FDA says 561 deaths tied to recalled Philips sleep apnea machines
cbsnews.com
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Edit: I used a combination of the Snore Gym app and Vik Veer's videos on Youtube. After a couple months my snoring became barely audible, but it doesn't always work for everyone. I was tilting my head down at night which blocked off my throat somewhat, so I lifted my head up higher with a bigger pillow.
For comparison, I used some of those nasal strips before surgery and the post-surgery were very comparable, so that might be an inexpensive option to try? I also recall someone mentioning some sort of nose plug thing from Amazon you could get that does the same thing.
I've read horror stories about that. Apparently a lot of the problems could be solved by teaching kids how to breathe (no mouth breathing), having a proper diet (chewing), &c. of course once you're fucked you're fucked and you have to go to these extremes to get your life back. It's like our lifestyle is slowly evolving us out of this planet
https://www.news-medical.net/news/20230803/TENS-machine-may-...
They also use TENS as part of their protocol.
It took me 8 years to stumble upon finding the practice-protocol for a problem I figured I had but couldn't find dentists to solve for it.
The training for dentists and full protocol-processes followed, and has been evolving, is from Las Vegas Institute - https://www.lviglobal.com
They have a directory listing of the dentists who have done their various courses. NOTE: Not all are up-to-date and so be sure to check they have the necessary relevant training, and that the course wasn't taken say 15 years ago; their dentists are recommended to regularly do courses to keep track of the improvements to their processes.
I’m due for a new machine soonish and I’m probably going to push for a bipap. I’m on an autos range of 17-20, and I will max that out sometimes. My scores are usually real good (like, sub 1.0), but the lack of headroom is concerning. 20 is as high as my machine (Resmed, luckily) goes, but my understanding is most bipaps go to 25, and the actual bilevel feature will likely be useful as well.
I did the deviated septum surgery which did help a lot but not for the reason most here say (since mine is anatomy related). It helped because I can now use a nose only mask which I find way more comfortable. I'd recommend it if you end up with headaches or pain due to the mask fit.
Just don't ever do the surgeries around the mouth (where they cut the Palate or stuff like that). Blows my mind they allow those given the terrible long term outcomes with scar tissue. It ends up making your apnea worse.
His brother apparently was a horrible snorer, but that was due to his nose, that the "skin" would collapse inwards when he took a sharp breath through his nose, instead of expanding. Apparently just having some kind of tape on his nose to stop that from happening while sleeping made a huge difference.
CPAP user here. I tape my mouth. The risk of suffocating due to a blocked nose seems low to me, for two reasons. First, because I can simply do a one-sided smile and breathe normally through my mouth -- I've tried many times for funsies and it's never failed. Second, because you should always fold the two bottom corners of the tape to facilitate its quick removal in the morning anyway.
The real risk of taping your mouth at night, in my opinion, is if there's any chance of vomiting. Without any other way to go, you would aspirate the vomit and that's bad. What I do to reduce that risk is not eating for three hours before using the CPAP.
So why go through all that effort when one could simply use a full face CPAP mask? That's because it is difficult to produce an airtight seal around your whole face, which is necessary for CPAP therapy to work. Creating a seal around your nose is much easier and the smaller size of a nasal nask allows you to sleep on your side, which for most people means you can get away with using lower pressures, which in turn are more comfortable.
Among other reasons this can happen because CPAP therapy can cause you to swallow air unwittingly while you sleep due to the pressure it places on your epiglottis. The subsequent burps can contain a mixture of swallowed air and the contents of your stomach.
Or, you know, I may be speaking from personal experience.
Guess they're just covering their arse with that advice.
Also, when you're on nasal CPAP, and pressurised air is being blown into your nose, you'd have to have really weird things happening to suddenly get a nose that's completely obstructed in spite of the pressure....
I personally use:
- better breath strips from aliexpress
- a 3D print similar to https://noson.eu/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360393/
"Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial"
Snoring is a useful but not 100% correlated marker for sleep apnea. It’s very possible to improve snoring without reducing the sleep apnea itself.
Because even if there are some outliers like yourself, I can confidently claim that most people can correlate improvements in sleep apnea symptoms and sleep quality more generally with the way the feel in the morning.
You can have an AHI of 1 and still get zero REM sleep because every time you start going into REM, a respiratory event knocks you out of it.
