Tuesday, May 5, 2009
NY Times story re FDA approval process
The New York Time’s Science section had a disturbing story today about a urinary incontinence device marketed to women that has caused devastating injuries for hundreds if not thousands of women. One of the more problematic implications of the story is that the Food and Drug Administration approved this dangerous device based on it being “substantially equivalent” to a sling that had already been recalled; which the FDA apparently claims is not a problem. The agency told the Times in an email that, “Any legally marketed device can serve as a predicate for a premarket submission.” Even if it’s been recalled! For a comment on this go here.