The U.S. Food and Drug Administration (FDA) An update has been published Recall affecting millions of Philips sleep apnea devices saying They may be linked to at least 561 reported deaths.
The agency said in a statement Wednesday that it has received more than 116,000 reports of respiratory problems since April 2021, which have caused problems such as suffocation, inhalation of foreign objects and an increased risk of cancer. announced that it has been found to cause serious health damage.
The device is used for sleep apnea and similar sleep disorders and is made from polyester-based polyurethane (PE-PUR) foam, which has been found to break down over time and enter the user’s airways. doing. According to the FDA notice, the foam used to reduce sound and vibration degrades with use, and “black foam pieces or certain invisible chemicals” can be “inhaled by the person using the device.” or be swallowed. . ”
Phillips is first recall In 2021, there will be more than 5 million devices.
Philips has since reached an agreement with regulators to stop selling these and similar devices in the United States, and a proposed class action settlement is underway. A Phillips spokesperson issued the following statement to USA TODAY:
“Based on our investigation to date, Philips Respironics has found no conclusive data linking these devices to the deaths reported in these medical device reports. Importantly, the MDR submission itself There is no evidence that the device caused or contributed to any harmful outcome or event. Philips Respironics investigates all complaints and allegations of malfunction, serious injury, or death received.”
Here’s what we know about the Philips sleep machine recall.
Discontinuation of sleep apnea devices:Philips stops selling sleep apnea device in the US due to continuing safety concerns
recalled device
This is what I remembered about my ADHD medication.FDA says bottle may contain wrong pills
Philips has agreed to discontinue sales of its sleep apnea devices in the United States, and existing devices manufactured between 2009 and April 2021 are subject to breakage of the PE-PUR foam used. Subject to recall as it may pose a risk of serious injury.
Devices included in recall include:
- A series BiPAP A30
- A Series BiPAP A40 (ventilator)
- A Series BiPAP Hybrid A30
- A Series BiPAP V30 Automatic (Ventilator)
- C series ASV (ventilator)
- C-Series S/T and AVAPS
- dream station
- Dream Station ASV
- dream station go
- Dream Station ST, AVAPS
- dolma 400
- dolma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- Remstar SE Auto
- System One ASV4
- SystemOne (Q series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
- be Trilogy Evo Ventilator Specific serial number.
Some products that were modified to solve this problem were also recalled.Specifically, certain reworks Philips Respironics Trilogy 100/200 Ventilatorbecause the FDA required additional safety testing of silicone foam materials used in place of PE-PUR foam.
These products include:
Class action settlement and filing of claims
Philips has reached a settlement with the FDA and the U.S. Department of Justice, agreeing to stop selling the affected products in the United States. pay at least $445 million To compensate users of the devices under a proposed class action settlement for people who purchased recalled Philips Respironics CPAPs, BiPAPs, or ventilators sold in the United States between 2008 and 2021.
Eligible users may submit claims to receive compensation in the following ways: Payment site. This does not prevent them from filing further lawsuits and means those affected can file further lawsuits at a later date.
Eligible persons are entitled to:
- Device payment benefits For each recalled device purchased, leased, or rented.
- $100 device return benefit For each recalled device, you have purchased, leased, rented, returned, or been instructed to return to Philips Respironics by August 9, 2024. and/or;
- Device exchange benefits If you purchased an equivalent CPAP, BiPAP, or ventilator at your own expense between June 14, 2021 and September 7, 2023 to replace the recalled device.
Those who believe they may be eligible to receive a portion of this settlement can review their eligibility and receive further instructions through the settlement. Administrator website. Important dates to remember if you want to join a class action lawsuit.
The last date to file a claim is August 9th.
What are the symptoms of sleep apnea?
Sleep apnea is a common condition where breathing stops and starts again during sleep. The most common forms are obstructive sleep apnea and central sleep apnea. According to the National Heart, Lung, and Blood Institute.
Obstructive sleep apnea occurs when the upper airway becomes obstructed and airflow is reduced or stopped completely. Central sleep apnea occurs when the brain is unable to send signals to the areas of the body needed for breathing.
A common symptom of sleep apnea is loud snoring. Health experts also say people with sleep apnea tend to wake up multiple times during the night, sometimes gasping for air or choking. This is because the brain reacts to the lack of oxygen and alerts the body, forcing it to wake up from sleep to restore normal breathing.
According to Dr. Kin Yuen, a sleep medicine expert at UCSF Health and spokesperson for the American Academy of Sleep Medicine, patients with sleep apnea experience abnormal breathing phenomena in which airflow is reduced or stopped. He said he could experience this 5 to 100 times an hour. .
“By the time 100 events occur per hour, these people have been suffering for a long time without seeking help and are more likely to become completely disabled,” she said.
Many people do not know that they have sleep apnea. american medical association It is estimated that approximately 30 million people in the United States may have sleep apnea, but only 6 million have been diagnosed.
Even if patients don’t know whether they are snoring or waking up during the night, daytime symptoms such as daytime fatigue, mood changes, difficulty concentrating, and morning headaches can indicate sleep apnea. Yuen said it can be identified.
How can I treat sleep apnea?
According to Yuen, the gold standard treatment for sleep apnea is the use of continuous positive air machines (CPAP).
This machine uses pressure to force air into the upper airways, pushing away potential blockages and keeping the breathing cycle uninterrupted.
“This whole Philips recall has made it very difficult to treat our patients effectively because this is an important part of our care for our patients,” she said.
Some people may need dental appliances or undergo surgery to correct structural problems in the jaw that can interfere with breathing.
What happens if sleep apnea is not treated?
According to Yuen, sleep is the body’s way of repairing itself from the day’s fatigue, and interrupting this natural process can have negative effects on all parts of the body.
Normally, when a person sleeps, blood pressure, heart rate, and blood sugar levels decrease. However, if your blood pressure remains high due to sleep deprivation, you may be at increased risk for high blood pressure, cardiovascular disease, and diabetes.
Insomnia caused by sleep apnea can also impair a patient’s social and emotional health and increase the risk of mental health disorders such as depression.
Can sleep apnea be cured?
If a patient’s sleep apnea is due to a structural problem, the condition will only go away with corrective surgery, Yuen said.
However, if your sleep apnea is caused by other factors, there may be ways to improve it.
People who gain weight rapidly are more likely to develop sleep apnea because excess tissue around the upper airways obstructs airflow. Losing that weight may alleviate these blockages and improve your sleep apnea.
Sleep apnea can also be caused by increased throat irritation and irritation from excessive drinking, smoking, and vaping. Taking breaks or cutting back on drinking and smoking can help reduce inflammation and improve airflow.