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THE FINE PRINT

Recall of sleep apnea machines leaves many in the lurch, and worried

Jim Curran has sleep apnea, but the manufacturer of his CPAP machine has issued a recall, leaving him and many like him frustrated.
Jim Curran has sleep apnea, but the manufacturer of his CPAP machine has issued a recall, leaving him and many like him frustrated.David L. Ryan/Globe Staff

Two years ago, Jim Curran of Marshfield was diagnosed with obstructive sleep apnea, which is a serious medical condition affecting millions of people worldwide.

People with sleep apnea repeatedly stop breathing while they sleep, only to be partially or fully awakened when their brains don’t get enough oxygen. It deprives those who have it of restful sleep, and it is linked to a range of ailments, including high blood pressure, heart disease, type 2 diabetes, and liver dysfunction.

Using a machine known as a CPAP is the most widely used treatment for sleep apnea. Users wear a mask or nosepiece attached to the machine that provides a steady flow of pressurized air while they sleep.

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But Philips Respironics, the world’s largest manufacturer of CPAPs, last month issued an urgent recall of as many as 4 million of its machines, including Curran’s.

Philips says the foam used in its machines for noise reduction can break down and be ingested by users, causing serious, even life-threatening, injury, though no deaths have been reported.

Curran, 70, a retired federal worker, contacted me in frustration as he tried to figure out what to do. Here’s what I found out:

Q. What is the problem with the Philips CPAP machines?

A. Philips says it has received “a limited number” of reports of users complaining of headaches, upper airway irritation, cough, chest pressure, and sinus infection.

After investigation, Philips says it determined that patients exposed to the degradation of the foam also risk much more serious consequences, including “asthma, adverse effects on other organs (e.g., kidney and liver) and toxic carcinogenic effects.”

Q. How did Philips become aware of the problem?

A. Philips says it first discovered the breakdown of the foam and its risks to patients through its own quality management system. After “extensive ongoing analysis,” Philips decided to issue the recall.

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Q. What is Philips promising to do about the problem?

A. It says it will repair or replace affected machines.

Jim Curran's CPAP machine.
Jim Curran's CPAP machine.David L. Ryan/Globe Staff

Q. What’s the first thing Philips CPAP users should do?

A. Register your Philips machine online. By doing so you will find out if your model is affected. To get to the online registration page, type “Philips and CPAP recall” into your browser. You will be asked for the serial number listed on the bottom of your machine (be sure to use the one for the machine, not the humidifier).

Q. How long will it take to fix or replace my machine?

A. It’s been weeks since Philips made its announcement on June 14. And, unfortunately, more delays are likely, given the size of the recall. In reply to questions from me, a Philips spokesman declined to provide a time line, saying the company is “working to address this issue as expeditiously as possible.” He pointed out Philips has already begun the process of getting approval from the Food and Drug Administration for its repair and replacement program.

“Right now, all of our attention is focused on starting” that program, the spokesman said. On its website, Philips says “affected devices may be repaired under warranty.”

Q. Should I use my Philips CPAP machine while I wait?

A. The Philips spokesman said patients should follow the advice of their physicians “as they are the most familiar with a patient’s medical history.”

Q. What do experts say about using the Philips CPAP machines?

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A. I contacted the Sleep Disorders Center at Beth Israel Deaconess Medical Center, which logs more than 10,000 patient visits a year, many of them sleep apnea patients.

Dr. Anjali Ahn, medical director of the center, said her staff is telling patients to follow the recommendation of the American Thoracic Society, a nonprofit that specializes in sleep disorders, among other issues.

It says only high-risk patients should continue to use their Philips CPAP devices while they await repair or replacement. A high-risk patient is anyone with severe breathing or cardiac problems; patients who can’t sleep well without their device or have a lot of daytime sleepiness; or patients who work in high-risk occupations, such as commercial drivers or pilots.

Those who are not at high risk should discontinue use of their CPAP machines.

Ahn said any patient who has a cough, sore throat, or headache after using their Philips CPAP machine should speak with their doctor.

Q. How difficult is it for people with sleep apnea to give up their CPAP machines, even temporarily?

A. It’s a big deal. Ahn said patients who regularly use CPAP machines “often do not want to stop using them,” even temporarily, because of concerns about their sleep and about their management of related health issues such as high blood pressure and certain cardiac and respiratory disorders.

Q. What steps can patients take after discontinuing use of their Philips CPAP machines?

A. Patients can try sleeping on their side or with the head of their bed elevated to improve breathing during sleep, Ahn said. Patients should avoid alcohol close to bedtime as it can worsen breathing during sleep. Patients should also be watchful for any increased sleepiness or fatigue when driving.

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Q. Are there treatment alternatives?

A. Mouth guards have been used to treat sleep apnea for decades. Contact a dentist or oral surgeon to discuss. Surgery is another option.

Q. What causes sleep apnea?

A. It happens when the soft tissue at the back of the throat collapses and blocks the airway during sleep. It can happen hundreds of times a night.

Q. How many people have sleep apnea?

A. Sleep apnea is very common in the general population but especially common in patients with high blood pressure, obesity, heart disease, and stroke, according to the Sleep Disorder Center. Studies suggest as many as 24 million people have undiagnosed sleep apnea in the United States.

Q. How big is Philips’ market share for supplying CPAP machines?

A. Philips, a Dutch multinational with an array of health care technology products and more than $20 billion in annual sales, accounts for about 37 percent of the CPAP market, more than any competitor, according to the firm BCC Research. Philips estimates that as many as 2 million of its CPAP machines are in use in the United States. Other brands of CPAP machines are not affected by the Philips recall.

The CPAP market, valued at $3.3 billion in 2019, is projected to grow to $4.5 billion by 2024, BCC Research says.

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Got a problem? Send your consumer issue to sean.murphy@globe.com. Follow him on Twitter @spmurphyboston.