Apneas and Hypopneas have to last for 10 seconds or more to be included in the AHI count. You can literally have hundreds of respiratory events and have an AHI of zero, but you're still going to feel pretty bleedin' awful.
There is also an RDI, Respiratory Disturbance Index, which includes the AHI events but also includes arousals caused by breathing issues. It is typically much higher than AHI in un(der)treated patients. It's also imperfect, and it's harder to measure.
Then, of course, we come to the CPAP machine reported AHI, which seems to be what insurance and doctors are interested in. In short: the number is garbage. These machines are absolutely TERRIBLE at correctly identifying events. Using those numbers as the basis for any kind of decision is awful.
Maybe one day we'll get CPAP devices with EEG devices in the head strap and with unobtrusive SpO2 sensors that actually work. Maybe then we can start reporting useful numbers which can actually be used in support of treatment.
Until then, it's very much possible to keep feeling like shit even though your sleep apnea is allegedly "under control".
About a year ago, Out of NOWHERE I began snoring at night, and only when laying on my back. Never snored my entire life. No other position. But it drives my wife crazy. The problem is we cosleep with our baby, and laying on my back is the safest position.
I don't have apnea so I don't qualify for insurance for any kind of mouthpiece. The ENT just laughs me off like it's no big deal. My nose is fine and he's zero help.
I know it's something to do with my tongue but I have no idea what to do about it.
I've tried thin pillows, thick ones, no pillows. Doesn't help.
Normally sleeping on your back maximizes airflow instead of creating an obstruction (snoring)
No, the safest position is not having an infant in your bed with you while sleeping.
Also, it really depends on what they mean by baby. An infant: probably shouldn't cosleep. A baby older than two to four months: probably fine if you have a large enough bed or side bed and take the proper precautions such as enough space for the baby, a flat surface with no sheets bunched up, no pillows or anything that can fall on them, etc. Some cultures promote sleep sharing yet have lower instances of SIDS than the U.S., and it's perhaps not clear how the studies arrived at it being so unsafe. Plus, as a parent, you are quite aware of the baby's presence. I think parents probably sleep worse during cosleeping, but the baby sleeps and bonds better.
https://www.npr.org/sections/goatsandsoda/2018/05/21/6012896...
> Current SIDS ratio is 0.44/1,000 live birth.
https://www.nature.com/articles/pr1999959z
US:
> 38.4 deaths per 100,000 live births in 2020
https://www.cdc.gov/sids/data.htm
38.4 / 100 = .384
You're saying 0.384 > 0.44 ?
Either way, the person I was replying to has a diagnosed sleep disorder. You're really going to say it's a good idea for someone with a sleep disorder to sleep in the same bed as a child?
No.
The safest place for the child to sleep is in their own crib. You may choose to ignore those risks, it's not against the law or anything, but no matter how you slice it cosleeping is a riskier behavior than not cosleeping.
Is cosleeping more dangerous than a crib? Yes. The question is by how much given precautions, bed arrangement, health and age of the baby, and several other factors. Of course that's up to the parents to decide, and it's usually an evolving situation.
Absolutely anecdotal but a jaw alignment mouth guard worked for me.
ZQuiet is that one I have: https://zquiet-usa.com/
I havnt used them but Zyppah looks like it is doing the same thing: https://zyppah.com/
The idea is to force your jaw into a slightly different position which keeps your tongue from falling back and blocking your airway.
I tried it before a sleep machine because its like $50. It works well enough and my wife doesnt complain about snoring anymore if I sleep on my back.
I was better off buying the machine outside of insurance. Insurance was testing to force me through some sort of rent-to-buy thing where the machine would get taken away if not used a certain number of hours per week. My out of pocket cost for the rental added up to significantly more that just buying the machine outright, and by buying the machine myself I didn’t have to share that data with the insurance company.
I require a bipap with ASV machine due to having complex sleep apnea, and it costs at least a couple grand.
I ended up scrambling to get a replacement. The old one works perfectly fine, but I can’t safely use it due to the recall. Even after insurance I had to pay a grand out of pocket because they make you rent it at first.
https://www.propublica.org/article/philips-kept-warnings-abo...
A complete failure of the QMS.
I know the FDA wants/needs to keep Philips around to manage the recall, and like... people with CPAPs need them, but I really wish they would just terminate all of Philips' licenses/approvals/clearances right now. I hope the DOJ has bigger penalties to lay down.
