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Tampon Safety
Safer, Healthier,
Environmentally-Friendly
Feminine Hygiene Products,
Information, Education and Resources
www.TamponSafety.com
Femgyn Inipads are like a pantyliner - but NOT a pantyliner..... Femgyn Inipads are like a tampon, but not a tampon! Our new Femgyn Inipads are similar to the previous "inter labial pads" in that they are placed between the labia minora (smaller lips) of a woman's vulva, on the outside of her vagina, and not in the vagina (picture below) like tampons.Best of all, our Femgyn Inipads are made from 100% certified organic cotton, the safest and best material that can be used for feminine hygiene.... with no adhesives or harsh chemicals are used! Our Femgyn Inipads
stay in place naturally in the "interlabial" space between a
woman's labia minora without any harsh chemicals or adhesives. |
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Tampon Safety
Feminine Hygiene, Gynecology & Menstruation Education, Information and Resources for Dads & Husbands
Tampon Facts and Information About Tampon Usage in the United States
About 70% of the 73 million women are of menstruating age in the U.S. use tampons.
Lifetime tampon usage is about 11,400 tampons per woman! This number based on each woman having 5 days of menstrual bleeding/month x 5 tampons used per day x 38 years
In the U.S., women between 11 and 60 years of age reported 216 cases of menstrual TSS reported in 1993; 244 cases in 1994
The risk of TSS is higher for women under 30 years old; 60% of patients are between 15 and 24 years of age
The fatality rate of TSS is 3% to 5%, but it is estimated that only 10% of cases of TSS are reported, as many women suffer only flu-like symptoms
Absorbency enhancers in tampons can cause peeling of the mucous membrane, vaginal dryness, ulcers, and lesions
Perfumes and fragrances in some tampons are reported to cause vaginal irritation, allergic reactions, and disruptions of a woman's microbial balance
"Tampon users were demonstrated to be 18 times more likely to develop menstrual TSS as non-users", Infectious Diseases in Obstetrics & Gynaecology, 1993, Gilles R.G. Monif
"of [Toxic Shock] cases occurring in menstruating women, up to 99% were using vaginal tampons", Obstetrics and Gynaecologic Infectious Disease, 1994, James McGregor and James Todd, (Chapter 21 - Toxic Shock Syndrome)
"Vaginal inflammation can result from rayon fibres from tampons becoming embedded in vaginal walls", Journal of Obstetrics and Gynaecology, 1980
Tampons made chiefly of rayon have some levels of dioxin.
"Rayon tampons amplify the growth of the Toxic Shock Syndrome bacteria TSST-1" American Society for Microbiology Journal, May 1994, Dr. Philip Tierno of NYU Medical Center
Dioxin levels once thought acceptable are now reported to adversely affect the reproductive and immune systems, "A Health Assessment Document for Dioxin", published by the Environmental Protection Agency, 1996
"Cotton tampons offer no protective advantage over cotton/rayon tampons with regard to protection from TSS" Journal of Infectious Diseases, October 1995 (study by Dept. of Microbiology, University of Minnesota.
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
Chlorine gas, which can produce a small amount of dioxin, used to be the bleaching agent for rayon used in tampons. "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."
Symptoms of toxic shock syndrome can be hard to recognize because they mimic the flu. If you experience sudden high fever, vomiting, diarrhea, dizziness, fainting, or a rash that looks like a sunburn during your period or a few days after, contact your doctor right away. Also, if you're wearing a tampon, remove it immediately. One or two weeks after initial symptoms begin, flaking and peeling of the skin occurs, mainly on the palms and soles. If your doctor determines that your symptoms are TSS, you will probably be sent to a hospital for treatment. With proper treatment, patients usually get well in two to three weeks.
Women under 30, especially teenagers, are at a higher risk for TSS, because some females that age may not yet have antibodies to the toxin. Using any kind of tampon--cotton or rayon of any absorbency--puts a woman at greater risk for TSS than using menstrual pads.
Absorbency--the rate at which a tampon absorbs or soaks up menstrual blood--is measured in grams of fluid. Research suggests that the risk of toxic shock syndrome may increase with tampon absorbency. But that doesn't mean you have to steer clear of higher absorbency tampons completely, according to Colin Pollard, chief of FDA's obstetrics and gynecology branch. "You should match absorbency to your flow," he says. For a lighter flow, use regular or junior absorbency. If your tampon absorbs as much as it can and has to be changed before four hours, you may want to try a higher absorbency. There's usually less need for higher absorbency when your period is ending.
When you shop, you'll find these absorbency terms and ranges on all tampon packages:
Junior absorbency: 6 grams and under
Regular absorbency: 6 to 9 grams
Super absorbency: 9 to 12 grams
Super plus absorbency: 12 to 15 grams
According to the American College of Obstetricians and Gynecologists, your tampon is probably too absorbent if the tampon is hard to remove, you experience vaginal dryness, if a tampon shreds, or if it doesn't need to be changed after several hours. Vaginal dryness and ulcerations may occur when a tampon is too absorbent for your flow.
The strategy had worked for years, says Tracy, 28. She always inserted a small tampon on the morning she expected her period. But a few years ago, her period started one day late. "By the time it came, I had forgotten about the first tampon," she says. "The bleeding was so heavy that I figured I must not have had one in. So I put another one in."
All day she changed her tampon every few hours like she normally does. Then on one trip to the bathroom that night, she noticed a second string. When she finally removed the first tampon, the mild cramps she had experienced all day worsened. The pain became so intense she couldn't walk. Severe cramps and heavy bleeding ultimately landed her in the emergency room.
Putting in a tampon and forgetting about it is rare, but it does happen, says Gerald Joseph, M.D., former chairman of the department of obstetrics and gynecology at the Ochsner Medical Foundation. Joseph says he sees such cases--mostly among women under 30--a few times each year. Joanne, 44, says she forgot once and didn't realize the tampon was still there until six days later when she went to her doctor complaining of foul odor and vaginal discharge.
FDA recommends the following tips to help avoid tampon problems:
Follow package directions for insertion.
Choose the lowest absorbency for your flow.
Change your tampon at least every 4 to 8 hours.
Consider alternating pads with tampons.
Know the warning signs of toxic shock syndrome.
Don't use tampons between periods.
The Truth About Tampons
By Catherine-Elliott Lopez
Fall 1998
Swedish studies have shown a link between tampons containing dioxin, and other chlorine by-products, and an increased risk of cancers of the female reproductive tract (especially the uterus, ovaries and bladder).
Rayon itself poses another risk. Unknown to most women, rayon and rayon-cotton blend fibers are widely used in commercial feminine hygiene products. Rayon used to make tampons is usually treated with chemicals to increase the absorption capability.
These super absorbent fibers then absorb not only the menstrual blood, but normal vaginal secretions as well, causing drying, and ulceration of vaginal tissues. The fibers can also become imbedded in the vaginal walls. Rayon fibers have been scientifically proven to amplify the production of Toxic Shock Syndrome Toxin TSST1.
