Tampons have been associated with toxic shock syndrome, a newly-recognized disease which attacks women of menstrual age and has caused at least 84 deaths so far. A study of the medical literature since 1933, when tampons were first put on the market, reveals warning of possible dangers as a foreign body, as an irritant, as a carrier of bacteria. Today more health professionals are aware of the dangers of tampon use, but they have not yet applied this knowledge to diseases other than TSS. We believe this should be done. Tampons, now considered a Class II Medical Device, should be re-classified into Class III, where pre-market testing is mandatory.