Most patients are better off using a recalled device because the risks of untreated sleep apnea still outweigh the potential harms of the disintegrating foam, physicians say. But doctors have been hard pressed to help patients find new machines, which generally cost between $500 and $1,000, and were already in short supply due to supply chain problems.
. The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips machines, including Trilogy ventilators.to expand its communication effort, including “clearer information about the health risks of its products.” Regulators estimated then that only half of U.S. consumers affected had registered with the company.
“Once I got off their machine, all of that cleared right up,” said Reed, 62, who obtained a competitor’s device after several months. Like other users, Reed can’t definitively prove his problems were caused by Philips’ device. Medical device companies typically conduct recalls voluntarily, and former FDA officials say the agency has never actually used its authority to force additional steps.“The FDA shares the frustrations expressed by patients who are awaiting a resolution for this recall,” the agency said in a statement. Philips still hasn’t provided “all information we requested to evaluate the risks from the chemicals released from the foam.
In a May 2018 email, foam supplier William T. Burnett wrote to Philips in an email: “We would not recommend use of polyester foam in such an environment. ... It will eventually decompose to a sticky powder,” according to an affidavit filed as part of a lawsuit over the foam.