370,000 patients use this device in France, the sound-absorbing foam of which produces potentially carcinogenic particles.
Are we heading for a major health scandal? In recent days, the Dutch company Philips is in the center of all eyes following a malfunction of its breathing apparatus equipped for people with sleep apnea was unveiled. At issue is a sound-absorbing foam, the particles of which escape and can be inhaled or ingested by the patient.
The immediate risk, and reported by multiple patients: irritation but also coughs and headaches. But Philips mostly talks regarding a theoretical risk of cancer in the longer term, although there is still no indication of its real existence.
In France, 370,000 people use these tools, a figure that rises to 1.5 million on a European scale. In mid-2021, the company announced a large recall of these devices.
Appearance of a task
Since then, fear has set in among patients. Met by BFMTV, Marie-Hélène Noillet, suffering from chronic lung disease and sleep apnea, has been dependent on this respirator since 2017. “If I didn’t have a machine, I might have strokes,” she says.
“Today I’m scared regarding the consequences it brings, but I mightn’t do without the machine, I don’t think,” says the five-year-old, a few days following being informed of this case in the media.
A situation with direct consequences, since Marie-Hélène was recently diagnosed with a lung problem.
“Is it this machine that caused this nodule or is it something else, who’s going to tell me?”, she hammers.
7% of replaced devices only
Last June, the group promised to replace all the devices. Only, more than 6 months later, the account is not there: in France, according to the ANSM, only 7% of them have been taken over.
So, the authority wants to use the strong way once morest Philips, whose accounts have also already suffered heavily from this case with a provision of several hundred million euros to deal with the potential shortfall.
The ANSM will, in the coming days, initiate a “sanitary police decision”. In practical terms, this means that Philips will be subject to criminal prosecution if the company does not comply with the timetable imposed by the authority.
“If they don’t comply, we can make a report to the prosecutor and then see if he takes up the case,” Caroline Semaille, deputy director general of the ANSM, assures our antenna.
This requires in particular that the group has replaced three quarters of the devices by the end of June. She also asks him to launch a study to accurately assess the risks, especially those of cancer.
Avoiding panic
Because at the moment, the assumed risks are only theoretical. A situation that puts the health authorities in a delicate situation. On the one hand, they are encouraged to act quickly in the face of the concern of patient associations. Some media have also relayed isolated testimonies of people with cancer in recent days following using these devices, although it is impossible to establish a causal link.
The French agency, which claims to be at the forefront on the subject compared to its European counterparts, is also facing the example of the American health authority, the FDA, which has been investigating for months and says it has established that Philips had been aware for years of potential problems.
But, by drawing attention to the problems of Philips respirators, the authorities are also aware that they can create a wind of panic among users, which can be much more harmful than the hypothetical risks of cancer. Speaking to BFMTV, Jan Kimpen, Philips World Medical Director, also wanted to reassure users.
“With the data we have, we have no reason to believe that these devices give cancer. I’m a doctor, and I’m confident when I tell patients that,” he says.
For the time being, and pending the complete replacement of the devices, the ANSM cites in particular a study carried out in Canada on a group of patients with sleep apnea to reassure patients. “For now, the results (…) do not show ‘over-risk'”, assures Caroline Semaille.
“It’s better to keep a faulty device rather than have no device at all,” she warned. “What we don’t want is for there to be an alarmist wave.”
