Philips puts the health of patients with respiratory disorders at riskA manufacturing defect in 370 Philips devices used by French people suffering from sleep apnea or respiratory diseases exposes them to risks such as headaches, coughs, irritation and even cancer.
In six months, however, less than 5% of machines have been replaced.While sleeping, Pierre (see Black Box) held his breath without realizing it thirty-three times an hour. It even happened that he did not breathe for 1 min 20, before waking up with a start to catch his breath. With such nights, it was difficult for the teacher to deliver lessons in front of his students the next day. He has sleep apnea, like 4% of the population and even 30% of those over 65, according to Medicare.
For ten years, he has been sleeping with a mask over his nose connected to a continuous positive pressure (CPAP) ventilation machine which regulates his oxygen supply. It is the only possible treatment for people with severe sleep apnea. Connected every night to his Philips brand device, he still suffers, but less, at the rate of five or six micro-alarms per hour.
Except that “for the past seven years, my migraine problems have increased when they were supposed to be induced by sleep apnea. I began to have chronic sinusitis and rhinitis as well as to develop hypersensitivity, testifies this 62-year-old Parisian. For example, we had our bedroom repainted with a product containing as few chemicals as possible in June. Six months later, we still can't sleep in it. Pierre loves his job as a teacher, but he is seriously considering retirement due to his health problems.
Until recently, he had never suspected his machine made by Philips, "the badly named Dreamstation", he squeals. But on June 14, the Dutch firm announced the recall of 370 of its devices used in France and manufactured before April 000, 26. Its machine is one of the dozen types of products concerned: 2021% of it is 'CPAP devices, therefore intended for patients with sleep apnea. They are only found to treat patients at home, not in hospitals.
The manufacturing defect also affects 29 ventilators, often vital for patients of all ages with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation syndrome (SOH), kyphoscoliosis or neuromuscular pathologies.
The worst part is the slowness in replacing the machines. The mosses continue to loosen, we are letting people inhale poison every night and die in their corner.
Marie-Agnès Wiss-Laurent, president of the FFAAIR patient association
On the Philips website, better known for having invented the audio cassette, a certain Damien, user of the Dreamstation range machine, boasts "this 100% organic treatment, without medication, exclusively composed of air" ... The problem, This is because volatile organic compounds can escape from the foam used to reduce device noise as it degrades.
Inhaling these substances all night long can cause headaches, irritation, inflammation, breathing problems, hypersensitivity, nausea, vomiting, and worse yet, produce toxic and carcinogenic effects, Philips said bluntly in a report. press release to announce this global product recall, in June 2021.None of Pierre's doctors warned him. “The people concerned are not all informed. As there is not necessarily a plan B to propose, it seems that we do not want to create a wind of panic, but patients have the right to know the risks of these defective machines ”, plague Yann Mazens, technical advisor at France Assos Santé, a group of patient associations. It is true that Philips holds a little more than a quarter of the market share among users of CPAP machines and even more in the case of respirators used at home in France.
As with most of the patients concerned,
it was finally Pierre's home health care provider, responsible for delivering and paying for the devices, who notified him by mail.In mid-August, when he found this writing in his mailbox, he made a direct link between his everyday ailments and the list of listed dangers.
The next day, Pierre called the service provider to request a change of machine. “He took my case as a priority and delivered me a device from another manufacturer. After a few weeks of adjustments, not only do I only get two to three sleep apneas per hour at night, but I suffer less headaches during the day. I went from fifteen powerful anti-migraine drugs per month last winter to only one to four per month since the machine was replaced, ”compares the XNUMX-year-old.
He has since been considering a possible legal action by Philips. On July 9, a class action claim in Canada was filed by lawyer Andrea Grass of the Consumer Law Group. "So far, just under 5 people from across Canada have registered on our website to be kept informed of the request," said the lawyer.
Mediapart was able to consult the request which sets out the facts to be clarified, namely whether Philips has "shown negligence in the marketing and sale of the recalled breathing apparatus" and if the firm has "failed to warn consumers of the associated risks ".
In France, six months after its sudden announcement, Philips only changed 16 of the dangerous PPC generators concerned, or less than 411%. And as for the ventilators, the firm indicates that "the repair and the replacement will begin from the month of January 5".
