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The US Food and Drug Administration (FDA) has issued an update to a recall affecting millions of Philips sleep apnea machines, saying which may be linked to at least 561 reported deaths.
In a statement issued Wednesday, the agency said it has received more than 116,000 reports since April 2021 about breathing devices that have been found to break down and cause serious health risks, including suffocation, inhalation of foreign particles and a increased risk of cancer.
The devices, used for sleep apnea and similar sleep disorders, were made from polyester-based polyurethane (PE-PUR) foam, which breaks down over time and enters the airways of people who use them. According to the FDA notice, the foam, which is used to reduce sound and vibration, degrades with use, causing “black pieces of foam or certain chemicals that are not visible” to be “breathed in or swallowed by the person using the device.” “.
Philips tried to solve this problem after a initial memory of more than 5 million devices in 2021.
Philips has since agreed with regulators to stop selling these and similar devices in the US, and a proposed class-action settlement is underway. A Philips spokesperson shared the following statement with USA TODAY.
“Based on investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports. Importantly, the presentation of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all complaints and allegations received regarding malfunction, serious injury or death.”
Here’s what we know about the Philips sleep machine recalls.
Discontinued sleep apnea machines:Philips to suspend sales of sleep apnea machines in US over safety concerns
Retired devices
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Philips has agreed to stop selling sleep apnea machines in the US and existing devices manufactured between 2009 and April 2021 are subject to recall as they may pose a risk of serious injury due to the breakdown of PE foam. -PUR used in them.
Devices included in retirement include:
- BiPAP A30 Series A
- A Series BiPAP A40 (ventilator)
- A30 Series A Hybrid BiPAP
- Series A BiPAP V30 Auto (ventilator)
- ASV C Series (fan)
- CS/T and AVAPS series
- dream station
- Dream Station ASV
- Dream season go
- DreamStation ST, AVAPS
- Bedroom 400
- Sleep 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q Series)
- Trilogy 100 (fan)
- Trilogy 200 (fan)
- TRUE Trilogy Evo fans with specific serial numbers.
Some products that were modified in an attempt to resolve the problem have also been recalled. Specifically, some modifications Philips Respironics Trilogy 100/200 Ventilatorsas the FDA has requested additional safety testing on the silicone foam material used to replace PE-PUR foam.
These products include:
Class Action Settlement and Filing a Claim
Philips reached a settlement with the FDA and the US Department of Justice and agreed to stop the sale of the affected products in the US. Philips agreed pay at least 445 million dollars in compensation to users of the devices under a proposed class action settlement for people who purchased a recalled Philips Respironics CPAP, BiPAP or ventilator sold in the US between 2008 and 2021.
Eligible users can submit a claim for compensation via the agreement website. This does not prevent them from filing new actions, meaning affected individuals can still file new actions at a later date.
Those who qualify will have the right to:
- A prize for paying for the device for each recalled device they purchased, rented, or rented;
- A $100 device return prize for each recalled device you purchased, rented, or were prescribed and have already returned or are returning to Philips Respironics before August 9, 2024; I;
- A device replacement award if they spent their own money to purchase a CPAP, BiPAP or comparable ventilator between June 14, 2021 and September 7, 2023, to replace a recalled device.
Individuals who believe they may be entitled to part of this agreement can verify their eligibility and receive further instructions through the agreement. administrator website. Important dates to keep in mind if you want to participate in the class action lawsuit.
The deadline to file a claim is August 9.
What are the symptoms of sleep apnea?
Sleep apnea is a common condition in which breathing stops and starts 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 blocked, reducing or completely stopping airflow. Central sleep apnea occurs when the brain does not send signals to the regions of the body needed to breathe.
A common symptom of sleep apnea is loud snoring. Health experts also say that people with sleep apnea tend to wake up several times during the night, sometimes gasping and choking. This is because the brain responds to a lack of oxygen by alerting the body, forcing the person to wake up from sleep to restore normal breathing.
Patients with sleep apnea can experience abnormal breathing episodes, in which airflow is reduced or stopped, between five and 100 times in an hour, said Dr. Kin Yuen, a sleep medicine specialist at UCSF Health and spokesperson for the American Academy of Sleep Medicine. .
“When we get to 100 events per hour, these are the people who have suffered for a long time without seeking help and are more likely to have complete blockages,” he said.
Many people don’t know they have sleep apnea. The American Medical Association It is estimated that while about 30 million people live in the United States with sleep apnea, only 6 million are diagnosed.
Patients who don’t know if they snore or wake up in the middle of the night can identify sleep apnea through daytime symptoms, Yuen said, such as feeling tired during the day, mood swings, trouble concentrating and morning headaches. .
How is sleep apnea solved?
The gold standard for treating sleep apnea is the use of a continuous positive air, or CPAP, machine, Yuen said.
The machine uses pressure to blow air into the upper airways, removing potential obstructions, to maintain the respiratory cycle without interruption.
“It’s an important part of our treatment for patients, so this whole Philips recall has created tremendous difficulty… in being able to treat our patients effectively,” he said.
Some people also need braces or surgery to correct structural problems in the jaw that could inhibit breathing.
What happens if sleep apnea is left untreated?
Sleep is the body’s way of repairing itself from the day’s wear and tear, Yuen said, and disrupting this natural process can wreak havoc on every part of the body.
Blood pressure, heart rate, and blood sugar usually drop when a person sleeps. But if they remain elevated due to lack of sleep, this could increase the risk of high blood pressure, cardiovascular problems and diabetes.
Insomnia due to sleep apnea can also harm a patient’s social-emotional health and increase the risk of mental health disorders, such as depression.
Can sleep apnea go away?
If a patient’s sleep apnea is due to structural problems, Yuen said, the condition will not go away without corrective surgery.
However, there could be ways to improve sleep apnea if it is caused by other factors.
People who gain weight quickly are also more likely to develop sleep apnea, as excess tissue around the upper airways blocks airflow. Losing that weight could help reduce those blockages and improve sleep apnea.
Sleep apnea can also be caused by increased irritation or inflammation of the throat due to excessive alcohol, tobacco, and vaping. Taking a break or abstaining from drinking and smoking may help decrease inflammation and improve airflow.
