Medical device manufacturer Philips will halt all sales of its sleep apnea machines on the heels of a recall of more than five million devices in a potential agreement with regulators.
A pending settlement deal with federal regulators could cost the Dutch manufacturer more than $393 million to cover remediation measures and upgrades.
In 2021, the company’s CPAP machines, used to treat sleep apnea, were found to be blowing gas and foam into users’ airways as they slept, putting them at increased risk of cancer.
The discovery led to the company recalling more than 5million machines, but attempts to repair and replace affected machines has been dragging on for years.
Now, the company said it had agreed to a deal with the deal with the Food and Drug Administration and Justice Department, pending US court approval, which stipulates that the company will continue servicing existing machines but suspend new sales until specific conditions are met.
An estimated 30 million Americans have sleep apnea, a condition characterized by pauses in breathing or choking for air during sleep. But only about 6 million have gotten a diagnosis, while about 5 million Americans have at least tried using a CPAP device.
CPAP masks come in various styles and sizes to accommodate different preferences and facial structures. They consist of a motor that draws in room air and pressurizes it. The pressurized air is delivered through a hose to a mask worn over the nose, mouth, or both
Sleep apnea is often associated with snoring and sudden gasps for air, but continuous positive airway pressure, or CPAP, machines are an effective means to combat the condition that causes sufferers to briefly stop breathing multiple times per night.
The machine delivers a steady stream of mild air pressure through a tube connected to a snorkel-like mask to keep the airways from collapsing.
In addition to the costly recall, Philips is facing over 600 lawsuits over the devices that have all been consolidated in a federal court in Pennsylvania.
Philips Chief Executive Officer Roy Jakobs said: ‘Patient safety and quality remain Philips’ highest priority across the company.
‘Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.’
It’s a major setback for the company leading the sleep device field, which is estimated to grow from a value of $5 billion in 2021 to $7.2 billion in 2030.
The FDA, for its part, said: ‘Until there is a finalized agreement that has been signed and filed with the court, we cannot comment further.’
A 2021 recall saw Philips pull millions of their Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices for the same reason – foam used to dampen the sound of the machine can degrade and enter the airway, which carries a risk of cancer.
The foam particles can potentially induce irritation and inflammation in the respiratory system, which is especially threatening for individuals with pre-existing lung conditions or poor heart-lung function.
Exposure to deteriorated foam can also cause inflammatory responses, headaches, asthma, and adverse effects on other organs, such as the kidneys and liver, including ‘toxic carcinogenic effects.’
The foam in the recalled CPAP machines was made with polyester-based polyurethane which was found to degrade into smaller particles and toxic gases that would be inhaled by the user.
In addition to potentially causing asthma, respiratory infections, and organ damage, this foam is also linked to lung, bladder, kidney, breast, stomach, liver, thyroid, and blood cancers sych as leukemia and Non-Hodgkin lymphoma.
Philips Respironics has documented numerous complaints related to the discovery of black debris or particles in the part of the machine that feeds air into the sleeping person.
There have also been reports of various symptoms like headaches, upper airway irritation, cough, chest pressure, and sinus infections.
Philips is currently facing more than 700 suits over claims that its products caused users to develop cancers and other health problems. One of those suits comes from Kansas-native Robert Dix who filed suit against Philips in April 2022.
Mr Dix was prescribed and purchased a Philips CPAP machine in March 2016 but later suffered injuries ‘including harm to his respiratory system, cellular damage, DNA damage, and lung cancer.’
Philips said it has been conducting testing on its CPAP machines since the 2021 recall and that using the devices ‘is not expected to result in appreciable harm to health in patients.’
Last fall, Philips reached a $479 million partial settlement in a class action suit over design flaws that caused carcinogenic foam specks to make their way into the user’s airways.
Sleep apnea becomes more common with advancing age, and more men experience it than women.
It occurs in about 3 percent of normal-weight individuals but affects more than 20 percent of obese people.
Sufferers snore, choke, and gasp 20 to 30 times every hour throughout the night and, as a result, unknowingly and repeatedly wake up, which means the body does not get enough rest.
To test for sleep apnea, sleep experts will connect a person to equipment that monitors breathing patterns and blood oxygen levels while they sleep, commonly known as a sleep study.
When breathing stops for 10 seconds or more at a time, oxygen levels in the blood fall, increasing the risk of hypertension, stroke, and heart attacks later in life.
Robert Johnson is a UK-based business writer specializing in finance and entrepreneurship. With an eye for market trends and a keen interest in the corporate world, he offers readers valuable insights into business developments.
