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Philips’ U.S. sales of sleep apnea devices face years-long halt after FDA deal
CNBC ^ | 1/29/2024 | Reuters

Posted on 01/29/2024 2:33:16 PM PST by ducttape45

Dutch health technology company Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the Food and Drug Administration (FDA) announced on Monday.

The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.

Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make at its Respironics plants in the U.S.

Until the conditions are met, no new Respironics devices will be sold in the U.S., the company said.

Philips shares traded down 8.5% in afternoon trading in Europe, after news of the agreement, which ING analyst Marc Hesselink said was “very punitive”.

“We believe it will be very difficult for Philips to recover its U.S. Respironics market position,” Hesselink said in a note.

The decree is being finalized and will be submitted to the relevant U.S. court for approval. It was not clear how long that would take.

CEO Roy Jakobs declined to give details on the conditions that Philips will have to meet, but as a general indication said it on average takes between five and seven years to comply with consent decrees in the medical equipment industry.

Philips said the costs of the agreement led to a provision of 363 million euros ($393.5 million) in the fourth quarter of last year, and were expected to be about 1% of total revenues in 2024.

Even after the consent decree, Philips faces numerous cases brought by patients who say their health has suffered due to the use of the devices, and the outcome of an investigation by the U.S. Department of Justice into the handling of the recall.

Philips said the agreement did not change its financial targets for 2025, set out last year.

Due to the provision, Philips core profit in the fourth quarter remained roughly stable at 653 million euros, while comparable sales fell 1%.

Analysts in a company-compiled poll on average had predicted adjusted EBITA would rise to 672 million euros, from 651 million euros a year before, with comparable sales growth of 2.6%.


TOPICS: Health/Medicine
KEYWORDS: apnea; philips; sleep; sleepapnea; sleepapneadevices; tcoyh
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To: Taxman
Maybe someday the shady lawyers will be take out of service

As in Back to the Future Part 2?

61 posted on 01/30/2024 4:43:38 PM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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To: ducttape45

I haven’t used it for any of my naps, which seemed to be more often as the years go by:) I average about 6 - 8 hours/night. One thing I don’t like is the new Resmed machine I was issued which has dreaded WIFI and APRIA uses that data for MEDICARE compliance. More big brother watching.


62 posted on 01/30/2024 5:15:40 PM PST by grcuster
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To: ducttape45

I wish I could get use to sleeping a full night after all these years of usage, but I’m always wrestling with the tube when I turn and I have an air leak, annoying. However, my rest without it is worse.


63 posted on 01/30/2024 5:21:05 PM PST by grcuster
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To: grcuster

So far I don’t have Medicare but yeah, I can see that being a concern. I usually don’t normally nap (fall asleep nap) but when I lay down it helps me relax.


64 posted on 01/30/2024 6:27:53 PM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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To: grcuster

Getting used to having a mask on all night has been one of the major hurdles for me but I’m getting more used to it. Last night was a really good night for me and they seem to be getting better.


65 posted on 01/30/2024 6:28:50 PM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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To: ducttape45

LOL!

That WAS classic, wasn’t it!

“How did you do that?”

“First, we hanged all the lawyers!”

I loved it!


66 posted on 01/30/2024 7:04:24 PM PST by Taxman ((SAVE AMERICA! VOTE REPUBLICAN IN 2024! SAVE AMERICA!))
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To: ducttape45

I also will use my CPAP if I lay down for a nap during the day. I often nap sitting up, though, so I don’t need it then. So I am using it 6-8 hours a day. And my new machine doesn’t connect to wi-fi so I’m not broadcasting my sleep patterns - nobody’s business anyway.


67 posted on 01/30/2024 7:23:41 PM PST by Some Fat Guy in L.A. (Still bitterly clinging to rational thought despite its unfashionability)
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To: ducttape45
Mine goes on at bed time. Sometimes that works out and I sleep well all night (midnight to 7 AM). Lately, it goes poorly and I pull it off after a couple hours of flopping around. In recent weeks I've started my workday with as little a 1 hour of decent sleep between midnight and 7 AM. Last Friday I just ditched the CPAP entirely. 7 hours of good sleep. No alarms. SPO2% of 96% on my Charge 5. I really get mixed results with the CPAP machine. On the nights I ditch it, I'm recording 4 events per hour. On the nights it works well, the hourly average can be under 0.5 events per hour.
68 posted on 01/30/2024 8:30:37 PM PST by Myrddin
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To: grcuster
If your mask is not working for you try another type until you find one that works, my uncle went through about a dozen styles until he found one that kind of works.
69 posted on 01/30/2024 9:22:36 PM PST by Harmless Teddy Bear ( In a quaint alleyway, they graciously signaled for a vehicle on the main road to lead the way. )
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To: gov_bean_ counter

I too have that machine but was told my particular machine didn’t need replacing.


