Medical devices occupy an increasingly important place in global medical care, and yet the risk management systems that govern them are largely overlooked in academic literatures. In the US, home to the largest medical devices market, Food and Drug Administration (FDA) regulation allows most medical devices to enter the market based on analogy, or substantial equivalence, with previously marketed devices. Thus, risk assessment is administered without premarket clinical trials for safety and efficacy. This system represents a permissive regulatory regime based in neoliberal tenets, where risk, in the form of adverse events, is inherently tolerated within governance structures, evidencing risk colonisation. This paper employs a case study approach, examining market clearances of vaginal mesh surgical devices, which have been the subject of US multi-district litigation. We identified 266 devices cleared before 31 December 2017 and analysed the complicated web of device ‘ancestry’ whereby devices as disparate as cardiac patches and hernia mesh allowed clearance of surgical devices for urogynecology. Perhaps of greatest concern, 10 recalled or withdrawn devices influenced new device clearances for up to 17 years after their market-removal. While the FDA must balance its dual mandate to safeguard patients and promote innovation, we find that medical device regulation structurally favours innovation over safety. ‘Light touch’ risk assessment is not counterbalanced with postmarket mechanisms to safeguard against residual and developmental risks that are associated with medical devices, particularly permanent implants. The proportionality principle associated with a precautionary approach should inform medical device risk management.

医疗器械在全球医疗保健中占有越来越重要的地位，但是管理它们的风险管理系统在学术文献中却被大大地忽略了。在拥有最大医疗设备市场的美国，食品药品监督管理局（FDA）法规允许大多数医疗设备基于与以前销售的设备的类比或实质等效性进入市场。因此，无需进行上市前临床试验就可以进行安全性和有效性的风险评估。该系统代表了一种基于新自由主义原则的宽松监管制度，其中，以不良事件形式出现的风险在治理结构中被固有地容忍，从而证明了风险殖民化。本文采用案例研究方法，研究了阴道网状外科手术器械的市场准入情况，这些已成为美国多地区诉讼的主题。我们确定了266项在2017年12月31日之前清除的设备，并分析了复杂的设备``祖先''网络，其中设备与心脏补丁和疝气网不同，可以清除用于泌尿妇科的外科设备。也许最令人担忧的是，有10台被召回或撤回的设备在撤市后长达17年的时间里影响了新设备的许可。尽管FDA必须权衡其双重职责以保护患者并促进创新，但我们发现医疗器械法规从结构上更倾向于创新而不是安全。“轻触式”风险评估与上市后机制（用于预防与医疗设备（尤其是永久性植入物）相关的残留和发育风险）的平衡不平衡。