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Zuckerman D.M.,National Research Center for Women and Families | Brown P.,National Research Center for Women and Families | Nissen S.E.,Cleveland Clinic
Archives of Internal Medicine | Year: 2011

Background: Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. Methods: We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review. Results: There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n=23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology. Conclusions: Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices. © 2011 American Medical Association. All rights reserved.


Zuckerman D.,National Research Center for Women and Families | Booker N.,National Research Center for Women and Families | Nagda S.,National Research Center for Women and Families
Reproductive Health Matters | Year: 2012

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 (US) and European Union (EU). In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US than in the EU, a decision US government health agencies can point to with pride. 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. © 2012 Reproductive Health Matters.

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