Abstract
Vaginal tampons are Class II medical devices used by women to manage menstruation. The purpose of this study was to investigate intravaginal temperature changes with simulated and actual menstrual tampon use. Tampons (with varying absorbent compositions) embedded with a thermocouple sensor were used to study temperature effects in vitro in a model of the vagina (condom placed in a hollow glass tube, jacketed in a 37Β°C water bath, and dosed with human menses to fluid saturation) and clinically during menstrual tampon wear under controlled conditions (up to 8 h in a stationary, supine position). Elevations in the temperature of the tampon core occurred upon menses fluid acquisition both in vitro and clinically. Temperature profile characteristics varied from a transient spike with commercial cottonβrayon blend tampons of two different absorbencies to a small but sustained rise (β₯6 h) with a carboxymethyl cellulose (CMC)βcontaining prototype. On the basis of the results from this study, fluid absorption by tampons generates an exothermic event whose characteristics vary with tampon design and composition. We speculate the small, sustained increased in tampon temperature noted during this study may enhance the production of a bacterial exotoxin associated with tampons composed of CMC. Β© 2009 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2010