FDA's post market surveillance relies on manufacturers to be sufficiently honest. Philips sat on thousands of reports for over a decade. This is simply unacceptable. For the FDA to be able to say with a straight face that their post market surveillance has value, they need stronger assurances that manufactures will play by the rules, and I feel that means really making an example of Philips here.
I've worked in medical devices before, and I am quite aware of how easily QMS and SOP can diffuse responsibility. It's so easy as a line worker/line manager/middle manager to shrug and go "well, I did my role as prescribed by QMS and SOP - it's not my problem that we're sitting on 10k medical device reports that we should be notifying the FDA about". And that's a huge problem.
Obviously upper management has the most blame here, but no one involved is blameless. The QMS has some boilerplate about how everyone is responsible for quality. If that's true, then everyone involved is also responsible in some part.
I know terminating all of Philips' licenses for like 5 years or something will basically make a lot of people jobless. But like 500 people died because some assholes decided to go for the $$$, and everyone else involved let it happen. That's not an acceptable corporate standard.
500 people died so far and that we know of.
So yeah, fully agree with your points.
Why is every CEO that held the reins during this debacle at Philips not in jail right now for manslaughter?
Casual cynicism is as foolish as casual naivety, and more toxic and dangerous.
Until capitalism stops treating people like they are a renewable resource to squeeze profit from - capitalists need to be put on notice that acting like criminals means they get treated like criminals.
Stop. Pretending. There. Are. Good. Corporations.
It's not casual cynicism either, at this point it's professional cynicism because we've all seen this film 1000 times before and we know how it typically ends. Personally I'd reserve the use of words such as "toxic" and "dangerous" for Philips' CPAP machines and their leadership.
They're going to pay less than $1 million per victim while their annual profits are in the billions. Would you feel good about that amount if they killed your dad, mom, brother, sister, son or daughter?
https://www.propublica.org/article/philips-kept-warnings-abo...
> In June 2010, Philips found that a machine sent back to the company by a customer was contaminated with “foam particles,” FDA records show. Rather than alerting the government as federal law required, records reveal that the company kept the report about the problem in-house for the next decade.
> A similar report came in the following year, describing another CPAP with “black contamination.” That, too, was not turned over to federal regulators.
> Another report was also held back, this one from a patient who found particles in the tube that carries air to the nose and mouth. A complaint two years later described a 3-year-old girl who was using a ventilator with a filter that had turned black.
> By the end of 2014 — about six years after Philips started using the foam — more than 500 reports from health care workers, patients and others had flooded the company in a pattern that would not be revealed to the government or the public for years, the records show.
> [...]
> In 2015, Philips was moving to dominate the market, but the foam problem threatened the momentum. That year, a company engineer questioned the supplier, emailing, “Have you ever seen this occur to the foam?” company records show.
> Two and a half years later, as new complaints came in from Australia, Philips scientists were summoned to a series of emergency meetings outside Pittsburgh to come up with a plan. The day after one of the sessions, another engineer detailed the safety risk in an email to the foam supplier.
> “The material sheds and is pulled into the ventilator air path. As you can imagine, this is not a good situation for our users,” engineer Vincent Testa wrote that April, sharing photos of the foam breaking apart. “I flagged this message with high importance since we are addressing a potential safety concern.”
> Without alerting the FDA or the public, the company started replacing the foam in some ventilators but once again left the vast majority of machines untouched, including the widely used DreamStation, FDA records show. Testa did not respond to interview requests.
> Customers weren’t told even as debris turned up on their bedsheets, pillows and faces.
> [...]
> In the spring of 2020, as the COVID-19 virus raged and thousands died, Philips boosted production of another ventilator to help ease the burden on overwhelmed intensive care units.
> These, too, were built with the same foam.
> Over the course of the year, operating profits from ventilators, CPAP machines and other devices soared to about $800 million, more than double what they were the year before, according to reports by Philips’ parent company.
> Response from customers “remains very positive, resulting in market share gains,” Royal Philips’ then-CEO Frans van Houten said during a fourth-quarter earnings call.
> During the call, van Houten made no mention of the turmoil inside the company, including internal studies that showed the DreamStation had failed emissions testing for volatile organic compounds. The chemicals can be found in everyday products, such as gasoline, paints and pesticides, but in breathing machines, the fumes can be inhaled for hours at a stretch.
> [...]
