Many users of a Philips breathing machine remain without a solution, eight months after it was recalled over fears of patients inhaling cancer-causing chemicals through a foam sound filter.
Left untreated, sleep apnea can put people at risk of hypertension, heart failure, increased risk of heart attack and stroke as well as a lower quality of life.
People feel tired and, in the worst cases, can fall asleep during the day causing accidents and injuries.
The local agent said it has supplied Malta’s 1,000 machine users with additional filters to use over the faulty existing ones, collected some machines, and was now waiting for Philips to supply loaner units to be able to replace customers’ machines.
In June last year, the company issued a voluntary recall on the Philips Respironics in the United States, a machine used by people with sleep apnea, a disorder that can cause breathing to stop repeatedly during sleep. The machine works by pushing air into the lungs.
Philips said it was concerned that users could be inhaling cancer-causing chemicals through a type of foam embedded in the machines.
Back then, George Bonello, chief executive of Sidroc, the local agent for Philips, explained that the company was in the process of contacting all 1,000 patients on their database who used the machines.
He said they were providing clients with a temporary filter for free to ensure foam particles never reach the patient.
Meanwhile, the company provided Philips with all the serial numbers of the machines and was waiting to hear from them on a way forward.
Philips had said it would either provide clients with new foam filters or they will replace the machines entirely within a year.
However, one man who has been using the machine since 2019 – after being diagnosed with sleep apnea – said the additional filter supplied by the local supplier made it more difficult to breathe with the machine.
“Using the machine has had a positive impact on my life, increasing alertness and energy levels,” he said.
“When the news broke [about the recall], I was left with Hobson’s choice and opted to continue using the machine with the filter because I need it to function well... I was optimistic that the issue would be resolved within a month or two.
“However, this period has now stretched for months with no communication at all from the agent. I have had enough,” he added.
Now, the man wants to buy an alternative brand machine and is calling for the local agent to issue refunds.
Bonello said the company already started collecting some machines from those who had more than one unit.
“As a distributor, I am still waiting from Philips to send us loaner units as now all the machines have to be sent back for either replacement or upgrading,” he said.
“This decision is to be taken by Philips themselves. As soon as we receive loaner units, we will send for more clients to collect their machine.”
Bonello said the company is not issuing refunds as it is “following what is being done in Europe by Philips”.
It is entirely up to them for any reimbursement. The machines are entirely fine in delivering the treatment, he noted.
“The problem is that the sound-proofing foam started creating problems, especially for those who use ozone as a cleaning method for the machine.
“This is like buying a car and then one finds there is a manufacturing defect with the silencer. It does not mean the car is faulty but that the silencer needs to be changed or upgraded according to the manufacturer’s instructions.”