Tampons and Toxic Shock

DOCTOR JAMES K. TODD of the University of Colorado first identified Toxic Shock Syndrome (TSS) in 1978. TSS is a type of blood poisoning caused by the release of toxins from the growth of bacteria. TSS develops from a common bacterium, staphylococcus aureus, which can live on the skin and in the nose, armpit, groin, or vagina.

Though the disease is rare, it can be fatal. Symptoms of TSS include high sudden fever, muscle aches, vomiting, diarrhea, rashes, rapid pulse, fatigue, sore throat, dizziness, fainting, and a drop in blood pressure. Although TSS can arise from[Page 785] wounds or infections and is seen in some men, it normally manifests in women 30 years old and younger. The most common cause of TSS is tied to the use of super absorbent tampons which trap the bacteria and act as a breeding ground when left in place for extended periods.

Super absorbent tampons were being marketed by numerous companies in the mid-1970s, including Procter & Gamble, Playtex, Tampax, Kimberly Clark, and Johnson & Johnson. Initial concerns about the tampons were based on anecdotal evidence and appeared in the absence of scientific research. Court documents suggest, however, that manufacturers were aware of the link between the tampons and TSS but continued to market the dangerous product.

Matters worsened for the manufacturers when the Centers for Disease Control (CDC) entered the fray in 1980. The CDC's investigation focused primarily on the Rely brand tampon. Ultimately, the CDC identified 55 fatal cases and 1,066 nonfatal cases of TSS, though companies continued to sell the product without warnings of the possible risks. A CDC study showed that 70 percent of the victims of TSS reportedly used Rely tampons. Eventually 38 deaths were attributed to the tampon.

Procter & Gamble's ultra-absorbent tampon, Rely, was introduced in 1974. The company released the new, improved product with claims of having conducted extensive research on its safety. Rely was the only tampon that used a highly absorbent synthetic material, polyester foam. The corporation introduced the Rely tampon in a fiercely competitive market but had hopes of out-selling Tampax, the leading product. Procter & Gamble later claimed that the sales of Rely amounted to less than 1 percent of the company's total consolidated annual revenues of $10.8 billion.

When the Rely tampon first was released in a test market, the company logged more than 100 complaints per month. In 1980, Procter & Gamble sent 60 million sample packages directly to households across the nation.

Rely was voluntarily recalled by the company on September 22, 1980 based on the CDC's studies, finished in June 1980, that linked incidents of TSS with the use of tampons. The cost of the recall to the company was estimated at $75 million and was done only under protest. The company continued to claim that the Rely tampon was not defective and that TSS would continue to occur even after the tampon was removed from the market. The company's agreement with the Food and Drug Administration (FDA) also included a massive advertising campaign that began in October with ads on 600 television stations, 350 radio stations, and 1,200 newspapers designed to reach all American households. The agreement included a detailed plan to provide consumer refunds, and prohibited the sale of the tampons overseas or in the United States without prior FDA approval. Nonetheless, Procter & Gamble faced some 400 civil lawsuits.

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