ProPublica
•85% Informative
Emails obtained by ProPublica and the Pittsburgh Post-Gazette show the FDA rejected Philips ' safety claims.
The FDA said it still considered the machines a significant health threat that could inflict severe injury or even death.
The emails reveal a startling lack of transparency by both Philips and the government while patients and doctors struggled to make sense of one of the largest and most tumultuous medical device recalls in years .
ProPublica and the Post-Gazette obtained internal communications from Philips .
The company announced last month it would not sell any new sleep apnea machines in the U.S. The FDA said it had received 561 reports of deaths associated with the machines since 2021 .
The dispute reached the company’s highest levels.
The devices tested positive numerous times for genotoxicity, the ability of a chemical to cause cells to mutate, company records show.
Medical experts interviewed by ProPublica and the Post-Gazette say it may take years to determine the health consequences.
The biggest challenge is conducting more comprehensive testing, they said.
VR Score
86
Informative language
84
Neutral language
69
Article tone
informal
Language
English
Language complexity
60
Offensive language
not offensive
Hate speech
not hateful
Attention-grabbing headline
not detected
Known propaganda techniques
not detected
Time-value
short-lived
External references
10
Source diversity
8
Affiliate links
no affiliate links