> In April 2021, Philips unveiled the DreamStation 2, a sleeker and more advanced model with a color touch screen and more personalized settings. Another change separated the new model from the old one: Philips chose different foam, one that would hold up in heat and humidity.
> With the launch of the new device, the company’s stock price reached a high of $61 a share — more than double what it was five years earlier.
> It was only then, during a late-April earnings call with investors, that Philips for the first time revealed that the foam it had used for years in millions of machines was at risk of breaking down.
> “Regretfully, we have identified possible risks,” said then-CEO van Houten, adding that the company had set aside 250 million euros to deal with the problem. “We are taking proactive action here.”
> Van Houten went on to reassure investors: “The device is safe to be continued to use to the best of our knowledge at this time.”
> [...]
> As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government. The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.
> Philips said the reports of illnesses and injuries are not evidence that its devices caused harm. But six medical experts who spoke to ProPublica and the Post-Gazette said the complaints are an indisputable indicator of a sprawling public health crisis. They said more harm is likely to emerge in coming years, much as the effects of tobacco and asbestos only became clear decades later.
Emphasis mine.
You should read the article I linked in a sibling comment.
I'm confident that the law aligns with my notion of what the law "ought to be" in this case because the damage is so clear, with years of documented coverups. Whether I'm right or wrong on this is really besides the point.
If you insist on arguing in support of corporations being allowed to kill people with impunity, please don't waste my time with it.
> "Something I read about in an article, where people died and it seemed very wrong"
That's such a bad faith take on the article that goes into exhaustive detail and pinpoint accurate accounting of events with many insider sources and commentary from medical professionals, you must be trolling.
I don't know anything about this case, but "561 deaths have been reported in connection to" does not mean they were all indeed "caused by". They may have reports of anyone who died while using the device, from whatever cause like old age. Now they will investigate and hopefully conclude something.
thou i would argue that dead people are a negative externality of most major industries (think tabaco, oil, cars)
As soon as you catch wind of this sort of issue, this is what should be legally required to happen in order to escape lengthy prison time:
- immediately take full responsibility and take your products off the market
- work with relevant agencies to identify impact and produce a list of everyone who could be affected
- recall every device that could possibly suffer from the same issue
- offer to pay for preventative medical exams for any customer who's suffering from any early symptoms
- offer at least 7-8 figure sum of money to each victim's family
- fix the design defect and publish a full transparency report that details the issue and how it was addressed, verified by a relevant agency
Just to rub it in, Philips gets to settle without admitting any wrongdoing.
"Hey, it could be worse". < what your comment reads as .
What if : "How can it be better?" ? ? < what it could be !
The way that would work is the Philips name would be retired and all patents, copyrights and trademarks would be released to the public domain. All ownership would end the same way as when someone dies, and assets would be distributed to next of kin. The company might be broken up and sold at auction, with the proceeds donated to shareholders and any other owners/investors. Or parts of it could be sold to other companies to pay for lawsuits and other costs, like when splitting up a company under antitrust laws.
Looks like Philips has a market cap of just over $20 billion. Shifting that intellectual property to the public could start an open source revolution in medical research. The ripple effects of that are hard to predict, but might put more of a focus on cures than treatments.
We could see gene therapy for the primary inherited conditions arriving years earlier than expected. Conditions that at least 10% of the population have to deal with every single day that affect quality of life and aren't being addressed by for-profit corporations. Imagine the relief for mental health that would come through these cures, reducing the isolation and alienation for the people who have been forced to internalize their situations because the larger population is oblivious to their experiences.
Gene therapies start around $1 million per person. But the main cost lies in research, not application. Why are we performing medical research under a for-profit model? We didn't use to.
Recent trends show that large corporations are focusing on profits over the health of their customers. If they've abandoned their charters, then maybe it's time for alternative approaches. IMHO the priority today should be large epidemiological studies to provide big data for AI to spot the correlations which lead to cures. But the astronomical profits of big pharma have diverted those funds to the point that those companies are slowing progress and increasing costs for all of us.
> A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.
I have two affected machines (one for each place I regularly sleep, I bought two so I didn't have to keep dragging them around). One of them is so bad that if I let it blow through a facemask for a day, the inside is all black. The air also smells really awful, like plastic fumes. Strange enough the other one which I use a lot more regularly fares a lot better.