Toxic Shock Syndrome is a rare bacterial illness that caused over 50 deaths between 1979 and 1980. Unlike medical grade cotton, upon which the TSS toxin will not grow, the rayon acts like a petri dish encouraging bacterial growth. What makes these toxic residues even more disturbing, is that they come in direct contact with some of the most absorbent tissue in a woman's body.
According to a doctor at New York University Medical Center, almost anything placed on this tissue, including Dioxin, gets absorbed into the body.
Why is it acceptable to have toxic substances in our feminine hygiene products? The tampon industry is convinced that women need bleached white products. They seem to think that we view this as "pure" and "clean." The fact is, if Dioxin puts women at risk for cancer and Dioxin is stored in fatty tissue (just like that found in the vagina), and a woman uses as many as 11,000 tampons in her lifetime, could the long term use of tampons increase cancer risk?
An FDA report said that "the most effective risk-management strategy would be to assure that tampons, and menstrual pads, contain no Dioxin." Although the FDA currently requires tampon manufacturers to monitor Dioxin levels, the results are not available to the public. The dioxin tests, are done by the manufacturers themselves, who insist their products are safe. Tampon manufacturers are not required to disclose ingredients to consumers, although many will do so voluntarily.
How much Dioxin exposure is considered safe for humans? Why has there been more research done on the possible health effects of chlorine-bleached coffee filters than on chlorine bleached tampons and related products? Women need to demand that more research be done on these issues. We have a right to know about any potential hazards associated with tampons and related products. It is only when women fully understand the consequences that we can make informed decisions regarding our health and well being.
Writer's note: Currently there are only a few non-chlorine bleached all cotton tampons available in the US. Ask about them at your local store, if they are not available, ask them to special order!
The
Pros And Cons Of Tampons
The type of tampon you choose may affect your health
By Laurel Kallenbach
Today's average woman uses an estimated 12,000 tampons in her lifetime, a convenience that allows an unprecedented freedom to be active and confident in avoiding embarrassing leaks. We've come a long way since rags pinned into undergarments or belted-on bulky pads were the norm, but with our freedom comes risk. There are potential problems attached to tampon use that every consumer should know about: Chlorine-bleached products, as some tampons are, contain traces of carcinogenic dioxins. Highly absorbent tampons may still cause toxic shock syndrome, a potentially fatal bacterial infection that occurs when tampons are worn for too long. There are even environmental ramifications, including pesticides sprayed on cotton crops and pollution created when tampon ingredients are bleached.
But,
there are safe and ecological alternatives that enable women to still benefit
from tampons. Here, natural is the rule of thumb. "Plainer is just better
when it comes to tampons," says Pam Chandler, a family nurse practitioner
and certified nurse midwife who practices at the holistic clinic Wellspring for
Women in
Dioxin
Dilemma
The most urgent tampon health concern is that chlorine-bleached and
rayon-containing products carry trace amounts of dioxin, an extremely toxic
chemical that is associated with cancer of the stomach, sinus lining, liver and
lymph system. Many people are familiar with the danger of dioxins from publicity
about Agent Orange and the
Check your tampon box for a list of ingredients. Whereas natural brands state that they're nonchlorine bleached, some conventional brands mention little on the subject, because along with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), they believe chlorine-dioxide bleaching is safe.
Tierno disagrees: While trace quantities of dioxin aren't in and of themselves a problem, tampons aren't your only exposure. "The problem is that measurable amounts of dioxins are everywhere, including food and water. Some portion of the dioxin that enters your bloodstream lodges in the body's fat cells and stays there a long time," he says. "This residual effect becomes progressively larger as you're exposed to even more dioxins."
The only way to avoid vaginally absorbed dioxin, Tierno says, is to eliminate chlorine-bleached and rayon-containing tampons and switch to peroxide-bleached products instead. Tierno also says if the label on your tampon box doesn't say "nonchlorine-bleached," it's possible that it contains chlorine. Most manufacturers proudly promote the fact that their product doesn't contain chlorine.
The cumulative risks of dioxin are unknown. While a single tampon may contain only 0.1 parts per trillion of dioxin, the fact that most women use between 10,000 and 15,000 tampons in a lifetime increases the exposure. "A trace quantity of dioxin is not acceptable in a tampon, because a woman does not expose herself to a single tampon," Tierno says. "It's trace quantity upon trace quantity upon trace quantity, multiplied by the number of tampons per month, multiplied by the number of months in a year, multiplied by 40 years of menstruation. Then add in all the dioxins you get from your diet, plus all the ones occurring in the environment."
Earth-friendly
Options
The environmental impact of the manufacturing of feminine products is another
reason to use organic tampons. While cotton tampons may seem better than
synthetic, most cotton undergoes industrial bleaching in a polluting process
that dumps dioxins, along with other hazardous organochlorines, into the water
supply. Organic cotton tampons and pads are treated with hydrogen peroxide
instead of bleach, making them a safer alternative. If the label states that the
product is third-party certified organic, that means the cotton has been grown
without pesticides on land where no pesticides have been applied for at least
three years.
In response to concerns over dioxin in tampons and their impact on the environment, the EPA and some manufacturers have worked to find a better way of purifying wood pulp and cotton without creating dioxins. The result is chlorine-dioxide bleaching, a process that has replaced the elemental chlorine-gas method of the past but still generates low trace levels of dioxins.
The packaging of tampons is another troublesome environmental issue. Most are encased in a paper or cellophane wrapper, contain a cardboard or plastic applicator, and are packed in boxes. Though you can't recycle cotton tampons, there are waste-saving alternatives to dealing with menstruation, such as washable natural sponge tampons and cloth pads, and reusable, but awkward, vaginally inserted menstrual cups that collect flow.
Toxic
Shock: Still A Risk
In the '70s and '80s, toxic shock syndrome (
"Highly absorbent tampons, especially those containing synthetic fibers, increase the amounts of toxin present in the vagina," says Tierno.
In the mid-'70s, synthetic fibers were used in tampons because manufacturers wanted to produce more absorbent, leak-resistant products. Since then, three of the four problematic synthetics have been eliminated from tampons. "The only one left is viscose rayon," Tierno says.
To
minimize your risk of contracting
Most
precautions for guarding against
Choosing
a tampon with proper absorbency is crucial to preventing
Careful
Liberation
Within the last couple of years, a rash of e-mails warned women that tampon
manufacturers put asbestos in their tampons to make women bleed more in hopes of
selling more product. Tierno says the rumor was false. "I have been privy
to every manufacturer's records over the last 21 years, and I have never seen
anything related to asbestos in tampons," he says.
Though the asbestos scare amounted to nothing but an urban myth, true additives to be concerned about are fragrances and deodorants. Perfumes may mask odors, but some women suffer allergic reactions to them. "Without question, a deodorized tampon is dangerous," asserts Tierno, adding that deodorants encourage overgrowth of certain bacteria, upset the vagina's normal flora and irritate the mucous membrane.
The
main point, when it comes to tampon use, is to stay informed and weigh the
options. "Over the years, tampons have allowed women to be more active and
fuss less during their periods," says
What
is Toxic Shock Syndrome?
