R.A.Bright, D.E.Dwyer, CDRH, Rockville, MD
Although the incidence of tampon-related Toxic Shock Syndrome (TSS) has apparently decreased since the early 1980s, TSS and other tampon problems continue to be reported. FDA received 404 reports of 412 events during 8/1/1996 — 9/1/2002; 123 were for TSS (including 7 deaths), 34 for local infection, and 198 for tampon breakage. Emergency room care was specified for 31. The National Electronic Injury Surveillance System (NEISS) for 7/1/1999-6/30/2000 was used to estimate national rates of tampon-related emergency room visits: 67 emergency room visits were related to tampons (national estimate: 2100, with 95% confidence interval (CI) of 1100 to 3100). Cause-specific national estimates were 18 visits for TSS, 227 for pain or infection, and 2014 (CI: 1402-2626) for tampon removal, specifically because it was “stuck” for 1589 (CI: 1113-2065). For both data sources, the rates were highest for women in their teens and twenties. Comparing data from FDA and NEISS showed underreporting to FDA by 30 to 400 fold, depending on the tampon problem being reported. Tampon retention is a surprisingly frequent problem that might increase the probability of TSS.