Unfortunately Philips still didn't bother replacing mine. They are an awful company to deal with. I registered them over 2 years ago. Only last September I got an email back asking me to confirm some details. Since then again nothing. They don't even bother replying to requests for a timeline.
I still use the other machine regularly but it's also starting to taint masks when I test it with them. The local health service (I'm in Europe) lent me another brand but I really need these replaced.
The disregard for their customers' lives is really appalling. Not surprised people have actually died.
I paid big money for them too, 800 and 600 euro roughly (one of them is a full auto, the other isn't). A lot of money for what is basically a pressure fan in a box.
I'm not using the bad one though. The one that smells and blackens face masks. Only the other one. I regularly let it blow into a mask for a day to verify.
I used to wake up with really painful teeth and I also felt them starting to misalign. Like they were pushing my teeth around like braces.
Supposedly you can "train" your tongue to stay in position with tongue & jaw exercises, but I saw no effect.
It's annoying that they're so restricted here with all the medical red tape. They can't even go high enough to do actual damage. It's not like a respirator.
Or do they take foreign prescriptions too?
But I can probably get a new prescription. Where do you find this secure email? I don't know what you mean, I only have the email address they emailed me from. Maybe that secure email is a US thing?
But I don't know how long I'll have the loaner for and I want safe machines (that I paid a lot of money for) so I don't constantly have to drag it from place to place. That's why I got two in the first place.
> That's like really bad, long term is there a risk of lung tissue fibrosis?
No idea to be honest. I'm not a doctor, just a patient.
CPAP, you were the chosen one! It was said that you would bring balance to the respiratory system, not leave it in darkness!
This problem seem easy to recreate in a workshop or lab. There is really no excuse for this.
> The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down ... amid reports they were blowing gas and pieces of foam into the airways of those using the devices.
Dirty water tanks/hoses can cause infections or cough. Having sleep apnea is often associated with having asthma. Exacerbation can lead to pneumonia, etc.
I'm assuming the FDA didn't just look at these patients in isolation, but compared them to non-Philips-CPAP controls and to untreated apnea controls?
My father passed away a few years ago, after being diagnosed with IPF only about 1-1.5 years before passing. He had no past of being exposed to anything hazardous. His pulmonologist couldn’t ever figure out what could’ve caused it.
He was diagnosed with sleep apnea probably 15 or so years before passing, and used a CPAP nightly.
He eventually developed a nasty cough that never went away, and was finally diagnosed with IPF.
I’m not looking for any sort of retribution, more just possible answers or even just clues, since it’s not clear whether it was related to anything hereditary (I have 3 siblings).
And to be clear, I’m not even sure what brand/model he used (though my mom would likely know). So there’s a decent chance it’s unrelated.
https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-l...
The recall was handled by a third party company, with a third party domain. All communications came from the third party domain.
I was unable to communicate with anyone from the manufacturers domain.
So I had to respond to emails from shadysounding.com and give my info to phone numbers on www.shadysounding.com.
I’m glad the recall list wasn’t leaked. Otherwise there would be tons of ID theft.
Barylick knows his way around cheap PU foam that emits toxic particles in lethal doses. He helped the victims of the 2003 Station Nightclub fire, where 100 people died, mainly due to a toxic combination of PU and PE foam that was used for soundproofing. [1]
Watch his talk [2] if you feel you can stomach the horrendous details. It includes an excerpt from a bootleg digital sound recording made during the disaster. (The digital tape was later found amidst the ashes, next to the body of one of the victims, and fully restored.)
[1]: https://www.bu.edu/articles/2013/damages-station-nightclub/
This evidence can pay off big time if, god forbid, you have lung damage taking years off your life, but look up statute of limitations and talk to a bunch of personal injury lawyers for product liability cases, etc. Good luck and I’ll be checking in on my folks that have a machine as well to do the same.
I've been suspicious of myself having sleep apnea for quite awhile now, and I held off on getting an official diagnosis in no small part because those CPAP machines give me anxiety; I'm somewhat convinced that I would never really get used to them, and I would wake up feeling like a head crab was attacking me. I had also heard some horror stories (not dissimilar to the Phillips machines) that really held me off.
I'm very grateful that the oral appliances exists, now even more so.
I have one, it works alright. It lives in my backpack for when I forget to pack my prescribed oral appliance.
> Some of the samples tested by the Zero Mercury Working Group contained as much as 65,000 ppm of mercury – an astounding 65,000 times the legal limit of 1 ppm set by the Food and Drug Administration.
https://www.ewg.org/news-insights/news-release/2022/03/dange...
