More than 21,000 reports of health problems and 124 of deaths. Since Philips announced a year ago that its sleep apnea devices can be dangerous for users, complaints have been pouring in. That appears from an update from the US health watchdog FDA.
Philips is in a global operation repairing or replacing millions of machines in 130 countries. These are sleep apnea devices that blow air into the lungs of users at night through a mask. A year ago, Philips reported that the sound-damping foam, made of plastic, appears to be crumbling from some devices. Logically, that can end up in the lungs of users. The company allocated 900 million euros for the recall, plus all legal costs from claims for damages.
Prior to the disclosure of this issue, Philips had received thirty complaints of health problems related to the sleep apnea devices. At the time, however, the company already had more than a thousand (the exact number is unclear) other reports of problems with the devices, such as foreign particles being seen in the mask.
The FDA now reports reports of cancer (sometimes fatal), pneumonia, asthma, difficulty breathing, headache, cough, chest pain and dizziness. The FDA points out that the reports – for example of deaths – do not have to mean that there is a connection with the machines.
It is not clear how many complainants are Dutch. The Dutch law firm SAP has held Philips liable, and five hundred people have now joined the procedure. Most of them also have health problems and are concerned, the office said.
A Philips spokesperson says it is “deeply sorry that patients are concerned”. The company has conducted its own research into the volatiles released from the controversial foam, which were found to be “very low and no long-term risks.” A company study into the risk of the foam’s floating particles will be released in June. Philips also refers to a Canadian study that found no increased risk of cancer in patients using a Philips sleep apnea device.
Also read this article: The uncertainty about the risks of Philips apnea devices will remain for users for a while
20 billion euros evaporated
Painfully, this isn’t the company’s only flimsy machine affair. Last year there were also three different problems with some of the ventilators sold. There are also problems with defibrillators: the patches with electrodes (for the chest during CPR) did not always stick well.
Shareholders are well fed up, it became apparent during the shareholders’ meeting earlier this month. Within a year, the share price had halved, in other words: more than 20 billion euros had evaporated. At the shareholders’ meeting, no less than 80 percent voted against the bonus policy for the top in an advisory vote. Philips will still pay the bonuses, as it turned out last week.