Patients’ rage and irritation over the widespread recall of millions of sleep apnea equipment has fueled U.S. officials’ consideration of taking unprecedented legal action to expedite a replacement effort expected to linger into the following year.
Manufacturer Philips warned in June 2021 about the possibility of customers inhaling microscopic black particles or dangerous substances as they sleep due to sound-dampening foam in the pressurized breathing devices degrading over time.
At first, Philips thought it could fix or replace the units in a year.
However, the Dutch corporation now claims the process will last until 2023 as the worldwide recall has grown to include more than 5 million devices.
Many patients are now forced to decide between utilizing a potentially dangerous gadget or seeking unsafe solutions, such as removing the foam, purchasing used equipment online, or forgoing therapy altogether.
The equipment is called CPAP, or continuous positive airway pressure, machines. To keep their airways open as they sleep, they pressurize a mask.
People with untreated sleep apnea may stop breathing hundreds of times every night, which increases their risk of having a heart attack and puts them in danger.
Estimates for the number of adults affected range from 10% to 30%, with males experiencing the issue more frequently than women.
According to doctors, most patients are better off using a recalled product since the dangers of untreated sleep apnea still outweigh any potential concerns from the foam that disintegrates.
However, doctors have struggled to assist patients in locating new devices, which typically cost $500 to $1,000 and were already in short supply due to supply chain issues.
According to Dr. John Saito, a respiratory specialist close to Los Angeles, “The company just said, ‘Talk to your doctor.’ But doctors can’t make new devices out of thin air.”
According to the Food and Drug Administration, risks from the foam include headache, asthma, allergic responses, and impacts that can cause cancer in internal organs.
Because just half of the affected U.S. consumers had registered with Philips, the FDA took the unusual step of directing Philips to increase its communication efforts, including “clearer information regarding the health risks of its devices,” in March last year.
The agency had not given such a command in many years.
Continuing testing on the recalled goods, according to a statement from Philips, is “encouraging” and reveals low amounts of particles and chemical byproducts released by its top-selling brand of machines.
The company stated that the deterioration appears to be exacerbated by unapproved cleaning techniques, and Philips described its initial statement about the dangers posed by the foam as “a worst-case scenario for the probable health risks.”