Man using sleep apnea device.Photo:Roberto Machado Noa/LightRocket via Getty
Roberto Machado Noa/LightRocket via Getty
The Food and Drug Administrationannounced this weekthat previously recalled sleep apnea machines have been linked to the deaths of 561 people.
In June 2021, the agency announced a recall of Philips Respironics BiPAP and CPAP machines — devices worn overnight while someone sleeps — as well as ventilators, saying the “polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway.”
Since that initial recall, the FDA says it has received “561 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.”
Person using a device for sleep apnea.Ute Grabowsky/Photothek via Getty
Ute Grabowsky/Photothek via Getty
Although sleep apnea is generally managed through such devices, it can be fatal — and was named as acontributing factor in the deathofCarrie Fisher.
Since the recall, the FDA has received more than 116,000 reports of actual or suspected incidents of foam breaking down in the machines.
In a statement to PEOPLE, a representative for Philips wrote: “Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports. Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death."
The company also asserts that “based on thetesting and analysisto date, Philips Respironics concluded that use of its sleep therapy devices with PE-PUR foam is not expected to result in appreciable harm to health in patients. Further testing is ongoing.”
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If you have a Philips breathing machine, you can look up the serial numberon this website— which will also let you know if you’re eligible to be a part of a class action suit against the manufacturer.
Apart from frequently waking at night, those with sleep apnea wake up tired, and may experience depression and anxiety, theCleveland Clinic explains.
Snoring is also a common symptom of sleep apnea — but not everyone who snores has the disorder.
source: people.com
