Philips delays recovering faulty respirators, authorities react

Some breathing apparatus Philips have for some time been accused of causing cancers in their users. French health authorities are now putting pressure on the industrial giant to speed up the replacement of the devices.

Some 370,000 defective breathing apparatus in France (1.5 million in Europe) are likely to cause health problems in their users. In the summer of 2021, Philips announced a large recall of these devices, mainly used against sleep apnea. At issue is a sound-absorbing foam, the particles of which escape and can be inhaled by patients.

Is Philips liable to criminal prosecution?

The immediate risk is irritation causing coughing and headaches in users. But Philips had also mentioned a theoretical risk of cancer in the longer term. The group had therefore promised to replace all the devices. But several months later, only 7% of the defective devices were recovered by the company.

“Philips is not respecting its commitments,” Caroline Semaille, deputy director of the National Security Agency, said on Tuesday. drug (ANSM), which considers that the situation is “no longer acceptable”. The authority now wants to use the strong way and will, in the coming days, initiate a “sanitary police decision” in this matter.

In concrete terms, Philips will face criminal prosecution if it does not comply with the schedule imposed by the ANSM. This requires that the group has replaced three quarters of the devices by the end of June and asks it to launch a study to accurately assess the risks, especially those of cancer.

A cancer risk to assess

The risk of cancer is indeed only theoretical at the moment but it puts the health authorities in a delicate position. On the one hand, they are encouraged to act quickly in the face of the concern of the associations of patients, some media outlets having recently relayed isolated testimonials about patients who have developed cancers.

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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 could be much more harmful than the hypothetical risks of cancer. While showing its firmness towards the group, the ANSM therefore wants to be reassuring and encourages patients not to get rid of the devices.

The data currently available are rather reassuring about the risk of cancer. In particular, the ANSM cites a Canadian study that does not show an “over-risk”, according to Caroline Semaille. However, the authority wishes to have its own elements and will launch a study in France and establish a committee of experts to evaluate the file.

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