Information on growing patient harm is suppressed by powerful interests that benefit from underfunded research and regulation. Taxpayers and consumers deserve to know which medical devices are safe and effective. (Especially now when joint replacements are the #1 expenditure of Medicare!) Patients deserve to know more about an implant device than they do about a toaster oven they are considering for purchase. Informed consent must include a discussion about the FDA 510(k) clearance debate and medical device Supreme Court pre-emption (Riegel v Medtronic) and tort reform that weakens patient protections when a device fails. The epic failures of various ICD's, surgical mesh and metal-on-metal hips were preventable. The device industry is not entitled to profit without accountability.
Please support Consumers Union Safe Patient Project! These patients are bravely telling their stories to benefit us all!