Toxic
shock syndrome is a rare infection that can happen during a woman's period. The
symptoms include a sudden fever of over 101 degrees or more, diarrhea (the
runs), vomiting (throwing up), muscle aches and a sunburn-like rash. If you have
these symptoms during you period, see a doctor right away.
To
help prevent toxic shock syndrome, you should follow these guidelines:
1.
Wash your hands before unwrapping and placing a new tampon in your vagina.
2.
Never use super-absorbent or deodorant tampons.
3.
Change your tampon at least every 4-6 hours (read the tampon manufacturers
information inside the box).
4.
Do not use tampons all the time and switch to a pad for part of each day.
5.
Do not use a birth control sponge or diaphragm during your period. During your
period it is preferable to use other methods such as condoms and/or foam.
There are allegations that tampons made from rayon, or cotton with rayon, may cause or be a contributing factor to Toxic Shock Syndrome, as well as vaginal dryness or ulcerations of vaginal tissues.
Toxic Shock Syndrome is a rare but potentially fatal disease caused by a bacterial toxin. (Different bacterial toxins may cause Toxic Shock Syndrome, depending on the situation, but most often streptococci and staphylococci are responsible.) The number of reported Toxic Shock Syndrome cases has decreased significantly in recent years. Approximately half the cases of Toxic Shock Syndrome reported today are associated with tampon use during menstruation, usually in young women. Toxic Shock Syndrome also occurs in children, men, and non-menstruating women. In 1997, only five confirmed menstrual-related Toxic Shock Syndrome cases were reported, compared with 814 cases in 1980 [according to data from the Centers for Disease Control and Prevention (CDC)]. Although scientists have recognized an association between Toxic Shock Syndrome and tampon use, the exact connection remains unclear. Research conducted by the CDC suggested that use of some high absorbency tampons increased the risk of Toxic Shock Syndrome in menstruating women. A few specific tampon designs and high absorbency tampon materials were also found to have some association with increased risk of Toxic Shock Syndrome. These products and materials are no longer used in tampons sold in the U.S. Tampons made with rayon do not appear to have a higher risk of Toxic Shock Syndrome than cotton tampons of similar absorbency.
Vaginal dryness and ulcerations may occur when women use tampons more absorbent than needed for the amount of their menstrual flow. Ulcerations have also been reported in women using tampons between menstrual periods to try to control excessive vaginal discharge or abnormal bleeding. Women may avoid problems by choosing a tampon with the minimum absorbency needed to control menstrual flow and using tampons only during active menstruation.
To help women compare absorbency from brand to brand, FDA requires that manufacturers measure absorbency using a standard method and describe absorbency on the package using standardized terms. Thus, the terms "junior," "regular," "super," and "super plus," always describe a specific range of tampon absorbency regardless of the brand.
Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome -- United States, 1980-1990
In May 1980, investigators reported to CDC 55 cases of toxic-shock syndrome (TSS) (1), a newly recognized illness characterized by high fever, sunburn-like rash, desquamation, hypotension, and abnormalities in multiple organ systems (2). Fifty-two (95%) of the reported cases occurred in women; onset of illness occurred during menstruation in 38 (95%) of the 40 women from whom menstrual history was obtained. National and state-based studies were initiated to determine risk factors for this disease. In addition, CDC established national surveillance to assess the magnitude of illness and follow trends in disease occurrence; 3295 definite cases have been reported since surveillance was established (Figure 1).
In June 1980, a follow-up report described three studies which detected an association between Toxic Shock Syndrome and the use of tampons (3). Case-control studies in Wisconsin and Utah and a national study by CDC indicated that women with Toxic Shock Syndrome were more likely to have used tampons than were controls. The CDC study also found that continuous use of tampons was associated with a higher risk of Toxic Shock Syndrome than was alternating use of tampons and other menstrual products. Subsequent studies established that risk of Toxic Shock Syndrome was substantially greater in women who used Rely brand tampons than in users of other brands and that risk increased with increased tampon absorbency (4-6). In September 1980, Rely tampons were voluntarily withdrawn from the market by the manufacturer.
In 1980, 890 cases of Toxic Shock Syndrome were reported, 812 (91%) of which were associated with menstruation. In 1989, 61 cases of Toxic Shock Syndrome were reported, 45 (74%) of which were menstrual. In 1980, 38 (5%) of 772 women with menstrual Toxic Shock Syndrome died; in 1988 and 1989, there were no deaths among women with menstrual Toxic Shock Syndrome. Reported by: Meningitis and Special Pathogens Br, Div of Bacterial Diseases, Center for Infectious Diseases, CDC.
On July 22, this notice was posted as an MMWR Dispatch on the MMWR website (http://www.cdc.gov/mmwr).
On July 19, 2005, the Food and Drug Administration (FDA) issued a public health advisory regarding the deaths of four women in the United States after medical abortions with Mifeprex® (mifepristone, formerly RU-486; Danco Laboratories, New York, New York) and intravaginal misoprostol (1). Two of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these U.S. cases had clinical illness consistent with toxic shock and had evidence of endometrial infection with Clostridium sordellii, a gram-positive, toxin-forming anaerobic bacteria. In addition, a fatal case of C. sordellii toxic shock syndrome after medical abortion with mifepristone and misoprostol was reported in 2001, in Canada (2). All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension, multiple effusions, hemoconcentration, and a profound leukocytosis. C. sordellii previously has been described as a cause of pregnancy-associated toxic shock syndrome (3).
Investigation by FDA, CDC, and state and local health departments into the two most recently identified U.S. deaths after medical abortion is ongoing. Empiric therapy for patients suspected of having postpartum or postabortion toxic shock syndrome should include antimicrobials with anaerobic activity against Clostridium species. Health-care providers are encouraged to report any cases of postpartum or postabortion toxic shock syndrome to their state or local health department and to CDC at telephone 800-893-0485. Cases potentially associated with use of mifepristone or misoprostol should also be reported through the FDA MedWatch system available at http://www.fda.gov/medwatch/index.html or telephone 800-FDA-1088.
Food and Drug Administration. FDA Public Health Advisory: sepsis and medical abortion. Rockville, Maryland: Food and Drug Administration, Center for Drug Evaluation and Research; 2005. Available at http://www.fda.gov/cder/drug/advisory/mifeprex.htm.
Sinave C, Le Templier G, Blouin D, Leveille F, Deland E. Toxic shock syndrome due to Clostridium sordellii: a dramatic postpartum and postabortion disease. Clin Infect Dis 2002;35:1441--3.
McGregor JA, Soper DE, Lovell G, Todd JK. Maternal deaths associated with Clostridium sordellii infection. Am J Obstet Gynecol 1989;161:987--95.
Editorial Note: The number of Toxic Shock Syndrome cases reported annually to CDC has decreased substantially in the 10-year period since menstrual Toxic Shock Syndrome was first recognized. Changes in public awareness and diminished attention to Toxic Shock Syndrome in the medical literature might have resulted in reduced diagnosis and reporting. However, reporting of non-menstrual Toxic Shock Syndrome has remained constant during this time while menstrual Toxic Shock Syndrome reporting has decreased.
