October 18, 2021 5 min read
In June 2021, Philips Respironics voluntarily recalled millions of breathing devices due to possible health concerns. The devices, which include CPAP, BiPAP, and mechanical ventilators, have been showing issues with their polyester-based polyurethane (PE-PUR) sound abatement foam that the company’s tests found could put a user’s health at risk.
Philips announced that the device’s PE-PUR foam seems to degrade into particles that can enter the device’s air pathway from where they can reach users’ lungs and other tissue. This problem can become even worse with inappropriate cleaning, leading to off-gassing.
In the wake of the recall, millions of sleep apnea sufferers have turned to oral appliances, according to Sleep Review magazine. Could this mean CPAP is becoming somewhat obsolete as users turn to a safer and simpler alternative?
Philips, the world’s largest producer of continuous positive airway pressure (CPAP) machines, has issued a recall of several lines of their breathing devices in the US. The recall is due to two issues concerning the synthetic foam used to dampen noise in these devices:
1) The foam may degrade into toxic particles that can end up in the user’s body.
2) The foam may off-gas dangerous chemicals.
The potential health consequences of this problem are serious. Philips claims these toxic particles may cause permanent and even life-threatening issues.
The company has received a small number of complaints regarding black debris in the air paths of their breathing devices. Their clients have also complained about headaches, sinus infections, and upper airway symptoms, further prompting them to look into problems with their products.
Philips has also explained the potential risks of being exposed to these chemicals:
The devices in question include those used to treat sleep apnea. The company has advised this group of users to discontinue their use of these devices and to speak to their health provider about possible alternatives. As a result, both sleep apnea patients and their physicians have been turning their attention to oral appliances.
Oral appliances are one option to treat sleep apnea as well as simple snoring. Also called sleep apnea mouthpieces, the term “oral appliance” refers to medical devices that you wear in your mouth to prevent sleep-disordered breathing. They include mandibular-advancement devices and tongue-stabilizing devices, among many others.
These devices have been a popular alternative to CPAP machines for a long time. While they may not be as effective as CPAP machines, studies have shown that patients are more likely to stick to oral appliances than they are to CPAP machines. Patients adherence is an important aspect of treatment, and CPAP machines just don’t cut it in this respect.
Just consider results from a 2016 review on the trends in CPAP adherence over 20 years. The researchers looked at 82 papers and found a 34% non-adherence rate based on a 7 hours per night sleep time. They also noted that non-adherence rates range between 30-40%, which is fairly high.
And now with the Philips CPAP recall in place, people are given more reasons to switch to oral appliances as a safer alternative to breathing machines.
These devices can also serve as temporary alternatives to CPAP machines in some sleep apnea patients while they’re waiting for Philips to replace and repair their faulty devices, which can take up to a year once they get the green light from the FDA.
CPAP machines will probably remain an essential form of therapy in the treatment of some cases of sleep apnea. Central sleep apnea, for example, is unlikely to respond to oral appliances. Severe cases of obstructive sleep apnea may also benefit more from CPAP machines than oral appliances.
However, the recall may have increased trends we’ve already been seeing in the oral appliances market. The global market of these devices has been steadily rising over the past few years as consumers are becoming aware of the dangers of sleep apnea and the alternatives they may have, according to Business Wire.
The recent recall may prompt doctors to suggest oral appliances to their patients as first-line therapy or at least as an alternative when patients don’t adhere to continuous positive airway pressure therapy.
However, Business Wire also notes that the complex referral pathways and long waiting periods at sleep centers often deter patients from getting a diagnosis of sleep apnea. And according to a piece in Sleep Review Magazine, ambiguity around insurance reimbursement can also hinder people from switching to oral appliances during the Philips CPAP recall.
If you’ve been impacted by the recent CPAP recall or are simply interested in oral appliances as an alternative, there are two main types of oral appliances you can speak to your doctor about:
The first is also called a mandibular repositioning device and works by slightly moving the jaw and tongue forward. This helps keep the tongue and other throat structures from blocking the upper airway during sleep.
Most mandibular advancement devices are custom-made for comfort and perfect fit. Others are available over the counter as boil-and-bite for at-home fitting.
However, devices that move the jaw forward are not suitable for people with dentures or severe dental problems. In that case, tongue-retaining devices can be a better alternative.
A tongue-retaining device, also called a tongue-stabilizing device, is a small piece of plastic that looks somewhat like a large pacifier. It holds your tongue slightly forward to help keep it from collapsing at the back of your throat, in this way keeping your airways open.
Tongue-stabilizing devices are available over-the-counter and don’t require fitting. They’re as easy to use, safe, and effective as snore solutions. Consider one of ourGood Morning Snore Solution mouthpieces as your new alternative to CPAP. These have been clinically proven to reduce snoring and come with a satisfaction guarantee.
Philips Recall Letter. URGENT: Medical Device Recall. Philips. Available athttps://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-letter-2021-05-a-2021-06-a.pdf
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions. U.S. Food and Drug Administration. Available athttps://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions
Spear L. Will More Sleep Apnea Patients Turn to Oral Appliance Therapy in the Wake of the Philips CPAP Recall? Aug 2021. Available athttps://www.sleepreviewmag.com/sleep-treatments/therapy-devices/oral-appliances/philips-cpap-recall-sleep-apnea-oral-appliance/
Zhang M, Liu Y, Liu Y, et al. Effectiveness of oral appliances versus continuous positive airway pressure in treatment of OSA patients: An updated meta-analysis.Cranio. 2019;37(6):347-364.doi:10.1080/08869634.2018.1475278
Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve.J Otolaryngol Head Neck Surg. 2016;45(1):43. Published 2016 Aug 19.doi:10.1186/s40463-016-0156-0
$482.5 Billion Sleep Apnea Oral Appliances Market - Global Forecasts to 2023 - ResearchAndMarkets.com. Business Wire. May 2018. Available at https://www.businesswire.com/news/home/20180523006226/en/
February 20, 2024 3 min read
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