> Amazon Japan K.K. and the two companies in Gifu and Saitama prefectures sold key chains and compasses containing tritium, a radioactive isotope of hydrogen, without reporting it to the NRA, in violation of the radiation hazard prevention law, the NRA said.
https://www.japantimes.co.jp/news/2017/09/20/business/nuclea...
Incredible life changer. You are fortunate that an appliance works, but I absolutely don't regret getting tested for it and using one.
I'm in my mid 30's and not obese, and didn't consider OSA to be likely but got tested due to grogginess and my Dad's recent diagnosis.
I'll do a bit of research on the Fisher and Paykel masks.
The perfect mask for me is the nose cushion. N30i for me, if anyone is curious.
The noise doesn't bother me much. By the time it ramps up I'm asleep.
When the fan is spinning at a constant speed, the noise level should be low. When you switch from inhaling to exhaling, the motor will ramp down, and then up again as you inhale. If you have EPR enabled (or if you are on bilevel), the motor will spin down even more when you exhale, meaning it will have to work harder to spin back up when you inhale. This can cause more noise.
Much like in software architecture, everything in CPAP is a tradeoff. High pressures can cause mask leaks and excessive farting. Low pressures can be more comfortable but can cause snoring or apneas. EPR can cause noise and possibly reduce efficacy. Heated humidification can improve comfort, but requires more maintenance on mask/hose/tank. One mask make be more quiet, but may start to leak as you roll over. Etc.
And much like software projects, every patient is slightly different. Finding out what works isn't easy. Fortunately, you have the rest of your life to optimize therapy. And the better you optimize, the longer that life will be.
Thanks for this comment. I'm finally talking to a sleep doctor next week after years of putting it off for the very same reason. I'm hopeful it will be as life-changing as comments here suggest, but I'm still nervous about the remedies.
1. The breakdown of foam is inevitable over time, maybe it should have been easily replaceable.
2. You can have my CPAP when you pry it from my cold dead fingers. I love my CPAP. It keeps me alive, and I'll swallow some foam to keep it.
3. Why isn't there an inline filter someone made to attach to the standard slimline (or heated) tubing that catches the foam chunks? Standard care instructions would be to check and empty it daily. If there is foam in it, immediately replace the foam piece (which I already said should have been user replaceable.) Maybe the foam WAS the filter, and such filters will always break down over time, especially in a device that gets tens of thousands of hours of use blowing humidified and heated air through it.
4. If a more expensive piece if foam would have fixed this, the idiot who did not demand such better foam should be called out publicly.
5. CPAPs save lives, and I think some mortality is expected/allowed if it gives better performance in trade.
6. There may soon be a shortage of these machines.
I'm wondering if common wisdom will change dramatically in the next 50-100 years on human lifestyles, and most of these diseases will be largely resolved (like gout was for the upper classes of a few centuries ago).
I recently got gout when I really pushed my body hard by running 4x my normal distance in one week, still worked out, kept eating lots of junk (lots of sugary stuff), and drinking 3-4 drinks a night regularly. I also got a cold. Right after that, I got hit with massive toe pain on one foot.
Thankfully it was just a little bit of prednisone but it caused me to back off drinking and eat less sweet things. I'm relatively fit (~35" waist, 203-205ish pounds at 6'1"), but I also dropped down about 5 pounds (was about 208-210) after that and will probably continue to lose more.
https://web.archive.org/web/20240131023937/https://www.fda.g...
If I'm doing the math correctly...they are settling for $400 million...that's only~$3500 per complaint...that's not much money by any means...for a product that can cause cancer.
Please correct me if I am wrong.
It seems far worse (per capita) to get in a single fender bender than it does to cover up defective airbags for decades…
“Numbers sanctify my good friend” - Monsieur Verdoux
As both the article and settlement website say:
> The settlement does not impact or release any claims for personal injuries or medical monitoring relief, according to the administrator with the U.S. District Court for the Western District of Pennsylvania.
In otherwords, there can be additional penalties/lawsuits more directly related to health damages.
Wonder if they'll ever go after alcohol and processed meat as known group 1 carcinogens (i.e. not the flimsy 'in the state of california' kind)
FDA does not provide evidence that they will provide better controls or improved safety, just that there were very minor reports from LDTs. CPAP machines were reclassified to class II devices in 2018, which requires that companies perform QMS and tell the FDA, and sometimes get audited.
