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. MATERIALS AND METHODS: For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. RESULTS: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. CONCLUSION: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

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. We identify a) the different ways mixtures originate (product source, pollution source, shared mode of action, or shared effect on health outcome), b) the use of indicator chemicals to address mixtures, and c) the requirements for epidemiological studies to be informative for regulatory purposes. DISCUSSION: The principal advantage of considering mixtures is to obtain a more complete understanding of the role of the chemical environment as a determinant of health. Incorporating other exposures may improve the assessment of the net effect of the chemicals of interest. However, the increased complexity and potential loss of generalizability may limit the value of studies of mixtures, especially for mixtures based on mode of action or shared health outcomes. Our recommended strategy is to successively assess the marginal contribution of individual chemicals, joint effects with other specific chemicals, and hypothesis-driven evaluation of mixtures rather than applying hypothesis-free data exploration methods. Although more ambitious statistical approaches to mixtures may, in time, be helpful for guiding regulation, the authors believe conventional methods for assessing individual and combined effects of chemicals remain preferable. https://doi.org/10.1289/EHP11899.

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.g., stress, urgency, mixed) exist, and inconsistent symptom assessment tools, age, and gender can affect the estimate of incidence. Disposable Adult Incontinence products were first introduced into the market in the late 1970s and initially were used mostly in nursing homes and hospitals. However, during the 1980s, the market for incontinence products via retail outlets dramatically increased as awareness of the benefits of the products grew and stigma about their use declined. Today's products that manage urine loss have an extensive history and have evolved with time. Always products were introduced into the market in 2014 and are designed to meet the needs of women of all ages. Considered medical devices in some countries, regional regulations and global guidelines require clear planning, thorough assessment, and concise documentation of clinical safety. This manuscript will briefly review the regulatory landscape with a specific focus on European Union regulations. As previously published, the iterative, risk assessment framework used to assess the safety of Always incontinence products confirms that these products are compatible with skin and can be used safely. This manuscript will expand on the current literature highlighting additional steps that help assure the safety and compliance of the products from quality assurance programs through comprehensive post-market safety surveillance. Recommendations to help ensure several of the key regulatory requirements are met are outlined in the context of a risk assessment framework used to assure safety.

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 in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) 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. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products. Methods/Results: Each product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone. Discussion: The data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment.