In June 2021, under pressure from American users, Philips launched a security alert and decided to recall 5.3 million rrespirators and ventilators, devices that allow people with sleep apnea to breathe better at night. Of those using these ventilators, some 382,000 registered in France.
One of the reasons for this recall : the polyurethane foam which soundproofs the interior of the machines can degrade into chemical particles directly inhaled by the users. A possible risk of cancer is mentioned by the Dutch giant.
Nearly a year and a half after this alert, at least 128,000 French people are still using these machines every night. Contacted by franceinfo, Philips France acknowledges that the recall plan has taken a long time because of “the shortage of electronic components and raw materials and the volume of devices to be produced”. The group says 60% of failed respirators and ventilators have been replaced or are in the process of being replaced. By the end of the year 2022, ensures Philips, 97% of recalls will have been carried out with a majority of new devices and others “corrected” with a new foam.
To date, no scientific study has established a proven link between the use of the machines affected by the recall and cancer. But no reliable epidemiological study makes it possible to exclude the carcinogenic risk either, underlined on several occasions the epidemiologists questioned in recent months by the National Agency for the Safety of Medicines and Health Products (ANSM), which took up this health record.
A very anxiety-provoking in-between for patients on which the ANSM has decided. It urges all patients to continue to use their machine under penalty of known complications. : drowsiness, increased cardiovascular risk, worsening of respiratory failure. On internet forums where users with sleep apnea syndrome exchange, the anxiety is real. Questions abound about replacement times, the manufacturer’s lack of transparency, the steps to take to file a complaint.
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A growing number of them do not hesitate to make the link between their respirator and the appearance of health problems: headaches, asthma, appearance of nodules or even cases of cancer. This is the case of Violette*, 62 years old. She sang semi-professionally all over Hauts-de-France for more than 30 years. When he is prescribed his Dreamstation Expert end 2020, she suffers from sleep apnea but no respiratory problems, as an X-ray and a certified medical report from a general practitioner we consulted seem to attest.
“Before, I was never out of breath. I did a lot of concerts, so in terms of voice and breath, frankly, I was never out of breath.”
As the nights go by, Violette has increasing problems breathing. She tells her doctor about fatigue, edema, irritation of the eyes, face, inflammation. At her request, Violette changed her mask several times, then her respirator. In April 2021, the affair breaks out. “One day I heard about this Philips case, she continues. So I insisted with my doctor who told me: ‘We are going to do extensive examinations’. And then we found a tumor in the upper left lobe of my lung. A month later the tumor had grown so the entire lobe was removed. But on the other hand, in view of the results, it was very cancerous. So within eight days, I’m starting chemo sessions.”
“We don’t have the guarantee that it’s that, but hey, there’s a good chance that it was this device that destroyed my health. Philips wouldn’t have recalled devices like that.”
Violette now uses a respirator from a competing brand of Philips. She says she no longer feels embarrassed. Like 1 425 other users of faulty machines, Violette took the plunge and joined a collective action for a civil complaint against the giant Philips for “lack of information” in particular. .
The 20 June 2022, the public health department of the Paris Public Prosecutor’s Office opened a preliminary investigation for endangering the lives of others, aggravated deception and administration of harmful substances. On his desk, twenty complaints pending and eight registered complaints, four of which are related to cases of cancer. According to our information, a hundred French people, including more than a dozen cases of lung cancer, also intend to file a criminal complaint against Philips. Finally, the ANSM has to date received nearly 3,074 reports of adverse effects, including 159 mention cancer.
In France, the French Federation of Associations for the Sick, Insufficient or Respiratory Handicapped, which represents 51 associations of respiratory patients, very early positioned itself on this little publicized affair which it does not hesitate to compare to that of the Pick. In April 2022, Philips refuses to communicate to the FFAIR the exact composition of its polyurethane foam, the identity of the producer and the studies which make the group say before the National Medicines Safety Agency that the risk of cancer is not proven .
The Sick Federation decided to summon Philips to appear on 16 November 2022 before the Nanterre court to force him to give his documents. Christian Trouchot, of the FFAIR, denounces a lack of transparency to the detriment of patients : “In the evening, we are forced to use the machine. And when we put the mask on our nose, we say to ourselves : What am I breathing ? Are we sure about the foam ?”
“And there, we have no study, we have nothing. Philips is not able to provide any or does not want to provide any.”
Christian Trouchotat franceinfo
Since the recall of these respirators, the ANSM recommends to all those who still use Philips machines not to stop their treatment. A recommendation which is largely based on the conclusions and work of two eminent members of so-called learned societies : Professor Frédéric Gagnadoux, President of the French Society for Sleep Research and Medicine, and Professor Jesus Gonzalez, Vice-President of the French-speaking Pneumology Society. Both dismissed very early on, including in the press, the links between polyurethane foam and the appearance of cancer.
On September 29, during a so-called stakeholder meeting before the ANSM, Professor Jesus Gonzales even suggested the next lifting of the respirator recall. Problem: over the past five years, these two doctors have both been paid a few thousand euros by the Philips group to carry out conferences and training, as Professor Jesus Gonzales openly said before the National Health Agency on 8 June 2022. “I work with all manufacturers without exception, he indicated during the public hearing carried out by the ANSM’s committee of experts. I am not an employee of one of the manufacturers, but I give advice and I participate in training. It is important that I say this. So don’t believe me 100% because I have some conflicts of interest.”
In addition to sponsored meetings, Professor Gagnadoux (who did not wish to answer our questions) was paid by Philips as an investigator of clinical studies according to his declaration of interest 2019 consulted by franceinfo. The French study led by Professor Gagnadoux of the CHU d’Angers was the subject of a publication in the journal European Respiratory Society last April. This study is cited by the Philips group as one of two “independent” studies on the subject. Situations of potential conflicts of interest, strangely avoided by the ANSM during its last meetings, which are not likely to reassure users of respirators and Philips ventilators, nor the associations which represent them.
This lack of transparency of the Dutch group is also denounced by the shareholders of Philips in the Netherlands. In September, the powerful association of private investors VEB (Vereniging van Effectenbezitters) based in The Hague, put Philips on notice for failure to inform the markets.
The VEB, which has started negotiations with the group, estimates the damage at 16 billion euros. Armand Kersten, his spokesperson, explains to franceinfo: “The criticism of Philips is that it was late in informing the markets about the serious problems with the ventilators, he points out. The US Federal Food and Drug Administration (FDA) found during searches that the director of Philips in the United States was already aware of a problem concerning these foams as early as January 2020, possibly as early as 2015. Philips did not inform the markets until April 26, 2021. The stock price of the stock has collapsed by 50% in one year.”
“For us, concludes Armand Kersten, this failure to inform the markets constitutes a breach of the European Union’s market abuse regulation, which obliges companies to make inside information public as soon as possible. It’s serious.”
* The name has been changed