“Evasive” or even “non-existent” answers, and patients between anger, fear and uncertainty. Almost a year after the recall by Philips Group many of its respiratory devices due to potential risks to the health of their users, the National Medicines Safety Agency (ANSM) convened an ad hoc committee of experts on Wednesday to better understand the potential risks. Objective: to push the group to accelerate the rate of replacement of the devices in question, and to answer the many questions of patients left in worry.
These devices, prescribed mainly against sleep apnea and used by approximately 350,000 patients in France and 1.5 million throughout Europe, have been the subject of an international recall since last summer due to a material used in their composition: a sound-absorbing foam whose group noticed that particles came out of certain devices and could thus be inhaled or ingested by patients. However, Philips is slow to replace defective devices. The ANSM in response initiated a “health policy decision” against the group, which it ordered to replace or repair three quarters of the devices in question by mid-2022, a rate that will probably not be reached. Much to the chagrin of patient users.
“Philips remained absolutely deaf and dumb to our questions”
The group “Philips remained absolutely deaf and dumb to our questions”, regretted Christian Trouchot, member of the French Federation of Respiratory Insufficiencies and representative of the main patient associations during this day of hearing. However, there are many questions about the potential risks associated with these defective devices, which can cause coughing, irritation or even headaches. More worryingly, the group also mentioned a “potential” risk of cancer long-term.
However, the group has not undertaken to dispel the doubts and concerns of patients using its respiratory devices. “If Philips is a manufacturer of medical devices, it is not a manufacturer of information, tackled Christian Trouchot. Our federations have asked Philips for the name of the manufacturer of the foam, and if they supply other manufacturers of similar devices, but the group has opposed us on business secrecy, so we have not had any response,” said he lamented.
“Device replacement schedule”, “toxicological analyses, clinical trials, real risks for the patient, carcinogenic risk: during these long months of hearings, we have multiplied the questions. But Philips’ responses were either evasive or simply non-existent, he added. Patients are between a rock and a hard place, the hammer being the patient’s pathology, the anvil being his machine”.
Preventive reminders, but worried patients
Also questioned by the ANSM, the representatives of Philips emphasized the fact that this recall campaign had been initiated as a pure precaution and had been followed by more in-depth tests to find out at what point these devices release particles potentially threatening. “These tests really take a huge amount of time,” explained Dr. John Cronin, medical lead for respiratory devices at Philips. But “to date, we have received around ten reports of harm, reporting generally limited effects such as cough, headache or congestion, he reassured. And no evidence of cancer or death” related to these devices.
However, there is too little information to reassure patients using these devices on a daily basis. The announcement of the recall last summer “led to a very strong spike in contacts with service providers, materializing the anxiety of patients in the face of the risks mentioned, confirmed Alexandra Duvauchelle, general delegate of the Federation of Home Health Providers (FEDEPSAD). This campaign has caused a tsunami of necessary support for us, without having the prospect of replacement dates for these devices, ”she told ANSM.
Torn between the potential risks associated with their respirator and those – proven – to endanger their health by ceasing to use it, the patients, worried, are lost. “There is anxiety linked to this risk of cancer and to the change of device, but also the confidence that the patient has in his machine” and which is difficult to maintain when it is called into question. For his part, Dr Cronin called on patients to “not make any decision without discussing it with their doctor”.
If the group has not yet communicated on its ability to replace its implicated devices in France within the time allowed, the ANSM, after this day of hearings, plans to issue an opinion within the coming weeks, and could revise its recommendations to continue the treatments, issued last summer.