Essential Trace Minerals
www.EssentialTraceMinerals.com


What are Essential Trace Minerals and why do we need them?

According to the late health and nutrition researcher, Dr. Linus Pauling, “you can trace every ailment, every sickness and every disease to an Organic Trace Mineral deficiency.”  Dr. Pauling was a much-acclaimed and heralded leader in researching disease and received 2 Nobel Prizes in his lifetime.  

Quantum Silver

Broken down, by category, are the Macro-minerals, Essential Trace Minerals, Potentially-essential Trace Minerals, and Toxic Minerals and Heavy Metals

The Macrominerals: 

Calcium       Chloride     Magnesium    Phosphorus 

Potassium   Silicon         Sodium            Sulfur 

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The Essential Trace Minerals 

Chromiun       Cobalt         Copper 

Iodine               Iron             Manganese 

Molybdenum   Selenium   Zinc 

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Potentially-essential Trace Minerals 

Boron               Fluoride        Germanium 

Lithium           Nickel             Rubidium 

Strontium       Tin                   Vanadium 

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Toxic Minerals and Heavy Metals 

Aluminum       Arsenic           Cadmium           Lead 

Mercury           Antimony       Barium               Beryllium 

Bismuth           Bromine         Thallium             Uranium 

What are Organic Trace Minerals and why do we need them?

According to the late health and nutrition researcher, Dr. Linus Pauling, “you can trace every ailment, every sickness and every disease to an Organic Trace Mineral deficiency.”  Dr. Pauling was a much-acclaimed and heralded leader in researching disease and received
2 Nobel Prizes in his lifetime.   

Organic Trace Minerals are needed by the human body for optimum health.  Organic Trace Minerals help the body create “balance” - also known as "homeostasis."

Because of the way we grow most of our food, and with all the fertilizers, pesticides, and non-organic farming methods, soil depletion has caused a loss of the organic trace minerals that used to be in our foods that were grown on the farm. All of the non-organic chemical fertilizers applied on the crops being grown in today's "factory farms" kill the microorganisms in the soil that used to produce Organic Trace Minerals. When our farmer's soils are destroyed by the chemical fertilizers that are so widely used in the production of our crops that are grown on the "factory farms," the "natural" organic humus soils are destroyed, and the plants/crops grown in that soil are missing the "natural" organic trace minerals.  This was the finding over 70 years ago by Dr. Northern in 1936, and as documented in the U.S. Senate Document 264. 

Without Organic Trace Minerals, the body cannot utilize amino acids, fats and vitamins properly. Organic Trace Minerals are absolutely necessary and required by every cell, organ, gland, muscle and vital life functions in the human body. Without Organic Trace Minerals, optimum health cannot be achieved, and diseases and accelerated oxidation occurs in the body.  

Organic Trace Minerals are “the gift of life” and cellular nutrition and function becomes impossible without all of the essential Organic Trace Minerals.  

Verbatim Unabridged extracts from the 74th Congress 2nd Session in 1936 about the Importance of Organic Trace Minerals:

"Our physical well-being is more directly dependent upon the minerals we take into our systems than upon calories or vitamins, or upon the precise proportions of starch, protein or carbohydrates we consume."

"Do you know that most of us today are suffering from certain dangerous diet deficiencies which cannot be remedied until depleted soils from which our food comes are brought into proper mineral balance?"

"The alarming fact is that foods (fruits, vegetables and grains) now being raised on millions of acres of land that no longer contain enough of certain minerals are starving us - no matter how much of them we eat. No man of today can eat enough fruits and vegetables to supply his system with the minerals he requires for perfect health because his stomach isn't big enough to hold them."

"The truth is that our foods vary enormously in value, and some of them aren't worth eating as food. Our physical well-being is more directly dependent upon the minerals we take into our systems than upon calories or vitamins or upon the precise proportions of starch, protein or carbohydrates we consume."

"This talk about minerals is novel and quite startling. In fact, a realization of the importance of minerals in food is so new that the textbooks on nutritional dietetics contain very little about it. Nevertheless, it is something that concerns all of us, and the further we delve into it the more startling it becomes."

"You'd think, wouldn't you, that a carrot is a carrot - that one is about as good as another as far as nourishment is concerned? But it isn't; one carrot may look and taste like another and yet be lacking in the particular mineral element which our system requires and which carrots are supposed to contain."

