Donna R. Hill

Use of porcine vaginal tissue ex-vivo to model environmental effects on vaginal mucosa to toxic shock syndrome toxin-1

Menstrual toxic shock syndrome (mTSS) is a rare, recognizable, and treatable disease that has been associated with tampon use epidemiologically. It involves a confluence of microbial risk factors (Staphylococcus aureus strains that produce the superantigen-TSST-1), as well as environmental characteristics of the vaginal ecosystem during menstruation and host susceptibility factors. This paper describes a series of experiments using the well-characterized model of porcine vaginal mucosa ex-vivo to assess the effect of these factors associated with tampon use on the permeability of the mucosa. The flux of radiolabeled TSST-1 and tritiated water ((3)H2O) through porcine vaginal mucosa was determined at various temperatures, after mechanical disruption of the epithelial surface by tape stripping, after treatment with surfactants or other compounds, and in the presence of microbial virulence factors. Elevated temperatures (42, 47 and 52°C) did not significantly increase flux of (3)H2O. Stripping of the epithelial layers significantly increased the flux of labeled toxin in a dose-dependent manner. Addition of benzalkonium chloride (0.1 and 0.5%) and glycerol (4%) significantly increased the flux of (3)H2O but sodium lauryl sulfate at any concentration tested did not. The flux of the labeled toxin was significantly increased in the presence of benzalkonium chloride but not Pluronic® L92 and Tween 20 and significantly increased with addition of α-hemolysin but not endotoxin. These results show that the permeability of porcine vagina ex-vivo to labeled toxin or water can be used to evaluate changes to the vaginal environment and modifications in tampon materials, and thus aid in risk assessment.

Intravaginal and in vitro temperature changes with tampons of differing composition and absorbency

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 37 degrees 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 cotton-rayon blend tampons of two different absorbencies to a small but sustained rise (> or =6 h) with a carboxymethyl cellulose (CMC)-containing 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.