Why We Are Here ~ To Put a Face on Adverse Events
January 31, 2013 ~ Quite simply put the reason we are here at Mesh Medical Device News Desk (MDND) is to calculate the human toll of complications from the unregulated world of medical devices.
Most Americans do not understand that the vast majority of medical devices 75-90% approved in the U.S. bypass any safety and efficacy review by the U.S. Food and Drug Administration(FDA). Because there is no post-market registry in the U.S. either, we hear about these “adverse events” AFTER they occur from the mouths of those who are injured, many permanently. They and their families will never be the same. Some of these injuries are fatal.
Mesh patient, Jaye Lee tells the story simply with this wonder wall of mesh injured men and women. From both transvaginal, hernia an abdominal placement of polypropylene mesh, petroleum-based byproduct – here are the faces of “adverse events.” That’s why we are here.
Thank you Jaye Lee!
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Jane Akre, Editor