En France, environ 1,4 million de patients sont sous PPC.

The ANSM has convened a temporary scientific committee on the subject of the Philips Respironics ventilation devices affected by the June 2021 recall. One year after this recall, patients are still waiting for their device to be replaced.

On June 14, 2021, the manufacturer Philips sleep apnea therapy devicesquietly announced on its website that it was recalling several of its marketed models due to health risks associated with the use of these continuous positive airway pressure devices that provide airflow in the airways breathing in people with sleep apnea

At the origin of recall of these machines by Philips, the degradation of the sound-absorbing foam of certain devices which gives off chemical particles. This Polyester based polyurethane foam, minimizes the noise produced by the device when it is used at night. But since it is located in the air passage of the device, theMicroscopic plastic dust is sent deep into the lungs, causing irritation and ENT disorders. They are even potentially carcinogenic.

However, despite these health risks, the recall of defective devices has been carried out at very low speed for a year. This is why, this Wednesday, June 8, 2022, the National Medicines Safety Agency (ANSM) convened a temporary scientific committee on the subject of the Philips Respironics ventilation devices affected by the June 2021 recall.

During this committee, scientists, health professionals but also representatives of patients affected by the recall of Philips respirators were heard. Without forgetting the representatives of the industrialist who were asked to take stock of the situation. “The objective of this committee is to issue an opinion on the risks associated with the use of respirators (and in particular the risk of cancer) and to update the recommendations issued a year ago on maintaining use of defective devices pending their replacement” reminded Dr. Christelle Ratignier-Carbonneil, director of the ANSM.

In June 2021, the ANSM recommended not to interrupt the treatment. “Stopping treatment presents a proven risk in the short term, for example aggravation of respiratory failure. According to the first data available, the risk of cancer linked to the use of these devices is not proven” underlined the Agency which could revise its recommendations in the coming weeks.

>> The committee of experts will issue an opinion in the coming weeks. In the meantime, it is possible to watch all of the public hearings (lasting 6 hours) on the ANSM’s youtube platform.

Philips ventilators: who is affected?

These devices, used at home, are intended for people who suffer from sleep apnea or who need respiratory assistance. In France, approximately 1.4 million patients are on CPAP (all manufacturers combined) and 80,000 on home ventilation. The number of devices concerned by this recall would be around 350,000 for CPAP and 29,500 for ventilation.

What risks have been identified?

Two risks have been identified by Philips: a risk of exposure to 2 volatile organic compounds (VOCs) and a risk of exposure to particles resulting from the degradation of the foam. Potential risks from particulate exposure include:

  • Skin irritation of the eyes, respiratory tract
  • Headaches
  • Adverse effects on the liver or kidneys
  • carcinogenic risks.

Towards a “respiratorgate”?

Friday, February 11, 2022, a collective legal action was launched by 1261 patients who suffer from sleep apnea against the Philips group, to expedite the recall process for defective sleep apnea devices.

Two procedures will thus be launched: one in civil proceedings to obtain a compensation for moral damage for anxiety, and the other criminally for endangering the lives of others and administering harmful substances, for patients with a disease that can be attributed to the inhalation of polyurethanes or the use of a defective continuous positive pressure device.

But other patients could soon join them because registrations for this collective action have been reopened until June 30, on the MyLeo platform, around lawyer Christophe Léguevaques, lawyer at the Paris bar and specialist in collective actions (c it was he who notably obtained the judgment of Merck in the Levothyrox case).

Is there a risk of cancer or not?

In order to assess the potential risks, including the potential risk of cancer, linked to the use of these machines and to change the actions to be taken if necessary, the ANSM will soon to convene a committee of experts, made up of health professionals, scientists and patient associations. “At the same time, we are evaluating the possibility of launching an independent epidemiological study based on data collected by home health providers and those of the National Health Data System (SNDS).

For its part, France Assos health also requests that all studies be carried out now “to finally objectify the risk of cancer potentially induced by exposure to defective equipment”.

Remember that this is the testimony of a 44-year-old man, who uses one of these devices every night to treat his sleep apnea and who, when he came to consult for a persistent cough, learned that he was suffering from lymphoma, a cancer of the lymph nodes, which ended up alerting public opinion to the lack of safety of the Philips brand continuous positive pressure devices. “I learned by chance that there was a recall campaign for my device and I have not received any letter or communication from Philips. I would like to know why I was not contacted, of course, I would like to know if the machine is the cause of my cancer“, he had declared on the antenna of RMC.

As this 44-year-old patient points out, like the other patients concerned, who created a Facebook page to alert them to this problem, they received no emails, messages or calls from their pulmonologist, Philips or the service provider. , while Philips “recommends discontinuation of use of the device in view of the identified risks described in the notification” and specifies that it is “important to consult the doctor to determine the most appropriate options for continuing treatment” .

Which CPAP devices are affected by the recall?

In France, this recall involves the following continuous positive airway pressure devices:

  • REMstar Pro, Auto, Expert (DreamStation, PR1 / SystemOne, Q-series)
  • BiPAP Auto
  • DreamStation Go

The recall affects devices manufactured between November 2009 and April 2021.

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