Development of methods to model the impact of vaginal lactobacilli on biofilm formation on menstrual cups as well as validation of recommended cleaning directions.

Introduction: Menstrual cups (MC) are a reusable feminine hygiene product. A recent publication suggested that () biofilms can form on MCs which may lead to increased risk of menstrual Toxic Shock Syndrome (mTSS). Additionally, there is concern that buildup of residual menses may contribute to microbial growth and biofilm formation further increasing mTSS risk.

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.

Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone.

Background: Ensuring menstrual cup safety is paramount, yet a menstrual cup safety assessment scheme is lacking. This paper presents a quadripartite scheme, showing how it can be applied.

Methods: The Tampax Menstrual Cup was evaluated in the safety assessment scheme: (1) Biocompatibility and chemical safety of cup constituents.

Impact of Advertising on Tampon Wear-time Practices.

Objectives: (1) To determine whether advertising nighttime tampon use for up to eight hours was understood to be consistent with label recommendations and (2) to determine whether television and print advertising with this message affected tampon wear times in adults and teens.

Methods: (1) A comprehension study (online advertising and follow-up questionnaire) among women aged 14-49 years (300 per group) who viewed either the test or a control advertising message; (2) Diary-based surveys of tampon wear times performed prior to (n = 292 adults, 18-49 years, 74 teens, 12-17 years) and after (n = 287 adults, 104 teens) the launch of national advertising.

Results: Significantly more test message viewers than controls stated tampons should be worn less than or equal to eight hours (93.

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.

A strategy for safety assessment of chemicals with data gaps for developmental and/or reproductive toxicity.

Alternative methods for full replacement of in vivo tests for systemic endpoints are not yet available. Read across methods provide a means of maximizing utilization of existing data. A limitation for the use of read across methods is that they require analogs with test data.