“We were amazed when we learned about these risks. The worst part is the slowness in replacing the machines. The mosses continue to loosen, we are letting people inhale poison every night and die in their corner. About thirty users of Philips machines contacted us. They tell us to cough a lot and when they spit, they find very black dirt, ”reports Marie-Agnès Wiss-Laurent, president of the French Federation of associations and friendships for the sick, insufficient or disabled (FFAAIR).
313 reports of coughs, headaches and irritations, mainly, received by the Medicines Agency.“What I see in the short term is that at least I understand the origin of my sinusitis and headache problems and that they are decreasing, although I think that part of what I have picked up for ten years is irreversible, reacts Pierre. In the long term, that's the big question mark, if I ever develop cancer in five, ten years… ”
On September 16, he drew up a declaration of his adverse reactions to the National Agency for the Safety of Medicines and Health Products (ANSM). In all, since June, it has received 313 reports of coughs, headaches and irritations, mainly, a priori related to the use of the recalled Philips machines.
Rare are the mentions of the appearance of cancer and for the time being, no cause and effect link has been established with defective machines. This disease often strikes with a delay, years after exposure and it is sometimes difficult to relate the origin to a specific factor. Especially since until now, health insurance did not list the brands of medical devices used by patients, which makes long-term follow-up difficult in the event of a massive recall of products with specific references.
On the other hand, health providers have detailed data: patient associations then request that a study be initiated with the aim of establishing in the long term a possible link between the use of defective machines and the appearance of cancer.
While the Philips company itself mentions this risk, she told Mediapart: “We do not have clinical data indicating that exposure to particles or organic compounds is likely to cause cancer. Extensive testing and research is underway to better identify and understand the real risks. "
In its latest recommendations to healthcare professionals relayed by the French-language Pneumology Society (SPLF), the ANSM no longer even cites “carcinogenic risks” and, on the other hand, invites you to monitor symptoms such as headaches, eye irritations and pathways. respiratory, inflammatory reactions, cough, chest pressure, asthma and sinus infection.
So is this danger stifled or exaggerated? “There is no toxicological study that would show a link between the use of Philips machines and the appearance of cancer. This is a theoretical risk. We cannot exclude it, but it has not been proven, ”specifies Thierry Thomas, deputy director of medical devices at ANSM.As for the manufacturer, he replies that "as a precautionary measure, Philips considered the possible risks and considered the most pessimistic scenario in terms of severity, including for example the emergence of carcinogenic risks". “Was it for Philips to cover itself as much as possible in the event of problems that would arise after this announcement, as is done a lot in the United States? », Asks Yann Mazens, of France Assos Santé.
Health authorities powerless in the face of Philips' inertia
Another ad raises the same question. As a first step, Philips recommended that the minority of patients using ventilators with life support function to continue treatment despite the dangers, for lack of an alternative. "Without a ventilator, the patients most at risk can die from respiratory failure or fall into a hypercapnic coma within a few days", underlines Jesus Gonzalez, pulmonologist at the Pitié-Salpêtrière hospital in Paris and head of the company's equipment group. scholar SPLF.
In contrast, Philips called on people using the affected CPAP devices and ventilators without life-support functions to stop their use and consult their doctors, creating panic among informed patients. However, “without a device, those who suffer from sleep apnea will experience an upsurge in drowsiness which can cause them to fall asleep in the workplace or while driving. Unfortunately, we are no longer within a few months of inhaling potentially toxic substances in the face of the absence of an alternative, ”resolves Professor Gonzalez.
Philips subsequently modified its recommendations for France and aligned itself with those of the ANSM. The latter recommended on July 8 “not to stop treatment regardless of the type of device used”. “Initially, Philips had a very disturbing, disturbing message. Asking more than 300 people to stop their treatment means making them take even more risks, ”said Thierry Thomas, from the ANSM.
Philips plans to find a solution for the entire fleet concerned by the end of 2022 only.In calculating this morbid benefit-risk balance, Philips' failure to immediately replace its defective machines is taken into account. If the company were able to replace them, patients would not continue to face the perils in question. Today, they continue to use the possibly harmful device through the fault of the manufacturer while waiting for a solution that is seriously slow to arrive.
