Over the summer, Royal Philips NV sparked a scramble among sleep apnea patients when it recalled millions of machines many use to breathe at night, fearing the foam in the devices could pose a health risk.
Another curveball was thrown at users last week when the Food and Drug Administration warned that the replacement machines the Dutch healthcare giant has been rolling out since September could also be harmful. The FDA has not ordered a recall of around 250,000 replacement devices that Philips has sent to users, but said it was concerned that a silicone-based foam used in the replacement devices could release harmful gases. This has raised new questions among users about what to do.
“It’s disappointing and frustrating,” said Paula Martin of Laramie, Wyo., Who received her new device in October. “I feel like you can give me something that is safe and I should be reassured that it is safe.”
Critics blame Philips for the lack of communication about the problems with the old devices and now the new ones. As the summer progressed, users began looking for alternative devices that suddenly ran short. Doctors and so-called long-life medical device providers, or DMEs, which act essentially like pharmacies for many doctor-prescribed devices, had no answers.
Philips takes the matter seriously and is fully cooperating with the FDA.
The recall wasn’t limited to the US and left millions of users across Europe and elsewhere in the dark about what to do as well. The company recalled up to 4 million devices in June, about half of which were in the United States. The foam is made from a material called polyester-based polyurethane, or PE-PUR, which Philips says can break down and be breathed in by the user. It can also release harmful gases which, along with the particles, could be carcinogenic, according to the recall notice.
Most of the devices affected by the recall are so-called CPAP and BiPAP devices that regulate breathing by gently pushing air into the lungs through a mask. They are mainly used to treat sleep apnea, a condition that causes people to stop breathing for a short time while they sleep. The recall also affects some ventilators.
Philips promised to repair or replace affected devices but didn’t begin until September after the FDA approved their revision plan. It expects to repair or replace all affected machines within a year. Some users have turned to Philips’ main competitor ResMed. agile Inc.
Others bought old machines second-hand or tore out the foam themselves.
The latest FDA concern, made public on Friday, came during a recent inspection of the Murrysville, Pennsylvania facility where Philips manufactures its CPAP and BiPAP devices. The inspectors found that a similar device, sold outside the US that also uses silicone-based foam, failed a safety test because it released potentially harmful gases.
The agency’s approval of the silicone foam for the Repair and Replace program was based on tests by Philips, which showed acceptable results. The FDA has asked Philips to contract an independent laboratory to conduct additional testing on devices using the silicone-based foam to identify potential safety risks.
The FDA said it will await the results of those tests to decide whether the silicone-based foam poses a risk to patients. Philips said it would continue to ship replacement units.
In the meantime, the FDA recommends that patients continue to use devices that contain the silicone-based foam as it would be more harmful to stop treatment altogether. Without treatment, sleep apnea sufferers can develop serious long-term conditions such as high blood pressure, stroke, diabetes, and heart problems. The lack of sleep associated with untreated sleep apnea has also been linked to road traffic accidents.
Ms. Martin, 50, said she had been using her original CPAP machine until the replacement machine was received and will continue to use the replacement machine. “I know what bad sleep and sleep apnea do with my life expectancy,” she said.
Melvyn Ball, 74, received his replacement device in October but found it emitted a strong odor that caused him headaches and nausea. He doesn’t know whether the smell is related to the silicone-based foam. For now, he has returned to his original CPAP machine with the PE-PUR foam. “I worry, I worry if this will make me sick, but I also have to deal with the fact that I need this to sleep at night,” said Ball, who lives in Merrimac, Massachusetts.
The FDA report contains detailed results suggesting that for years the company has taken inadequate action to respond to complaints about foam breakdown. Philips stock fell sharply on the Monday following the FDA’s Friday report.
Frans van Houten, Philips CEO, said in a statement that the company was in talks with the FDA about the findings of the report. According to FDA regulations, Philips has 15 business days from the reporting date, November 9th, to respond. “We remain fully committed to serving the community of patients who depend on the affected devices, as well as the clinicians and customers who are dedicated to meeting patient needs,” he added.
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