Product News and Recalls

FDA: Philips Ventilator Foam Killed Over 100

fda releases numbers on Philips foam death tollAs patients wait for Philips to take action on the sound-deadening foam used in the manufacture of tens of thousands of ventilators and other respiratory devices, 124 have died and over 21,000 complaints of adverse reactions have been received over exposure to the substance. The Food and Drug Administration recently released the updated numbers as Philips continues to drag its feet on informing the public of how exactly it plans to handle the situation.

The data came in an updated safety communication aimed at emphasizing the importance of informing patients and their medical care providers of the issue. Philips has come under heavy fire from the agency over concerns that it hasn’t done enough to ensure patient safety and that the pace of information flowing out of the company is far too slow.

The issue comes from the deterioration of the sound-deadening foam used to quiet the machines. In April of 2021, Philips noted that the foam can break down and allow particles to enter the devices’ breathing circuits sending those particles directly into patients’ airways and lungs. Initially described as something that could cause irritation and/or aggravated asthmatic responses, the FDA’s warnings escalated earlier this year when it was noted that the particles could also be carcinogenic. The agency eventually classified the need to recall the respiratory devices as a Class I issue; a designation reserved for situations where the continued use of the device could lead to serious injury or death.

The new data from the FDA also includes a significant number of additional ailments and diseases related to the use of the devices. These include confirmed cases of cancer, pneumonia, asthma, infection, headaches, chest pain, the development of various types of nodules, and others.

While chiding the corporation for the pace of its reaction and threatening it with further investigation, the agency also continues to give Philips the benefit of the doubt and said in its report that “under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about frequency of use” could mean that not all of the 21,000 complaints that have been received thus far are tied directly to the use of the Philips device.