(DailyDig.com) – On January 31, the Food and Drug Administration announced that 561 individuals lost their lives as a result of using CPAP machines, which were recalled by Philips due to their use in treating breathing disorders such as “obstructive sleep apnea.”
According to the Cleveland Clinic, sleep apnea is a condition in which a person stops breathing while sleeping. In an effort to keep the individual breathing, their brain wakes them to breathe, but it interrupts their natural cycle of sleep. To treat people with this problem, they use CPAP (continuous positive airway pressure) and BiPap equipment at night.
The Food and Drug Administration announced on January 31 that over 116,000 complaints of foam falling apart in Philips CPAP and BiPAP sleep treatment equipment have been received since April 2021. Among these reports were the previously mentioned 561 deaths.
After allegations surfaced that the CPAP and BiPAP machines were releasing particles of foam and gas into the patient’s airways, Philips recalled millions of the devices.
The vibration-reduction and sound polyurethane foam in the devices may decompose into invisible substances or black fragments of foam that the user may breathe in or consume. The Food and Drug Administration has warned that these problems pose a significant risk of harm to patients, and they may need medical attention to mitigate any long-term effects.
The devastating death toll was announced in a regulatory filing, only days after Philips announced a deal with the Justice Department and Food and Drug Administration that it would discontinue sales of the equipment in the United States. Experts estimated that the settlement would cost approximately $400 million.
Philips has agreed to continue repairing existing apnea devices but will not sell any new ones unless certain requirements are satisfied. This deal must be U.S. court-approved.
In the wake of the U.S. Department of Justice’s investigation into Philips’ handling of their recall, the company is facing lawsuits filed by consumers who claim the devices have negatively impacted their health.
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