Public health implications of differences in US and European Union regulatory policies for breast implants

摘要: AbstractThe recall of tens thousands defective breast implants in Europe 2011–12 as well new data on risks have raised questions about regulatory standards for these and other medical the United States (US) European Union (EU). In US, are regulated high-risk devices that must be proven reasonably safe effective clinical trials subject to government inspection before they can sold. contrast, inspections not been required or implanted EU; approval is based information. As a result differing standards, PIP were recalled across had removed from market years earlier US than EU, decision health agencies point with pride. Nevertheless, FDA track record post-marketing implant research indicates poorly implemented studies little meaningful enforcement ensure t...