Consumer Reports targets medical devices' safety - latimes.com

 Blogger's Note: search blog for other posts regarding 'surgical mesh' issues/concerns

Consumer Reports targets medical devices' safety - latimes.com

"In a report issued Wednesday the consumer magazine also expressed concerns about risks related to surgical mesh, metal hips and certain cardiac devices. It highlighted how the federal government allows some products to be sold with little or no advance safety testing......

Perspective: Postmarketing Surveillance of Medical Devices — Filling in the Gaps — NEJM

open access: Regulation of Medical Devices in the United States and European Union — NEJM (comparing differences pro's/con's)

Conclusions

Systems for approving new medical devices must provide pathways to market for important innovations while also ensuring that patients are adequately protected. To achieve these goals, the United States and European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes.

Study Calls Approval Process for Medical Devices Flawed - NYTimes.com

Calls to Make Europe the Global Leader for Medical Devices