In a major development, medical device giant Philips has agreed to a consent decree with the Justice Department over its faulty sleep apnea machines and ventilators. This comes nearly three years after the company acknowledged that an industrial foam used in its devices could degrade, releasing toxic particles and fumes into the masks worn by patients.

An investigation conducted by ProPublica and the Pittsburgh Post-Gazette last year revealed that Philips had withheld thousands of complaints about the foam for over a decade before issuing a warning to its customers. The foam posed a significant risk to medically vulnerable patients, including infants and the elderly.

Furthermore, it was discovered that the replacement machines, which used a silicone-based foam, also emitted dangerous chemicals, including formaldehyde, a known carcinogen. Although Philips argued that the new foam was safe, scientists raised concerns, prompting the Food and Drug Administration (FDA) to require further testing.

Under the consent decree, Philips is obligated to conduct additional tests on the silicone foam if the independent safety monitor deems the prior testing inadequate. The agreement also prohibits Philips from selling sleep apnea devices and other respiratory machines in the United States.

While Philips had already announced that it would no longer distribute the machines in the U.S. during negotiations with the Justice Department, it still has the ability to export devices to other countries. Within the United States, the company is permitted to sell a select group of machines deemed "medically necessary" by the FDA, but a portion of the revenue must be turned over to the government.

The consent decree asserts that Philips violated federal law by selling "adulterated" machines that did not adhere to manufacturing requirements. While the company did not admit fault, if it fails to comply with the agreement, it could face penalties of up to $20 million annually.

Notably, the recall of the faulty foam has raised concerns about the potential impact on patient health. Reports of respiratory tract illnesses, headaches, nausea, and even cancer have surfaced. The FDA has received 561 reports of deaths allegedly associated with the degraded foam since 2021, while almost 2,000 cases of cancer, 600 liver and kidney illnesses, and 17,000 respiratory ailments have been identified.

In response, Philips has asserted that the foam in the recalled devices does not cause long-term harm, despite repeated positive tests for genotoxicity, which can lead to cell mutation and potential cancer risks. Rebuilding trust with customers may prove challenging for the company, as Michael Twery, former director of sleep disorders research at the National Institutes of Health, questioned how Philips could reestablish integrity after misleading the FDA.

The consent decree is pending approval by a judge, and the FDA has refrained from providing comment until the settlement is finalized. Patient safety advocates emphasize the need for thorough assessment of the devices' impact on patient health, a process that may take years to complete.

With this development, Philips faces significant repercussions and must undertake additional testing and safety reforms to rebuild its reputation and restore its business.

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