Our latest #ImplantFiles story reveals that the FDA kept hundreds of thousands of breast implant incident reports out of public sight. It also raises some pretty basic questions about a major FDA program called alternative summary reporting (thread)
icij.org/investigations…
Alternative summary reporting is a program that lets medical device makers report many adverse events in non-public quarterly summaries. At least 1.1 million incidents were kept from public view by ASR since 2016, @By_CJewett revealed this month
khn.org/news/hidden-fd…
The FDA & device industry give two main defenses for ASR: that it reduces the burden of medical device reporting, and the types of incidents it covers are common, non-lethal problems that the agency already knows about
But here's the thing... neither of those are reasons to keep quarterly summaries hidden from public sight. And if I were a patient or health provider, I'd definitely want to know how common a certain problem was if I was considering using a device
In fact, as far as I can tell (and I'm open to new perspectives on this), the ONLY interest served by keeping quarterly summaries out of public view is that of companies trying to conceal the risk profile of their devices
icij.org/investigations…
Which makes it especially troubling that the FDA is expanding summary reporting to include almost all device malfunctions (device errors that don't harm patients). The FDA has said that these reports will be visible to the public, but then didn't answer when we followed up.
That raises a basic question for the @US_FDA: will all alternative summary reports be disclosed publicly in the future? And if not, what is the rationale?
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