This article has been updated with comments from the FDA and from Madris Tomes.
A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men.
The report published by the International Consortium of Investigative Journalists (ICIJ) shows that among 340,000 people whom the FDA listed as having been injured by a medical device, women made up 67%, compared with men at 33%. The FDA’s MAUDE database contains adverse event reports submitted by medical professionals, medtech companies and the public, but does not reveal a patient’s gender directly, as the FDA’s drug- and biologic-related adverse-event database, FAERS, does. ICIJ wrote its own algorithm to plumb the database, searching on terms gendered pronouns such as “she” or “he,” and adjectives such as “female” and “male.”
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