Reemergence of staphylococcal toxic shock syndrome in the United States since 2000.

Schlievert et al. recently reported that the increased number of cases of toxic shock syndrome (TSS) observed by their surveillance group over the last 4 years in the Minneapolis-St. Paul metropolitan area is consistent with Centers for Disease Control and Prevention findings of an 18% increase in the incidence of TSS from 2002 to 2003 (3). He wisely cautioned medical practitioners and women using tampons (especially teenagers and young women) to be aware that the TSS incidence is rising. Further, Schlievert et al. suggested that while the reason for this increased incidence is unclear, the possible role of changed tampon usage patterns might offer an explanation (3). I would like to support that contention with two additional observations. First, in 1999 the Food and Drug Administration proposed an amendment to tampon labeling regulation 21CFR 801.430(e)(1) which provided an absorbency term for tampons that absorb 15 to 18 g of fluid, namely, ultra. Soon thereafter tampons with this increase in absorbency became widely available on the marketplace, thereby making five categories of extant tampons, namely, light ( 6 g), regular (6 to 9 g), super (9 to 12 g), super-plus (12 to 15 g), and ultra (15 to 18 g). Clearly, this permitted increase in absorbency is of concern because the statistical association of highly absorbent tampons with development of TSS has been unequivocally established (1, 2, 4). Thusly, this absorbency increase might also be a reason for the observed increased incidence of TSS. In the past, increases in absorbency were achieved by using more absorbent synthetic fibers. Although tampon composition has not recently changed, the increases in tampon absorbency can be accounted for by increased weight of the current component fibers. Second, the Food and Drug Administration’s position on “8-h/overnight” usage of menstrual tampons may have also inadvertently contributed to the observed increased incidence of TSS by allowing manufacturers to use the word “overnight” on their packaging (even though they explain that by that word they mean 8 h or less). Simply put, women may not be able to precisely control their sleeping cycles and therefore may sleep considerably longer than 8 h with a more absorbent tampon in place, thus increasing their risk for TSS development. Implicit with the pattern of tampon usage is its absorbency, which in turn is related to length of use. In conclusion, it seems prudent, in light of accumulating data, to suggest that if tampons are to be used at bedtime the timeframe of their use must be controlled or they should not be used. Additionally, tampon absorbency should be reduced to the pre-2000 absorbency levels with capacity limits of no more than 15 g of fluid as an extra measure of safety.