Aaron Horton, a sleep apnea sufferer, stops breathing for brief periods hundreds of times every night. To keep his oxygen levels up, he uses a device made by Royal Philips NV that is now subject to a huge recall by the Dutch healthcare conglomerate. It warned in June that the machines could be sending potentially cancer-causing particles into users’ airways.
When Mr. Horton, a 30-year-old paramedic from Glen Allen, Va., called his medical-device supplier for an alternative, he was told none was available. For now, he is continuing to use the Philips machine.
“Every night, I feel like I’m having to pick between cancerous inhalants and my oxygen saturation dropping,” he said.
He is one of roughly two million people across the U.S. affected by the recall. Philips has said an internal sound-dampening foam could release potentially harmful gases or particles. Philips has promised to repair or replace affected machines, but says it will take around a year to do so.
Aaron Horton’s CPAP machine at his home in Virginia.
Since the recall was announced, doctors have been inundated with calls from worried patients. Prices for machines made by Philips’ main competitor, ResMed Inc., have shot up and the devices are becoming more difficult to get. Some patients, feeling ping-ponged between Philips, medical-device suppliers, doctors and insurers, are taking matters into their own hands, either by removing the foam themselves or bypassing insurance to buy new or used machines out of pocket.
The recall affects mainly devices known as CPAP and BiPaP machines, which gently push air into the lungs and are primarily used to treat sleep apnea. Without treatment, sleep apnea sufferers can go on to develop serious long-term conditions such as high blood pressure, stroke, diabetes and heart problems. Untreated sleep apnea is also a major cause of road traffic accidents, due to sleep deprivation, according to a 2018 study in BMC Medicine. Nearly 24 million people in the U.S. suffer from moderate or severe sleep apnea, according to a 2019 study in The Lancet Respiratory Medicine, although most are undiagnosed.
The Food and Drug Administration has given the recall its most serious classification, meaning there is a reasonable probability that using the device could lead to serious health issues.
In many cases, though, the risks of withdrawing treatment likely outweigh those posed by the device itself, according to Asha Singh, director of sleep medicine at the Oregon Health & Science University. She is trying to obtain alternative devices for patients affected by the recall. But in cases where she can’t, she is generally advising patients to continue using their machine.
“The patients are on it for a reason,” Dr. Singh said. “I’m really worried about patients with serious cardiovascular issues stopping their machines.” OHSU has hired around eight new nurses to staff a 24-hour hotline to field the deluge of calls about the recall.
Dennis Burger bought a used machine made by ResMed as an alternative to the Philips device.
PHOTO: DENNIS BURGEROne challenge for doctors is that Philips hasn’t supplied much detail about the complaints that led to the recall, which makes it difficult to assess the risks of continued use. In its recall notice, Philips said the number of complaints was small compared with the total number of devices sold, around 0.03% in 2020, and that no deaths had been reported.
Chief Executive Frans van Houten on a recent call with investors said the recall assumed a “worst case scenario,” and that Philips was conducting tests to ascertain the level of risk posed by affected machines.
A Philips spokesman said the company was committed to addressing the issue as quickly as possible, and that it regretted the inconveniences the issue has caused.
“We still don’t have any information on exactly what the risk and symptoms are,” said Raman Malhotra, president of the American Academy of Sleep Medicine. Dr. Malhotra, who treats patients at Washington University School of Medicine in St. Louis, is fielding dozens of calls a day from concerned patients.
Dennis Burger, a 49-year-old freelance technology journalist and editor who lives in Montgomery, Ala., spent a month trying to get a new device. He said his doctor, his insurer, Philips and his medical-device supplier all pointed him to one of the others for help.
“Stopping [treatment] was not an option for me,” he said. “I was stuck between this proverbial rock and hard place and not sure where to go.” He resorted to buying a used ResMed machine for around $300 because the prices for new machines had doubled to around $1,000.
ResMed doesn’t sell its devices directly to patients but through intermediaries known as durable medical equipment suppliers, or DMEs. The cost is usually covered by insurance, but patients can also pay out of pocket as long as they have a prescription.
Michael Nover removed the internal foam from his recalled device until he was able to get a new alternate machine through his insurance.
PHOTO: MIRANDA NOVERA ResMed spokesman said the company hadn’t increased its average selling prices to retailers. Johnny Goodman, president and chief executive of online supplier CPAP.com, where the price for a popular ResMed model has risen from $598 to $974.99 since the recall, declined to comment. Several other suppliers have made similar price increases.
Philips’ sleep division has devoted its entire manufacturing capacity to making replacement machines for customers affected by the recall and is taking no new orders.
ResMed Chief Executive Mick Farrell said on a recent investor call that the rise in demand following the Philips recall was so high that the company has started to give priority to patients with the greatest need. He added that the company plans to ramp up its production capacity, but that global electronic component shortages will constrain those efforts.
Brett Young, 49, opted to keep using his Philips machine because buying a new one would be too expensive. Mr. Young, an IT administrator from Washington, D.C., also figured that since he hadn’t experienced any symptoms, his machine probably wasn’t harming him. “I’m not frightened enough to buy a new one,” he said.
Michael Nover of Spokane, Wash., resorted to a YouTube video showing how to remove the foam from certain machines affected by the recall. The 64-year-old used the de-foamed machine for a few weeks until he was able to get a new device from ResMed through his insurance.
‘Every night, I feel like I’m having to pick between cancerous inhalants and my oxygen saturation dropping,’ Aaron Horton said.
If you've been affected by this recall and would like input on your individual situation, give us a call at 201-499-7361. Our medical experts can discuss your specific situation and support you in finding answers.
Article pubished 8/15/21 in the Wall Street Journal By Denise Roland, Photographs by Julia Rendleman for the Wall Street Journal
