“An important step.” Involved for possible health hazards, Philips respirators can return to the French market. Health authorities announced this on Tuesday, February 18, ensuring that no risk has been demonstrated, but some patients are concerned about a premature decision.
“Philips can start equipping with new patients (CAR), sufficient guarantees have been obtained,” he summarized with AFP Thierry Thomas, responsible for medical devices at the National Medicine Safety Agency (ANSM).
The case of the defective respirators of Philips has lasted several years. The Dutch giant had announced in 2021 that some of these devices, specially used in sleep apnea, gave rise to particles that probably cause multiple health problems, of which cancers potentially.
Philips then returned to these statements, finally informing that patients were not exposed to any dangerous substance.
Replaced devices
But several countries, including France, have demanded the replacement of defective devices, used by about 350,000 patients in the country and 1.5 million throughout Europe.
It is already done. The group, which has been very long in the replacement of the aircraft in question, finally reached the end of this task in France. Consequently, the ANSM authorizes him to take the sale of new devices, interrupted for almost three years.
Questioned by AFP, the group praised “an important step”, reiterating its claims that the studies carried out by him had finally demonstrated “without risk (…) for long -term health.”
The French decision is, in fact, good news for Philips, which is better known for its appliances, but has resolutely became the medical world with the repurchase of the A breathest group in the 2000s.
After having suffered a lot in the stock market in the case of support, the Dutch company has already reassured investors in the spring of 2024 upon reaching the United States to a friendly financial agreement with patients.
“The risk is not proven”
But their respirators are currently prohibited for sale in the US market, when they can return to France, which does not present any health risk according to the medication agency.
“The risk is not tested, the risk is not compatible, the risk is not confirmed,” Thierry Thomas insisted. He recalled in particular that the Ansm scientific committee analyzed the data provided by Philips to conclude that it is the absence of a carcinogenic substance.
The drug agency has always been cautious in its communication around philips respirators, for fear that patients suddenly stop using their support, without talking to their doctor, while the risks linked to sleep apnea are , well tested.
But this position barely convinces patient associations. Some fear that health authorities give Philips too fast a white verification by allowing him to return to the French market.
“Pandora Box”
“The ANSM reopens a pandora box: scientifically, it is not over, not everything is closed,” said AFP Christian Trouchot, a member of the French federation of respiratory insufficient (FFAIR).
It has been significantly surprised that the agency allows the return of Philips respirators, but at the same time it requires that the group communicates with it the results of a study in progress to determine if, in real life, the use of devices is associated With a more a great risk of cancer. However, this study, conducted in the United States, will only be completed in 2025.
“Suppose the analyzes are extremely negative for Philips: we will have sold this material for months,” said Christian Trouchot, who, more widely, lamented the silence of the Ministry of Health and accused the ANSM of “softness” since he seized it. Archive in 2022.
In his eyes, the Italian authorities, for example, were faster to go to court when Philips could not replace his respirators in time. The drug agency has presented for its part that it was the only European authority to make a decision of the “health police”, that is, a measure that has legal value, to put Philips before its obligations.
“Ansm’s action was to maintain maximum pressure on Philips with monthly monitoring,” said Thierry Thomas.
Source: BFM TV
