The Food and Drug Administration (FDA) recently delivered more bad news to patients already affected by a major recall concerning particular Philips Respironics sleep apnea treatment devices, specifically CPAP (continuous positive airway pressure) and BiPAP (bi-level positive airway pressure) machines and ventilators.
The machines were recalled due to a polyester-based polyurethane (PE-PUR) foam component found to be toxic enough to cause cancer and other serious illness if inhaled or ingested by users. Philips began sending out repaired/replaced machines to hundreds of thousands of customers. Then the FDA discovered during an inspection that the silicone-based replacement foam might also be dangerous. The agency’s latest statement says they’re awaiting further safety testing by the manufacturer.
“At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.,” said the statement.
The foam is used for sound and vibration abatement while the machines are in use by sleep apnea patients.
The ordeal for patients, who rely on the machines to treat symptoms and improve their quality of life, began about five months ago when the FDA issued a Class 1 recall, the most serious type. It was discovered that the PE-PUR foam could break down into pieces that can be swallowed by users while also releasing toxic fumes into their airways.
Phillips developed an FDA-approved plan to repair or replace all affected machines within a year in response to the recall. On September 1, they started by sending out about a third of 750,000 “new” machines.
However, the FDA is now concerned the replacement could be just as dangerous.
The new issue came to the FDA’s attention when agency inspectors visited a manufacturing facility in Murrysville, Pennsylvania. There they learned that a similar device using the same silicone-based foam, sold outside of the U.S., failed a safety test because of “…the release of certain chemicals of concern, called volatile organic compounds.”
Because of the revelation, the FDA promptly requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.
How the CPAP Recall Affects Those with Sleep Apnea
Sleep apnea patients have irregular breathing while sleeping, with some patients stopping and starting breathing each night. If sleep apnea is not treated, other health challenges can develop, including high blood pressure, heart problems, Type 2 Diabetes, and complications with surgery and medication.
The Philips CPAP recall, which affected an estimated 3-4 million devices, overwhelmed doctors, distributors, and of course, patients themselves who were forced to choose between several risky decisions. They could purchase a costly new machine out of pocket from a limited marketplace, continue to use their current machine and accept the risks, or stop using it altogether and return to sleepless nights.
As always, the FDA stressed that patients should consult their physician to determine what course of action is best for them before making a decision.
“Currently the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. The FDA has reached this determination based on an overall benefit-risk assessment,’’ the statement said. “At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient’s health and quality of life.”
Related: Philips Respironics CPAP Recall