Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings.

In an age of biomedicalization, medical devices have become more common and more technologically complicated, and adverse events associated with medical devices have increased. The U.S. Food and Drug Administration (FDA) relies on advisory panels to assist in regulatory decision making regarding medical devices. Public meetings held by these advisory panels allow stakeholders to testify, presenting evidence and recommendations, according to careful procedural standards. This research examines the participation of six stakeholder groups (patients, advocates, physicians, researchers, industry representatives and FDA representatives) in FDA panel meetings focused on the safety of implantable medical devices between 2010-2020. We use qualitative and quantitative methods to analyze speakers' opportunities for participation, bases of evidence, and recommendations, applying the concept of 'scripting' to understand how this participation is shaped by regulatory structures. Regression analysis demonstrates statistically significant differences in speaking time, where researchers, industry, and FDA representatives had longer opening remarks and more exchanges with FDA panelists than patients. Patients, advocates and physicians shared the least amount of speaking time, and were the parties most likely to leverage patients' embodied knowledge and recommend the most stringent regulatory actions like recalls. Meanwhile, researchers, FDA, and industry representatives rely on scientific evidence and, with physicians, recommend actions that preserve medical technology access and clinical autonomy. This research highlights the scripted nature of public participation and the types of knowledge considered in medical device policymaking.

Transactional sex, consumer society, and neoliberalism in Uganda: A political economic analysis of drivers and models of response.

Transactional sex is a topic within HIV research that is relatively undertheorised and lacking consensus. In this study, it is understood as the implicit, non-marital, non-commercial exchange of sex for material goods or social status, and we examine the phenomenon among youth. Within the existing literature, the paradigms of sex-for-survival and sex-for-consumption emerge, representing differing senses of agency, particularly among young women. Based on interviews with human service providers in Kampala, Uganda, we consider the latter paradigm, examining how providers frame transactional sex against the political-economic backdrop of consumer culture, including the mainstreaming of communication technology in youths' lives. We also examine providers' depictions of available models of response, focused mainly on HIV prevention, in the context of international and national policies and politics. This study aims to situate analyses of transactional sex within political-economic context, considering how structural shifts toward neoliberalism have shaped both this phenomenon of behavioural health, and the existing models of response.

Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis.

BACKGROUND: Surgery with vaginal mesh is often used to treat female urinary incontinence. Questions have emerged over the past decade about the safety and efficacy of vaginal mesh devices. OBJECTIVE: This study examines trends in adverse event reports associated with vaginal mesh devices, testing the hypothesis that Food and Drug Administration (FDA) announcements will result in increased adverse event reports to the FDA. METHODS: Using interrupted time series regression models, we analyzed adverse event report data collected from the FDA's Manufacturer and User Facility Device Experience reporting system in 1998 through 2015. RESULTS: FDA announcements had limited effects on the number of adverse event reports, whereas an announcement from a mesh manufacturer that it was withdrawing devices from the market resulted in a large spike in reports. CONCLUSIONS: These findings raise concerns about the dispersion of risk communications, the FDA's reliance on adverse event reports for postmarket surveillance, and the FDA's clearance of vaginal mesh without safety or efficacy testing.