Often “evasive” or even “non-existent” answers, and often patients between anger, fear and uncertainty. Nearly a year after the Philips group recalled the name of its respirators due to potential health problems for their users, the National Drug Safety Agency (ANSM) convened an ad hoc committee of experts on Wednesday. in order to better understand the potential risks. Objective: To push the group to speed up the replacement rate of the affected devices, and to answer the many questions of patients left in concern.
These devices mainly prescribe contra apnée du sommeil and are used by around 350,000 patients in France and 1.5 million across Europe, the source of the last year’s subject of an international recall due to incoming material. in their composition: a soundproof foam whose group noticed that particles came out of certain devices and could thus be inhaled or ingested by patients. Or, Philips is late to replace defective appliances. In response, the ANSM filed a “sanitary police decision” against the group, ordering it to replace or repair three-quarters of the devices involved by mid-2022. a rate that is unlikely to be reached. Much to the chagrin of patient users.
“Philips has remained absolutely deaf and dumb to our questions”
The group “Philips remained absolutely deaf and dumb to our questions,” regretted Christian Trouchot, a member of the French Federation of Respiratory Disorders and a representative of major patient associations during the day of the hearing. However, there are many questions about the potential risks associated with these faulty devices, which could cause coughing, irritation or even headaches. More worryingly, the group also mentioned a “potential” long-term cancer risk.
However, the group did not try to dispel the doubts and concerns of patients using its respirators. “If Philips is a manufacturer of medical devices, it is not a manufacturer of information, a Christian Trouchot tackle. New federations have asked Philips for the name of the foam manufacturer and supplied it to other manufacturers of similar devices, but the group does not oppose the secrecy of the business, we have no answer to the address -il déploré.
“Device Replacement Schedule,” “Toxicological Tests, Clinical Trials, Real Patient Risks, Carcinogenic Risk: During those long months of hearing, we multiplied the questions. Several Philips responses were either evasive or simply non-existent, he added. Patients are between the hammer and the anvil, the hammer being the pathology of the patient, the anvil being his machine ”.
Preventive reminders, but anxious patients
Also questioned by the ANSM, Philips representatives emphasized that this recall campaign was undertaken out of sheer caution and was followed by more in-depth testing to determine how well these devices emit potentially threatening particles. “These tests are really time consuming,” said Dr. John Cronin, a respiratory physician at Philips. Mais «à ce jour, we have received reports of prejudice, reporting generally limited effects such as cough, headache or congestion, he reassured. And no evidence of cancer or death ”related to these devices.
There is very little information, however, about providing patients with these devices on a daily basis. The announcement of the recall last summer “has led to a very strong spike in contacts with providers, materializing patients’ anxiety about the risks mentioned, confirmed Alexandra Duvauchelle, general delegate of the Federation of Home Health Care Providers (FEDEPSAD). This campaign has caused a necessary tsunami in our country, without the prospect of replacing these devices, ”she told ANSM.
Tugged between the potential risks associated with their respirator and those – proven – to endanger their health by stopping using it, patients, worried, are lost. “There is anxiety about the risk of cancer and the change in the device, but also the confidence that the patient has in his machine” and which is difficult to maintain when he is involved. For his part, Dr. Cronin called on patients to “not make any decisions without talking to their doctor.”
If the group has not yet communicated its ability to replace in time, share its devices in question in the Hexagon, the ANSM, after this day of auditions, plans to issue an opinion in in the coming weeks, and could revise its recommendations to continue treatment, issued last summer.