Reproductive health matters
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Reprod Health Matters · Dec 2012
Public health implications of differences in U.S. and European Union regulatory policies for breast implants.
The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (U. S.) and European Union (EU). In the U. ⋯ Nevertheless, the FDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation.