The safety assessment of tampons: illustration of a comprehensive approach for four different products.

Introduction: We illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of () and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up.

Assessing the dermal compatibility of a new female incontinence product line.

Context: We have developed a line of products designed to better meet the overall needs of women suffering from urinary incontinence. The products are more discrete and contain a unique odor neutralizing technology (ONT).

Objective: This paper describes the overall skin compatibility program for this product line in which the new products were compared to negative controls and/or commercially marketed reference products with an established history of safe use.

Safety assessment of sanitary pads with a polymeric foam absorbent core.

Sanitary pads for menstrual hygiene have a layered design consisting of a fluid permeable surface (topsheet), an absorbent core, and an impermeable backing with adhesive. Most sanitary pads employ cellulose-based cores. This describes the safety evaluation of a menstrual pad with an emollient-treated topsheet and a novel polymeric foam core.

Clinical safety assessment of an ultra absorbency menstrual tampon.

Background: Menstrual tampons are available in a range of absorbencies to allow women to use the product most appropriate to their needs. This study assessed the safety of an ultra absorbency (15 g to 18 g) tampon compared with a currently marketed super-plus absorbency (12 g to 15 g) tampon as a control.

Methods: Healthy women age 18-45 years (n = 95) were enrolled in this single-blind, crossover study.

Clinical safety-in-use study of a new tampon design.

Objective: To confirm the safety of a new experimental Tampax tampon and applicator compared with that of a currently marketed Tampax tampon and applicator using comprehensive gynecological and microbiological assessments.

Methods: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli, Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups.

Site-specific prevalence and cell densities of selected microbes in the lower reproductive tract of menstruating tampon users.

Objective: To assess differences in prevalence and cell densities of enterococci, Gram negative enterics (GNEs), yeast and Staphylococcus aureus among four genital sites and to examine whether the presence of organisms at one site affected the presence of organisms at other sites.

Methods: Swab samples from the perineum, below and above the hymen, and the posterior fornix obtained from 52 tampon users on menstrual cycle day 3 were analyzed for site-specific prevalence and cell densities of microorganisms.

Results: Enterococci and GNEs were the most prevalent study organisms at all sites and decreased in prevalence from the perineum to the posterior fornix.