Sleep apnea: controversy after the return of Philips respirators in France
Tuesday, February 18, 2025, after three years of suspension, Philips obtained authorization to put his respirators on the French market. In question, a sanitary alert launched In 2022 on possible health risks. Back on a divided case.
A ban raised after three years
In 2022, the Dutch group Philips had itself reported a major problem: some of its devices intended for patients with sleep apnea could release potentially toxic particles. These devices, manufactured before April 26, 2021, were recalled due to a defect in soundproofing foam, likely to deteriorate and cause health complications, including cancers.
Faced with this situation, the National Medicines Safety Agency (ANSM) had made a radical decision: suspend their marketing and impose their replacement. The devices concerned by the reminder of Philips, in 2021, included several models intended for the treatment of sleep apnea:
- Continuous positive pressure apparatus (PPC):
- Remstar Pro, Auto, Expert (Dreamsation, PR1/Systemone, Q-Series)
- Auto Bipap
- GO DREAMSTATION
- Fanters with life support:
- Vanitors without life support:
- Bipap Autosv (Dreamsation, Advanced, PR1/Systemone, C-Series)
- Bipap S/T and Avaps (Dreamsation, PR1, C-SERIES)
- Omnilab Advanced+
- Bipap A30
- Bipap A40
- Soh bipap
Three years later, the company kept its commitments. In France, the 350,000 aircraft deemed at risk have been replaced. This observation led the ANSM to lift the suspension of sales, believing that Philips had fulfilled its obligations.
A return under conditions
If the resumption of sales is now acted, it is accompanied by strict surveillance. The ANSM demands that Philips provide it with the results of an in progress American study, aimed at assessing the long -term effects of exposure to particles issued by these respirators.
“” The risk is not proven, the risk is not supported, the risk is not confirmed “Insisted Thierry Thomas, head of medical devices at the ANSM. However, the debate remains open and some voices are raised against this decision.
On the side of patient associations, distrust persists. “” The ANSM reopens a Pandora's box while scientifically, everything is not decided “, Land on Christian Trouchot, representative of the French Federation of respiratory insufficiency (FFAIR). He also underlines that other countries, like Italy, adopt a more strict approach on the file, while 1.5 million copies were sold across Europe.
The results of the American study, expected for the end of 2025, will be decisive to close, or relaunch, this sensitive file.
