April 21, 2015 -- Rylie Whitten used tampons from the time she started getting her period, like most of her peers. She didn’t expect that using a different brand for a few hours at the end of her period would nearly kill her.
Tampons were implicated in a spate of toxic shock cases in the late 1970s and early 1980s that included some deaths. Although it’s been rare since then, the cluster of cases in Michigan has prompted an FDA investigation.
“The FDA wants to test to see if there are particular issues around these brands. But these brands have been used before. Is this a statistical blip or something we don’t know? We’ll learn more when the FDA concludes its investigation,” says Eden Wells, MD, chief executive officer of the Michigan Department of Health and Human Services.
Wells says she's unsure whether the five young women who fell ill with toxic shock had worn their tampons longer than recommended.
Menstruation-related toxic shock syndrome (TSS) seems to affect younger women. That's possibly because they haven’t had enough contact with a type of bacteria that can collect and grow in tampons called "staph A," so their bodies aren't primed to defend against the toxins of the bacteria, says Daliya Khuon, MD. She's a pediatric epidemiologist at the Helen DeVos Children’s Hospital in Grand Rapids, where Rylie and two other young women were treated.
“The only real conclusion I’ve been able to draw is that over time, as TSS has decreased in prevalence, it’s gone out of the public health consciousness, and maybe kids this age aren’t aware of it. There are package inserts, but how many people read package inserts?” Khuon says.
Tampon Companies Respond
The brands involved in the Michigan cases were Playtex Sport and U by Kotex tampons, Michigan's Health and Human Services department says.
Edgewell Personal Care, which owns Playtex Sport, says in a statement it has been in contact with the FDA and is “working to better understand the reports of toxic shock syndrome in Michigan.”
“We wish to remind women that Playtex tampons are safe when used as directed and meet all relevant FDA regulations,” the statement says.
Kotex encourages tampon users to read instructions and warnings about toxic shock syndrome in tampon packages, says spokesman Bob Brand. He says Kotex products “have to meet exacting safety and quality measures in our manufacturing process.”
A Tough Road to Recovery
Khuon says her hospital typically sees one person with toxic shock syndrome a year.
Rylie’s case and another Grand Rapids case were severe. The others were considered mild, Wells says.
Rylie, a violinist and member of her school’s dance squad, was on life support for a month.
She continues struggling with health problems -- she says she needs leg surgery to repair an artery. She also expects more physical therapy “and many more follow-ups,” she says.
What Can Cause the Disease?
After researchers identified the use of highly absorbent tampons as the culprit in toxic shock syndrome cases 30 years ago, the FDA began regulating these sanitary products as a medical device. It ordered tampon makers to place warnings on boxes and in package inserts, telling consumers to change tampons every 6-8 hours and avoid leaving them in overnight. Also, some tampon designs and some materials used in them were pulled from the market.
The number of menstruation-related toxic shock cases has dropped dramatically -- from nearly 14 in 100,000 in 1980 to about 1 in 100,000 menstruating women and 0.3% of the general population.
The disease is caused when toxins of Staphylococcus aureus (staph A) enter the bloodstream. A tampon is the perfect host -- its warmth and moistness allow for the collection and growth of bacteria. Using a highly absorbent tampon when menstrual flow isn’t heavy can cause vaginal dryness and tiny tears in the vaginal wall. That can allow toxins into the bloodstream to wreak havoc.
There are other causes of toxic shock, too. About half are from toxins entering wounds from surgery, burns, or postpartum or other wounds. About three-quarters of the cases happen in women.
Are Label Warnings Strong Enough?
Philip Tierno, PhD, a professor of microbiology at NYU School of Medicine, thinks the man-made fibers like rayon that are used in most tampons are better hosts of the bacterial toxins that cause toxic shock syndrome. He says all-cotton tampons, which are more expensive to make, would prevent it. The FDA disagrees, and research has been inconclusive on that point.
The agency released a short statement saying it is working with Michigan public health authorities to investigate the cases, and it's recommending that women “read and follow the instructions on tampon package labels to minimize their risk of TSS and to understand the warning signs.”
Rylie says her illness “changed my view of how precious life really is.
“And I definitely won’t use tampons anymore,” she says. “Sooo not worth almost dying.”
Tierno, meanwhile, says warnings on tampon boxes are too weak.
“I wanted warnings on tampon boxes to have a skull and crossbones. It makes you pay attention to the warnings, so [women] are aware of the symptomology and can go to the doctor or hospital and stop using the tampon immediately if they have these symptoms,” he says.
Take these steps when you use tampons:
- Wash your hands before inserting the product.
- Use the lowest-absorbency tampon you can.
- Use them for no more than 6 to 8 hours each, and switch to a pad at night.
- Use less-absorbent tampons as bleeding subsides.
If you have a high fever, sunburn-like rash, body aches, or diarrhea, then remove the tampon and get medical care right away.