A multistate active surveillance study in 1986-1987 confirmed the trends detected by national passive surveillance (7). Through active case-finding efforts in an aggregate population of 34 million persons, the rate for menstrual Toxic Shock Syndrome was determined to be 1.0 per 100,000 women 15-44 years of age (7). This rate represented a substantial reduction from rates reported in similar studies in 1980 (6.2 per 100,000 women 12-49 years of age in Wisconsin (8), 9.0 per 100,000 women 12-45 years of age in Minnesota (9), and 12.3 per 100,000 women 12-49 years of age in Utah (10)). Active surveillance also confirmed that the proportion of Toxic Shock Syndrome associated with menstruation had decreased considerably: in 1988, menstrual Toxic Shock Syndrome accounted for 55% of cases detected both by active surveillance (7) and by the passive surveillance system.
A principle reason for the decreased incidence of menstrual Toxic Shock Syndrome may be decreases in the absorbency of tampons. In 1980, when tampon absorbency (in vitro) ranged from 10.3-20.5 g (4), very high absorbency products ( greater than 15.4 g) were used by 42% of tampon users (9). After the association between Toxic Shock Syndrome and absorbency was recognized, manufacturers lowered the absorbency of tampons. In 1982, the Food and Drug Administration (FDA) issued a regulation requiring that tampon package labels advise women to use the lowest absorbency tampons compatible with their needs. By 1983, tampon absorbency ranged from 6.3-17.2 g (6), and the proportion of tampon users using very high absorbency tampons had declined to 18%. By 1986, very high absorbency products were used by only 1% of women who used tampons. Effective March 1990, the FDA instituted standardized absorbency labeling of tampons, which currently range from 6-15 g.
Tampon composition has also changed since 1980. Rely tampons consisted of polyester foam and cross-linked carboxymethylcellulose, a combination that is no longer used in tampons. Polyacrylate-containing tampons were withdrawn from the market in 1985. Current tampons are manufactured from cotton and/or rayon. The unique composition of Rely tampons may have been responsible for the increased risk associated with those products (11); however, the role of current tampon composition as an independent risk factor for Toxic Shock Syndrome is unclear since composition may vary even for a particular brand and style of tampon marketed at a given time.
Other factors may have contributed to decreased reports of menstrual-related Toxic Shock Syndrome. For example, public awareness of the syndrome may cause women to seek medical care earlier in their illness; milder disease may not meet the surveillance case definition of severe multisystem illness. Increased variety in menstrual products and concern related to Toxic Shock Syndrome may have resulted in fewer women using tampons or fewer using tampons continuously.
Current public health efforts to prevent menstrual-related Toxic Shock Syndrome include tampon package labels and package inserts which describe early signs and symptoms of Toxic Shock Syndrome and warn the consumer about the risk associated with tampons. Tampon users are encouraged to select lower absorbency products to further decrease risk of Toxic Shock Syndrome. Standardized absorbency labeling permits consumers to compare absorbency between brands.
The precise mechanism by which Rely tampons increased the risk of Toxic Shock Syndrome is unknown. The increased risk associated with high absorbency tampons is also poorly understood; high absorbency may be a surrogate for another effect. However, the withdrawal of Rely tampons and the subsequent decrease in use of high absorbency tampons correlate with a marked decrease in incidence of menstrual-related Toxic Shock Syndrome. The rapid demonstration of the risk of Rely and high absorbency tampons resulted in prompt public health interventions and substantial reduction in menstrual Toxic Shock Syndrome.
Tampon
Truth's and Tragedies
The Following Information Courtesy of: http://www.tamponalert.org.uk
and
in Memory of Alice Kilvert, who died at the age of 15 due to
Tampon use and Toxic Shock Syndrome
Alice Kilvert, aged 15, died on Tuesday, 26th November 1991 of tampon-related Toxic Shock Syndrome at Trafford General Hospital, Manchester.
Alice's symptoms were initially very mild and did not cause any undue concern. On the Sunday prior to her death she complained of a headache which persisted, but eased with aspirin. During Sunday evening she was able to watch television, but she was sick during the night. Although very pale on Monday morning, she went to school in order to start her mock GCSE exams, but was taken home as she appeared to be developing influenza.. Alice went straight to bed and by tea time she had a slight temperature. At 7pm she was alert enough to talk about the early evening TV she had missed, but by 10pm she seemed vague and confused and a little faint.
The next morning Alice's breathing was shallow and she had a higher temperature, so the emergency doctor was called. The doctor phoned for an ambulance for Alice to be taken to hospital, but when the ambulance staff tested for blood pressure, it was so low it hardly registered. She arrived at hospital at 9am and her condition was diagnosed as either TOXIC SHOCK SYNDROME or meningitis, and treatment began. She was taken into Intensive Care and put onto a ventilator as her breathing was giving cause for concern. However, the strain on her heart brought on two cardiac arrests. She did not recover from the second one and died at 1pm.
More Stories on Women and Girls who Died or were Injured due to Tampon-induced Toxic Shock
1.
KATIE OF NOTTINGHAMSHIRE.
In the summer of 1990, Katie, then aged 15, went on holiday to Devon with her
family. It was a holiday that she'll never forget.
One morning she woke up with a headache and feeling shivery. Her mother thought
that it could be flu and suggested that she should stay in bed. During the day
her symptoms worsened as her temperature rose; she had aching muscles, a stiff
neck and a sore mouth.
By tea time she became breathless and she was so weak that she needed assistance
to go to the toilet. Her parents sent for the doctor, who diagnosed a virus and
prescribed antibiotics. That night Katie's temperature soared to 102 degrees.
The next morning she felt awful and had a severe headache. Her mother noticed a
red rash on her leg. Katie's eyes were pink and sticky and her skin was turning
yellow. The doctor was called again. He took one look at her and called for an
ambulance. She was rushed to hospital.
At the hospital, the doctors performed a lumber puncture to test for meningitis
and took a blood sample to test for glandular fever. Then the doctor discovered
that Katie was menstruating and took a vaginal swab for testing. By now, her
joints were swollen, her mouth was blistered, her liver and kidneys were failing
and her veins and arteries had gone into spasm. She was transferred to Intensive
Care.
The next morning a microbiologist had identified that Katie was suffering from
Toxic Shock Syndrome, brought on by the tampons she had been using. She was
being treated by the right antibiotics, and the doctors said that they would
just have to wait and hope. Katie remained conscious for the three days that she
was in Intensive Care. The pain was excruciating. She was transferred to a ward
and after a week she was strong enough to go home with the aid of a wheelchair.
Katie felt weak for months. Thick layers of skin peeled off her hands and feet.
This was as a result of the blood supply being cut off from her extremities
during her illness. Then her hair started to fall out in clumps. This lasted for
six months, and it has never grown back to its previous thickness. She realized
that her memory wasn't as good and her ability to concentrate had diminished.
