# Recalled Philips sleep apnea machines linked to 500 deaths: FDA
The U.S. Food and Drug Administration (FDA) has provided an update on a massive recall of Philips sleep apnea machines, linking them to at least 561 reported deaths. The FDA disclosed that since April 2021, over 116,000 reports have been received concerning the respiratory devices, which have been found to deteriorate and lead to serious health risks, including choking, intake of foreign particles, and increased cancer risk. These devices, designed for sleep apnea and similar conditions, were constructed with polyester-based polyurethane (PE-PUR) foam, which has been discovered to degrade over time and enter the airways of users. The FDA notice explains that the foam, used to diminish sound and vibration, degrades with usage, resulting in the inhalation or ingestion of “black pieces of foam, or certain chemicals that are not visible” by the user.
Philips attempted to rectify this issue following an initial recall of over five million devices in 2021, but the remedies turned out to be unsafe, reportedly obstructing the airways of users. Philips has agreed to discontinue the sale of these and similar devices in the U.S., and a proposed class action settlement is in progress. Previously, the FDA had not reported any deaths related to the recalls, but the updated warning now includes a chart showing the number of deaths and their reporting dates.
Here is what we know about the Philips sleep machine recalls:
– Philips has ceased sales of sleep apnea machines in the U.S. due to ongoing safety concerns.
– Existing devices manufactured between 2009 and April 2021 are subject to recall as they pose a serious injury risk resulting from the breakdown of the PE-PUR foam utilized in them.
– Recalled devices encompass A-Series BiPAP A30, A-Series BiPAP A40 (ventilator), DreamStation, and various others.
Philips has settled with the FDA and U.S. Justice Department, agreeing to stop the sale of the affected products and pay at least $445 million in compensation to users of the devices. A proposed class-action settlement is now underway for individuals who purchased a recalled Philips Respironics CPAP, BiPAP, or Ventilator in the U.S. between 2008 and 2021. Eligible individuals can submit a claim to receive compensation via the settlement website. This action does not prevent them from pursuing further action, meaning affected individuals can still take further action at a later date. The final date to submit a claim is August 9.
Sleep apnea, a condition where breathing stops and restarts during sleep, has common forms such as obstructive sleep apnea and central sleep apnea. Loud snoring and waking multiple times during the night, sometimes gasping and choking, are common symptoms of sleep apnea. Patients with undiagnosed sleep apnea may experience daytime symptoms such as fatigue, mood changes, trouble concentrating, and morning headaches.
The treatment for sleep apnea is typically a continuous positive air machine (CPAP) that uses pressure to blow air into the upper airways. Sleep apnea, if left untreated, can lead to high blood pressure, cardiovascular issues, diabetes, and mental health disorders, such as depression.
In certain cases, sleep apnea due to structural problems may require corrective surgery, while weight loss and lifestyle changes can improve sleep apnea caused by other factors.
