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Sleep apnea sufferers frustrated over CPAP machine recall

A voluntary recall of thousands and thousands of CPAP respiration machines, used primarily to deal with sleep apnea, has many customers questioning if they have been inhaling cancer-causing toxins of their sleep.

At least 25 million U.S. adults have sleep apnea, a doubtlessly severe sleep problem through which respiration repeatedly stops and begins all through the evening, stopping them from getting a great evening’s sleep. A steady constructive airway stress, or CPAP machine, pushes a gentle stream of air right into a consumer’s nostril and mouth, protecting airways open.

But CPAP customers now face the selection of utilizing a machine that the company says may really damage their well being – or going with out, which suggests they will not get an honest evening’s sleep.

In June, the producer Philips voluntarily recalled millions of its standard DreamStation CPAP machines due to attainable well being results.

Philips mentioned sound-dampening foam used within the DreamStation “may degrade into particles” and “off-gas… chemicals.” The FDA says respiration these in may “result in serious injury which can be life-threatening” or “cause permanent impairment” starting from irritation to bronchial asthma… and even “toxic or carcinogenic effects.”

“It’s caused a lot of anxiety,” mentioned Dr. David Claman, the medical director of the Sleep Disorders Center at University of California, San Francisco. He says a lot of his sufferers have recalled machines.  

CBS News shopper investigative correspondent Anna Werner requested, “What are you telling your patients to do?”

“I’m advising the more severe patients to stay on CPAP. and then I’m to some degree in the milder cases, letting them choose, because I also feel uncomfortable with saying I can’t know that this is safe.” 

Werner heard from some frustrated sleep apnea sufferers, together with James Colbert, who described his life 13 years in the past earlier than he began utilizing a CPAP machine (together with, for the previous two years, the Philips DreamStation): “There were times where I would literally fall asleep mid-sentence talking to someone because I was so exhausted from not going to sleep the night before.”

Since utilizing CPAP, Colbert mentioned, “I actually woke up refreshed, and could go throughout the course of my day with, you know, a ton of energy that I needed for work or, you know, time with my family.”  

Philips has recalled the DreamStation CPAP machine that sleep apnea sufferer James Colbert makes use of. He says he can do with out it. 

CBS News

Jozefa Kozyra, of Lehighton, Pennsylvania, relied on her DreamStation to sleep so she may present round the clock take care of her son, Kamil, who has muscular dystrophy.

Kamil advised Werner, “She needs to bathe me, dress me, feed me, and other exercises to do during the day.”

But for the reason that recall, she mentioned her physician suggested her not to make use of the machine – and he or she’s struggling with out it. “I’m very tired, I’m very slow,” mentioned Jozefa.

Werner requested, “How much sleep do you get without the machine?”

“When I don’t have machine now, two hours, three hours,” she replied.

Her son mentioned Medicare turned her down for a substitute machine, and she will’t afford to spend tons of of {dollars} to purchase a brand new one.

Kamil mentioned, “She called several times to her insurance and Medicare, and they’re saying, because it hasn’t been five years, even though it’s not her fault at all, they’re not willing to pay for a new machine.”

Jozefa Kozyra says that with out a CPAP machine she will solely get two to a few hours of sleep at evening. 

CBS News

Philips now says it is going to “replace or repair devices” … “within approximately 12 months” as soon as the FDA approves an answer.

It’s unclear what number of sufferers have suffered well being results; the company mentioned it acquired complaints on 0.03 % of its machines in 2020, together with some the FDA despatched about “the presence of black debris/particles” in some machines.

Philips mentioned its testing revealed “possible risks,” which raises questions for Dr. Claman: “Is this just the tip of the iceberg, or is this all there is?”

As for James Colbert, he mentioned the dangers of not carrying the machine are higher than attainable unknown well being results, so he is persevering with to make use of his. 

“I cannot afford to not use it, because I would get so little sleep in,” Colbert mentioned. “And if I slept without it, I would stop breathing so many times during the course of the night.”

But he has a message for Philips: “To tell me that it could take up to a year? That’s a year that I could be putting myself in jeopardy,” Colbert mentioned. “People just cannot afford to wait 12 months for a resolution.”

Colbert has additionally joined a lawsuit in opposition to Philips, he mentioned, to push them to behave quicker on this drawback.

Philips didn’t reply to CBS News’ request for touch upon the lawsuit. (In April, Philips got here out with a brand new machine, the DreamStation 2, which it says will not be affected by this recall.)

Connecticut Senator Richard Blumenthal is demanding answers about how many individuals are affected by the recall, and what Philips is doing to assist them.

There’s one different potential drawback which may be coming into play right here:  many individuals with the machines use an ozone cleansing system to scrub them, and which may be degrading the sound abatement foam quicker.