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.

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework.

Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%-70% of the population experiences incontinence with most studies suggesting 25%-45% of the population. Varying definitions of UI (e.

Evaluating Chemical Mixtures in Epidemiological Studies to Inform Regulatory Decisions.

Background: Epidemiological studies are increasingly going beyond the evaluation of health effects of individual chemicals to consider chemical mixtures. To our knowledge, the advantages and disadvantages of addressing chemical mixtures for informing regulatory decisions-as opposed to obtaining a more comprehensive understanding of etiology-has not been carefully considered.

Objectives: We offer a framework for the study of chemical mixtures in epidemiological research intended to inform regulatory decisions.

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

Background And Objectives: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments.