Following a recall of the Philips company’s breathing machines in the early summer of 2021, the Food and Drug Administration reports that replacement CPAP devices that are now being shipped to users have the potential to be harmful, resulting in new CPAP replacements concerns.
When Philips recalled a large number of its breathing machines in June due to worries that foam utilized in Philips equipment could create health complications, a large number of people were left in the uncomfortable situation of figuring out how to respond.
Users were met with another challenge after the Food and Drug Administration claimed that replacement equipment produced by the company might also be harmful. The FDA has not issued a recall on 250,000 devices intended as replacement equipment that the company sent to its users but has expressed concern that the silicone-based foam placed in the equipment could give off hazardous gases. As a result, many users of Philips breathing machines have been left wondering what to do.
The Dangers Created by Philips’ Foam
The foam contained in Philips breathing machines is produced from polyester-based polyurethane that the Philips company reports can break down and be inhaled by a user. The foam can also give harmful gases which in addition to the particles might be carcinogenic.
Inadequate Communication by the Philips Company
Critics cite the Philips company for inadequate communication about the problem posed by the old devices as well as the new ones. Over the summer due to the recall and delay in receiving replacement products, users tried desperately to find alternate devices. Physicians as well as medical equipment providers that function like pharmacies for doctor-prescribed equipment did not have answers. The Philips company has stated that it takes the issue seriously and is fully complying with the FDA’s recommendations.
The Extent of the Philips Recall
This recall was not limited to the United States and instead resulted in millions of users throughout Europe as well as elsewhere in the world uncertain about how to respond.
Many of the devices impacted by the recall are BiPAP and CPAP machines, which are devices that regulate breathing by gently pushing air into the user’s lungs through a mask. These devices are primarily used to treat sleep apnea, which is a medical impairment that results in users experiencing stopped breathing for brief periods while asleep. Recall can also impact ventilators.
The Philips’ Company and Recall Efforts
The Philips company promised to either replace or repair impacted devices but only began doing so in September 2021 once the FDA had approved its rework plan. Philips expects to either repair or replace all impacted machines within a year. Some users have begun to use devices manufactured by ResMed Incorporated, which is a major competitor of Philips. Other users of Philips equipment purchased old machines secondhand or ripped the foam out on their own.
Concerns Following Murrysville Plant Inspection
The FDA’s most recent focus arose during an inspection of the company’s Murrysville, Pennsylvania operation where the Philips company produces its own BiPAP and CPAP machines. Inspectors found that a similar device sold outside the United States that also uses silicone-based foam failed a safety test because the product releases potentially hazardous gases.
The agency’s approval of silicone-based foam was based on testing provided by Philips revealing acceptable results. The FDA requested Philips retain an independent laboratory to perform further tests on devices that utilize silicone-based foam to identify safety risks.
The FDA states that it will await the results of testing to assess whether silicone-based foam presents any hazard to its users. Philips has stated that the company will continue sending replacement machines to users.
Interim Recommendations by the FDA
In the interim, the FDA recommends that patients continue using devices containing silicone-based foam because it would be more hazardous to discontinue treatment entirely. Without treatment, people afflicted with sleep apnea can end up developing serious long-term consequences including high blood pressure, diabetes, heart problems, and stroke. Sleep deprivation connected with untreated sleep apnea has been connected to major traffic accidents.
One woman states that she used her original CPAP machine until she received a replacement device and will continue using the replacement device. Another man received his replacement device but discovered a strong odor that gave him a headache and nausea. The man is not sure if the smell is connected to the silicone-based foam, but he has temporarily resorted to using his original CPAP machine.
The FDA’s report’s findings suggest that the company took inadequate action for years in response to complaints connected to foam degradation. Shares in the Philips company have dropped substantially following the publication of the FDA report.
What’s Next for Philips?
The Chief Executive of Philips also issued a statement revealing that the company is in discussions with the FDA concerning findings in the report. Under FDA rules, the Philips company has 15 working days from the report date to respond.
How to Respond if Your Breathing Device Has Been Recalled
The FDA recommends that people who use recalled Philips CPAP machines speak with their medical provider if they discover they have been impacted by the recall.
Currently, the FDA does not recommend people who have received a repaired device from Philips stop using their machine.
After weighing the available options, your medical provider might decide to discontinue CPAP treatment, recommend a CPAP device that is not subject to recall, try other available treatments like oral appliances or positional therapy, suggest lifestyle therapies like discontinuing smoking, or even suggest that you continue using the device if the benefit outweighs the risks.
If you have been negatively impacted by a recalled Philips device, you might end up deciding to pursue a lawsuit to receive compensation for the resulting damage. You should remember, however, that a statute of limitations applies and that a time limit exists in which to pursue compensation.
Contact an Experienced Defective Product Attorney
If you or a loved one has been harmed after the use of Philips’ defective breathing machines, it is important to remember that you have the right to pursue compensation. Contact the Law Office of Cohen & Jaffe LLP today to schedule a free case evaluation.
For a free legal consultation, call 516-358-6900