In June 2021, Philips Respironics recalled millions of CPAP and BiPAP machines due to a defect with the polyester-based plyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration in the device. This recall has forced many people who rely on CPAP machines to treat sleep apnea to look for other ways to ensure that they can breathe comfortably throughout the night.
When the foam breaks down, it can enter the device’s air pathway, causing the user to inhale the debris and gases. Laboratory tests have shown that degraded PE-PUR debris contains many toxic chemicals, some of which can even cause cancer. Older devices – as in, those that are three or more years old – are more likely to be affected by PE-PUR breakdown. Devices that have been exposed to high heat or a humid environment are also at risk.
Because of the risks involved, the FDA classified the Philips CPAP recall as a Class I recall. A Class I recall means that the product in question could potentially cause serious injury or even death under certain circumstances.
The recall affects many of Philips’ breathing devices. About 80% of the recalled devices are CPAP machines while the remaining 20% are ventilators. The number of recalled devices isn’t necessarily set in stone; in January 2022, the FDA announced that Trilogy EVO ventilators were to be added to the recalled devices list.
CPAP machines are recommended to patients with obstructive sleep apnea. The device continually forces air into the throat in order to keep the airway unblocked, thus avoiding the obstructions that can cause apnea episodes. Without CPAP machines, sleep apnea patients are once again vulnerable to interruptions in their breathing that prevent them from getting quality sleep.
As of May 19, 2022, Philips has yet to submit a complete plan for repairing or replacing the recalled devices. Since sleep apnea is a condition that can grow more severe than time, affected customers cannot afford to wait. As such, many have started searching for alternatives to help them manage their condition.
For example, Irving dental practice 21st Century Dental offers oral appliance therapy as a solution for sleep apnea. An oral appliance can hold the lower jaw forward in open in order to prevent the tongue and throat tissues from collapsing over the airway, thus reducing sleep apnea symptoms.
In general, oral appliances for sleep apnea are marketed as a possible treatment option for people who are uncomfortable using a CPAP machine. However, with Philips recalling many of its devices and not giving a clear timeline on when new ones will be provided, many people may not have a choice but to switch to oral appliances.
In order to get an oral appliance for sleep apnea, one needs to schedule an appointment with a sleep dentist. They can evaluate the mouth to determine the root cause of sleep apnea and decide whether or not an oral appliance is a viable option in their particular case. There are many different kinds of oral appliances that might be recommended based on the patient’s needs and preferences.
If an oral appliance isn’t enough to address sleep apnea symptoms, people with the condition should talk to their doctors as soon as possible to see what other options are available. Untreated sleep apnea can cause severe drowsiness that makes it dangerous to drive, and it can raise the risk of potentially deadly heart problems. In short, people who have been affected by the recall need to act quickly to take control of their situation before they are affected by the worst of the health consequences.