FDA Accuses Philips of 561 Sleep Apnea Related Deaths

(IntegrityPress.org) – The US Food and Drug Administration (FDA) has commented on the recall of Philips sleep apnea machines. They have revealed that their machines may have been responsible for nearly 600 deaths.

In a statement, the FDA said it received more than 115,000 reports since April 2021 concerning these respiratory devices and their effects on people’s health. The machines, designed for sleep apnea and related disorders, were made with polyester-based polyurethane foam. Over time, this foam has been found to degrade, posing serious health risks, including choking, inhalation of foreign particles, and a risk of cancer because of the toxins.

The FDA notice highlighted that as the foam breaks down with use, it can result in users inhaling or swallowing entire pieces of foam, inhaling fumes, and more. Philips, the manufacturer, attempted to address this issue after an initial recall of over 5 million devices in 2021. As a response, Philips has stopped selling these devices and similar ones in the US, and an ongoing class action settlement is in progress. In an official statement, a Philips spokesperson claimed that there is no legitimate evidence linking the devices to reported deaths. They clarified that the submission of a Medical Device Report (MDR) itself doesn’t mean that the claimed cause is actually what caused injury or death, and the company thoroughly investigates all complaints and allegations.

Philips reached an agreement with the FDA and US Department of Justice, committing to stop the sale of the affected products in the US. A proposed class-action settlement is in place, where Philips is set to pay a minimum of $440 million in compensation to users who purchased the recalled devices between 2008 and 2021. Eligible users can submit claims through the settlement website, and this action doesn’t preclude them from pursuing further legal remedies in the future.

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