LDTs require Lab Directors to take responsibility for the quality of a test at the risk of their license. Auditing is performed by professional societies, to high level. Public health labs and hospitals are furious about the extra, unnecessary paperwork that FDA taking this action would cause, for no apparent benefit.
The FDA allowing more than 500 deaths to happen is a massive indictment of their quality of auditing, and should signal that if they take over LDT regulation, more lives will be at risk.
The US FDA has many flaws to be sure, and they are not known for making fast decisions. It sounds like more lives could have been saved.
A member of my family fortunately stopped using their device when it was recalled and has struggled to find a replacement.
Maybe in the consumer space. But they’re still a huge conglomerate, and one of the biggest MedTech companies in the world. I’m not questioning their malfeasance here, but I doubt it’s going to impact sales on their MRI, CT, EKG… devices very much.
However the brand as a whole is not enjoying its day in the sun, and I hope more people do not get hurt or worse.
Yeah, heavy regulation is that reason. Somehow, heavy regulation that doesn't kick-in when they do something wrong, but only kicks-in when a smaller company wants to make a first product.
But well, it's an area that needs regulation. It's just the format that isn't looking good.
I have no idea how to solve it, but demanding big capital is exactly what led us to the situation that the corporations are too big to punish, and can kill as many people as they wish, making the regulation completely moot.
The regulation will always take some capital, and slow innovation by some amount. But the current mindset is completely counterproductive.
People tend to mostly agree that certain industries should be highly regulated, with medicine being one of the least controversial examples of that. Highly regulated will always mean a big regulatory moat. If it takes years or even decades to get a product to market, and if developing, testing and getting approval for that product requires spending a lot of money, then you need big capital somewhere along the way to make it happen.
There’s not really any decent counter argument to this, it’s basically a truism that if something is very expensive to do, then you need a lot of money to do it. To say that’s counter productive seems like your own value judgement, because what do you think they should be trying to produce? The goal of the regulations is safety and rigour, and perhaps those regulations have some flaws, but there’s no solution to that problem that doesn’t involve high costs for compliance.
There are multiple unique factors here and microplastics are not involved.
The positive pressure used to force air through patients airways may have included broken down particulates of polyurethane foam? Of which may have been a major contributing factor to those health problems listed?
What you say is a bit of a common sense rule of thumb usually used for stuff we digest and poop out.
So that may rule out microplastics, which was shown to cross into tissue (including lungs) which means it would accumulate. And definitely nanoplastic, as those enter even individual cells and screw up their mechanics.
I wouldn't be surprised if in a few years we would consider no safe level of micro/nanoplastic exposure. Maybe we would already if not for the interests of manufacturers and oil industry.
I wasn't providing an answer I was presenting a question like what the other commenter was, which is could those health effects have come from microplastics emitted from the foam.
I’ve just read the FDA response which says:
The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include:
Irritation to the skin, eyes, nose, and respiratory tract (airway), Inflammatory response, Headache, Asthma, Toxic or cancer-causing effects to organs, such as kidneys and liver.
So it looks like it is the case
The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include:
Irritation to the skin, eyes, nose, and respiratory tract (airway), Inflammatory response, Headache, Asthma, Toxic or cancer-causing effects to organs, such as kidneys and liver.
If the machine had a large residue of metal dust from manufacturing, or a grinding in the motor which made it into the airstream, there are severe consequences [2].
A similar issue could if there was some sort of wood dust [3] that made it into the airstream (e.g if they had a wood trim for aesthetics, and it was shaved down by the motor and made it into the air stream). If instead just the dampening of the wood caused mold spores to grow that made it into the air stream [4], that could also cause major issues.
So yes, in this case it's foam, but most foreign particulates are going to be a problem.
[1]: https://www.ccohs.ca/oshanswers/chemicals/lungs_dust.html#se...
[2]: https://lunginstitute.com/can-breathing-metal-dust-hurt-you/
[3]: https://www.osha.gov/wood-dust
[4]: https://www.mayoclinic.org/diseases-conditions/aspergillosis...
Don't we know that for a while already ? The endocrine disrupting effect alone is a major concern.
I feel like we're back at the "is lead in gas really _that_ bad?"
