Continuous Positive Airway Pressure (CPAP) therapy is the standard medical treatment for obstructive sleep apnea, a disorder where breathing repeatedly stops and starts during sleep. The machine gently pressurizes air delivered through a mask, keeping the airway open to ensure continuous breathing and prevent serious long-term health issues associated with untreated sleep apnea. However, a significant public health concern has emerged regarding whether the materials within some of these life-sustaining devices could introduce a cancer risk. This anxiety stems from specific material degradation issues that have prompted users to question the safety of their nightly therapy.
The Origin of the CPAP Safety Question
The widespread public concern about CPAP machine safety stemmed from a major manufacturer’s recall, not traditional epidemiological studies. In June 2021, Philips Respironics initiated a voluntary recall for millions of its sleep and respiratory care devices, including CPAP and BiPAP machines. This was due to the degradation of the polyester-based polyurethane (PE-PUR) foam used for sound abatement within the devices. Degradation could cause users to inhale or swallow foam particles and chemical gases, bringing material safety into the public spotlight.
The recall was classified by the U.S. Food and Drug Administration (FDA) as a Class I event, the most serious type, signifying potential for serious injury or death. The announcement led to a dramatic spike in adverse event reports to the FDA’s database, including reports of cancer associated with CPAP use. This influx created a perceived association between CPAP use and malignancy, even though most adverse event reports involved device problems without an associated injury.
Current Scientific Consensus on Direct Cancer Risk
Epidemiological studies investigate whether CPAP use increases the systemic risk of developing cancer. Research comparing cancer incidence in CPAP users versus non-users with sleep apnea shows no evidence of a direct, causal link between the therapy and an elevated risk of cancer overall. Meta-analyses involving tens of thousands of participants suggest that CPAP therapy does not increase the risk of a new cancer diagnosis.
It is important to distinguish between correlation and causation when reviewing reports of cancer linked to specific CPAP models. The dramatic rise in reported cancer cases following the 2021 recall is likely a “bandwagon effect,” where greater public awareness leads to increased reporting of pre-existing or unrelated conditions. The FDA’s adverse event reporting system documents all reported issues, but these reports do not prove that the device caused the condition. Untreated obstructive sleep apnea itself has been linked to an increased risk of cancer due to factors like intermittent low oxygen levels (hypoxia) and inflammation.
Material Safety and Volatile Organic Compound Concerns
The core cancer concern relates to the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP models. Over time, especially when exposed to heat, humidity, or unapproved cleaning methods like ozone, this foam can break down.
When the PE-PUR foam degrades, it releases black foam particles and invisible chemical gases, known as volatile organic compounds (VOCs), directly into the device’s air pathway. Users can then inhale or swallow these particles and compounds while they sleep. Some VOCs released from the degrading foam are known or suspected carcinogens. Exposure to these compounds is also associated with respiratory tract irritation, headaches, and other organ damage.
The health risk is specific to the inhalation of these toxic substances from the degrading material, rather than a general effect of the CPAP therapy itself. The FDA has acknowledged that the recalled devices are capable of causing permanent injury and serious illnesses. The severity of long-term health consequences depends on factors like the extent of foam degradation and the duration of device use.
Official Regulatory Guidance and User Actions
In response to the material safety concerns, the FDA issued a Class I recall for affected devices manufactured by Philips Respironics. The FDA recommends that patients who used these recalled machines consult with their health care provider. A medical professional can help determine if the benefits of continuing therapy outweigh the risks, or if alternative treatments for sleep apnea should be pursued.
Users should immediately check their device model against the official recall list provided by the manufacturer or regulatory bodies. Follow only the cleaning instructions provided by the CPAP manufacturer, typically involving mild soap and water. The FDA specifically warned against using ozone gas or ultraviolet (UV) light products, as these methods can worsen foam degradation and increase the release of harmful compounds. The FDA has also flagged concerns about the new silicone foam used in some replacement models, which may release other chemicals of concern, requiring ongoing vigilance.