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.
 

FAQ's About Tampons and
Toxic Shock Syndrome

I thought that you only got TSS if you forgot to change your tampon. Is this true?

[googmonify]9497296296:right:250:250[/googmonify]Any woman may develop TSS when using tampons as directed by the manufacturer's instructions if she is carrying the particular strain of bacteria that produces toxins and if she has not developed immunity to these toxins.

The exact combination of circumstances in which toxin production occurs in the vagina of individual women is not known. It is therefore not possible to state any completely safe time limits on the use of a tampon, although it could be assumed that the longer a tampon is left in place or the more tampons are used continuously, the greater the chance of toxin production starting. This is why we recommend keeping tampon use to a minimum and breaking the use regularly by using a sanitary towel/pad.

All known victims of TSS followed the manufacturers instructions on usage implicitly, but they still became seriously ill or even died.

We think that there are several reasons why people think that a "forgotten tampon" causes Toxic Shock Syndrome-

• Many women have been admitted to hospital with TSS whilst still using a tampon. They had become seriously ill extremely quickly and had not been physically capable of removing or changing their tampon.
• The term "retained tampon" in medical reports, refers to a tampon being in place on admission to hospital. It is not an indication of length of use.
• It blames the tampon user, who was too ill to defend herself; it exonerated the tampon manufacturers and it reassured dedicated tampon users.
• It made it easier for newspaper editors (usually men) to explain why someone was ill.

Can you catch TSS from other people?

No. TSS is not a contagious disease.
 

What is the link between TSS and tampon use?

The link is not clearly understood.

However, tampon research highlights three high RISK FACTORS high absorbency tampons, continuous tampon use and low body immunity.
 

Tampon Absorbency

the higher the absorbency the higher the risk; the lower the absorbency the lower the risk. That is why a woman should always use the lowest absorbency tampon for her menstrual flow. It also accounts for the high number of deaths due to super-absorbent tampons in 1980.
 

Continuous tampon use

women should not use tampons continuously during a period. It is recommended that the most convenient time to break the continuous use is at night, by using a sanitary towel/pad.
 

Low immunity

this is the factor that you cannot control as it may vary from time to time. It is generally understood that immunity improves with age therefore girls are at a higher risk that older women.
 

Is it possible to get TSS more than once?

Yes. A person who has had TSS can develop it again. If a women or girl has had TSS in the past, it is advisable not to use tampons again.

Menstrual TSS recurs in around 30% of cases. Dr Mary Andrews of the Dartmouth-Hitchcock Medical Centre in New Hampshire, advises that symptoms were most likely to return in women who were not treated during their first attack, and continued to use tampons. Two thirds of Dr Andrews' study group experienced a recurrence within 5 months, although only 16% of women who were treated had recurring symptoms of TSS.
 

Toxic Shock Syndrome Symptoms

What are the symptoms of TSS?

Symptoms can be similar to flu or food poisoning, but they can become serious very quickly.

The symptoms of TSS include one or more of the following

• Always begin AFTER a menstrual period starts.
• Early symptoms may include headache, and/or sore throat,
• aching muscles and high temperature (fever).
• Followed by vomiting, watery diarrhea,
• Confusion and dizziness
• A red, sunburn-like, rash on chest, abdomen or thighs
• Very low blood pressure.

Please note Only one or two of the above symptoms may occur. They do not necessarily occur all at once and may not persist.

What should I do if I get these symptoms?

If you have any of these symptoms and are using a tampon you should, remove and save your tampon and seek immediate medical attention (preferably at an emergency HOSPITAL). Tell the doctor that you have been using tampons and suspect TSS (Take a TSS information leaflet with you).

Don't worry about wasting the doctor's time, you could be saving your life.

What Is The Treatment For TSS?

With early diagnosis, TSS can generally be effectively treated with antibiotics and other medication to counteract the symptoms.

Professor Joan Chesney, Head of Pediatrics at the University of Tennessee said in September 1997 that concerns that Staphylococcus aureus could become resistant to antibiotics have so far proved unfounded. Tests on TSS-associated strains of S-aureus at the Dartmouth-Hitchcock Medical Center in New Hampshire failed to find any methicillin-resistant Staphylococcus aureus (MRSA), the strain which has caused so many problems for hospitals in Europe and America. All 62 samples from menstrual and non-menstrual cases referred to the D-H Medical Center between 1984 and 1995, were susceptible to two key antibiotics – oxacillin and clindamycin – although only a handful would have responded to treatment with penicillin.

Standard therapy for TSS continues to be on high-dose antibiotics, usually with a betalactam agent, with or without clindamycin or a related drug. You also need to stop toxin production which can be best done with a protein synthesis inhibitor such as clindamycin, gentamycin, erythromycin or clarithromycin. Introvenous fluids are another essential aspect of management, but doubts remain over the value of introvenous immunoglobulin (IVIG) injections as they carry the risk of side-effects.

Choosing the Right Tampon Absorbency or "Size"

When using tampons, it's important to choose the lowest absorbency necessary for your menstrual flow. Because the amount of flow varies from day to day, it is likely that you will need to use different absorbencies on different days of your period. Selecting the right absorbency comes with experience, but as a guide, if a tampon absorbs as much as it can and has to be changed before 4 hours, then you may want to try a higher absorbency. On the other hand, if you remove a tampon and after 4-6 hours white fiber is still showing, you should choose a lower absorbency.

Research indicates that tampons should not be used continuously during a period as continuous use is a high risk factor. The most obvious time to break this continuous use is at night. AKTA recommends the use of a sanitary towel at night. However, if you choose to use a tampon at night, choose the lowest absorbency needed, insert a fresh one just before going to bed and remove it as soon as you wake up in the morning. Slim line tampons are quite absorbent for their size, so it is highly recommended that young girls do not use tampons at night.

TSS Now Rare, but Women Still Should Take Care

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-gramtampons (ultra absorbency) that may help women manage heavier menstrual flows.

"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 Staphylococcusaureus 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 tool kits 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 18percent 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.

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 Med Watch 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."

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."
 

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.

In1980, 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.

Clostridiumsordellii Toxic Shock Syndrome After Medical Abortion with Mifepristone and Intravaginal Misoprostol — United States and Canada, 2001–2005

On July 22, this notice was posted as an MMWR Dispatch on the MMWR website.

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. sordelliitoxic 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, hem concentration, and a profound leukocytosis. C. sordelliipreviously 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 post abortion toxic shock syndrome should include antimicrobials with anaerobic activity against Clostridium species. Health-care providers are encouraged to report any cases of postpartum or post abortion 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 MedWatchsystem or telephone 1-800-FDA-1088.

References

1.      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.

2.      Sinave C, Le Templier G, Bluin D, Leveille F, Deland E. Toxic shock syndrome due to Clostridium sordellii a dramatic postpartum and post abortion disease. Clin Infect Dis 2002;351441–3.

3.      McGregor JA, Soper DE, Lovell G, Todd JK. Maternal deaths associated with Clostridium sordellii infection. Am J Obstet Gynecol 1989;161987–95.

Editorial Note

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.

Amultistate 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 per100,000 women 12-45 years of age in Minnesota (9), and 12.3 per 100,000 women12-49 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 carboxymethy lcellulose, 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.

References