got her to take a look at this again," Tierno said after talking with the congresswoman.
"Given the sheer number of women who use these products and the potential cumulative adverse effects, it's time women have definitive answers about the potential risk these products pose to their health," said Rep. Carolyn B. Maloney (D-NY).
Even today, the FDA does not independently test the amount of dioxin released when tampons are used. But in a separate case, a 1994 report from the EPA clearly states dioxins are a "probable human carcinogen ... ought to be a great cause of concern".
Asked if the warning label on tampon packaging is enough, Tierno answered: "No, it's not bold,” and said he’d like to see a skull and crossbones icon on the box.
Those at highest risk of toxic shock are younger girls just starting their periods,
ages 15-20. Tierno said they are least likely to have antibody protection from the tampon toxin. He said young girls need to wear a pad a night and notes changing a tampon isn’t enough. He said the body needs eight hours for the toxin to dissipate. He said he believes all-cotton tampons would be safer.
I-Team 8 found at least one tampon manufacturer specifically targeting young girls.
The 2007 annual report from Playtex says: "Our Feminine Care marketing strategies ... caters to the active, young female. It centers on attracting first-time users, converting full-time feminine protection pad users to tampon users."
"The biggest people not listening are the tampon manufactures. It's as simple as that," Tierno said.
I-Team 8 called all the major tampon manufacturers. Only two returned our calls looking for comment.
We heard back from Proctor & Gamble the afternoon the story was going to air. They sent two studies that demonstrate cotton and rayon are equally safe. They say their work "directly refutes earlier research suggesting otherwise."
A spokesman for Kimberly Clark, maker of Kotex, didn't believe they had research on toxic shock syndrome but agreed to give a statement in writing. I-Team 8 never heard back.
Rep. Maloney said she plans to introduce the legislation in the next session.
And Amy Elifritz’s mom has launched a social media campaign and a non-profit to spread the word to young girls and doctors that toxic shock did not go away with the '80s.