Are women more likely to be harmed by medical device failures? - ICIJ
The best source for gender-specific data on injuries and deaths linked to medical devices should be the U.S. Food and Drug Administration. The FDA collects that information in “adverse event” reports filed by manufacturers, doctors and others when a device has harmed a patient – or has experienced a malfunction that would lead to harm if it were to recur. An ICIJ analysis of this data identified more than 83,000 deaths and 1.7 million injuries linked to medical devices.
Yet the FDA won’t make gender information public. An agency spokeswoman told ICIJ that revealing gender or age would violate patient confidentiality rules and that more broadly, “conclusions can not be drawn” about sex-specific differences in adverse event rates, because the reports themselves often contain unverified and incomplete information.