Katie remembers being told at school that Toxic Shock Syndrome is caused by
leaving a tampon in too long. Now she knows differently. Any woman or girl who
uses tampons can get TSS. That's why she'll never use tampons again. It might be
rare, but you never know who it might strike next.
Posted 30/12/2000
2.
JEAN OF SURREY.
Jean was 46 when she suffered from Toxic Shock Syndrome. It was the second day
of her period and she was using tampons. She'd had a headache all day that
wouldn't go away, so she decided to go to bed early that evening. Jean couldn't
sleep and her headache intensified. Suddenly she was vomiting and suffering from
diarrhea. Jean thought that it must be food poisoning. The next day, Jean felt
no better, although the sickness and diarrhea had stopped. When she began to
lapse into unconsciousness her daughter telephoned the doctor, who immediately
summoned an ambulance. By this time Jean's lips had a bluish tinge and she was
having breathing difficulties. She went into a coma on the way to hospital as
her blood pressure plummeted.
In Intensive Care, Jean needed a ventilator and dialysis as her kidneys had
ceased to function. Doctors noticed that the tips of her fingers and toes were
turning black with gangrene. Over the next three weeks Jean was so weak that she
only had a 20% chance of survival. Because of the drugs her weight ballooned
from 10 stone to 13 stone. Her blonde hair turned grey and her green eyes turned
blue. The gangrene spread to her knee, nose and the back of her head. Jean went
into stress and was given a tracheotomy to help her to breathe. Her veins were
collapsing and it was almost impossible to insert the necessary drips.
At this point the doctor asked Jean's husband if he could try an experimental
drug which he hoped would increase her extremely low blood pressure. Within
minutes Jean started to respond and her blood pressure began to increase. She
was going to make it, although she was still critically ill. Two days later she
opened her eyes and asked where she was. She noticed her black toes. Jean spent
six months in hospital and eventually had her toes amputated. Her feet were very
painful and she had to get used to walking again. Now she wears special shoes
and occasionally uses a walking stick. Jean finds it difficult to concentrate
and has problems with her short-term memory.
Jean says that it's a miracle that she's alive today. She has enormous
admiration for the doctors, nurses and of course her family who were with her
all the time. Jean says that she will never use a tampon again. She has told all
her friends and neighbors not to believe those trendy tampon adverts on the TV.
"Tampons nearly killed me and they will kill others," she says.
Posted 30/12/2000
3.
JUDY OF OXFORDSHIRE.
Judy, a 27 year old mother, had been using tampons since she was 12. Her episode
of Toxic Shock Syndrome began 10 weeks after the birth of her second daughter.
She woke up on the third day of her period feeling tired and her head was
spinning, but she had to look after her new baby and her 2 year old daughter. By
evening she was exhausted and went to bed really early and just slept. The next
morning, Judy got up and felt fine. But an hour after her husband had gone to
work she had no strength to do anything. She vomited twice and had severe
diarrhea. She phoned her mother to look after the girls and went back to bed.
She felt worse and worse before eventually getting off to sleep.
The next morning was the same. Judy was fine until after her husband had left
for work. A sudden attack of diarrhea hit her before she could reach the toilet.
Once again she asked her mother to look after the children, and her mother also
called the doctor. Judy was taken to the hospital by her sister-in-law and
nearly fainted. Her legs were so painful and weak that she needed a wheelchair.
Her skin was yellow. Judy was admitted to the infectious diseases ward for tests
and the diarrhea was still running out of her. Within the hour they had put two
drips into her. The doctors had found her tampon by now and had taken it away
for testing. She had a rash on her lower legs and feet.
By the next morning, and numerous doctors later, they had diagnosed Toxic Shock
Syndrome. Judy was put on even more drips and had heart and kidney checks. Her
fingers and toes tingled all the time, like a burning sensation. The skin on her
fingers and toes later peeled off and it was terrifying and very painful. A week
in hospital and she was fit enough to go home.
Judy had to take tablets and return to hospital for heart and kidney checks and
blood tests. She seemed to recover quite well, but lost her sense of taste for
about 5 weeks. She was under health surveillance for 6 months and received the
all clear. Then Judy's hair started falling out. It didn't leave her bald, but
it was very thin in places. This lasted about two months before getting back to
normal.
Judy says that not enough people know about the dangers of tampons and Toxic
Shock Syndrome. She will never use tampons again, and there's no way she'd let
her daughters use them either.
Posted 30/12/2000
4.
ANNETTE OF MIDDLESEX
Annette was a healthy 17 year old at boarding school in Surrey. One Friday, in
June 1989, just seven weeks before her 18th birthday, she felt a bit under the
weather. She had just started her period and was using high absorbency tampons.
By Sunday, she was in the school sick bay, and her worried parents were driving
to visit her. Annette had a high temperature, severe headache and "appeared
distant". However, it wasn't until the Wednesday that she was rushed to
hospital, with what doctors thought was a burst appendix.
In the early hours of the Thursday, she was put onto a ventilator, and her
parents had what was to be their last conversation with Annette. The doctors
advised her parents that she was suffering from toxic shock syndrome, a disease
that they had never heard of.
During the night Annette's condition suddenly deteriorated and she suffered two
massive heart attacks and died.
Posted 30/12/2000
5.
KAREN OF HAMPSHIRE.
One Thursday in January 1991, 20 year old Karen became ill with sickness and
diarrhea. Although she was not aware of the connection, she was having her
period and using tampons. She called the doctor who initially diagnosed
gastro-enteritis and gave her some medicine. Karen continued vomiting, suffered
severe diarrhea and was in agony, and on Sunday the doctor suspected
appendicitis and she was rushed to hospital. As she was severely dehydrated,
Karen was immediately put on a drip, whilst the diagnosis was being made.
The next morning (Monday), Karen felt fine and was laughing and joking with her
parents. However, her mother noticed that her breathing was labored and that she
had a red rash on her leg. But by 3 pm, Karen's condition worsened and she was
given oxygen. By 9 pm she had lapsed into unconsciousness and transferred to
Intensive Care. The medical staff did not know what was causing the problem,
although toxic shock was considered. She had 15 tubes going into and out of her.
At 10 pm Karen suffered a cardiac arrest, and the IC staff resuscitated her, but
her condition was critical.
At 1 am on the Tuesday morning, Karen had a last injection to stimulate her blood flow, and her parents were told that this was her last hope.
Tragically, Karen died at 2.15 am from Toxic Shock Syndrome due to tampons.
Posted 30/12/2000
6.
DELYSE OF BUCKINGHAMSHIRE.
Delyse was a 32 year old secretary. Early in August 1993, Delyse' menstrual
period started and she began using tampons as usual. However, this time it was
to have tragic consequences.
On Saturday morning, Delyse suddenly started vomiting, had severe diarrhea and a high temperature. She thought that she was suffering from food poisoning. Later that day her partner called the doctor, who diagnosed flu.
On the Monday, Delyse went back to her GP who diagnosed gastritis - inflammation of the lining of the stomach. Her condition worsened and on Tuesday she was admitted to the local hospital with a suspected burst appendix.
