Philips announced on Monday that it will stop selling its sleep apnea machines in the United States, more than two years after it started recalling the breathing devices due to potential health risks. The decision comes as Philips agreed to a consent decree with the Food and Drug Administration (FDA) and the Department of Justice that could cost the company $400 million.
In 2021, Philips' CPAP machines, designed to treat sleep disorders, were found to be releasing gas and foam into users' airways as they slept, posing an elevated risk of tumors, which elevated the chances of having cancer. This revelation prompted the company to recall over 5 million machines.
Philps Finally Takes a Backstep
In June 2021, Philips issued a recall for specific breathing devices manufactured between 2009 and April 26, 2021, as well as certain ventilators distributed from April 15, 2021, to May 24, 2021.
"The polyester-based polyurethane foam used in these devices to reduce sound and vibration can break down," the FDA wrote on its recall page.
"If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device," the notice continued.
However, efforts to address and replace the affected machines have been prolonged, extending over several years.
The FDA indicated that inhaling or swallowing particles from the foam in the affected Philips breathing devices could lead to various health issues. These included irritation to the skin, eyes, nose, and respiratory tract, as well as symptoms such as headaches, asthma, and potential toxicity to the kidneys and liver.
Inhaling chemicals released into the air tubes of the affected devices from the foam could potentially result in various health issues. These may include headaches, dizziness, irritation, allergic or immune system reactions, nausea, vomiting, and concerns related to cancer.
Total Recall
As a result of actions taken by the FDA and the Justice Department, Philips has been compelled to suspend all new sales until they effectively address the issues associated with the old, potentially faulty devices.
In its 2023 performance statement released on Monday, Philips said that it allocated approximately $393 million for "remediation activities, inventory write-downs, and onerous contract provisions."
Philips CEO Roy Jakobs reassured analysts and investors that the company is committed to prioritizing "safety and quality at the center of everything we do with a greater level of accountability."
The FDA told media outlets that it is unable to provide comments on Philips' announcement until a final agreement is "signed and filed with the court."
The majority of the 5 million recalled devices are CPAP machines, which work to keep airways open by delivering a continuous air pressure through a mask.
Philips currently faces 675 personal injury lawsuits related to the recalled devices, with customers reporting difficulties in obtaining refunds or receiving new or refurbished machines on time.
Around 30 million Americans are estimated to have sleep apnea, a condition marked by pauses in breathing or choking for air during sleep. However, only about 6 million have received a formal diagnosis, and around 5 million Americans have, at the very least, attempted to use a CPAP (Continuous Positive Airway Pressure) device.
