Hydrophilic polymer embolism the medical name for coating material that separates from medical device surfaces and causes complications.
Health Canada and the U.S. Food and Drug Administration are near opposites in their responses to rising evidence of patient harms caused by some medical devices.
The FDA issued a safety bulletin in 2015 which said there were 500 reports of coating delamination in just two years. There were also 11 device recalls and nine U.S. deaths associated with the peeling or flaking from guide wires used during cardiac angiograms or angioplasties. Last year, the FDA followed up with additional recommendations.
“To be truthful, it wasn’t on my radar. But it is now. And I’m not trying to belittle the study, but we have clinical trial data on these devices showing they are generally safe and effective.” This week, Rupal Mehta said there has been enormous pushback from physicians and medical device industry personnel who insist complications are too rare to worry about.
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