70 posted on 01/30/2024 9:35:25 PM PST by cherry
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To: Myrddin

Well one advantage of hubby having tricare for life is they seem to cover all of it.


71 posted on 01/30/2024 9:38:27 PM PST by cherry
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To: ducttape45

“The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.”

My neighbor and I, both in our late 70s, quit using our ResMed devices. His wife is an MD, and I always awakened to the pump running powerfully with the mask displaced from my face. (And now have a full beard anyway).

Periods of apnea were detected by two nights of monitoring, but in three years have only one “episode” of awakening to a lack of oxygen. As a light sleeper, I’m not too concerned, as one’s body reacts to high CO² levels.

If you don’t hear from me again, you’ll know I was wrong!
;)


72 posted on 01/31/2024 1:10:53 AM PST by Does so ( 🇺🇦..."Christian-Nationalists" won WWII...Biden NOT NEXT DNC nominee!)
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To: Myrddin

We seem to have the same results...


73 posted on 01/31/2024 1:13:02 AM PST by Does so ( 🇺🇦..."Christian-Nationalists" won WWII...Biden NOT NEXT DNC nominee!)
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To: Harmless Teddy Bear

I did try a variety of masks and finally settled for the pillows as they seemed less intrusive. Full mask or ones covering the nose were uncomfortable especially when waiting for the air ramp up. Air bleeding into the eyes was not pleasant.


74 posted on 01/31/2024 5:53:30 AM PST by grcuster
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To: ducttape45

Naps are the best part of the day:) However, my wife lets me know that when I nap no one else can between the snoring or catching my breath.


75 posted on 01/31/2024 5:55:45 AM PST by grcuster
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To: Does so
This week is especially rough. I went for an insurance company blood draw as part of an application for a new term life policy. The results included elevated GGT, elevated ALP, cholesterol below range, HDL below range, NT-Pro BNP high. Net result was denial of the application. There are two things that I suspect shifted the GGT/ALP...800 mg ibuprofen at bedtime nightly and a 12 oz lite beer with dinner. The BNP has secondary observable problems including neuropathy and edema in my lower legs. I suspect the BNP is from heart damage caused by the apnea.

This week I'm running without ibuprofen at bedtime and beer with dinner. The pain from the rheumatoid arthritis is making it impossible to sleep. Most nights 1 to 2 hours between midnight and 7 AM. No beer with dinner is no big deal. I'll get another blood draw to test my suspicion that the ibuprofen/beer skewed the liver results. I hurt too bad to use the CPAP this week.

76 posted on 01/31/2024 7:46:19 AM PST by Myrddin
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To: ducttape45

I have thought about this too. I only have blocked airways when I fall into a sleep state, and if I don’t have the AVAP system, (assured volumne) I suppose I will just wake up again. But all this equipment is a pain to have available, so it only makes sense to use it at night.

At first I was provided with O2 and a breathing tube (cannula) but that too is not comfortable and I don’t seem to benefit from it when watching TV or whatever.

This is because by having good O2 at night I manage to perform in the daytime pretty well, Even can play a round of golf, although the effort does strain the muscles.

Take care.


77 posted on 01/31/2024 8:18:40 AM PST by KC_for_Freedom (retired aerospace engineer and CSP who also taught)
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To: Myrddin
I find that usage of my CPAP usage is now consistent, if somewhat irregular.

What is mean is that are nights where I can fall right asleep with the mask on, but other nights where I have to fall asleep without it, wake up, then put it on later and fall back asleep. But my usage of it has greatly increased to about 8-10 hours in a 24 period of time, sometimes more. But my quality of sleep has gotten better so I'm satisfied with the results.

Plus, I don't want to end up like my former co-worker who died in his sleep due to severe sleep apnea. That scared the bejesus out of me, and it still kind of haunts me to this day.

78 posted on 01/31/2024 10:12:04 AM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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To: Does so; All

I appreciate your comments. I was hoping this thread would take on a life of its own and it certainly has. Bottom line though, sleep apnea is nothing to take lightly and I’m happy to see folks sharing their experiences and insights. This is what Free Republic is all about!


79 posted on 01/31/2024 10:13:59 AM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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To: grcuster

Hahaha! :-)


80 posted on 01/31/2024 10:14:28 AM PST by ducttape45 (Proverbs 14:34, "Righteousness exalteth a nation: but sin is a reproach to any people.")
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