"Laboratory tests prove that the fruits, the vegetables, the grains, the eggs, and even the milk and the meats of today are not what they were a few generations ago (which doubtless explains why our forefathers thrived on a selection of foods that would starve us!)"

"No man today can eat enough fruits and vegetables to supply his stomach with the mineral salts he requires for perfect health, because his stomach isn't big enough to hold them! And we are turning into big stomachs."

"No longer does a balanced and fully nourishing diet consist merely of so many calories or certain vitamins or fixed proportion of starches, proteins and carbohydrates. We know that our diets must contain in addition something like a score of minerals salts."

"It is bad news to learn from our leading authorities that 99% of the American people are deficient in these minerals, and that a marked deficiency in any one of the more important minerals actually results in disease. Any upset of the balance, any considerable lack or one or another element, however microscopic the body requirement may be, and we sicken, suffer, shorten our lives."

"We know that vitamins are complex chemical substances which are indispensable to nutrition, and that each of them is of importance for normal function of some special structure in the body. Disorder and disease result from any vitamin deficiency. It is not commonly realized, however, that vitamins control the body's appropriation of minerals, and in the absence of minerals they have no function to perform. Lacking vitamins, the system can make some use of minerals, but lacking minerals, vitamins are useless."

"Certainly our physical well-being is more directly dependent upon the minerals we take into our systems than upon calories or vitamins or upon the precise proportions of starch, protein of carbohydrates we consume."

"This discovery is one of the latest and most important contributions of science to the problem of human health."

What is "Organic For Life™"

"Organic for Life™" is our company's name for our new line of organic products.

What is the National Organic Program?

The National Organic Program is a set of legal standards and regulations developed and enforced by the United States Department of Agriculture (USDA) that define farming, production and certification practices for foods bearing the organic label and sold in the United States.

What are the National Organic Standards and National Organic Standards Board (NOSB)? 

The National Organic Standards are the standards for the organic industry as promulgated and set forth by the National Organic Standards Board (NOSB).

The National Organic Standards Board is a 15-member, non-governmental, federal advisory committee created by the Secretary of Agriculture under the Organic Food Production Act ("OFPA") and the Federal Advisory Committee Act ("FACA"). By law the NOSB's makeup is a diverse constituency representing organic farming operations (4 people), organic handling operations (2), retail establishments with significant trade in organic product (1), experts in environmental protection and resource conservation
(3), public interest or consumer interest groups (3), scientific experts in toxicology, ecology or biochemistry (1) and an organic certifying agent (1). 

The USDA appoints all National Organic Standards Board members, although the public is allowed to make recommendations for appointments. National Organic Standards Board members serve staggered five-year terms. 

In general, the National Organic Standards Board is designed to be a public voice concerning the regulation of organic food. It is responsible for advising the Secretary of Agriculture on implementing our national organic food laws. Board is responsible for evaluating substances for inclusion on the National List of allowed
(or prohibited) synthetic substances. 

Unfortunately, in the first proposed national organic rule the USDA ignored most of the National Organic Standards Board's recommendations. For example, the proposed rule allowed for genetically engineered foods even though the National Organic Standards Board specifically stated that they should not be allowed in organic. 

The National Organic Standards Board meets between two to four times a year to develop recommendations on a number of issues concerning organic food. The meetings are open to the public and the Board often publishes working papers that are available for public comment. Please review the National Organic Standards Board's website at: 

http://www.ams.usda.gov/nop/nosbinfo.htm 
for more information.


Why Should I, My Wife, or My Daughter(s) Use Organic Cotton Tampons?

 

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 (5 days X 5 tampons 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.


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 Boulder , Colo. Chandler encourages patients to use nonchlorine-bleached, 100 percent-organic cotton tampons and pads. "We're lucky to have healthier choices," she says.

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 Love Canal catastrophe. Tampons are linked to carcinogenic dioxin formed during the bleaching process that manufacturers use to purify and whiten both raw cotton and the wood pulp that goes into synthetic fibers such as rayon, a common fiber in tampons. "You find trace amounts of dioxin in some tampons, which have maximal contact with the vagina's mucous membrane, which absorbs substances directly into the bloodstream," explains Philip Tierno, MD, director of clinical microbiology and immunology at New York University Medical Center . To ensure that your tampon is free of dioxin, switch to a brand that's nonchlorine-bleached, rayon-free, and made of 100 percent-organic cotton. Though cotton is a natural fiber, the majority of cotton crops are heavily treated with insecticides, pesticides and herbicides. Organically grown cotton is not.