Delyse seemed to be in a stable condition whilst the diagnosis began, but within 24 hours, she was rushed into Intensive Care, then onto a ventilator as her lungs had collapsed. She was then transferred to a specialist hospital nearby, where her condition improved slightly. When her vital organs, including liver and kidneys, failed, Delyse was put onto a dialysis machine.
After 5 weeks of fighting for her life, Delyse suffered a massive brain haemorrhage and died on 9th September.
Posted 30/12/2000
7.
SHARON OF COUNTY DURHAM.
Sharon, a keen sportswoman, died of Toxic Shock Syndrome two months after giving
birth to her second child.
Her husband Anthony recalls the joy and the tragedy of eight weeks in late 1991.
Twenty six year old Sharon used tampons for her first period after the birth of Rebecca. It started one Sunday when she began to feel very tired.
By Monday, Sharon was suffering with diarrhea, vomiting and a prickly red rash. The doctor was called and diagnosed a virus.
On
Thursday, her condition had deteriorated. Now, Sharon's fingernails and lips
were turning blue, the rash was like sunburn and she was having breathing
difficulties.
Sharon was rushed to hospital. Her condition improved slightly, but then her
kidneys collapsed and she was transferred to Intensive Care. Doctors diagnosed
toxic shock syndrome, caused by the tampon that she had been using.
The deadly toxins were causing all sorts of problems as they poisoned every part of her body. Her lungs were beginning to fail and she was transferred to the Regional specialist hospital where a lung transplant was considered. However, Sharon was too ill to undertake this operation. Doctors fought so hard to save her life, but after eight weeks of intensive care, Sharon suffered a cardiac arrest and died
Posted 30/12/2000
8.
SHANE OF BRISTOL.
Thirty three year old mother of two, Shane, died of tampon-related Toxic Shock
Syndrome in March 1994.
On Friday 4th March, Shane said she didn't feel well. During the early hours of Saturday morning she began vomiting and felt awful. She asked her mother to look after the children.
By
Sunday she was suffering severe diarrhea, she had a red rash and was now semi
conscious. She had a high temperature, her breathing was labored, and she had
pus coming from her eyes. At 9 am her husband phoned the doctor who suggested
that it was a stomach bug. Shane's husband insisted that the doctor must visit,
but on arrival, the doctor confirmed a stomach bug, and suggested paracetamol to
lower her temperature.
By Monday, Shane's condition had not improved and her mother called the doctor
again. The doctor took one look at Shane and called an ambulance. She arrived at
hospital at 3 pm and went straight into Intensive Care. But after six cardiac
arrests, Shane died at 5.30 pm.
Posted 30/12/2000
9. PAMELA OF EDINBURGH.
One Sunday in March 1993, Pamela aged 34, took to her bed with a severe sore throat. At the time she knew that a lot of people round about had flu, so she thought that she must be getting it too.
On Monday morning she felt really faint. Her husband went off to work, but asked Pamela's mother to phone the doctor. The doctor diagnosed a sore throat and prescribed penicillin. Although Pamela was able to talk coherently to the doctor, she can't remember the rest of the day, not even talking strangely to her husband when he arrived home from work. She felt so tired. The doctor was telephoned again and he suggested looking to see if Pamela had spots on her feet! She did have. The doctor called 'round again and got her admitted to hospital with suspected meningitis.
Luck was with Pamela that evening because the Specialist on duty had seen Toxic Shock Syndrome before. The tampon that had been removed when Pamela was admitted to the hospital was tested positively for Staphylococcus aureus and TSS was diagnosed.
Ten days of hospital treatment saved Pamela's life, but she was so weak that she had to leave the hospital in a wheelchair and learn how to walk again.
It took months to recover physically and even longer to recover mentally. She lost a lot of her hair, her skin started peeling off and she ached all over. She had been using tampons since she was 17, but will never again use tampons.
Posted 30/12/2000
10. FIONA OF ROSS-SHIRE.
On New years Eve 1990, 22 year old Fiona, woke up with crippling period pain. Her mother phoned work to let them know that Fiona would not be in today. As the day wore on Fiona became worse and started vomiting. At tea time the doctor was called and flu was diagnosed. But over the next few hours, Fiona's condition deteriorated. She started with diarrhea, her temperature soared and she developed a rash all over her neck. A worried mother called the doctor again at 2 am, and again flu was diagnosed.
The next morning, Fiona was unconscious and the ambulance was called. On arrival at the hospital, meningitis was first suspected, (but it wasn't until 3 months later that tampon-related toxic shock syndrome was confirmed). Fiona's temperature had rocketed and she was surrounded by bags of ice. The intensive care staff worked through the day, but at 3 am the next morning, Fiona suffered a cardiac arrest. The team managed to save Fiona, but the shattering news was that Fiona may be brain damaged, blind and paralyzed in all four limbs.
In the next two weeks Fiona fought for her life. Her kidneys failed and she needed dialysis, and her toes turned black with gangrene and would have to be amputated.
Three months later, Fiona started to come out of her coma. She couldn't speak, but she could hear and smile. Fiona stayed in hospital over the next year and was on drips and dialysis, and having physiotherapy and speech therapy. She was transferred to a Nursing home to be close to her parents. As a result of using a tampon, Fiona is totally blind, confined to a wheelchair, unable to use her arms and only has limited speech.
For more information on the above stories, please contact:
Toxic Shock Syndrome (TSS)
What is " Toxic Shock" and Toxic Shock Syndrome?
Toxic
shock syndrome is a rare infection that can happen during a woman's period. The
symptoms include a sudden fever of over 101 degrees or more, diarrhea (the
runs), vomiting (throwing up), muscle aches and a sunburn-like rash. If you have
these symptoms during you period, see a doctor right away.
To
help prevent toxic shock syndrome, you should follow these guidelines:
1.
Wash your hands before unwrapping and placing a new tampon in your vagina.
2.
Never use super-absorbent or deodorant tampons.
3.
Change your tampon at least every 4-6 hours (read the tampon manufacturers
information inside the box).
4.
Do not use tampons all the time and switch to a pad for part of each day.
5.
Do not use a birth control sponge or diaphragm during your period. During your
period it is preferable to use other methods such as condoms and/or foam.
There are allegations that tampons made from rayon, or cotton with rayon, may cause or be a contributing factor to Toxic Shock Syndrome, as well as vaginal dryness or ulcerations of vaginal tissues.
Toxic Shock Syndrome is a rare but potentially fatal disease caused by a bacterial toxin. (Different bacterial toxins may cause Toxic Shock Syndrome, depending on the situation, but most often streptococci and staphylococci are responsible.) The number of reported Toxic Shock Syndrome cases has decreased significantly in recent years.
Approximately half the cases of Toxic Shock Syndrome reported today are associated with tampon use during menstruation, usually in young women.
Toxic Shock Syndrome also occurs in children, men, and non-menstruating women. In 1997, only five confirmed menstrual-related Toxic Shock Syndrome cases were reported, compared with 814 cases in 1980 [according to data from the Centers for Disease Control and Prevention (CDC)].