And again, the patients of France would not be the most to be pitied, according to the press service of Philips which indicates to Mediapart that "France was the first country in Europe and the third at the world level", to have saw the start of the replacement of defective equipment in September thanks to "the relentless commitment of the Philips teams".The Dutch manufacturer plans to find a solution for the entire fleet concerned in France by the end of 2022, so in just one year. By the voice of Thierry Thomas, the ANSM considers this time “unsatisfactory”. Philips justifies its slowness by "the difficulties inherent in the current global context: shortage of electronic components and raw materials, tensions linked to the entire logistics and transport chain".
The health authorities are taken by the throat and find themselves without legal leverage all along the chain.
Yann Mazens, from France Assos SantéHow can the multinational afford to continue exposing patients and abandon them in such disarray? Because it benefits from a lax legal framework. The ANSM was only informed of the safety notification on June 10, four days before Philips communicated the recall to the public. However, the manufacturer has known the dangers since April.
“What is open to criticism is discovering the problem overnight. The situation is abnormal and detestable for the patients in the first place, it is very anxiety-provoking. We immediately perceived that the problem was going to be very complex to manage because of its global character and the multiplicity of actors involved. We classified it as “critical”, ”comments Thierry Thomas, from the ANSM.
Manufacturers of medical devices such as breathing apparatus, however vital, have no obligation to warn health authorities well in advance in the event of worrying analyzes leading to machine recalls. To believe that health products are consumer goods like any other ... Such as televisions, kitchen machines, irons, razors or electric toothbrushes also sold by Philips. The Dutch brand focused on its health branch only in the 2010s.
The health authorities also do not have the legal leverage to force manufacturers to immediately propose a solution to alleviate the serious problems for which they are responsible given the quality defect; nor to fine them in order to encourage them to speed up corrective action.This powerlessness of the public authorities was already between the lines of another global health scandal, the Implant files, in particular revealed by Le Monde. To market medical devices, their manufacturers do not have to file substantial files with health agencies. A request for European certification is sufficient.
“Upstream, everything goes through certified organizations to authorize the devices, then downstream, we cannot draw information related to product safety as is the case in a marketing authorization application file. of a drug. The health authorities are taken by the throat and find themselves without legal leverage all along the chain ”, deplores Yann Mazens, of France Assos Santé.
A second most serious product recall
However, security flaws are frequent ... In any case at Philips, which has been increasing the number of disappointments since mid-2021. On August 4, the Food and Drug Administration (FDA), the American health police, indeed triggered a class 1 alert, the most serious level, concerning a second recall of Philips machines, still related to apnea. sleep, but of a different range.Their users are at risk of oxygen starvation due to problems with the software that regulates the flow of machines with the possible consequence of "serious adverse events, including death," according to the FDA.
On August 10, Philips sends the procedure for correcting the software. "This alert was even more serious from the point of view of the immediate medical consequences, but corrective action to adjust the machines could be implemented quickly by the service providers", comments Jesus Gonzales, professor of pulmonology at the Sorbonne medical school. University.
Second rebound on November 12. Following the first recall in June, the FDA conducted an inspection at a Philips plant in the United States where respirators are produced. Following which the health agency asked the firm to conduct more tests on the foam.
Obviously, patient associations are wondering: does this alert concern machines used to replace those designated as defective in June? Those pointed out by the FDA this time are not distributed in Europe, for the time being. The CPAP devices concerned in France by the recall have been replaced by machines which include a "new silicone foam" tested by the FDA and having "demonstrated acceptable results", specifies the Dutch firm.
In any case, the confidence of prescribers and users of Philips machines is broken. As more information reaches them, patients ask their home care provider or pulmonologist for a new device from another brand. "When a patient requests it, we prescribe a machine from other manufacturers who follow without problem for now and we stop prescribing Philips until everything is resolved," reports Professor Gonzales.
If its competitors ResMed and Air Liquide quickly replied to Mediapart that their products were not affected by the defect reported by Philips due to the use of another type of soundproofing foam, they remain vague as to their capacity. to come to the rescue of all the patients left behind by Philips.
The ResMed company, born in Australia and headquartered in San Diego, California, says in any case "currently in high demand by new customers" and says it is working "to bring as many devices to the market as possible given delays in the supply of the components necessary for their manufacture ”. As for the French firm Air Liquide, it specializes in the manufacture of respirators for hospitals ... Demand for which has exploded with the massive arrival of Covid-19 patients.
Rozenn The Saint
