This device has changed the lives of more than 3,000 people with sleep apnea in Polynesia. A machine that has become essential for sleeping at night and yet it would be potentially dangerous…
Since June 2021, Philips respirators have been suspected of causing headaches, coughs, and even cancer risks. In question: a sound-absorbing foam inside the devices which degrades and forms toxic particles. On its website, the National Agency for the Safety of Medicines and Health Products (ANSM) indicates that the replacement of the equipment concerned is in progress.
In Polynesia, this is also the case for the 4 existing healthcare providers. The devices concerned have been isolated and are being returned to the manufacturer of the brand, explains the general manager of ISIS Medical Polynesia, Mahera Arakino. “As of July 2021, a protocol has been put in place by Philips and by the ANSM which requests the replacement of devices that are in the field […] with the obligation to replace all these devices by December 31, 2022. In terms of replacements, we are at a replacement rate of 16% of these devices”adds the director who ensures that“we do not detect any risk in Polynesia”. “It is a potential risk, there is no confirmed risk. The real confirmed risk would be a cessation of patient treatment”.
In his office, Dr. Bouayad, pulmonologist at the Paofai clinic, reports that indeed, several patients have asked for their machine to be replaced. However, he recommends not abandoning the treatment because “today, we have no proven proof by scientific studies”advance the doctor. “On the contrary, there, if you stop using nasal ventilation or this machine, you run the risk of respiratory failure. I advise my patients to continue”.
In France, 370,000 patients are concerned. To date, only 7% of defective respirators have been replaced. The ANSM took February 11 “a health policy decision to speed up the replacement of certain devices” Philips, it said in a statement, days after announcing it would take such a step. The agency also wants Philips to undertake a precise study of the risks represented by its devices and send its results to it within a year.
Explaining its delay by the global economic context of shortage of raw materials, Philips assured that it had only mentioned carcinogenic risks out of “extreme precaution” and reported the first reassuring elements on this subject. All affected devices should be replaced by the end of 2022.
For more information, contact your doctor, your home care provider, or go to the ANSM website by clicking HERE