Although scientists have recognized an association between Toxic Shock Syndrome and tampon use, the exact connection remains unclear. Research conducted by the CDC suggested that use of some high absorbency tampons increased the risk of Toxic Shock Syndrome in menstruating women. A few specific tampon designs and high absorbency tampon materials were also found to have some association with increased risk of Toxic Shock Syndrome. These products and materials are no longer used in tampons sold in the U.S. Tampons made with rayon do not appear to have a higher risk of Toxic Shock Syndrome than cotton tampons of similar absorbency.
Vaginal dryness and ulcerations may occur when women use tampons more absorbent than needed for the amount of their menstrual flow. Ulcerations have also been reported in women using tampons between menstrual periods to try to control excessive vaginal discharge or abnormal bleeding. Women may avoid problems by choosing a tampon with the minimum absorbency needed to control menstrual flow and using tampons only during active menstruation.
To help women compare absorbency from brand to brand, FDA requires that manufacturers measure absorbency using a standard method and describe absorbency on the package using standardized terms. Thus, the terms "junior," "regular," "super," and "super plus," always describe a specific range of tampon absorbency regardless of the brand.
Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome -- United States, 1980-1990
In May 1980, investigators reported to CDC 55 cases of toxic-shock syndrome (TSS) (1), a newly recognized illness characterized by high fever, sunburn-like rash, desquamation, hypotension, and abnormalities in multiple organ systems (2). Fifty-two (95%) of the reported cases occurred in women; onset of illness occurred during menstruation in 38 (95%) of the 40 women from whom menstrual history was obtained. National and state-based studies were initiated to determine risk factors for this disease. In addition, CDC established national surveillance to assess the magnitude of illness and follow trends in disease occurrence; 3295 definite cases have been reported since surveillance was established (Figure 1).
In June 1980, a follow-up report described three studies which detected an association between Toxic Shock Syndrome and the use of tampons (3). Case-control studies in Wisconsin and Utah and a national study by CDC indicated that women with Toxic Shock Syndrome were more likely to have used tampons than were controls. The CDC study also found that continuous use of tampons was associated with a higher risk of Toxic Shock Syndrome than was alternating use of tampons and other menstrual products. Subsequent studies established that risk of Toxic Shock Syndrome was substantially greater in women who used Rely brand tampons than in users of other brands and that risk increased with increased tampon absorbency (4-6). In September 1980, Rely tampons were voluntarily withdrawn from the market by the manufacturer.
In 1980, 890 cases of Toxic Shock Syndrome were reported, 812 (91%) of which were associated with menstruation. In 1989, 61 cases of Toxic Shock Syndrome were reported, 45 (74%) of which were menstrual. In 1980, 38 (5%) of 772 women with menstrual Toxic Shock Syndrome died; in 1988 and 1989, there were no deaths among women with menstrual Toxic Shock Syndrome. Reported by: Meningitis and Special Pathogens Br, Div of Bacterial Diseases, Center for Infectious Diseases, CDC.
On July 22, this notice was posted as an MMWR Dispatch on the MMWR website (http://www.cdc.gov/mmwr).
On July 19, 2005, the Food and Drug Administration (FDA) issued a public health advisory regarding the deaths of four women in the United States after medical abortions with Mifeprex® (mifepristone, formerly RU-486; Danco Laboratories, New York, New York) and intravaginal misoprostol (1). Two of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these U.S. cases had clinical illness consistent with toxic shock and had evidence of endometrial infection with Clostridium sordellii, a gram-positive, toxin-forming anaerobic bacteria. In addition, a fatal case of C. sordellii toxic shock syndrome after medical abortion with mifepristone and misoprostol was reported in 2001, in Canada (2). All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension, multiple effusions, hemoconcentration, and a profound leukocytosis. C. sordellii previously has been described as a cause of pregnancy-associated toxic shock syndrome (3).
Investigation by FDA, CDC, and state and local health departments into the two most recently identified U.S. deaths after medical abortion is ongoing. Empiric therapy for patients suspected of having postpartum or postabortion toxic shock syndrome should include antimicrobials with anaerobic activity against Clostridium species. Health-care providers are encouraged to report any cases of postpartum or postabortion toxic shock syndrome to their state or local health department and to CDC at telephone 800-893-0485. Cases potentially associated with of mifepristone or misoprostol should also be reported through the FDA MedWatch system available at http://www.fda.gov/medwatch/index.html or telephone 800-FDA-1088.
Food and Drug Administration. FDA Public Health Advisory: sepsis and medical abortion. Rockville, Marylan: Food and Drug Administration, Center for Drug Evaluation and Research; 205. Available at http://www.fda.gov/cder/drug/advisory/mifeprex.htm.
Sinave C, Le Templier G, Bluin D, Leveille F, Deland E. Toxic shock syndrome due to Clostridium sordellii: a dramatic postpartum and postabortion disease. Clin Infect Dis 2002;35:1441--3.
McGregor JA, Soper DE, Lovell G, Todd JK. Maternal deaths associated with Clostridium sordellii infection. Am J Obstet Gynecol 1989;161:987--95.
Editorial Note: The number of Toxic Shock Syndrome cases reported annually to CDC has decreased substantially in the 10-year period since menstrual Toxic Shock Syndrome was first recognized. Changes in public awareness and diminished attention to Toxic Shock Syndrome in the medical literature might have resulted in reduced diagnosis and reporting. However, reporting of non-menstrual Toxic Shock Syndrome has remained constant during this time while menstrual Toxic Shock Syndrome reporting has decreased.
A multistate active surveillance study in 1986-1987 confirmed the trends detected by national passive surveillance (7). Through active case-finding efforts in an aggregate population of 34 million persons, the rate for menstrual Toxic Shock Syndrome was determined to be 1.0 per 100,000 women 15-44 years of age (7). This rate represented a substantial reduction from rates reported in similar studies in 1980 (6.2 per 100,000 women 12-49 years of age in Wisconsin (8), 9.0 per 100,000 women 12-45 years of age in Minnesota (9), and 12.3 per 100,000 women 12-49 years of age in Utah (10)). Active surveillance also confirmed that the proportion of Toxic Shock Syndrome associated with menstruation had decreased considerably: in 1988, menstrual Toxic Shock Syndrome accounted for 55% of cases detected both by active surveillance (7) and by the passive surveillance system.
A principle reason for the decreased incidence of menstrual Toxic Shock Syndrome may be decreases in the absorbency of tampons. In 1980, when tampon absorbency (in vitro) ranged from 10.3-20.5 g (4), very high absorbency products ( greater than 15.4 g) were used by 42% of tampon users (9). After the association between Toxic Shock Syndrome and absorbency was recognized, manufacturers lowered the absorbency of tampons. In 1982, the Food and Drug Administration (FDA) issued a regulation requiring that tampon package labels advise women to use the lowest absorbency tampons compatible with their needs. By 1983, tampon absorbency ranged from 6.3-17.2 g (6), and the proportion of tampon users using very high absorbency tampons had declined to 18%. By 1986, very high absorbency products were used by only 1% of women who used tampons. Effective March 1990, the FDA instituted standardized absorbency labeling of tampons, which currently range from 6-15 g.