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 ( TSS ) struck thousands of women. The crisis peaked in 1980 with 814 cases of TSS , of which 38 women died, most due to extended use of the high-absorbency Rely tampon. Today, women still get TSS , though cases are rarely publicized. Yet tampon safety is once again a national issue, in part due to the efforts of Rep. Carolyn Maloney, D-N.Y., who introduced a bill to address the health problems associated with tampon use. The Robin Danielson Act (HR 360) is named after a 44-year-old woman who died in 1998 from TSS because she didn't recognize her symptoms. The bill directs the National Institutes of Health to conduct reliable, independent research to determine the health risks posed by the presence of synthetic fibers, dioxin and other additives in tampons.

TSS is caused when staph or strep bacteria grow in the vagina, usually encouraged by the presence of a higher absorbency tampon or one that has been inserted more than eight hours. The bacteria produce toxins that are absorbed into the bloodstream, which can cause a severe drop in blood pressure (shock) and/or organ failure, especially of the liver and kidneys. In some cases, TSS is fatal. Its symptoms are similar to the flu, including a high fever, vomiting and diarrhea, muscle aches, dizziness or fainting, a red rash, headaches, bloodshot eyes and sore throat.

"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 TSS , choose a tampon made of 100 percent cotton, preferably organic. "You're at the lowest risk possible with cotton," says Tierno. "In my research, every synthetic fiber amplified toxin development, whereas cotton did not."

Most precautions for guarding against TSS are simple, says holistic nurse practitioner Pam Chandler, a specialist in women's health care. Wear a tampon for a maximum of six to eight hours to avoid bacterial growth. However, she recommends leaving it in for at least two hours. "If you remove a tampon too soon, it won't be saturated," she says. "Then you risk scraping the dry, fragmented cotton across the vaginal mucosa, irritating it and setting the scenario for infection." Also, using a tampon overnight, when planning to sleep longer than eight hours, is risky. At night, consider wearing a pad instead, she advises.

Choosing a tampon with proper absorbency is crucial to preventing TSS . "At the beginning of your period, if your flow is heavy, you may need Super Absorbency so you don't have to change tampons too often," says Chandler . When the flow slows, however, don't be tempted to continue with a Super because it's more convenient. Switch to a lower absorbency tampon instead. Also, use tampons only during menstruation.

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 Chandler , who points out that while this is liberating, it also makes it easy to take their use for granted.


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.

Clostridium sordellii 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 (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.

References

  1. 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.

  2. 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.

  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

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.

References

  1. CDC. Toxic-shock syndrome--United States. MMWR

1980;29:229-30.

2. Todd J, Fishaut M, Kapral F, Welch T. Toxic-shock syndrome associated with phage-group-1 staphylococci. Lancet 1978;2:1116-8.

3. CDC. Follow-up on toxic-shock syndrome--United States. MMWR 1980;29:297-9.

4. Osterholm MT, Davis JP, Gibson RW, et al. Tri-state toxic-shock syndrome study: I. Epidemiologic findings. J Infect Dis 1982;145:431-40.

5. Schlech WF, Shands KN, Reingold AL, et al. Risk factors for development of toxic shock syndrome: association with a tampon brand. JAMA 1982;248:835-9.

6. Berkley SF, Hightower AW, Broome CV, Reingold AL. The relationship of tampon characteristics to menstrual toxic shock syndrome. JAMA 1987;258:917-20.

7. Gaventa S, Reingold AL, Hightower AW, et al. Active surveillance for toxic shock syndrome in the United States, 1986. Rev Infect Dis 1989;2(suppl S1):S35-42.

8. Davis JP, Chesney PJ, Wand PJ, LaVenture M, the Investigation and Laboratory Team. Toxic-shock syndrome: epidemiologic features, recurrence, risk factors, and prevention. N Engl J Med 1980;303:1429-35.

9. Osterholm MT, Forfang JC. Toxic-shock syndrome in Minnesota: results of an active-passive surveillance system. J Infect Dis 1982;145:458-64. 10. Latham RH, Kehrberg MW, Jacobson JA, Smith CB. Toxic shock syndrome in Utah: a case-control and surveillance study. Ann Intern Med 1982;96:906-8. 11. Broome CV. Epidemiology of TSS in the United States: overview. Rev Infect Dis 1989;2 (suppl S1):S14-21.


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