More than a year ago, Philips Respironics announced a recall of more than 5 million continuous positive airway pressure (CPAP) machines.
CPAP is the most commonly prescribed sleep apnea treatment. It works by forcing air into the lungs, using air pressure to keep the airway open so that people don’t experience airway collapses that cut off their ability to breathe. Sleep apnea treatment can be life-changing and life-saving. People with sleep apnea experience a wide range of symptoms such as daytime sleepiness, mood problems, difficulty concentrating, as well as life-threatening health risks such as an increased risk of strokes, heart attack, and more. While treatment can reduce symptoms and risks, when people just stop using CPAP, the symptoms and risks can return.
Since the recall started, millions of people have been waiting on a replacement machine, suffering as a result. The FDA has expressed frustration at the recall delays and is considering taking exceptional action against the manufacturer. Meanwhile, people still waiting for a replacement machine should consider options, such as whether they are eligible for oral appliance therapy for their sleep apnea. Columbus, Ohio sleep dentist Dr. Mike Firouzian can assess you to determine if an oral appliance will work for you.
Revelations Highlight the Severity of the Recall
In the more than a year since the recall announcement, we have learned a lot about the problems related to the recalled machines. Most seriously, the FDA announced in May that it had received more than 21,000 reports of complications associated with foam breakdown in the devices. This includes 124 deaths potentially linked to the machines.
The FDA notes that these reports are relatively informal. The reports come from consumers. The FDA conducts no detailed examination of the circumstances; therefore, it cannot say that the complications and deaths are directly related to the machines.
In addition, the FDA notes that Philips Respironics had potentially known the machines were defective since at least 2015 when they started manufacturing and selling them. However, the company did not notify the FDA or its customers. This suggests that Philips might have acted with either reckless disregard or outright contempt for the safety of its customers.
Remarkably, through six years of dealing with this ongoing issue, the company claims it has only one email to document the company’s response to the degrading foam, claiming all other communication on the issue was via phone calls.
The Recall Drags on
Since the recall started, Philips says it has repaired or replaced only half of the 2.8 million devices affected by the recall in the US. While Philips hoped to replace all the machines by this fall, the real replacement will take well into 2023. We don’t know how many people in the Columbus area are affected and still waiting on replacement machines.
Meanwhile, the FDA is accusing Philips of not being very effective at communicating with its customers. The FDA randomly selected 182 patients with affected CPAP machines, and it found that about 15% (28) were unaware of the recall.
People Finding Their Own Solutions
In the desperate situation of having to choose between being without sleep apnea treatment and using a defective CPAP, people are finding their own solutions. Some people buy machines from other companies. Others find CPAP machines used by former patients.
There are even people who are taking the concerning foam from their machines. They share the directions on how to do this online. However, it is not recommended that people take apart or alter their CPAP machines.
CPAP Alternatives Exist
Remarkably, reporting on this recall rarely mentions that many people with CPAP have another treatment alternative. For people with mild to moderate sleep apnea, oral appliance therapy can be as effective as CPAP. Oral appliance therapy repositions your jaw to hold open your airway. Doctors in Columbus may not initially inform patients of this option, so many do not know if they are eligible to get treated without CPAP.
Oral appliances offer benefits that make them a better choice for many people. They offer:
- Easy use
- Easy maintenance
- Silent operation
- No need for power
- No stifling mask or pressure
Oral appliances are easy to use. You just put the appliance in your mouth, similar to a sports mouthguard or whitening tray. The appliance is similarly easy to maintain. To maintain a CPAP machine, you must take it apart to clean all the components individually, then dry them before reassembly. For an oral appliance, you simply put it in a cleaning solution to soak, then set it out to dry.
The degrading foam in the Philips CPAP machines muffles the sound of the motor. An oral appliance has no motor, so it operates completely silently without any degradable foam. In addition, oral appliances don’t need power to operate. This makes them easy to use wherever you are. You can even take them camping and won’t have to carry a ton of batteries.
Plus, many people find oral appliances to be more comfortable. There’s no mask covering your nose or mouth, no straps, and no suffocating pressure in your throat.
Oral appliance therapy is an effective alternative for truckers and it remains an option for many people in Columbus suffering as this recall stretches on interminably.
CPAP Alternatives in Columbus
If you are looking for a CPAP alternative in Columbus, we can help. Whether you were affected by this recall or just don’t like the idea of using CPAP, Columbus, OH sleep dentist Dr. Mike Firouzian can assess you for oral appliance therapy.
Please call (614) 683-4640 or use our online form to schedule an appointment at Firouzian Dentistry, located in Columbus’ Crossroads neighborhood.