Philips used to be one of the big ones, like GE or Samsung. The mismanagement and slow deathmarch of a giant.
They used to own ASML, they used to own NXP, they owned Panasonic Batteries production I think, they had 30% of all shares in TSMC.
I mean you can forgive a single misstep, but if every single company you sell manages to becomes a de facto global leader in its industry the lack of foresight is something for the history books.
In hindsight, when the business men took over and moved the HQ to Amsterdam, where all the business people are, rather than in Eindhoven, where it was founded and where all the R&D and tech is, was the beginning of the end.
On the other hand, it can be said that it can still go worse than that... just look at Boeing and how far they have fallen.
Hey! That sounds exactly like what happened to a US plane manufacturer that has regularly been in the news the last few years. But Philips has a slight lead in the death count for now.
One thing that was really interesting in this process was understanding the machine itself. Being used to crappy consumer electronics, I was amazed at how robust the build quality was and the engineering involved. Every little eventuality of medical accessibility problems, or things that could go wrong were accounted for in the design somewhere. It's incredibly simple to use, easy to clean, easy to get spare parts if needed. I guess that's the quality you get when your device costs upwards of $2,000.
CPAP.com is great for decent prices and direct to consumer sales.
If the internal pressure is annoying, airtight earplugs help with keeping the sinus pressure even.
As you probably know, the severity of OSA is quantified in something called the apnea-hypopnea index. For every SINGLE point of BMI reduction (5-8lbs depending on height), you achieve an AHI reduction of 6.7%. That’s absolutely massive. [2]
It’s still multifactorial, one’s anatomy can be varyingly predisposed for OSA, sometimes to the point of causing problems without obesity. But in general, that’s one hell of a bet.
!! I’m a medical student. I have not yet achieved the status of approbated physician. Please adjust your trust accordingly. I don’t think i have to spell out the difference between informed medical advice and comments on HN, my comment is already patronizing enough as is, but regardless.
[1]Resta, O., et al. "Sleep-related breathing disorders, loud snoring and excessive daytime sleepiness in obese subjects." International journal of obesity 25.5 (2001): 669-675.
[2] Fattal D, Hester S, Wendt L. Body weight and obstructive sleep apnea: a mathematical relationship between body mass index and apnea-hypopnea index in veterans. J Clin Sleep Med. 2022 Dec 1;18(12):2723-2729. doi: 10.5664/jcsm.10190. PMID: 35929587; PMCID: PMC9713905.
My new one has LTE so that people know when I’m asleep to rob me, and a ton of other annoying “modern” features so I’m hoping this old one just keeps on going.
One relating to filter problems: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...
One relating to skin irritation: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...
One with WiFi connectivity issues preventing configuration(!): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...
One waking up with a burning sensation in their nose and throat: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...
One shut down during the night leading to too-low oxygen levels leading to hospitalization and death: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...
It boggles the mind that Philips would chose to report the WiFi complaint, but not the foam-dust complaints. To me it makes it seem even more likely that this issue was deliberately suppressed by management.
The standards of these industries have a long way to go before they catch up to us.
Every one of them is wrong.
It’s about being open and transparent about potential risks, being transparent about your mistakes and not outright illegally concealing them and cheating.
I've never seen someone say they could do better than air traffic controllers themselves. If this is about paying more and hiring more people... that's also something the average person is capable of handling.
It is precisely because I am less likely to kill people that I am a better engineer. Picking your battles is part of fighting.
I never noticed anything strange while using it, fwiw.
Impression: DSL, IHT. Circumferential pharyngeal wall collapse in the Nasopharynx and Oropharynx. Epiglottis falling backwards.
The doctor told me there is no surgery or anything else but only CPAP as the solution :( I dread of a day when there is no electricity or the machine stopping working. Posting it here to see if anyone else knows a good doctor or have a similar issue!
Philips had a very good reputation in the community, their accessories are more affordable, more “boring” is a good way. I really preferred a company that way, but after all it sounds like I’ve dodged a bullet.
WTF? So they're knowingly going to keep selling them elsewhere!?
I need to stop by mom’s house and see which he used. It’s different than mine which is not the recalled type.
> Why wasn't it recalled by other health agencies before or after?
I don't know about other countries but the situation here in Brazil is similar.
> Is the defect specific to the north american market?
Unlikely.
Will people ever learn?
Sleep apnea makes it nearly impossible to lose weight. It can cause obesity.