Tampon composition has also changed since 1980. Rely tampons consisted of polyester foam and cross-linked carboxymethylcellulose, a combination that is no longer used in tampons. Polyacrylate-containing tampons were withdrawn from the market in 1985. Current tampons are manufactured from cotton and/or rayon. The unique composition of Rely tampons may have been responsible for the increased risk associated with those products (11); however, the role of current tampon composition as an independent risk factor for Toxic Shock Syndrome is unclear since composition may vary even for a particular brand and style of tampon marketed at a given time.
Other factors may have contributed to decreased reports of menstrual-related Toxic Shock Syndrome. For example, public awareness of the syndrome may cause women to seek medical care earlier in their illness; milder disease may not meet the surveillance case definition of severe multisystem illness. Increased variety in menstrual products and concern related to Toxic Shock Syndrome may have resulted in fewer women using tampons or fewer using tampons continuously.
Current public health efforts to prevent menstrual-related Toxic Shock Syndrome include tampon package labels and package inserts which describe early signs and symptoms of Toxic Shock Syndrome and warn the consumer about the risk associated with tampons. Tampon users are encouraged to select lower absorbency products to further decrease risk of Toxic Shock Syndrome. Standardized absorbency labeling permits consumers to compare absorbency between brands.
The precise mechanism by which Rely tampons increased the risk of Toxic Shock Syndrome is unknown. The increased risk associated with high absorbency tampons is also poorly understood; high absorbency may be a surrogate for another effect. However, the withdrawal of Rely tampons and the subsequent decrease in use of high absorbency tampons correlate with a marked decrease in incidence of menstrual-related Toxic Shock Syndrome. The rapid demonstration of the risk of Rely and high absorbency tampons resulted in prompt public health interventions and substantial reduction in menstrual Toxic Shock Syndrome.
Tampon
Truth's and Tragedies
The Following Information Courtesy of: http://www.tamponalert.org.uk
and
in Memory of Alice Kilvert, who died at the age of 15 due to
Tampon use and Toxic Shock Syndrome
Alice Kilvert, aged 15, died on Tuesday, 26th November 1991 of tampon-related Toxic Shock Syndrome at Trafford General Hospital, Manchester.
Alice's symptoms were initially very mild and did not cause any undue concern. On the Sunday prior to her death she complained of a headache which persisted, but eased with aspirin. During Sunday evening she was able to watch television, but she was sick during the night. Although very pale on Monday morning, she went to school in order to start her mock GCSE exams, but was taken home as she appeared to be developing influenza.. Alice went straight to bed and by tea time she had a slight temperature. At 7pm she was alert enough to talk about the early evening TV she had missed, but by 10pm she seemed vague and confused and a little faint.
The next morning Alice's breathing was shallow and she had a higher temperature, so the emergency doctor was called. The doctor phoned for an ambulance for Alice to be taken to hospital, but when the ambulance staff tested for blood pressure, it was so low it hardly registered. She arrived at hospital at 9am and her condition was diagnosed as either TOXIC SHOCK SYNDROME or meningitis, and treatment began. She was taken into Intensive Care and put onto a ventilator as her breathing was giving cause for concern. However, the strain on her heart brought on two cardiac arrests. She did not recover from the second one and died at 1pm.
More
Stories on Women and Girls who
Died or Were Injured due to Tampon use and
Tampon-induced Toxic Shock Syndrome
1.
KATIE OF NOTTINGHAMSHIRE.
In the summer of 1990, Katie, then aged 15, went on holiday to Devon with her
family. It was a holiday that she'll never forget.
One morning she woke up with a headache and feeling shivery. Her mother thought
that it could be flu and suggested that she should stay in bed. During the day
her symptoms worsened as her temperature rose; she had aching muscles, a stiff
neck and a sore mouth.
By tea time she became breathless and she was so weak that she needed assistance
to go to the toilet. Her parents sent for the doctor, who diagnosed a virus and
prescribed antibiotics. That night Katie's temperature soared to 102 degrees.
The next morning she felt awful and had a severe headache. Her mother noticed a
red rash on her leg. Katie's eyes were pink and sticky and her skin was turning
yellow. The doctor was called again. He took one look at her and called for an
ambulance. She was rushed to hospital.
At the hospital, the doctors performed a lumber puncture to test for meningitis
and took a blood sample to test for glandular fever. Then the doctor discovered
that Katie was menstruating and took a vaginal swab for testing. By now, her
joints were swollen, her mouth was blistered, her liver and kidneys were failing
and her veins and arteries had gone into spasm. She was transferred to Intensive
Care.
The next morning a microbiologist had identified that Katie was suffering from
Toxic Shock Syndrome, brought on by the tampons she had been using. She was
being treated by the right antibiotics, and the doctors said that they would
just have to wait and hope. Katie remained conscious for the three days that she
was in Intensive Care. The pain was excruciating. She was transferred to a ward
and after a week she was strong enough to go home with the aid of a wheelchair.
Katie felt weak for months. Thick layers of skin peeled off her hands and feet.
This was as a result of the blood supply being cut off from her extremities
during her illness. Then her hair started to fall out in clumps. This lasted for
six months, and it has never grown back to its previous thickness. She realized
that her memory wasn't as good and her ability to concentrate had diminished.
Katie remembers being told at school that Toxic Shock Syndrome is caused by
leaving a tampon in too long. Now she knows differently. Any woman or girl who
uses tampons can get TSS. That's why she'll never use tampons again. It might be
rare, but you never know who it might strike next.
Posted 30/12/2000
2.
JEAN OF SURREY.
Jean was 46 when she suffered from Toxic Shock Syndrome. It was the second day
of her period and she was using tampons. She'd had a headache all day that
wouldn't go away, so she decided to go to bed early that evening. Jean couldn't
sleep and her headache intensified. Suddenly she was vomiting and suffering from
diarrhea. Jean thought that it must be food poisoning. The next day, Jean felt
no better, although the sickness and diarrhea had stopped. When she began to
lapse into unconsciousness her daughter telephoned the doctor, who immediately
summoned an ambulance. By this time Jean's lips had a bluish tinge and she was
having breathing difficulties. She went into a coma on the way to hospital as
her blood pressure plummeted.
In Intensive Care, Jean needed a ventilator and dialysis as her kidneys had
ceased to function. Doctors noticed that the tips of her fingers and toes were
turning black with gangrene. Over the next three weeks Jean was so weak that she
only had a 20% chance of survival. Because of the drugs her weight ballooned
from 10 stone to 13 stone. Her blonde hair turned grey and her green eyes turned
blue. The gangrene spread to her knee, nose and the back of her head. Jean went
into stress and was given a tracheotomy to help her to breathe. Her veins were
collapsing and it was almost impossible to insert the necessary drips.
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