FDA Raises Questions about Safety of Philips CPAP Repairs

In September, Philips announced a repair and replace program for CPAP machines and other devices included in the June 2021 recall. The devices were recalled over concerns that foam material used to reduce sound and vibrations could break down and enter the airway tube. Particles inhaled or swallowed are believed to cause a variety of serious health conditions. As of December 15, there are 137 lawsuits against Philips pending in multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania. 

The federal Food & Drug Administration (FDA) initially approved the substitution of a different material for the problematic foam, and the repair program was well underway. As of mid-October, the company said 750,000 repair kits and replacement units had been manufactured, and about 250,000 had already been distributed to consumers. Then, on November 12, the FDA issued an update raising questions about the silicone-based material being substituted for the original foam.

FDA is Uncertain Whether the Replacement Materials are Safe

Testing conducted by Philips had indicated that the silicone-based replacement material was a safe alternative. But, the FDA subsequently received information about an issue that had been identified during testing of the same material in another context. A device using the same material failed a safety test due to the release of “volatile organic compounds,” or “VOCs.” 

Based on that information, the FDA directed Philips to arrange for independent testing to determine the safety of the replacement material. Pending verification, the FDA says it doesn’t have sufficient information to tell the public whether or not the replacement devices or those that have been repaired with the silicone-based material are safe to use. 

This presents a problem, since many people who use the affected devices, including CPAP and BiPAP machines and ventilators, are dependent on those devices to address serious medical conditions. For some, the risk of discontinuing use may be greater than the risk of continuing to use the devices, despite the possible risk of chemical exposure.

What Should CPAP Users With Repaired or Replacement Devices Do Now?

The FDA isn’t currently recommending that users who have received replacement devices or had devices repaired with the silicone-based material discontinue use. In its announcement of the issue, the agency 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.” 

If you are using one of these repaired or replacement devices or are a caretaker for someone using such a device, it is important to monitor FDA updates for additional information. When independent testing results or other new information is available, these recommendations may change. 

If you’re still using an old CPAP machine or other device that was part of the recall, the FDA urges you to talk with your healthcare provider to determine what the best course of action is. This may involve continuing use in the short term, seeking out an alternative device that has not been identified as potentially dangerous, temporarily discontinuing use, or trying alternative treatments. There are risks associated with both continued use and discontinuing use, so you shouldn’t make this decision without talking to your doctor.

Did a Defective CPAP or Similar Device Make You Sick?

If you’ve used one of the recalled Philips Respironics CPAP machines or related products and are suffering from one of the many serious medical conditions alleged to be connected with the breakdown of the foam material, your next step should be to speak with a CPAP litigation attorney.

To learn more about whether you may be entitled to compensation, what types of compensation may be available, and what you can do now to protect your claim, just fill out the contact form on this site. We’ll put you in touch with an attorney handling CPAP lawsuits in your area. 

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