The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark
Kaiser Health News senior correspondent Christina Jewett explains how she investigated a Food and Drug Administration database where medical device makers report malfunctions and patient injuries, skirting the public record. Because the cache of information is buried deep within the agency, it’s often hard for physicians, researchers and patient safety advocates to access the information.
Press release. Video published on 7 March 2019 by Kaiser Health News.
One day after my @KHNews report on more than a million medical device reports going into an internal database, notably surgical staplers, the #FDA announces a sweeping plan to review stapler safety — and the hidden reports: https://t.co/JgEwL7zzIc via
This number is staggering: more than 1.1 million incidents of medical device related injuries and malfunctions since 2016 have been kept hidden from public view in the FDA's "alternative summary reporting" database. Powerful investigation by @By_CJewetthttps://t.co/VZs1RQA1Zy
The #FDA warned of complications re: pelvic #mesh in 2011. Then FDA granted lawsuit 'exemptions' to 8 mesh makers to file summary reports. The 2017 total? 11,969 mesh injuries submitted via spreadsheet to FDA, bypassing the public and MDs – https://t.co/9K7nDwBITX via @KHNews
Implant Files, video published by ICIJ, 24 November 2018
Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.