Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.
The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs. New reporting shows the regulatory lapses extend to many devices and companies.
The devices at their bedsides were lifelines, until they learned the foam inside could break down and make them sick. Now, they’re plagued by illness, lost sleep and worry.